Hepatitis C Virus Infection
Conditions
Brief summary
The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.
Interventions
DRUGLDV/SOF
90/400 mg FDC tablet administered orally once daily
DRUGSOF
400 mg tablet administered orally once daily
DRUGRBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females * Aged 20 years or older * Treatment naive or treatment experienced * At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV. Key
Exclusion criteria
* Previous exposure to an NS5A or NS5B inhibitor * Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) * Pregnant or nursing female or male with pregnant female partner Note: Other protocol defined Inclusion/
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 Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 3 | Week 3 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 4 | Week 4 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 5 | Week 5 | — |
| 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 10 | Week 10 | — |
| Percentage of Participants With HCV RNA < LLOQ at Week 12 | Week 12 | — |
| Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment. |
| Change From Baseline in HCV RNA at Week 2 | Baseline; Week 2 | — |
| Change From Baseline in HCV RNA at Week 3 | Baseline; Week 3 | — |
| Change From Baseline in HCV RNA at Week 4 | Baseline; Week 4 | — |
| Change From Baseline in HCV RNA at Week 5 | Baseline; Week 5 | — |
| Change From Baseline in HCV RNA at Week 6 | Baseline; Week 6 | — |
| Change From Baseline in HCV RNA at Week 8 | Baseline; Week 8 | — |
| Change From Baseline in HCV RNA at Week 10 | Baseline; Week 10 | — |
| Change From Baseline in HCV RNA at Week 12 | Baseline; Week 12 | — |
| Percentage of Participants With Overall 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 while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit. |
| Change From Baseline in HCV RNA at Week 1 | Baseline; Week 1 | — |
| Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | Posttreatment Week 24 | SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment. |
Countries
Japan
Participant flow
Recruitment details
Participants were enrolled at study sites in Japan. The first participant was screened on 12 April 2016. The last study visit occurred on 11 May 2017.
Pre-assignment details
266 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| LDV/SOF (Cohort 1) LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | 106 |
| SOF+RBV (Cohort 1) SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | 108 |
| LDV/SOF (Cohort 2) LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy | 25 |
| Total | 239 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | LDV/SOF (Cohort 1) | SOF+RBV (Cohort 1) | LDV/SOF (Cohort 2) | Total |
|---|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10.5 | 60 years STANDARD_DEVIATION 12.3 | 74 years STANDARD_DEVIATION 7.1 | 61 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 108 Participants | 25 Participants | 239 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HCV RNA Category < 800,000 IU/mL | 30 Participants | 36 Participants | 10 Participants | 76 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 76 Participants | 72 Participants | 15 Participants | 163 Participants |
| HCV RNA (log10 IU/mL) | 6.1 log10 IU/mL STANDARD_DEVIATION 0.79 | 6.1 log10 IU/mL STANDARD_DEVIATION 0.79 | 5.9 log10 IU/mL STANDARD_DEVIATION 0.72 | 6.0 log10 IU/mL STANDARD_DEVIATION 0.78 |
| IL28b Status CC | 88 Participants | 86 Participants | 15 Participants | 189 Participants |
| IL28b Status CT | 17 Participants | 19 Participants | 10 Participants | 46 Participants |
| IL28b Status TT | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 106 Participants | 108 Participants | 25 Participants | 239 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 54 Participants | 71 Participants | 19 Participants | 144 Participants |
| Sex: Female, Male Male | 52 Participants | 37 Participants | 6 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 106 | 0 / 108 | 0 / 25 |
| other Total, other adverse events | 25 / 106 | 48 / 108 | 7 / 25 |
| serious Total, serious adverse events | 1 / 106 | 1 / 108 | 1 / 25 |
Outcome results
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 12 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 0.9 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 1.9 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | 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 took at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.2 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 95.4 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 96.0 percentage of participants |
95% CI: [-5.3, 7.1]
Secondary
Change From Baseline in HCV RNA at Week 1
Time frame: Baseline; Week 1
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 1 | -4.18 log10 IU/mL | Standard Deviation 0.54 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 1 | -4.34 log10 IU/mL | Standard Deviation 0.602 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 1 | -4.24 log10 IU/mL | Standard Deviation 0.55 |
Secondary
Change From Baseline in HCV RNA at Week 10
Time frame: Baseline; Week 10
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 10 | -4.92 log10 IU/mL | Standard Deviation 0.785 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 10 | -4.93 log10 IU/mL | Standard Deviation 0.794 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 10 | -4.76 log10 IU/mL | Standard Deviation 0.719 |
Secondary
Change From Baseline in HCV RNA at Week 12
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 12 | -4.92 log10 IU/mL | Standard Deviation 0.785 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 12 | -4.92 log10 IU/mL | Standard Deviation 0.794 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 12 | -4.76 log10 IU/mL | Standard Deviation 0.719 |
Secondary
Change From Baseline in HCV RNA at Week 2
Time frame: Baseline; Week 2
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 2 | -4.76 log10 IU/mL | Standard Deviation 0.759 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 2 | -4.81 log10 IU/mL | Standard Deviation 0.772 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 2 | -4.64 log10 IU/mL | Standard Deviation 0.719 |
Secondary
Change From Baseline in HCV RNA at Week 3
Time frame: Baseline; Week 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 3 | -4.87 log10 IU/mL | Standard Deviation 0.78 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 3 | -4.89 log10 IU/mL | Standard Deviation 0.79 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 3 | -4.75 log10 IU/mL | Standard Deviation 0.714 |
Secondary
Change From Baseline in HCV RNA at Week 4
Time frame: Baseline; Week 4
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 4 | -4.89 log10 IU/mL | Standard Deviation 0.782 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 4 | -4.91 log10 IU/mL | Standard Deviation 0.794 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 4 | -4.76 log10 IU/mL | Standard Deviation 0.719 |
Secondary
Change From Baseline in HCV RNA at Week 5
Time frame: Baseline; Week 5
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 5 | -4.91 log10 IU/mL | Standard Deviation 0.781 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 5 | -4.92 log10 IU/mL | Standard Deviation 0.794 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 5 | -4.76 log10 IU/mL | Standard Deviation 0.719 |
Secondary
Change From Baseline in HCV RNA at Week 6
Time frame: Baseline; Week 6
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 6 | -4.91 log10 IU/mL | Standard Deviation 0.781 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 6 | -4.92 log10 IU/mL | Standard Deviation 0.793 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 6 | -4.76 log10 IU/mL | Standard Deviation 0.719 |
Secondary
Change From Baseline in HCV RNA at Week 8
Time frame: Baseline; Week 8
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LDV/SOF (Cohort 1) | Change From Baseline in HCV RNA at Week 8 | -4.92 log10 IU/mL | Standard Deviation 0.785 |
| SOF+RBV (Cohort 1) | Change From Baseline in HCV RNA at Week 8 | -4.93 log10 IU/mL | Standard Deviation 0.794 |
| LDV/SOF (Cohort 2) | Change From Baseline in HCV RNA at Week 8 | -4.76 log10 IU/mL | Standard Deviation 0.719 |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 1
Time frame: Week 1
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 24.5 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 31.5 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With HCV RNA < LLOQ at Week 1 | 32.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 10
Time frame: Week 10
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 10 | 100.0 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 10 | 100.0 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With HCV RNA < LLOQ at Week 10 | 100.0 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) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 12 | 100.0 percentage of participants |
| LDV/SOF (Cohort 2) | 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 2
Time frame: Week 2
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 73.6 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 76.6 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With HCV RNA < LLOQ at Week 2 | 76.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 3
Time frame: Week 3
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 3 | 90.6 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 3 | 90.7 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With HCV RNA < LLOQ at Week 3 | 96.0 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) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 98.1 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 96.3 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With HCV RNA < LLOQ at Week 4 | 100.0 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Week 5
Time frame: Week 5
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 5 | 98.1 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 5 | 99.1 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With HCV RNA < LLOQ at Week 5 | 100.0 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) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 99.0 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 99.1 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With HCV RNA < LLOQ at Week 6 | 100.0 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) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With HCV RNA < LLOQ at Week 8 | 100.0 percentage of participants |
Secondary
Percentage of Participants With Overall Virologic Failure
Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With Overall Virologic Failure | 2.8 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With Overall Virologic Failure | 3.7 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With Overall Virologic Failure | 4.0 percentage of participants |
Secondary
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Time frame: Posttreatment Week 24
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 96.2 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 95.4 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | 96.0 percentage of participants |
Secondary
Percentage of Participants With SVR at 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF (Cohort 1) | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | 97.2 percentage of participants |
| SOF+RBV (Cohort 1) | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | 98.1 percentage of participants |
| LDV/SOF (Cohort 2) | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | 96.0 percentage of participants |