Chronic HCV Infection
Conditions
Brief summary
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. * Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; * Cohort B: post-liver transplant, with or without cirrhosis; * Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) * Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.
Interventions
DRUGLDV/SOF
LDV/SOF FDC tablet administered orally once daily
DRUGRBV
RBV tablets administered orally in a divided daily dose
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide written informed consent * Chronic genotype 1 or 4 HCV infection * Normal ECG * Negative serum pregnancy test for female subjects * Male subjects and female subjects of childbearing potential must agree to use contraception * Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits
Exclusion criteria
* Serious or active medical or psychiatric illness * HIV or hepatitis B viral (HBV) infection * Stomach disorder that could interfere with the absorption of the study drug * Treated with an anti-HCV medication in the last 30 days * Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor * Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening * History of clinically significant medical condition associated with other chronic liver disease * Active spontaneous bacterial peritonitis at screening * Females who are breastfeeding * Infection requiring systemic antibiotics * Participated in a clinical study with an investigational drug or biologic within the last 30 days * Active or history (last 6 months) of drug or alcohol abuse * History of organ transplant other than liver or kidney
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. |
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 24 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | Posttreatment Week 8 | SVR8 was defined as HCV RNA \< LLOQ at 8 weeks after stopping study treatment. |
| Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | Posttreatment Week 24 | SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment. |
| Percentage of Participants With Virologic Failure | Up to Posttreatment Week 24 | Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ on 2 consecutive measurements while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit. |
| Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12 | Posttransplant Week 12 | pTVR was defined as HCV RNA \< LLOQ at Week 12 after transplant. |
| Percentage of Participants With HCV RNA < LLOQ at Week 1 | Week 1 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 2 | Week 2 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 4 | Week 4 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 6 | Week 6 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 8 | Week 8 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 12 | Week 12 | — |
| Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | Posttreatment Week 2 | SVR2 was defined as HCV RNA \< LLOQ at 2 weeks after stopping study treatment. |
| Percentage of Participants With HCV RNA < LLOQ at Week 20 | Week 20 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 24 | Week 24 | — |
| HCV RNA and Change From Baseline at Week 1 | Baseline; Week 1 | — |
| HCV RNA and Change From Baseline at Week 2 | Baseline; Week 2 | — |
| HCV RNA and Change From Baseline at Week 4 | Baseline; Week 4 | — |
| HCV RNA and Change From Baseline at Week 6 | Baseline; Week 6 | — |
| HCV RNA and Change From Baseline at Week 8 | Baseline; Week 8 | — |
| HCV RNA and Change From Baseline at Week 12 | Baseline; Week 12 | — |
| Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Baseline to Posttreatment Week 4 | Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. |
| Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Baseline to Posttreatment Week 4 | CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline. |
| Percentage of Participants With HCV RNA < LLOQ at Week 16 | Week 16 | — |
| Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States. The first participant was screened on 06 September 2013. The last study visit occurred on 25 March 2015.
Pre-assignment details
* Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; * Cohort B: post-liver transplant, with or without cirrhosis; * Group assignment within cohorts was based on severity of liver impairment at screening (or presence of disease for FCH groups); * Randomization was 1:1 within groups to 12 or 24 weeks of treatment.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9) | 30 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9) | 29 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12) | 23 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12) | 26 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3 | 55 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3 | 56 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6) | 26 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6) | 25 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9) | 26 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9) | 26 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12) | 5 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12) | 4 |
| Cohort B, Group 7 (12 wk): FCH LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH) | 4 |
| Cohort B, Group 7 (24 wk): FCH LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH | 2 |
| Total | 337 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 1 | 2 | 2 | 1 | 0 | 0 | 1 | 1 | 2 | 3 | 0 | 0 | 0 | 0 |
| Overall Study | Investigator's Discretion | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 3 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Randomized but Not Treated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Withdrew Consent | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Total | Cohort B, Group 7 (24 wk): FCH | Cohort B, Group 7 (12 wk): FCH | Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Cohort A, Group 1 (24 wk): CPT Class B (7-9) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 9.1 | 59 years STANDARD_DEVIATION 6.9 | 58 years STANDARD_DEVIATION 8.5 | 62 years STANDARD_DEVIATION 3.2 | 61 years STANDARD_DEVIATION 1.7 | 60 years STANDARD_DEVIATION 3.8 | 61 years STANDARD_DEVIATION 6.6 | 59 years STANDARD_DEVIATION 5.8 | 61 years STANDARD_DEVIATION 10.4 | 61 years STANDARD_DEVIATION 6.2 | 58 years STANDARD_DEVIATION 6.4 | 59 years STANDARD_DEVIATION 6.6 | 59 years STANDARD_DEVIATION 4.6 | 57 years STANDARD_DEVIATION 6.2 | 58 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 38 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants | 6 Participants | 4 Participants | 4 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 299 Participants | 2 Participants | 4 Participants | 4 Participants | 2 Participants | 23 Participants | 21 Participants | 23 Participants | 24 Participants | 50 Participants | 51 Participants | 22 Participants | 21 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HCV Genotype Genotype 1a | 19 participants | 238 participants | 2 participants | 3 participants | 3 participants | 4 participants | 18 participants | 20 participants | 17 participants | 17 participants | 40 participants | 40 participants | 18 participants | 15 participants | 22 participants |
| HCV Genotype Genotype 1b | 10 participants | 94 participants | 0 participants | 1 participants | 1 participants | 1 participants | 7 participants | 6 participants | 8 participants | 9 participants | 16 participants | 14 participants | 8 participants | 6 participants | 7 participants |
| HCV Genotype Genotype 4 | 1 participants | 5 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 2 participants | 0 participants |
| HCV RNA Category < 800 IU/mL | 14 participants | 98 participants | 0 participants | 1 participants | 0 participants | 1 participants | 9 participants | 6 participants | 0 participants | 7 participants | 10 participants | 10 participants | 15 participants | 14 participants | 11 participants |
| HCV RNA Category ≥ 800 IU/mL | 16 participants | 239 participants | 2 participants | 3 participants | 4 participants | 4 participants | 17 participants | 20 participants | 25 participants | 19 participants | 46 participants | 45 participants | 11 participants | 9 participants | 18 participants |
| Hepatitis C Virus (HCV) RNA | 5.9 log10 IU/mL STANDARD_DEVIATION 0.68 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.77 | 7.1 log10 IU/mL STANDARD_DEVIATION 0.9 | 6.5 log10 IU/mL STANDARD_DEVIATION 1.24 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.37 | 6.4 log10 IU/mL STANDARD_DEVIATION 0.42 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.67 | 6.3 log10 IU/mL STANDARD_DEVIATION 0.55 | 6.7 log10 IU/mL STANDARD_DEVIATION 0.34 | 6.2 log10 IU/mL STANDARD_DEVIATION 0.77 | 6.4 log10 IU/mL STANDARD_DEVIATION 0.93 | 6.5 log10 IU/mL STANDARD_DEVIATION 0.62 | 5.8 log10 IU/mL STANDARD_DEVIATION 0.71 | 5.6 log10 IU/mL STANDARD_DEVIATION 0.62 | 5.8 log10 IU/mL STANDARD_DEVIATION 0.82 |
| IL28b Status CC | 4 participants | 62 participants | 0 participants | 0 participants | 1 participants | 2 participants | 5 participants | 3 participants | 1 participants | 7 participants | 10 participants | 11 participants | 7 participants | 6 participants | 5 participants |
| IL28b Status CT | 20 participants | 193 participants | 1 participants | 2 participants | 2 participants | 2 participants | 16 participants | 14 participants | 19 participants | 11 participants | 27 participants | 33 participants | 15 participants | 13 participants | 18 participants |
| IL28b Status TT | 6 participants | 82 participants | 1 participants | 2 participants | 1 participants | 1 participants | 5 participants | 9 participants | 5 participants | 8 participants | 19 participants | 11 participants | 4 participants | 4 participants | 6 participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 participants | 3 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants | 30 participants | 0 participants | 0 participants | 0 participants | 1 participants | 2 participants | 5 participants | 4 participants | 3 participants | 4 participants | 4 participants | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Other | 0 participants | 4 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 2 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 29 participants | 299 participants | 2 participants | 4 participants | 4 participants | 4 participants | 24 participants | 21 participants | 20 participants | 21 participants | 49 participants | 50 participants | 24 participants | 21 participants | 26 participants |
| Region of Enrollment United States | 30 participants | 337 participants | 2 participants | 4 participants | 4 participants | 5 participants | 26 participants | 26 participants | 25 participants | 26 participants | 56 participants | 55 participants | 26 participants | 23 participants | 29 participants |
| Sex: Female, Male Female | 8 Participants | 73 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants | 3 Participants | 7 Participants | 10 Participants | 10 Participants | 8 Participants | 9 Participants | 11 Participants |
| Sex: Female, Male Male | 22 Participants | 264 Participants | 2 Participants | 4 Participants | 4 Participants | 5 Participants | 23 Participants | 22 Participants | 22 Participants | 19 Participants | 46 Participants | 45 Participants | 18 Participants | 14 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 30 | 28 / 29 | 22 / 23 | 26 / 26 | 54 / 55 | 54 / 56 | 25 / 26 | 23 / 25 | 23 / 26 | 26 / 26 | 5 / 5 | 4 / 4 | 4 / 4 | 2 / 2 |
| serious Total, serious adverse events | 3 / 30 | 10 / 29 | 6 / 23 | 11 / 26 | 6 / 55 | 12 / 56 | 3 / 26 | 4 / 25 | 5 / 26 | 11 / 26 | 1 / 5 | 3 / 4 | 1 / 4 | 1 / 2 |
Outcome results
Primary
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks
Population: Safety Analysis Set: participants who were randomized and received at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 0.0 percentage of participants |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 0.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 6.9 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 13.8 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 4.3 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 13.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 7.7 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 34.6 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 10.9 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 0.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 17.9 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 3.6 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 3.8 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 15.4 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 0.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 8.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 23.1 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 7.7 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 34.6 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 11.5 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 40.0 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 0.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 25.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 0.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 0.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 25.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued Any Study Drug | 0.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Discontinued LDV/SOF | 0.0 percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Population: Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 86.7 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 88.9 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 86.4 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 87.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.4 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 98.2 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.2 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 84.6 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 88.5 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 60.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 75.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 100.0 percentage of participants |
Secondary
HCV RNA and Change From Baseline at Week 1
Time frame: Baseline; Week 1
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.26 log10 IU/mL | Standard Deviation 0.695 |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.59 log10 IU/mL | Standard Deviation 0.476 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.49 log10 IU/mL | Standard Deviation 0.83 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.34 log10 IU/mL | Standard Deviation 0.658 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.11 log10 IU/mL | Standard Deviation 0.643 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.47 log10 IU/mL | Standard Deviation 0.579 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.46 log10 IU/mL | Standard Deviation 0.968 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.32 log10 IU/mL | Standard Deviation 0.669 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -4.14 log10 IU/mL | Standard Deviation 0.721 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.33 log10 IU/mL | Standard Deviation 0.983 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.98 log10 IU/mL | Standard Deviation 0.682 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.42 log10 IU/mL | Standard Deviation 0.73 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.40 log10 IU/mL | Standard Deviation 0.89 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.80 log10 IU/mL | Standard Deviation 0.712 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.86 log10 IU/mL | Standard Deviation 0.792 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.86 log10 IU/mL | Standard Deviation 0.759 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.41 log10 IU/mL | Standard Deviation 0.409 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.84 log10 IU/mL | Standard Deviation 0.678 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.68 log10 IU/mL | Standard Deviation 0.506 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.56 log10 IU/mL | Standard Deviation 0.774 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.75 log10 IU/mL | Standard Deviation 0.584 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.76 log10 IU/mL | Standard Deviation 0.571 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -3.52 log10 IU/mL | Standard Deviation 1.028 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.75 log10 IU/mL | Standard Deviation 1.065 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 1 | Week 1 | 2.28 log10 IU/mL | Standard Deviation 1.149 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -4.22 log10 IU/mL | Standard Deviation 0.864 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 1 | Change at Week 1 | -2.76 log10 IU/mL | Standard Deviation 0.526 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 1 | Week 1 | 4.30 log10 IU/mL | Standard Deviation 1.424 |
Secondary
HCV RNA and Change From Baseline at Week 12
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -4.70 log10 IU/mL | Standard Deviation 0.676 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -4.70 log10 IU/mL | Standard Deviation 0.842 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -4.44 log10 IU/mL | Standard Deviation 0.614 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -4.62 log10 IU/mL | Standard Deviation 0.737 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.33 log10 IU/mL | Standard Deviation 0.615 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.25 log10 IU/mL | Standard Deviation 0.943 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.09 log10 IU/mL | Standard Deviation 0.781 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.60 log10 IU/mL | Standard Deviation 0.345 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.14 log10 IU/mL | Standard Deviation 0.562 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.10 log10 IU/mL | Standard Deviation 0.682 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.21 log10 IU/mL | Standard Deviation 0.422 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.12 log10 IU/mL | Standard Deviation 0.368 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.36 log10 IU/mL | Standard Deviation 1.237 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 12 | Change at Week 12 | -5.91 log10 IU/mL | Standard Deviation 0.897 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 12 | Week 12 | 1.15 log10 IU/mL | Standard Deviation 0 |
Secondary
HCV RNA and Change From Baseline at Week 2
Time frame: Baseline; Week 2
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.60 log10 IU/mL | Standard Deviation 0.484 |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.25 log10 IU/mL | Standard Deviation 0.575 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.67 log10 IU/mL | Standard Deviation 0.574 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.16 log10 IU/mL | Standard Deviation 0.748 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.49 log10 IU/mL | Standard Deviation 0.404 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.09 log10 IU/mL | Standard Deviation 0.604 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.82 log10 IU/mL | Standard Deviation 0.748 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -3.98 log10 IU/mL | Standard Deviation 0.581 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.83 log10 IU/mL | Standard Deviation 0.72 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.64 log10 IU/mL | Standard Deviation 0.751 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.79 log10 IU/mL | Standard Deviation 0.845 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.59 log10 IU/mL | Standard Deviation 0.516 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.73 log10 IU/mL | Standard Deviation 0.631 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.48 log10 IU/mL | Standard Deviation 0.668 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.91 log10 IU/mL | Standard Deviation 0.641 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.84 log10 IU/mL | Standard Deviation 0.636 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.22 log10 IU/mL | Standard Deviation 0.489 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 2.03 log10 IU/mL | Standard Deviation 0.585 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.47 log10 IU/mL | Standard Deviation 0.503 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.76 log10 IU/mL | Standard Deviation 0.628 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.56 log10 IU/mL | Standard Deviation 0.765 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.80 log10 IU/mL | Standard Deviation 0.645 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.26 log10 IU/mL | Standard Deviation 0.825 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 2 | Week 2 | 2.00 log10 IU/mL | Standard Deviation 0.746 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.66 log10 IU/mL | Standard Deviation 0.637 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.85 log10 IU/mL | Standard Deviation 1.09 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 2 | Change at Week 2 | -4.81 log10 IU/mL | — |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 2 | Week 2 | 1.61 log10 IU/mL | — |
Secondary
HCV RNA and Change From Baseline at Week 4
Time frame: Baseline; Week 4
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.20 log10 IU/mL | Standard Deviation 0.117 |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -4.65 log10 IU/mL | Standard Deviation 0.668 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.21 log10 IU/mL | Standard Deviation 0.153 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -4.63 log10 IU/mL | Standard Deviation 0.789 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -4.44 log10 IU/mL | Standard Deviation 0.618 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.23 log10 IU/mL | Standard Deviation 0.265 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -4.56 log10 IU/mL | Standard Deviation 0.655 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.23 log10 IU/mL | Standard Deviation 0.629 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.24 log10 IU/mL | Standard Deviation 0.271 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.24 log10 IU/mL | Standard Deviation 0.929 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.16 log10 IU/mL | Standard Deviation 0.065 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.18 log10 IU/mL | Standard Deviation 0.12 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.01 log10 IU/mL | Standard Deviation 0.736 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.23 log10 IU/mL | Standard Deviation 0.212 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.52 log10 IU/mL | Standard Deviation 0.376 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.01 log10 IU/mL | Standard Deviation 0.537 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.24 log10 IU/mL | Standard Deviation 0.184 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.05 log10 IU/mL | Standard Deviation 0.662 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.18 log10 IU/mL | Standard Deviation 0.15 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.21 log10 IU/mL | Standard Deviation 0.422 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.12 log10 IU/mL | Standard Deviation 0.368 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.36 log10 IU/mL | Standard Deviation 1.237 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 4 | Change at Week 4 | -5.39 log10 IU/mL | Standard Deviation 0.159 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 4 | Week 4 | 1.67 log10 IU/mL | Standard Deviation 0.738 |
Secondary
HCV RNA and Change From Baseline at Week 6
Time frame: Baseline; Week 6
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -4.70 log10 IU/mL | Standard Deviation 0.676 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -4.69 log10 IU/mL | Standard Deviation 0.822 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -4.47 log10 IU/mL | Standard Deviation 0.616 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0.042 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -4.61 log10 IU/mL | Standard Deviation 0.695 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.32 log10 IU/mL | Standard Deviation 0.618 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0.004 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.25 log10 IU/mL | Standard Deviation 0.936 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.05 log10 IU/mL | Standard Deviation 0.788 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.60 log10 IU/mL | Standard Deviation 0.345 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.10 log10 IU/mL | Standard Deviation 0.559 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.09 log10 IU/mL | Standard Deviation 0.669 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.21 log10 IU/mL | Standard Deviation 0.422 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.12 log10 IU/mL | Standard Deviation 0.368 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.36 log10 IU/mL | Standard Deviation 1.237 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 6 | Change at Week 6 | -5.28 log10 IU/mL | — |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 6 | Week 6 | 1.15 log10 IU/mL | — |
Secondary
HCV RNA and Change From Baseline at Week 8
Time frame: Baseline; Week 8
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -4.70 log10 IU/mL | Standard Deviation 0.676 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -4.67 log10 IU/mL | Standard Deviation 0.834 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -4.47 log10 IU/mL | Standard Deviation 0.616 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.16 log10 IU/mL | Standard Deviation 0.081 |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -4.61 log10 IU/mL | Standard Deviation 0.715 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.33 log10 IU/mL | Standard Deviation 0.615 |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.25 log10 IU/mL | Standard Deviation 0.936 |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.05 log10 IU/mL | Standard Deviation 0.788 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.60 log10 IU/mL | Standard Deviation 0.345 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.11 log10 IU/mL | Standard Deviation 0.571 |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.10 log10 IU/mL | Standard Deviation 0.682 |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.21 log10 IU/mL | Standard Deviation 0.422 |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.12 log10 IU/mL | Standard Deviation 0.368 |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.15 log10 IU/mL | Standard Deviation 0 |
| Cohort B, Group 7 (12 wk): FCH | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.36 log10 IU/mL | Standard Deviation 1.237 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 8 | Change at Week 8 | -5.83 log10 IU/mL | Standard Deviation 0.787 |
| Cohort B, Group 7 (24 wk): FCH | HCV RNA and Change From Baseline at Week 8 | Week 8 | 1.22 log10 IU/mL | Standard Deviation 0.11 |
Secondary
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.
Time frame: Baseline to Posttreatment Week 4
Population: Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 0.0 percentage of participants |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 0.0 percentage of participants |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 100.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 23.3 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 13.3 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 63.3 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 11.5 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 38.5 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 50.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 10.5 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 89.5 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 0.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 0.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 72.2 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 27.8 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 68.2 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 18.2 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 13.6 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 47.8 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 52.2 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 0.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 56.5 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 34.8 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 8.7 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 9.1 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 59.1 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 31.8 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 50.0 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 0.0 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 50.0 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Increase | 0.0 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | Decrease | 100.0 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score | No Change | 0.0 percentage of participants |
Secondary
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Time frame: Baseline to Posttreatment Week 4
Population: Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 60.7 percentage of participants |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 21.4 percentage of participants |
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 17.9 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 20.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 12.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 68.0 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 28.6 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 61.9 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 9.5 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 5.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 80.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 15.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 30.4 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 39.1 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 30.4 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 16.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 52.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 32.0 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 66.7 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 14.3 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 19.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 5.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 70.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 25.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 20.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 40.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 40.0 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Decrease | 66.7 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | Increase | 33.3 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score | No Change | 0.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 1
Time frame: Week 1
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 6.7 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 6.9 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 13.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 3.8 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 16.4 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 12.5 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 15.4 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 4.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 3.8 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 7.7 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 0.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 0.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 25.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 0.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time frame: Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 96.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 16
Time frame: Week 16
Population: Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 16 | 100.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 16 | 100.0 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 16 | 100.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 16 | 100.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 16 | 100.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 16 | 100.0 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 16 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time frame: Week 2
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 36.7 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 41.4 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 39.1 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 38.5 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 49.1 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 41.8 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 34.6 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 28.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 8.0 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 42.3 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 40.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 25.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 50.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 0.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 20
Time frame: Week 20
Population: Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 20 | 100.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 20 | 100.0 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 20 | 100.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 20 | 100.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 20 | 100.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 20 | 100.0 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 20 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 24
Time frame: Week 24
Population: Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 24 | 100.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 24 | 100.0 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 24 | 100.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 24 | 100.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 24 | 100.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 24 | 100.0 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 24 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time frame: Week 4
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 83.3 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 82.8 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 100.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 84.6 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 87.3 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 90.9 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 88.5 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 80.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 72.0 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 88.5 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 100.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 100.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 50.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 6
Time frame: Week 6
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 96.2 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 96.4 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 50.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time frame: Week 8
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 96.6 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 92.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 96.0 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 96.2 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 50.0 percentage of participants |
Secondary
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
pTVR was defined as HCV RNA \< LLOQ at Week 12 after transplant.
Time frame: Posttransplant Week 12
Population: Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was \< LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12 | 85.7 percentage of participants |
Secondary
Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Population: Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 86.7 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 88.9 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 85.7 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 87.0 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 96.4 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 98.2 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 96.2 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 96.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 84.6 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 88.5 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 60.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 75.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24) | 100.0 percentage of participants |
Secondary
Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
SVR2 was defined as HCV RNA \< LLOQ at 2 weeks after stopping study treatment.
Time frame: Posttreatment Week 2
Population: Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 96.7 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 92.6 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 95.5 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 95.8 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 100.0 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 98.2 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 96.2 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 100.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 88.5 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 92.3 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 100.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 75.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2) | 100.0 percentage of participants |
Secondary
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Population: Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 90.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 88.9 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 90.9 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 95.7 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 96.4 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 98.2 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 96.2 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 88.5 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 92.3 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 75.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
Secondary
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
SVR8 was defined as HCV RNA \< LLOQ at 8 weeks after stopping study treatment.
Time frame: Posttreatment Week 8
Population: Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 86.7 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 88.9 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 86.4 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 95.7 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 96.4 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 98.2 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 96.2 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 100.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 88.5 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 88.5 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 60.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 75.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 100.0 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ on 2 consecutive measurements while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Time frame: Up to Posttreatment Week 24
Population: Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA \<LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A, Group 1 (12 wk): CPT Class B (7-9) | Percentage of Participants With Virologic Failure | 10.0 percentage of participants |
| Cohort A, Group 1 (24 wk): CPT Class B (7-9) | Percentage of Participants With Virologic Failure | 3.7 percentage of participants |
| Cohort A, Group 2 (12 wk): CPT Class C (10-12) | Percentage of Participants With Virologic Failure | 4.5 percentage of participants |
| Cohort A, Group 2 (24 wk): CPT Class C (10-12) | Percentage of Participants With Virologic Failure | 8.7 percentage of participants |
| Cohort B, Group 3 (12 wk): F0-F3 Fibrosis | Percentage of Participants With Virologic Failure | 3.6 percentage of participants |
| Cohort B, Group 3 (24 wk): F0-F3 Fibrosis | Percentage of Participants With Virologic Failure | 0.0 percentage of participants |
| Cohort B, Group 4 (12 wk): CPT Class A (5-6) | Percentage of Participants With Virologic Failure | 0.0 percentage of participants |
| Cohort B, Group 4 (24 wk): CPT Class A (5-6) | Percentage of Participants With Virologic Failure | 0.0 percentage of participants |
| Cohort B, Group 5 (12 wk): CPT Class B (7-9) | Percentage of Participants With Virologic Failure | 3.8 percentage of participants |
| Cohort B, Group 5 (24 wk): CPT Class B (7-9) | Percentage of Participants With Virologic Failure | 0.0 percentage of participants |
| Cohort B, Group 6 (12 wk): CPT Class C (10-12) | Percentage of Participants With Virologic Failure | 40.0 percentage of participants |
| Cohort B, Group 6 (24 wk): CPT Class C (10-12) | Percentage of Participants With Virologic Failure | 25.0 percentage of participants |
| Cohort B, Group 7 (12 wk): FCH | Percentage of Participants With Virologic Failure | 3.6 percentage of participants |
| Cohort B, Group 7 (24 wk): FCH | Percentage of Participants With Virologic Failure | 0.0 percentage of participants |