Phase 2 N=26 Treatment

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

Hepatitis C Infection With HIV Co-Infection

Bottom Line

View on ClinicalTrials.gov: NCT02457611 ↗

Enrolled (actual)

Serious AEs

3.9%

Results posted

Feb 2017

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12) — 76.9 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LDV/SOF (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)	76.9	—
PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	—	—
SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)	84.6	—
SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment	73.1; 88.5; 96.2	—
SECONDARY Change From Baseline in HCV RNA at Weeks 2, 4, and 6	-4.01; -4.16; -4.17	—
SECONDARY Percentage of Participants With Virologic Failure	15.4	—
SECONDARY Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.	—	—
SECONDARY Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4	100.0; 100.0; 95.2; 100.0	—
SECONDARY Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4	-0.3; 0.4	—

Summary

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.

Eligibility Criteria

Key Inclusion Criteria

Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks
Confirmed HIV-1 infection
CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/μL at screening for individuals without ART
Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner

Key Exclusion Criteria

Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non HCV etiology
Coinfection with hepatitis B virus (HBV)
Treatment with any investigational drug or device within 60 days of the screening visit.
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02457611). 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.