Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

Phase 3

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: LDV/SOF; Drug: RBV

• Registration Number: NCT02472886
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-16
• Study Start: 2015-06-17
• Primary Completion: 2016-03-30
• Study Completion: 2016-06-30
• Status Verified: 2017-03
• Results First Submitted: 2017-03-30
• Results First Submitted QC: 2017-03-30
• Results First Posted: 2017-05-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDV/SOF+RBV Retreatment	LDV/SOF	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.
LDV/SOF	LDV/SOF	Treatment-naive participants with genotype 1 HCV infection without cirrhosis will receive LDV/SOF FDC for 8 weeks.
LDV/SOF Coinfected with HIV-1	LDV/SOF	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.
LDV/SOF+RBV Retreatment	RBV	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	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)	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HCV RNA < LLOQ on Treatment	Up to 12 weeks
HCV RNA Change From Day 1	Up to 12 weeks
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	Virologic failure was defined as; * On-treatment virologic failure; * confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ, while on treatment (ie, breakthrough),; * confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse); * Relapse; * HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
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	SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
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