Phase 3
Completed N=239
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
Source: ClinicalTrials.gov NCT02738333 ↗Enrolled (actual)
239
Serious AEs
1.3%
Results posted
Mar 2018
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 96.2; 95.4; 96.0 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
96.2; 95.4; 96.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0.9; 1.9; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) |
97.2; 98.1; 96.0 | — |
| SECONDARY Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
96.2; 95.4; 96.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 1 |
24.5; 31.5; 32.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 2 |
73.6; 76.6; 76.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 3 |
90.6; 90.7; 96.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 4 |
98.1; 96.3; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 5 |
98.1; 99.1; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 6 |
99.0; 99.1; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 8 |
100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 10 |
100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ at Week 12 |
100.0; 100.0; 100.0 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 1 |
-4.18; -4.34; -4.24 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 2 |
-4.76; -4.81; -4.64 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 3 |
-4.87; -4.89; -4.75 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 4 |
-4.89; -4.91; -4.76 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 5 |
-4.91; -4.92; -4.76 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 6 |
-4.91; -4.92; -4.76 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 8 |
-4.92; -4.93; -4.76 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 10 |
-4.92; -4.93; -4.76 | — |
| SECONDARY Change From Baseline in HCV RNA at Week 12 |
-4.92; -4.92; -4.76 | — |
| SECONDARY Percentage of Participants With Overall Virologic Failure |
2.8; 3.7; 4.0 | — |
Eligibility 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/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02738333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.