Directly Observed Therapy for HCV in Chennai, India

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.

Timeline

Start

2015-09

Primary completion

2016-12

Completion

2016-12

Publications

• Solomon SS, Sulkowski MS, Amrose P, Srikrishnan AK, McFall AM, Ramasamy B, Kumar MS, Anand S, Thomas DL, Mehta SH. Directly observed therapy of sofosbuvir/ribavirin +/- peginterferon with minimal monitoring for the treatment of chronic hepatitis C in people with a history of drug use in Chennai, India (C-DOT). J Viral Hepat. 2018 Jan;25(1):37-46. doi: 10.1111/jvh.12761. Epub 2017 Aug 14.

Drugs

Indications