Clinical trial NCT02541409
Conditions: Hepatitis C, Chronic
Keywords: directly observed therapy sofosbuvir ribavirin pegylated interferon resource-limited setting
Sponsor: Johns Hopkins Bloomberg School of Public Health
Start date: 2015-09-01; Completion date: 2016-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this pilot trial is to evaluate the feasibility of 12 weeks vs. 24 weeks of field-based directly observed therapy (DOT) for HCV therapy in a resource-limited setting. The investigators will compare treatment completion rates among 50 persons chronically infected with HCV who will be randomized to receive either 1) 12 weeks of sofosbuvir (SOF) + ribavirin (RBV) + pegylated interferon alfa-2a (PEG); or 2) 24 weeks of SOF + RBV. Treatment will be delivered daily by field workers at a location of a participants choosing. Secondary objectives are 1) To compare the efficacy of SOF+RBV with or without PEG as measured by the proportion of subjects with sustained viral response at 12 weeks after discontinuation of therapy (SVR12); 2) To evaluate the safety and tolerability of SOF+RBV with or without PEG; 3) To assess the impact of SVR12 on insulin resistance.

Detailed description:
This will be a non-blinded randomized clinical trial with 50 participants randomized at a 1:1 allocation ratio to one of two treatment arms.

Arm 1: Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks

Arm 2: Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks

Pegylated-interferon alfa-2a (PEG) will be delivered subcutaneously once weekly. Sofosbuvir (SOF) and ribavirin (RBV) will be taken orally once daily for the entire study period.

The study will take place at the YR Gaitonde Centre for AIDS Research and Education (YRGCARE). YRG CARE is a non-profit medical and research institution in Chennai. YRGCARE Medical Centre provides medical care for more than 18,000 persons with HIV disease. Currently more than 8000 persons are receiving highly active antiretroviral therapy at the center.

Participants will be recruited from the YR Gaitonde Centre for Substance Abuse Research (YRGCSAR), which is affiliated with YRGCARE. The investigators will primarily recruit subjects from a cohort study of current and former people who inject drugs (PWID) that is ongoing at the same center. Eligible participants will be randomized to one of the two treatment arms after providing written informed consent. Treatment will be delivered directly to participants daily by field workers at a location of the participants choosing. Participants will be asked to visit the study clinic every four weeks during treatment and 12 weeks after completing treatment for additional study procedures. In addition, participants in Arm 1 will be asked to visit the clinic every week to receive their PEG injection.

The primary outcome is treatment completion. Secondary outcomes include SVR12, safety and tolerability and insulin resistance.

Arms: arm 1: Sofosbuvir (400mg/daily) + Pegylated Interferon alfa-2a (180µg/weekly) + Ribavirin (800mg/daily) for 12 weeks arm 2: Sofosbuvir (400mg/daily) + Ribavirin (800mg/daily) for 24 weeks
Interventions: intervention 1: Sofosbuvir intervention 2: Pegylated Interferon alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: Direct acting antiviral agent used for the treatment of hepatitis C intervention 2: Antiviral agent used for the treatment of hepatitis C intervention 3: Antiviral agent (guanosine analogue) used for the treatment of hepatitis C

Protocol documents: