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The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (GT 1a, Cohort 1) | Placebo Comparator | Participants with genotype (GT) 1a HCV infection will receive placebo once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 50 mg (GT 1a, Cohort 1) | Experimental | Participants with GT 1a HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 100 mg (GT 1a, Cohort 1) | Experimental | Participants with GT 1a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 300 mg (GT 1a, Cohort 1) | Experimental | Participants with GT 1a HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
|
| Placebo (GT 3, Cohort 2) | Placebo Comparator | Participants with GT 3 HCV infection will receive placebo once daily for 3 days under fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voxilaprevir | Drug | Voxilaprevir tablets administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment Emergent Adverse Events | First dose date up to Day 3 plus 30 days | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant. | First dose date up to Day 3 plus 30 days |
| Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA | The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo. | Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48 | The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). | Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48 |
| Antiviral Activity of Voxilaprevir as Measured by Number of Participants Achieving Reductions From Baseline in HCV RNA |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Costa Mesa | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Rodriguez-Torres M, Glass S, Hill J, Freilich B, Hassman D, Di Bisceglie A, Taylor J, Kirby B, Yang J, An D, Stamm L, Brainard D, Kim S, Krefetz D, Smith W, Marbury T, Lawitz E. The Pangenotypic NS3/4A Protease Inhibitor GS-9857 Demonstrates Potent Antiviral Activity in Patients Infected With HCV Genotype 1, 2, 3, or 4 in a 3-Day Monotherapy Study [Poster P0901]. Presented at the European Association for the Study of the Liver (EASL) 50th International Liver Congress 2015, April 22-26, 2015, Vienna, Austria. | ||
| 29063860 | Result | Lawitz E, Yang JC, Stamm LM, Taylor JG, Cheng G, Brainard DM, Miller MD, Mo H, Dvory-Sobol H. Characterization of HCV resistance from a 3-day monotherapy study of voxilaprevir, a novel pangenotypic NS3/4A protease inhibitor. Antivir Ther. 2018;23(4):325-334. doi: 10.3851/IMP3202. |
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Participants were enrolled in Cohorts 1, 2, 3, 4, 5, 6 and 10. Cohorts 7, 8, and 9 were not conducted.
Participants were enrolled at study sites in United States and Puerto Rico. The first participant was screened on 13 June 2014. The last study visit occurred on 28 September 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3. |
| FG001 | Voxilaprevir 50 mg | Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Voxilaprevir 50 mg (GT 3, Cohort 2) | Experimental | Participants with GT 3 HCV infection will receive voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 100 mg (GT 3, Cohort 2) | Experimental | Participants with GT 3 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 300 mg (GT 3, Cohort 2) | Experimental | Participants with GT 3 HCV infection will receive voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
|
| Placebo (GT 2, Cohort 3) | Placebo Comparator | Participants with GT 2 HCV infection will receive placebo once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 100 mg (GT 2, Cohort 3) | Experimental | Participants with GT 2 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 100 mg (GT 4, Cohort 4) | Experimental | Participants with GT 4 HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 100 mg (GT 1b, Cohort 5) | Experimental | Participants with GT 1b HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
|
| Voxilaprevir 100 mg Fed (GT 3a, Cohort 6) | Experimental | Participants with GT 3a HCV infection will receive voxilaprevir 100 mg once daily for 3 days under fed conditions. |
|
| Voxilaprevir 600 mg (Cohorts 7-9) | Experimental | Participants with genotypes 1a, 1b, 2, 3, or 4 HCV infection will receive voxilaprevir up to 600 mg under fasted or fed conditions for 3 days. |
|
| Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 1, Cohort 10) | Experimental | Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 after moderate fat meal and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC)on Days 2 and 3 after either a light or moderate-fat meal. |
|
| Voxilaprevir 100 mg + SOF/VEL 400/100 mg (Group 2, Cohort 10) | Experimental | Participants with any GT HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. |
|
|
| Placebo to match voxilaprevir | Drug | Placebo to match voxilaprevir tablets administered orally once daily |
|
| SOF/VEL | Drug | 400 mg/100 mg FDC tablet administered orally once daily |
|
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 to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). |
| Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48 |
| Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND) | The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). | Days 4, 5, 6, 7, 8, 10, and Week 48 |
| DeLand |
| Florida |
| United States |
| Orlando | Florida | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Berlin | New Jersey | United States |
| Marlton | New Jersey | United States |
| Philadelphia | Pennsylvania | United States |
| Knoxville | Tennessee | United States |
| San Antonio | Texas | United States |
| San Juan | Puerto Rico |
| FG002 | Voxilaprevir 100 mg | Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. |
| FG003 | Voxilaprevir 300 mg | Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. |
| FG004 | Voxilaprevir 100 mg Fed | Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. |
| FG005 | Voxilaprevir 100 mg + SOF/VEL 400/100 mg | Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus sofosbuvir (SOF)/velpatasvir (VEL) (400/100 mg) fixed-dose combination (FDC) on Days 2 and 3 after moderate fat or light meal. This arm was part of cohort 10. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants with HCV infection received placebo once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2 and 3. |
| BG001 | Voxilaprevir 50 mg | Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. |
| BG002 | Voxilaprevir 100 mg | Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. |
| BG003 | Voxilaprevir 300 mg | Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. |
| BG004 | Voxilaprevir 100 mg Fed | Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. |
| BG005 | Voxilaprevir 100 mg + SOF/VEL 400/100 mg | Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10. |
| 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 Genotype | Count of Participants | Participants | No |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | 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 | The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug (voxilaprevir or placebo). Data were summarized by dose. | Posted | Number | percentage of participants | First dose date up to Day 3 plus 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. The most severe graded abnormality from all tests was counted for each participant. | Participants in the Safety Analysis Set were analyzed. Data were summarized by dose. | Posted | Number | percentage of participants | First dose date up to Day 3 plus 30 days |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Antiviral Activity of Voxilaprevir as Measured by Change From Baseline in Plasma HCV RNA | The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). Data are summarized by treatment/cohort and placebo. | The Efficacy Analysis Set included all enrolled participants with appropriate genotype who received at least one dose of the study drug (voxilaprevir or placebo) and with at least one on-treatment HCV RNA assessment. Participants in the Efficacy Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Antiviral Activity of Voxilaprevir as Measured by Absolute HCV RNA Level Through Week 48 | The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). | Participants in the Efficacy Analysis Set with available data were analyzed. Data are summarized by treatment/cohort and placebo. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline (Pre Day 1 Dose); Days 4, 5, 6, 7, 8, 10, and Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Antiviral Activity of Voxilaprevir as Measured by 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 to each postdose assessment up to Week 48 by treatment/cohort and placebo. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). | Participants in the Efficacy Analysis Set were analyzed. | Posted | Count of Participants | Participants | Baseline; Days 4, 5, 6, 7, 8, 10, and Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Have HCV RNA < Lower Limit of Quantitation (LLOQ) Detected, and < LLOQ Target Not Detected (TND) | The lower limit of quantitation (LLOQ) detection for HCV RNA levels was 15 IU/mL. HCV detected means calculated HCV RNA level is below LLOQ of the assay. The outcome measure was assessed to evaluate antiviral activity of voxilaprevir only (cohorts 1 through 6). | Participants in the Efficacy Analysis Set were analyzed. Data are summarized by treatment/cohort and placebo. | Posted | Number | participants | Days 4, 5, 6, 7, 8, 10, and Week 48 |
|
Adverse Events: First dose date up to Day 3 plus 30 days; 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 (voxilaprevir or placebo). Data were summarized by dose.
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| 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. This arm was part of cohorts 1, 2, and 3. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG001 | Voxilaprevir 50 mg | Participants with HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. | 0 | 14 | 0 | 14 | 2 | 14 |
| EG002 | Voxilaprevir 100 mg | Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. | 0 | 30 | 0 | 30 | 2 | 30 |
| EG003 | Voxilaprevir 300 mg | Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. | 0 | 15 | 0 | 15 | 2 | 15 |
| EG004 | Voxilaprevir 100 mg Fed | Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. | 0 | 6 | 1 | 6 | 1 | 6 |
| EG005 | Voxilaprevir 100 mg + SOF/VEL 400/100 mg | Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10. | 0 | 16 | 0 | 16 | 2 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.0 | 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 |
|---|---|
| D006526 | Hepatitis C |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D018178 | Flaviviridae Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D006505 | Hepatitis |
Not provided
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| ID | Term |
|---|---|
| C000619503 | voxilaprevir |
Not provided
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| Male |
|
| White |
|
| Not Hispanic or Latino |
|
| 1b |
|
| 2 |
|
| 2a/2c |
|
| 2b |
|
| 3a |
|
| 4 |
|
| 4a/4c/4d |
|
| ≥ 800,000 IU/mL |
|
| OG003 | Voxilaprevir 300 mg | Participants with HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. This arm was part of cohorts 1 and 2. |
| OG004 | Voxilaprevir 100 mg Fed | Participants with HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. This arm was part of cohorts 1, 2, 3, 4, 5 and 6. |
| OG005 | Voxilaprevir 100 mg + SOF/VEL 400/100 mg | Participants with HCV infection received voxilaprevir 100 mg on Day 1 and voxilaprevir 100 mg plus SOF/VEL (400/100 mg) FDC on Days 2 and 3 after moderate fat meal. This arm was part of cohort 10. |
|
|
| OG003 |
| Voxilaprevir 300 mg (GT 1a, Cohort 1) |
Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| OG004 | Placebo (GT 3, Cohort 2) | Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG005 | Voxilaprevir 50 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
| OG006 | Voxilaprevir 100 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG007 | Voxilaprevir 300 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| OG008 | Placebo (GT 2, Cohort 3) | Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG009 | Voxilaprevir 100 mg (GT 2, Cohort 3) | Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG010 | Voxilaprevir 100 mg (GT 4, Cohort 4) | Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG011 | Voxilaprevir 100 mg (GT 1b, Cohort 5) | Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG012 | Voxilaprevir 100 mg Fed (GT 3a, Cohort 6) | Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. |
|
|
Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions.
| OG004 | Placebo (GT 3, Cohort 2) | Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG005 | Voxilaprevir 50 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
| OG006 | Voxilaprevir 100 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG007 | Voxilaprevir 300 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| OG008 | Placebo (GT 2, Cohort 3) | Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG009 | Voxilaprevir 100 mg (GT 2, Cohort 3) | Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG010 | Voxilaprevir 100 mg (GT 4, Cohort 4) | Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG011 | Voxilaprevir 100 mg (GT 1b, Cohort 5) | Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG012 | Voxilaprevir 100 mg Fed (GT 3a, Cohort 6) | Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. |
|
|
| OG003 |
| Voxilaprevir 300 mg (GT 1a, Cohort 1) |
Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| OG004 | Placebo (GT 3, Cohort 2) | Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG005 | Voxilaprevir 50 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
| OG006 | Voxilaprevir 100 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG007 | Voxilaprevir 300 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| OG008 | Placebo (GT 2, Cohort 3) | Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG009 | Voxilaprevir 100 mg (GT 2, Cohort 3) | Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG010 | Voxilaprevir 100 mg (GT 4, Cohort 4) | Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG011 | Voxilaprevir 100 mg (GT 1b, Cohort 5) | Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG012 | Voxilaprevir 100 mg Fed (GT 3a, Cohort 6) | Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed conditions. |
|
|
| Voxilaprevir 300 mg (GT 1a, Cohort 1) |
Participants with GT 1a HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| OG004 | Placebo (GT 3, Cohort 2) | Participants with GT 3 HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG005 | Voxilaprevir 50 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 50 mg once daily for 3 days under fasted conditions. |
| OG006 | Voxilaprevir 100 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG007 | Voxilaprevir 300 mg (GT 3, Cohort 2) | Participants with GT 3 HCV infection received voxilaprevir 300 mg once daily for 3 days under fasted conditions. |
| OG008 | Placebo (GT 2, Cohort 3) | Participants with GT 2 HCV infection received placebo once daily for 3 days under fasted conditions. |
| OG009 | Voxilaprevir 100 mg (GT 2, Cohort 3) | Participants with GT 2 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG010 | Voxilaprevir 100 mg (GT 4, Cohort 4) | Participants with GT 4 HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG011 | Voxilaprevir 100 mg (GT 1b, Cohort 5) | Participants with GT 1b HCV infection received voxilaprevir 100 mg once daily for 3 days under fasted conditions. |
| OG012 | Voxilaprevir 100 mg Fed (GT 3a, Cohort 6) | Participants with GT 3a HCV infection received voxilaprevir 100 mg once daily for 3 days under fed 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 |
|