Phase 3
Completed N=153
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
Source: ClinicalTrials.gov NCT02472886 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 100.0; 96.6; 96.3 percentage of participants
◆ Published Evidence
Emerging
10citations · ~1 / year
Ledipasvir-Sofosbuvir for 8 Weeks in Non-Cirrhotic Patients with Previously Untreated Genotype 1 HCV Infection ± HIV-1 Co-Infection.
Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.
Linked Publications
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Ledipasvir-Sofosbuvir for 8 Weeks in Non-Cirrhotic Patients with Previously Untreated Genotype 1 HCV Infection ± HIV-1 Co-Infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
100.0; 96.6; 96.3 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE) |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
100.0; 96.6; 96.3; 100.0; 96.6; 96.3 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
20.9; 39.0; 3.7; 65.7; 69.5; 59.3 | — |
| SECONDARY HCV RNA Change From Day 1 |
-3.97; -4.34; -4.12; -4.50; -4.76; -4.83 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 3.4; 3.7 | — |
| SECONDARY Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 |
100.0; 100.0; 97.2 | — |
| SECONDARY For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4 |
47; 159; 45; 202; 74; 172 | — |
Eligibility Criteria
Key Inclusion Criteria
- Participants who failed treatment in Study GS-US-334-0119 who meet relevant inclusion/exclusion criteria are eligible for retreatment in this study
- Chronic genotype 1 HCV infection
- HCV treatment-naive
- HCV RNA > 10, 000 IU/mL at screening
- Absence of cirrhosis
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria
- Pregnant or nursing female or male with pregnant female partner
- Infection with hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
- For HIV-1/HCV co-infected individuals:
- Opportunistic infection within 6 months prior to screening
- Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
- Treatment with an antiretroviral (ARV) regimen other than one of those listed in the study protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02472886) and the linked publication. 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.