Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Saint Michael's Medical Center
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).
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
