Phase 3 N=335 Treatment

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

Hepatitis C Virus · HIV

Bottom Line

View on ClinicalTrials.gov: NCT02073656 ↗

Enrolled (actual)

335

Serious AEs

2.3%

Results posted

Oct 2016

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 96.1 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LDV/SOF (Drug); RBV (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	96.1	—
PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	—	—
SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	96.7; 96.1	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12	29.3; 81.2; 98.8; 99.1; 99.4; 100.0	—
SECONDARY Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8	-4.68; -5.21; -5.30; -5.30; -5.33	—
SECONDARY Percentage of Participants With Virologic Failure	0.6; 3.0	—
SECONDARY Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment	98.5; 98.2; 97.9	—
SECONDARY Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24	0.05; 0.03; -0.02	—
SECONDARY For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)	88.9; 88.9; 88.9	—
SECONDARY For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24	88.9; 100.0; 100.0; 100.0; 100.0; 100.0	—
SECONDARY For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8	-5.01; -5.04; -5.04	—
SECONDARY For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure	0; 11.1	—

Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1. Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.

Eligibility Criteria

Inclusion Criteria

HCV RNA ≥ 10, 000 IU/mL at screening
HCV genotype 1 or 4
HIV-1 infection
Cirrhosis determination, a fibroscan or liver biopsy may be required
Screening laboratory values within defined thresholds
Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male

Exclusion Criteria

Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol
Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers)
Hepatitis B virus (HBV) infection
Pregnant or nursing female
Chronic use of systemically administered immunosuppressive agents

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02073656). 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.