Clareo Health | 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
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
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Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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