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

Saint Michael's Medical Center

Status and phase: Completed; Phase 4

Conditions: HIV Infection; Hepatitis C Infection

Treatments: Drug: Sofosbuvir, Ribavirin, and Stribild

Study type: Interventional

Funder types: Other

Identifiers

NCT02220868

IN-US-334-1527

Details and patient eligibility

About

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

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Sofossbuvir, Riabvirin, Stribild

Other group

Description:

Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild

Treatment:

Drug: Sofosbuvir, Ribavirin, and Stribild