Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection



Status:Completed
Conditions:Infectious Disease, HIV / AIDS, HIV / AIDS, HIV / AIDS, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:July 1, 2015
End Date:June 22, 2016

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A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of
treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV
infection who were coinfected with HIV-1.


Key Inclusion Criteria:

- HCV RNA ≥ 10^4 IU/mL at screening

- HCV genotype 1, 2, 3, 4, 5, 6

- Cirrhosis determination, a fibroscan or liver biopsy may be required

- HIV-1 infection

- Use of protocol specified method(s) of contraception

- Screening laboratory values within defined thresholds

Key Exclusion Criteria:

- Clinically-significant illness (other than HCV or HIV) or any other major medical
disorder that may interfere with individual's 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)

- Screening ECG with clinically significant abnormalities

- Pregnant or nursing female or male with pregnant female partner

- Infection with hepatitis B virus (HBV)

- Use of any prohibited concomitant medications as described in the protocol

- Chronic use of systemically administered immunosuppressive agents

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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