Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study

The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of
sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on
fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).

Inclusion Criteria:

- 18 years of age or older

- Chronic HCV genotype 1 infection

- Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.

- CD4 count >200 cells/mm3 at screening and no CD4 count <200 in previous 12 weeks

- HIV RNA PCR <50 copies/ml at screening and no HIV RNA PCR > 200 copies/ml in previous
12 weeks

Exclusion Criteria:

- History of integrase inhibitor resistance

- History of integrase inhibitor failure

- Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans <1200/mm3

- Patients with cirrhosis

- Platelet count under 90,000 per cubic millimeter

- Hemoglobin levels <11 gm/dl in women or <12 gm/dl in men

- Previous treatment with a DAA

- Hepatocellular carcinoma

- AFP>100 ng/mL

- hepatitis B virus (HBsAg positive)

- Evidence of decompensated liver disease including, but not limited to, a history of
presence of clinical ascites, bleeding varices, or hepatic encephalopathy