A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
Overview
- Phase
- Phase 3
- Intervention
- LDV/SOF
- Conditions
- Hepatitis C Virus Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 153
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
LDV/SOF
Treatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks.
Intervention: LDV/SOF
LDV/SOF Coinfected with HIV-1
Treatment-naive participants with genotype 1 HCV infection without cirrhosis and who are coinfected with HIV-1 will receive LDV/SOF FDC for 8 weeks.
Intervention: LDV/SOF
LDV/SOF+RBV Retreatment
Participants with genotype 1 or 3 HCV infection who failed to achieve SVR12 in Gilead Study GS-US-334-0119 will receive LDV/SOF FDC + RBV for 12 weeks.
Intervention: LDV/SOF
LDV/SOF+RBV Retreatment
Participants with genotype 1 or 3 HCV infection who failed to achieve SVR12 in Gilead Study GS-US-334-0119 will receive LDV/SOF FDC + RBV for 12 weeks.
Intervention: RBV
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)
Time Frame: Up to 12 weeks
Secondary Outcomes
- For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4(Up to Posttreatment Week 4)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With HCV RNA < LLOQ on Treatment(Up to 12 weeks)
- HCV RNA Change From Day 1(Up to 12 weeks)
- Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4(Up to Posttreatment Week 4)