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

Phase 4

Completed

• Conditions: Hepatitis C Infection; HIV Infection
• Interventions: Drug: Sofosbuvir, Ribavirin, and Stribild

• Registration Number: NCT02220868
• Lead Sponsor: Saint Michael's Medical Center

Brief Summary

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

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).

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sofossbuvir, Riabvirin, Stribild	Sofosbuvir, Ribavirin, and Stribild	Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild

Primary Outcome Measures

Name	Time	Method
• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy	12 weeks post treatment	patients who have achieved non-detectable HCV levels 12 weeks post treatment

Trial Locations

Locations (1)

Saint Michael's Medical Center; 🇺🇸 Newark, New Jersey, United States