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

Study Overview
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Brief Summary
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The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.

Detailed Description
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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).

Official Title
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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

Conditions
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Hepatitis C Infection, HIV Infection

Intervention / Treatment
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* Drug: Sofosbuvir, Ribavirin, and Stribild


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sofossbuvir, Riabvirin, Stribild<br>Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild | Drug: Sofosbuvir, Ribavirin, and Stribild<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy | patients who have achieved non-detectable HCV levels 12 weeks post treatment | 12 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, HCV, DAA