Regimen Switch to Dolutegravir + Rilpivirine From Current... | NCT02429791

ID	Type	Description	Link
2014-005147-40	EudraCT Number

Name	Class
Janssen Pharmaceuticals	INDUSTRY
GlaxoSmithKline	INDUSTRY

Label	Type	Description	Intervention Names
Current antiretroviral regimen (CAR)	Active Comparator	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.	Drug: CAR
DTG + RPV	Experimental	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).	Drug: DTG 50 mg Drug: RPV 25 mg

Name	Type	Description	Arm Group Labels	Other Names
DTG 50 mg	Drug	Participants received one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid.

Measure	Description	Time Frame
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm	Percentage of participants with plasma HIV 1 RNA <50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.	Week 48

Measure	Description	Time Frame
Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Measure	Description	Time Frame
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have been able to understand and comply with protocol requirements, instructions, and restrictions.
Participants must have been likely to complete the study as planned.
Participants must have been considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country, etc.).
HIV-1 infected men or women of greater than or equal to (>=)18 years of age.
Must have been on uninterrupted current regimen (either the initial or second combination antiretroviral therapy [cART] regimen) for at least 6 months prior to screening; Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification. Acceptable stable cART regimens prior to screening include 2 NRTIs plus INI (either the initial or second cART regimen), or an NNRTI (either the initial or second cART regimen), or a Boosted PI (or atazanavir unboosted) (either the initial or second PI-based cART regimen).
Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening;
Plasma HIV-1 RNA <50 c/mL at Screening;
A female may have been eligible to enter and participate in the study if she was of : Non-child-bearing potential either defined as post-menopausal (12 months of spontaneous amenorrhea and >=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, Child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: Complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for at least 2 weeks after discontinuation of all study medications and completion of the Follow-up visit; Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion); Male partner sterilization with documentation of azoospermia prior to the female participant's entry into the study and this male is the sole partner for that participant; The documentation on male sterility could come from the site personnel's review of participant's medical records, medical examination, and/or semen analysis, or medical history interview provided by her or her partner; Approved hormonal contraception for participants randomly assigned to DTG + RPV arm (and for participants randomly assigned to CAR following switch to DTG + RPV at Week 52) or approved hormonal contraception plus a barrier method for participants assigned to CAR through Week 52; Approved hormonal contraception included: Combined estrogen and progestogen oral contraceptive, Contraceptive subdermal implant, Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches. Any other method with published data showing that the expected failure rate is <1% per year. Any contraception method must have been used consistently, in accordance with the approved product label during treatment with study drug and for at least 2 weeks after discontinuation of study drug and completion of the Follow-Up Visit. The investigator was responsible for ensuring that participants understand how to properly use these methods of contraception. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception.
Participants who were willing and able to understand requirements of study participation and provided signed and dated written informed consent prior to screening.
For participants enrolled in France: participants were eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

Exclusionary Criteria prior to screening or Day 1:

Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement >=50 c/mL.
Within the 6 to 12 month window prior to screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL.
Within the 6 to 12 month window prior to screening and after confirmed suppression to <50 c/mL, 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
Any drug holiday during the window between initiating first HIV ART and 6 months prior to screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
Any switch to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement >=400 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen).

Exclusionary medical conditions:

Women who were pregnant, breastfeeding or planned to become pregnant or breastfeed during the study.
Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions included cutaneous Kaposi's sarcoma not requiring systemic therapy and historic CD4+ lymphocyte counts of <200 cells per cubic millimeter (cells/mm^3).
Participants with severe hepatic impairment (Class C) as determined by Child-Pugh Classification.
Unstable liver disease (as defined by the presence of any of the following: ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), and Hepatitis B surface antibody (HBsAb) as follows: Participants positive for HBsAg were excluded; Participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb were excluded.
Participants with an anticipated need for any Hepatitis C virus (HCV) therapy during the Early Switch Phase and for interferon-based therapy for HCV throughout the entire study period.
History or presence of allergy to the study drugs or their components or drugs of their class;
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization;
Participants who in the investigator's judgment posed a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should have been considered when evaluating for suicide risk;
Any pre-existing physical or mental condition which, in the opinion of the Investigator, could have interfered with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which could have compromised the safety of the participants;
Any condition which, in the opinion of the Investigator, could have interfered with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication;

Exclusionary Treatments prior to Screening or Day 1:

Use of medications which were associated with Torsades de Pointes.
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses.
Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study.
Participants who were participating or anticipated to be selected to participate in any other interventional study, with the exception of the DEXA sub-study 202094, after randomization
A history of use of any regimen consisting of only single NNRTI therapy (even if only for peri-partum treatment), or only single or dual NRTI therapy prior to starting cART.
Current or prior history of etravirine (ETR) use.
Current use of tipranavir/ritonavir or fosamprenavir/ritonavir.
Participants receiving any prohibited medication and who were unwilling or unable to switch to an alternate medication.

Exclusionary Laboratory Values or Clinical Assessments at Screening:

Evidence of viral resistance based on the presence of any resistance associated major PI, INI, NRTI, or NNRTI mutation and integrase (IN) resistance associated substitution R263K in any available prior resistance genotype assay results.
Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test was allowed during the Screening period to verify a result.
Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
Alanine aminotransferase (ALT) >=5 × upper limit of normal (ULN), or ALT >=3 × ULN and bilirubin >=1.5 × ULN (with greater than [>] 35% direct bilirubin).
Corrected QT interval (QTc [Bazett]) >450 milliseconds or QTc (Bazett) >480 milliseconds for participants with bundle branch block. The QTc was the QT interval corrected for heart rate according to Bazett's formula (QTcB).

Name	Affiliation	Role
GSK Clinical Trials	ViiV Healthcare	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Long Beach	California	90813	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
29310899	Background	Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6.
31307948

ID	Title	Description
FG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm

Percentage of participants with plasma HIV 1 RNA <50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.

Plasma samples were collected for quantitative analysis of HIV-1 RNA.

The analysis was performed on the Intent-to-Treat Exposed (ITT-E) population which consisted of all randomly assigned participants who received at least one dose of study drug.

Posted

Number

Percentage of participants

Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Units	Counts
Participants	OG000252 OG001256

Title

Denominators

Categories

Title	Measurements
	OG00095 OG00196

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Risk Difference (RD)	-0.6			2-Sided	95	-4.3	3.0			Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INI).		Non-Inferiority	Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.

Secondary

Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48

Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.

ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Cells per millimeter cube (mm^3)

At Weeks 24 and 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG + RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.

ITT-E Population

Posted

Number

Percentage of participants

Week 24

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize participant or may require medical or surgical intervention were categorized as SAE. AEs were graded as per Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Common AEs were those with >5% incidence for either treatment.

Safety Population included all randomized participants who have received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to Week 411 or study discontinuation

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Secondary

Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks

Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-Baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.

Safety Population

Posted

Count of Participants

Participants

Up to 48 weeks

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)

Secondary

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks

Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-Baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.

Safety Population

Posted

Count of Participants

Participants

Up to 48 weeks

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)

Secondary

Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mg/ Liter (L)

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Cystatin C at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mg/L

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in D-Dimer at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Nanomole/L fibrinogen equivalent units

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble Cluster Designation (CD)14 at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble cluster designation (CD)14. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Nanogram/milliliter

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Microgram (µg)/Liter

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mg/deciliter (dL)

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Urine Phosphate at Week 48

Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Millimoles (mmol)/ L

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Nanomoles/ L

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48

Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Grams (g)/ mol

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type I Collagen C-Telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

µg/ L

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)

Secondary

Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time point were analyzed.

Posted

Mean

Standard Deviation

Nanograms (ng)/ L

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48

Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR) index, the product of basal glucose and insulin levels divided by 22.5 (1,2), is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

HOMA-IR Score

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48

Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol/ L

At Week 24 and at Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Genotypic Resistance- Early Switch Phase

Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine [RPV], Dolutegravir [DTG], Emtricitabine [FTC], Tenofovir [TDF], Darunavir/r [DRV/r]) in participants Meeting CVW Criteria has been presented.

The analysis was performed on the Confirmed Virologic Withdrawal (CVW) resistance population which was comprised of all participants in the ITT-E Population who met confirmed CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion was met.

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Genotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase

Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir [EVG], Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine [NVP], RPV, Lamivudine [3TC], Abacavir [ABC], FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/r [ATV/r], DRV/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]) in participants Meeting CVW Criteria has been presented.

CVW resistance Population

Posted

Count of Participants

Participants

Up to Week 148

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Units	Counts
Participants

Secondary

Number of Participants With Genotypic Resistance-CAR Group Through Late Switch Phase

Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.

The analysis was performed on the Late Switch (LS) CVW resistance Population which was comprised of all participants in the LS-ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion was met. Only those participants with data available at the specified time point were analyzed.

Posted

Count of Participants

Participants

Post-Late switch (LS) Baseline (Week 52) up to Week 148

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Phenotypic Resistance-Early Switch Phase

Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.

CVW resistance Population

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Early and Late Switch Phase

Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.

CVW resistance Population

Posted

Count of Participants

Participants

Up to Week 148

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Phenotypic Resistance-CAR Group Through Late Switch Phase

Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.

LS CVW resistance Population. Only those participants with data available at the specified time point were analyzed.

Posted

Count of Participants

Participants

Post-LS Baseline (Week 52) up to Week 148

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Units	Counts
Participants

Secondary

Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Group Through Early and Late Switch Phase

Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76, and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early + late switch phase.

The analysis was performed on the Pharmacokinetic (PK) Parameter Population which consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

µg/L

Pre-dose at Week 4, 24, 48, 56, 76 and 100

ID	Title	Description
OG000	DTG 50 mg	Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
OG001	RPV 25 mg	Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.

Units	Counts

Secondary

Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Group Through Late Switch Phase

Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76, and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase.

The analysis was performed on the LS PK Parameter Population which was comprised of all participants who were randomized to CAR and received DTG + RPV in the Late Switch Phase and provided at least one evaluable estimate of Pre-dose concentration. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

µg/L

Pre-dose at Weeks 56, 76 and 100

ID	Title	Description
OG000	CAR-DTG 50 mg	Participants from CAR arm received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.
OG001	CAR-RPV 25 mg	Participants from CAR arm received DTG 50 mg +RPV 25 mg together once daily, with a meal, in an open-label fashion from Week 52 to Week 148 during late switch phase.

Units

Secondary

Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV

Two blood samples were collected pre-dose for DTG and RPV at Weeks 2,4 and 8 only for the first 20 participants who switch from EFV or NVP to DTG + RPV. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV.

The analysis was performed on the PK Parameter NNRTI Subset Extra Sampling Population which consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2,4 and 8. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

µg/L

Pre-dose at Week 2, 4 and 8

ID	Title	Description
OG000	DTG 50 mg	Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.
OG001	RPV 25 mg	Participants received DTG 50 mg + RPV 25 mg together once daily, with a meal, in an open-label fashion up to Week 52 during early switch phase.

Units	Counts

Secondary

Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy of DTG +RPV compared to continuation of CAR. Plasma samples were collected for quantitative analysis of HIV-1 RNA. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class and age group.

ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Number

Percentage of participants

Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class

Blood samples were collected for CD4 cell count assessment by flow cytometry was carried out to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Value at Day 1 was considered as Baseline. Change from Baseline was calculated as value at indicated time point minus Baseline value.

ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Cells per mm^3

At Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INI, NNRTI, or PI) was summarized. AEs were graded as per DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Count of Participants

Participants

Up to 48 weeks

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class

Blood samples were collected to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value at Day 1 was considered as Baseline. Number of participants who experienced maximum toxicity grade post-Baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INI, NNRTI, PI) was summarized. Clinical chemistry toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Count of Participants

Participants

Up to 48 weeks

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)

Secondary

Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class

Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Value at Day 1 was considered as Baseline. Number of participants who experienced maximum toxicity grade post-Baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Count of Participants

Participants

Up to 48 weeks

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)

Secondary

Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class

For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.

CVW resistance Population

Posted

Up to Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)

Secondary

Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class

For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.

CVW resistance Population

Posted

Up to Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)

Secondary

Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class

Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.

Safety Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

mmol/mL

At Week 24 and at Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
OG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase

Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. Symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. Day 1 was considered as Baseline value.

ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

At Week 4, Week 24 and Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Secondary

Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Group Through Early and Late Switch Phase

LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. Day 1 was considered as Baseline value.

ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

At Week 56, Week 76, Week 100 and Week 148

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Secondary

Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase

Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. Symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value. Value at Week 48 was considered as LS Baseline value.

LS ITT-E Population comprised of all participants randomized to CAR who received at least one dose of study treatment at or after the Week 52 Switch visit. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

At Week 56, Week 76, Week 100 and Week 148

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase

HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.

ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Median

Full Range

Scores on a scale

At Week 4, Week 24 and Week 48

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Secondary

Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Group Through Early and Late Switch Phase

ITT-E Population

Posted

Median

Full Range

Scores on a scale

At Week 56, Week 76, Week 100 and Week 148

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Secondary

Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Group Through Late Switch Phase

HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Week 48 was considered as LS Baseline value. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.

LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Median

Full Range

Scores on a scale

At Week 56, Week 76, Week 100 and Week 148

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Other Pre-specified

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Group Through Early and Late Switch Phase

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.

ITT-E Population

Posted

Number

Percentage of participants

At Weeks 100 and 148

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Units	Counts
Participants	OG000

Other Pre-specified

Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Group Through Early and Late Switch Phase

Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value.

ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Cells/mm^3

At Weeks 100 and 148

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Units	Counts
Participants	OG000

Other Pre-specified

Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Group Through Late Switch Phase

LS ITT-E Population

Posted

Number

Percentage of participants

At Weeks 100 and 148

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Units	Counts
Participants

Other Pre-specified

Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Group Through Late Switch Phase

Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.

LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.

Posted

Mean

Standard Deviation

Cells/mm^3

At Weeks 100 and 148

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Units	Counts
Participants

Secondary

Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase

For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were collected at Day 1. Number of participants with genotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI, INI, PI) were summarized.

The analysis was performed on the CVW Resistance population.

Posted

Count of Participants

Participants

Up to Week 411

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Units	Counts
Participants

Secondary

Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class-DTG+RPV Group Through Continuation Phase

For all participants who met virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were collected at Day 1. Number of participants with phenotypic resistance to DTG or RPV for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (NNRTI, INI, PI) were summarized.

The analysis was performed on the CVW Resistance population.

Posted

Count of Participants

Participants

Up to Week 411

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Units	Counts
Participants

Secondary

Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase

For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were analyzed in an attempt to obtain genotype data on as many samples as possible. Number of participants with genotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (INI) were summarized.

The analysis was to be performed on the Late Switch CVW Resistance population.

Posted

Count of Participants

Participants

Week 52 to Week 411

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class- CAR Group Through Continuation Phase

For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were analyzed in an attempt to obtain phenotype data on as many samples as possible. Number of participants with phenotypic resistance to CAR for those meeting virologic withdrawal criteria in subgroups, stratified based on baseline third agent treatment class (INI) were summarized.

The analysis was performed on the Late Switch CVW resistance population.

Posted

Count of Participants

Participants

Week 52 to Week 411

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Genotypic Resistance-DTG+RPV Group Through Continuation Phase

Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA >=50 c/mL and current plasma HIV-1 RNA >= 200 c/mL) to evaluate any potential genotypic evolution of resistance. Genotypic resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.

The analysis was performed on the CVW Resistance population which included all participants from the Intent-to-Treat Exposed (ITT-E) population who met CVW through the end of the visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.

Posted

Count of Participants

Participants

Up to Week 411

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Units	Counts
Participants

Secondary

Number of Participants With Phenotypic Resistance-DTG+RPV Group Through Continuation Phase

Plasma samples were collected for participants meeting the CVW criteria (previous plasma HIV-1 RNA >=50 c/mL and current plasma HIV-1 RNA >= 200 c/mL) to evaluate any potential phenotypic evolution of resistance. Phenotypic resistance data for the following drugs was presented: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r.

The analysis was performed on the CVW Resistance population which included all participants from the ITT-E population who met CVW through the end of the visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.

Posted

Count of Participants

Participants

Up to Week 411

ID	Title	Description
OG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).

Units	Counts
Participants

Secondary

Number of Participants With Genotypic Resistance-CAR Group Through Continuation Phase

The analysis was performed on the Late Switch CVW resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment genotypic resistance data at the time the CVW criterion was met.

Posted

Count of Participants

Participants

Week 52 to Week 411

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Secondary

Number of Participants With Phenotypic Resistance- CAR Group Through Continuation Phase

The analysis was performed on the Late Switch CVW Resistance population which included all participants from the Late Switch ITT-E population who met CVW through the end of visit window and had available on-treatment phenotypic resistance data at the time the CVW criterion was met.

Posted

Count of Participants

Participants

Week 52 to Week 411

ID	Title	Description
OG000	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DTG + RPV (Early Switch)	Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase.	0	252	10	252	107	252
EG001	CAR (Early Switch)	Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase.	1	256	13	256	102	256
EG002	DTG + RPV (Early + Late Switch)	Participants received DTG 50 mg + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase.	1	252	34	252	167	252
EG003	CAR (Late Switch)	Participants continued to receive their current antiretroviral regimen (two NRTIs + a third agent). A third agent included either an: INSTI, NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants who received CAR during the early switch phase, with HIV-1 RNA <50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed until Week 148.	0	238	22	238	134	238
EG004	DTG + RPV (Continuation Phase)	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).	0	186	6	186	0	186
EG005	CAR (Continuation Phase)	Participants continued to receive their CAR (NRTIs + a third agent). A third agent included either an: INSTI, a NNRTI or a PI. CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with HIV-1 RNA <50 c/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.	0	183	9	183	0	183

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hepatitis A	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0023 events3 affected252 at risk EG0033 events3 affected238 at risk EG0040 events0 affected186 at risk EG0050 events0 affected183 at risk
Suicide attempt	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0021 events1 affected252 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Hodgkin's disease mixed cellularity stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Plasmablastic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Acute hepatitis B	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Hepatitis C	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Pleural neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Rectal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Shigella infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Staphylococcal osteomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Testicular germ cell tumour mixed	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Thyroglossal cyst infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Thyroid mass	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Toxic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0011 events1 affected256 at risk EG0020 events0 affected252 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0021 events1 affected252 at risk EG003
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
COVID-19	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Septic shock	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Wound infection staphylococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Penile contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Cholelithiasis obstructive	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected252 at risk EG0010 events0 affected256 at risk EG0020 events0 affected252 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00033 events27 affected252 at risk EG00135 events31 affected256 at risk EG00284 events52 affected252 at risk EG00355 events39 affected238 at risk EG0040 events0 affected186 at risk EG0050 events0 affected183 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00025 events24 affected252 at risk EG00119 events17 affected256 at risk EG00243 events37 affected252 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00024 events22 affected252 at risk EG00118 events17 affected256 at risk EG00238 events35 affected252 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0009 events8 affected252 at risk EG00120 events19 affected256 at risk EG00228 events25 affected252 at risk EG003
Syphilis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00010 events8 affected252 at risk EG0017 events7 affected256 at risk EG00239 events27 affected252 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 events7 affected252 at risk EG00111 events10 affected256 at risk EG00232 events26 affected252 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected252 at risk EG0016 events6 affected256 at risk EG00220 events18 affected252 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected252 at risk EG0016 events5 affected256 at risk EG00219 events18 affected252 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 events8 affected252 at risk EG0015 events4 affected256 at risk EG00217 events14 affected252 at risk EG003
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected252 at risk EG00113 events12 affected256 at risk EG00212 events12 affected252 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected252 at risk EG0015 events4 affected256 at risk EG00219 events16 affected252 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected252 at risk EG0019 events9 affected256 at risk EG00210 events10 affected252 at risk EG003
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected252 at risk EG0012 events2 affected256 at risk EG00218 events17 affected252 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected252 at risk EG0013 events3 affected256 at risk EG00214 events13 affected252 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected252 at risk EG0012 events2 affected256 at risk EG00213 events13 affected252 at risk EG003

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D018986	Motor Vehicles
D014186	Transportation
D013676	Technology, Industry, and Agriculture

ID	Title	Description
BG000	DTG + RPV	Participants received DTG 50 mg + RPV 25 mg together, once daily, at approximately the same time, with a meal, in an open-label fashion up to Week 52, during the Early Switch Phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148).
BG001	Current Antiretroviral Regimen (CAR)	Participants continued to receive their CAR (two nucleoside reverse transcriptase inhibitors [NRTIs] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during the Early Switch Phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) less than (<) 50 copies (c)/mL, switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148.
BG002	Total	Total of all reporting groups