A Study to Assess the Safety, Tolerability and Efficacy o... | NCT01479868

NCT01479868

ID	Type	Description	Link
TMC435-TiDP16-C212	Other Identifier	Janssen Research & Development, LLC

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TMC435 + pegylated interferon alpha-2a + ribavirin	Experimental	Patients will be administered TMC435 150 mg along with pegylated interferon alpha-2a 180 microgram and ribavirin 1000 or 1200 mg for 12 weeks. Pegylated interferon alpha-2a and ribavirin will only be continued until 24 to 48 weeks.	Drug: TMC435 Drug: Pegylated interferon alpha-2a Drug: Ribavirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TMC435	Drug	TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.	TMC435 + pegylated interferon alpha-2a + ribavirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)	The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment.	12 weeks after end of treatment (Week 24 or 48)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)	The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.	24 weeks after end of treatment (Week 24 or 48)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26753774	Derived	Andersohn F, Claes AK, Kulp W, Mahlich J, Rockstroh JK. Simeprevir with pegylated interferon alfa 2a plus ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a meta-analysis and historical comparison. BMC Infect Dis. 2016 Jan 11;16:10. doi: 10.1186/s12879-015-1311-3.
26743093	Derived

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG000106 subjectsRestricted to subject who received at least one dose of treatment (TMC435/RBV/PegIFN).

Analysis population included all participants who received at least 1 dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	OG00073.6(65.1 to 82.1)

Secondary

Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)

The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.

The ITT population included all perticipants who had at least 1 dose of study drug.

Posted

Number

percentage of participants

24 weeks after end of treatment (Week 24 or 48)

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants

Secondary

Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable

Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.

ITT population included all participants who had at least 1 dose of study drug. Here, "N" (number of participants analyzed) is the number of participants analyzed for this outcome measure, "n" is the number of participants analyzed for this outcome measure at specific time points.

Posted

Number

percentage of participants

Week 4, 12, 24, 36, and 48

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants

Secondary

Percentage of Participants With On-treatment Failure

Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.

The ITT population included all participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 1 to 48

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Viral Breakthrough

Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.

The ITT population included all participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 1 to 48

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants

Secondary

Percentage of Participants With Viral Relapse

Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.

The ITT population included all participants who received at least 1 dose of study drug. Here, "N" (number of participants analyzed) is the number of participants analyzed for this outcome measure.

Posted

Number

percentage of participants

Week 1 to 72

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants

Secondary

Percentage of Participants With Normalized Alanine Aminotransferase Levels

Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.

The ITT population included all participants who received at least 1 dose of study drug. Here "N" signifies participants evaluable for this measure.

Posted

Number

percentage of participants

Baseline up to Week 72

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants	OG000

Secondary

Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure

Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.

Participants who received potent anti-HIV treatment with a combination of more than 3 anti-antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed.

Posted

Number

percentage of participants

Baseline to Week 72.

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load

Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here "n" signifies participants evaluable for this measure at specified time point.

Posted

Mean

Standard Deviation

copies per milliliter

Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in CD4+ Cell Count

Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, "n" is the number of participants analyzed for this outcome measure at spcific time points.

Posted

Mean

Standard Deviation

cell counts per microliter

Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4+ Cell Count in Percentage

Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, "n" is the number of participants analyzed for this outcome measure at spcific time points.

Posted

Mean

Standard Deviation

percentage of lymphocyte

Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.

Safety population included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Week 1 to Week 72

ID	Title	Description
OG000	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.

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	TMC435 150mg 12Wks PR24/48	Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.			11	106	103	106

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0002 affected106 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Mental status changes	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Psychotic disorder	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
General physical health deterioration	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Catheter site infection	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0001 affected106 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00048 affected106 at risk
Influenza like illness	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00025 affected106 at risk
Asthenia	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00024 affected106 at risk
Pyrexia	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00012 affected106 at risk
Chills	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0009 affected106 at risk
Injection site reaction	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0008 affected106 at risk
Pain	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0007 affected106 at risk
Injection site erythema	General disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0006 affected106 at risk
Insomnia	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00027 affected106 at risk
Mood altered	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00020 affected106 at risk
Depression	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00019 affected106 at risk
Anxiety	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00013 affected106 at risk
Sleep disorder	Psychiatric disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0006 affected106 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00031 affected106 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00025 affected106 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00014 affected106 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00012 affected106 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00033 affected106 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00030 affected106 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0006 affected106 at risk
Headache	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00035 affected106 at risk
Dizziness	Nervous system disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00013 affected106 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00019 affected106 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00016 affected106 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0008 affected106 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0007 affected106 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0007 affected106 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00017 affected106 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00015 affected106 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0008 affected106 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0006 affected106 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00011 affected106 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00010 affected106 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Non-systematic Assessment	EG0009 affected106 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 14.1	Non-systematic Assessment	EG00021 affected106 at risk
Weight decreased	Investigations	MedDRA Version 14.1	Non-systematic Assessment	EG00013 affected106 at risk
Neutrophil count decreased	Investigations	MedDRA Version 14.1	Non-systematic Assessment	EG0006 affected106 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment	EG0007 affected106 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 14.1	Non-systematic Assessment	EG0007 affected106 at risk

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
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
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D000069616	Simeprevir
C100416	peginterferon alfa-2a
D012254	Ribavirin

Ancestor Terms

ID	Term
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California		United States