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



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:February 2014
End Date:December 2015

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A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

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.


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
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