A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects With Genotype 1, 4, 5 and 6 Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
Overview
- Phase
- Phase 2
- Intervention
- LDV/SOF
- Conditions
- Hepatitis C Virus Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 95
- Locations
- 21
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Exclusion Criteria
- Not provided
Arms & Interventions
LDV/SOF for 8 weeks
Treatment-naive participants with genotype 1 without cirrhosis will receive LDV/SOF for 8 weeks
Intervention: LDV/SOF
LDV/SOF for 12 weeks
Treatment-experienced participants with genotype 1 and treatment-naive or treatment-experienced participants with genotype 2 (Taiwan only), 4, 5 and 6 without cirrhosis will receive LDV/SOF for 12 weeks
Intervention: LDV/SOF
LDV/SOF for 24 weeks
Participants with compensated cirrhosis will receive LDV/SOF for 24 weeks
Intervention: LDV/SOF
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method.
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Time Frame: First dose date up to Week 24
Secondary Outcomes
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ on Treatment(Weeks 2, 4, 6, 8, 12, 16, 20, 24)
- Change From Baseline in HCV RNA(Weeks 2, 4, 6, 8, 12, 16, 20, 24)
- Percentage of Participants With Virologic Failure(Baseline up to Posttreatment Week 24)
- Percentage of Participants Who Developed Resistance to LDV and SOF(Baseline up to Posttreatment Week 24)
- Pharmacokinetics (PK) Parameter: AUCtau of LDV(Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)))
- PK Parameter: AUCtau of SOF(Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)))
- Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)
- HCV RNA(Weeks 2, 4, 6, 8, 12, 16, 20, 24)
- PK Parameter: Cmax of LDV(Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)))
- PK Parameter: Cmax of SOF(Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)))
- PK Parameter: Cmax of GS-331007 (Metabolite of SOF)(Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)))
- PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)(Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)))