Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Velpatasvir 5 mg (GT 1a) | Experimental | Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 25 mg (GT 1a) | Experimental | Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 50 mg (GT 1a) | Experimental | Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 100 mg (GT 1a) | Experimental | Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 150 mg (GT 1a) | Experimental | Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velpatasvir | Drug | Tablets administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment Emergent Adverse Events | Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing). | First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing) |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose. | First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing) |
| Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline | Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo. | Baseline; Days 4, 5, 6, 7, 8, 10, and 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute HCV RNA Level | Baseline; Days 4, 5, 6, 7, 8, 10, and 17 | |
| Number of Participants Achieving Reductions From Baseline in HCV RNA | Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to < 2, ≥ 2 to < 3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials, LLC | Costa Mesa | California | 92626 | United States | ||
| Avail Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Hebner C, Gontcharova V, Chodavarapu RK, Rodriguez-Torres M, Lawitz E, Yang C, et al. Deep Sequencing of HCV NS5A From a 3-Day Study of GS-5816 Monotherapy Confirms the Potency of GS-5816 Against Pre-Existing Genotype 1-3 NS5A Resistance-Associated Variants [Abstract 470]. The Liver Meeting The 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2013 November 1-5; Washington, D.C. | ||
| Result | Lawitz E, Glass SJ, Gruener D, Freilich B, Hill JM, Link JO, et al. GS-5816, a Once-Daily NS5A Inhibitor, Demonstrates Potent Antiviral Activity in Patients with Genotype 1, 2, 3, or 4 HCV Infection in a 3-Day Monotherapy Study [Abstract 1082]. The Liver Meeting The 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2013 November 1-5; Washington, D.C. | ||
| 27353271 | Derived | Lawitz EJ, Dvory-Sobol H, Doehle BP, Worth AS, McNally J, Brainard DM, Link JO, Miller MD, Mo H. Clinical Resistance to Velpatasvir (GS-5816), a Novel Pan-Genotypic Inhibitor of the Hepatitis C Virus NS5A Protein. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5368-78. doi: 10.1128/AAC.00763-16. Print 2016 Sep. |
Not provided
Not provided
163 participants were screened. Participants were not enrolled in 'Velpatasvir up to 400 mg genotype (GT) 2' group.
Participants were enrolled at study sites in United States. The first participant was screened on 06 November 2012. The last study visit occurred on 24 January 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. |
| FG001 | Velpatasvir 5 mg | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Velpatasvir 150 mg (GT 1b) | Experimental | Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 150 mg (GT 2) | Experimental | Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 25 mg (GT 3) | Experimental | Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 50 mg (GT 3) | Experimental | Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 150 mg (GT 3) | Experimental | Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir 150 mg (GT 4) | Experimental | Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. |
|
| Velpatasvir up to 400 mg (GT 2) | Experimental | Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions. |
|
|
| Placebo | Drug | Tablets administered orally |
|
| Baseline; Days 4, 5, 6, 7, 8, 10, and 17 |
| Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected | The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. | Days 4, 5, 6, 7, and 8 |
| Plasma HCV RNA Levels by Treatment and IL28B Genotype | Days 4, 5, 6, 7, 8, 10, and 17 |
| Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf | AUCinf is defined as the concentration of drug extrapolated to infinite time. | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 |
| PK Parameter of Velpatasvir: AUCtau | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3 |
| PK Parameter of Velpatasvir: Cmax | Cmax is defined as the maximum observed plasma concentration of drug. | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose. |
| PK Parameter of Velpatasvir: CL/F | CL/F is defined as the apparent oral clearance following administration of the drug. | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose |
| PK Parameter of Velpatasvir: Ctau | Ctau is defined as the observed drug concentration at the end of the dosing interval. | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3 |
| Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints | The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs. | First dose date up to Day 17 |
| DeLand |
| Florida |
| 32720 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | United States |
| CRI Worldwide, LLC | Marlton | New Jersey | 08053 | United States |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | United States |
| New Orleans Center for Clinical Research-Knoxville | Knoxville | Tennessee | 37920 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Charles River Clinical Services Northwest, Inc. | Tacoma | Washington | 98418 | United States |
| Fundacion De Investigacion De Diego | San Juan | 00927 | Puerto Rico |
| 26183611 | Derived | Lawitz E, Freilich B, Link J, German P, Mo H, Han L, Brainard DM, McNally J, Marbury T, Rodriguez-Torres M. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015 Dec;22(12):1011-9. doi: 10.1111/jvh.12435. Epub 2015 Jul 16. |
| FG002 | Velpatasvir 25 mg | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| FG003 | Velpatasvir 50 mg | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| FG004 | Velpatasvir 100 mg | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| FG005 | Velpatasvir 150 mg | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (velpatasvir or placebo).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. |
| BG001 | Velpatasvir 5 mg | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. |
| BG002 | Velpatasvir 25 mg | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| BG003 | Velpatasvir 50 mg | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| BG004 | Velpatasvir 100 mg | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| BG005 | Velpatasvir 150 mg | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| HCV RNA (log10 IU/mL) | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV Genotype | Count of Participants | Participants | No |
| |||||||||||||||
| IL28B Genotype | Count of Participants | Participants | No |
|
| 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 Experiencing Treatment Emergent Adverse Events | Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing). | The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (velpatasvir or placebo). Data were summarized by velpatasvir or placebo. | Posted | Number | percentage of participants | First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing) |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose. | Participants in the Safety Analysis Set were analyzed. Data were summarized by dose. | Posted | Number | percentage of participants | First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing) |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline | Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo. | Participants in the Efficacy Analysis Set (all randomized participants with appropriate genotype who received at least one dose of the study drug (velpatasvir or placebo) and with at least one on-treatment HCV RNA assessment) with available data were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Days 4, 5, 6, 7, 8, 10, and 17 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute HCV RNA Level | Participants in the Efficacy Analysis Set with available data were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Days 4, 5, 6, 7, 8, 10, and 17 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Reductions From Baseline in HCV RNA | Categorical declines from baseline were summarized by the number of participants with a < 1, ≥ 1 to < 2, ≥ 2 to < 3, or ≥ 3 log10 IU/mL decrease in HCV RNA from baseline by treatment (velpatasvir dose/HCV genotype) and placebo at each collection time point through Day 17. | Participants in the Efficacy Analysis Set were analyzed. | Posted | Count of Participants | Participants | Baseline; Days 4, 5, 6, 7, 8, 10, and 17 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected | The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 25 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. | Participants in the Efficacy Analysis Set were analyzed. Data were summarized by treatment (velpatasvir dose/HCV genotype) and placebo. | Posted | Number | participants | Days 4, 5, 6, 7, and 8 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma HCV RNA Levels by Treatment and IL28B Genotype | Participants in the Efficacy Analysis Set with available data were analyzed. Data are were summarized by treatment (velpatasvir dose/HCV genotype and placebo) and IL28B genotype (CC and non-CC). Due to the small number of participants in each treatment group, no conclusions can be made on the effect of IL28B genotype on HCV RNA decline. | Posted | Mean | Standard Deviation | log10 IU/mL | Days 4, 5, 6, 7, 8, 10, and 17 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic (PK) Parameter of Velpatasvir: AUCinf | AUCinf is defined as the concentration of drug extrapolated to infinite time. | The PK analysis set included all randomized and treated participants who have evaluable PK profiles for velpatasvir. | Posted | Mean | Standard Deviation | h*ng/mL | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter of Velpatasvir: AUCtau | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | h*ng/mL | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter of Velpatasvir: Cmax | Cmax is defined as the maximum observed plasma concentration of drug. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose. |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter of Velpatasvir: CL/F | CL/F is defined as the apparent oral clearance following administration of the drug. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | mL/hr | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 1 for single dose and Day 3 for multiple dose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter of Velpatasvir: Ctau | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | ng/mL | 0 (predose), 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose at Day 3 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Associated Variants (RAVs) at Pretreatment or Postbaseline Timepoints | The full-length NS5A coding region was analyzed pretreatment (baseline) by deep sequencing using MiSeq for all 70 participants who received velpatasvir and for 8 of 17 participants who received placebo prior to and up to 2 weeks (Day 17) after dosing with velpatasvir. Participants were categorized by velpatasvir dose/HCV genotype and presence or absence of NS5A RAVs. | Participants in the efficacy analysis set who were sequenced at pre-treatment or post baseline treatment were analyzed. | Posted | Count of Participants | Participants | First dose date up to Day 17 |
|
Adverse Events: First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing); All-Cause Mortality: First dose date up to Week 48
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (velpatasvir or placebo). Data were summarized by velpatasvir and placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. | 0 | 17 | 0 | 17 | 3 | 17 |
| EG001 | Velpatasvir 5 mg | Participants with HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG002 | Velpatasvir 25 mg | Participants with HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. | 0 | 15 | 0 | 15 | 4 | 15 |
| EG003 | Velpatasvir 50 mg | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. | 0 | 12 | 0 | 12 | 1 | 12 |
| EG004 | Velpatasvir 100 mg | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG005 | Velpatasvir 150 mg | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. | 0 | 31 | 0 | 31 | 6 | 31 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000604171 | velpatasvir |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
| Not Hispanic or Latino |
|
| 1b |
|
| 2b |
|
| 3 |
|
| 3a |
|
| 4 |
|
| 4a/4c/4d |
|
| C/T |
|
| T/T |
|
| OG003 | Velpatasvir 50 mg | Participants with HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG004 | Velpatasvir 100 mg | Participants with HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| OG005 | Velpatasvir 150 mg | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
| OG003 | Velpatasvir 50 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG004 | Velpatasvir 100 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| OG005 | Velpatasvir 150 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG006 | Velpatasvir 150 mg (GT 1b) | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG007 | Velpatasvir 150 mg (GT 2) | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG008 | Velpatasvir 25 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| OG009 | Velpatasvir 50 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG010 | Velpatasvir 150 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG011 | Velpatasvir 150 mg (GT 4) | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| OG005 | Velpatasvir 150 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG006 | Velpatasvir 150 mg (GT 1b) | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG007 | Velpatasvir 150 mg (GT 2) | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG008 | Velpatasvir 25 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| OG009 | Velpatasvir 50 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG010 | Velpatasvir 150 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG011 | Velpatasvir 150 mg (GT 4) | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
| OG004 | Velpatasvir 100 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| OG005 | Velpatasvir 150 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG006 | Velpatasvir 150 mg (GT 1b) | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG007 | Velpatasvir 150 mg (GT 2) | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG008 | Velpatasvir 25 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| OG009 | Velpatasvir 50 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG010 | Velpatasvir 150 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG011 | Velpatasvir 150 mg (GT 4) | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
| OG004 | Velpatasvir 100 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| OG005 | Velpatasvir 150 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG006 | Velpatasvir 150 mg (GT 1b) | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG007 | Velpatasvir 150 mg (GT 2) | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG008 | Velpatasvir 25 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| OG009 | Velpatasvir 50 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG010 | Velpatasvir 150 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG011 | Velpatasvir 150 mg (GT 4) | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions.
| OG004 | Velpatasvir 100 mg (GT 1a) (IL28B Genotype CC) | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| OG005 | Velpatasvir 150 mg (GT 1a) (IL28B Genotype CC) | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG006 | Velpatasvir 150 mg (GT 1b) (IL28B Genotype CC) | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG007 | Velpatasvir 150 mg (GT 2) (IL28B Genotype CC) | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG008 | Velpatasvir 25 mg (GT 3) (IL28B Genotype CC) | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| OG009 | Velpatasvir 50 mg (GT 3) (IL28B Genotype CC) | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG010 | Velpatasvir 150 mg (GT 3) (IL28B Genotype CC) | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG011 | Velpatasvir 150 mg (GT 4) (IL28B Genotype CC) | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG012 | Placebo (IL28B Genotype Non-CC) | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG013 | Velpatasvir 5 mg (GT 1a) (IL28B Genotype Non-CC) | Participants with GT 1a HCV infection received velpatasvir 5 mg once daily for 3 days under fasted conditions. |
| OG014 | Velpatasvir 25 mg (GT 1a) (IL28B Genotype Non-CC) | Participants with GT 1a HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| OG015 | Velpatasvir 50 mg (GT 1a) (IL28B Genotype Non-CC) | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG016 | Velpatasvir 100 mg (GT 1a) (IL28B Genotype Non-CC) | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| OG017 | Velpatasvir 150 mg (GT 1a) (IL28B Genotype Non-CC) | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG018 | Velpatasvir 150 mg (GT 1b) (IL28B Genotype Non-CC) | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG019 | Velpatasvir 150 mg (GT 2) (IL28B Genotype Non-CC) | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG020 | Velpatasvir 25 mg (GT 3) (IL28B Genotype Non-CC) | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| OG021 | Velpatasvir 50 mg (GT 3) (IL28B Genotype Non-CC) | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG022 | Velpatasvir 150 mg (GT 3) (IL28B Genotype Non-CC) | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG023 | Velpatasvir 150 mg (GT 4) (IL28B Genotype Non-CC) | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
| OG004 | Velpatasvir 150 mg | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
| OG004 | Velpatasvir 150 mg | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
| OG004 | Velpatasvir 150 mg | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
| OG004 | Velpatasvir 150 mg | Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
| OG004 |
| Velpatasvir 150 mg |
Participants with HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
| OG003 | Velpatasvir 50 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG004 | Velpatasvir 100 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 100 mg once daily for 3 days under fasted conditions. |
| OG005 | Velpatasvir 150 mg (GT 1a) | Participants with GT 1a HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG006 | Velpatasvir 150 mg (GT 1b) | Participants with GT 1b HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG007 | Velpatasvir 150 mg (GT 2) | Participants with GT 2 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG008 | Velpatasvir 25 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 25 mg once daily for 3 days under fasted conditions. |
| OG009 | Velpatasvir 50 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 50 mg once daily for 3 days under fasted conditions. |
| OG010 | Velpatasvir 150 mg (GT 3) | Participants with GT 3 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
| OG011 | Velpatasvir 150 mg (GT 4) | Participants with GT 4 HCV infection received velpatasvir 150 mg once daily for 3 days under fasted conditions. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| < 1 log10 IU/mL decrease in HCV RNA |
|
| ≥1 and <2 log10 IU/mL decrease in HCV RNA |
|
| ≥2 and <3 log10 IU/mL decrease in HCV RNA |
|
| ≥3 log10 IU/mL decrease in HCV RNA |
|
| < 1 log10 IU/mL decrease in HCV RNA |
|
| ≥1 and <2 log10 IU/mL decrease in HCV RNA |
|
| ≥2 and <3 log10 IU/mL decrease in HCV RNA |
|
| ≥3 log10 IU/mL decrease in HCV RNA |
|
| < 1 log10 IU/mL decrease in HCV RNA |
|
| ≥1 and <2 log10 IU/mL decrease in HCV RNA |
|
| ≥2 and <3 log10 IU/mL decrease in HCV RNA |
|
| ≥3 log10 IU/mL decrease in HCV RNA |
|
| < 1 log10 IU/mL decrease in HCV RNA |
|
| ≥1 and <2 log10 IU/mL decrease in HCV RNA |
|
| ≥2 and <3 log10 IU/mL decrease in HCV RNA |
|
| ≥3 log10 IU/mL decrease in HCV RNA |
|
| < 1 log10 IU/mL decrease in HCV RNA |
|
| ≥1 and <2 log10 IU/mL decrease in HCV RNA |
|
| ≥2 and <3 log10 IU/mL decrease in HCV RNA |
|
| ≥3 log10 IU/mL decrease in HCV RNA |
|
| < 1 log10 IU/mL decrease in HCV RNA |
|
| ≥1 and <2 log10 IU/mL decrease in HCV RNA |
|
| ≥2 and <3 log10 IU/mL decrease in HCV RNA |
|
| ≥3 log10 IU/mL decrease in HCV RNA |
|
|
|
|
|
|
|