DOT of Sofosbuvir/Ribavirin +/- Peginterferon with Minimal Monitoring for the Treatment of Hepatitis C in People who Use Drugs in Chennai, India (C-DOT)

Author: Sunil S Solomon, Mark S Sulkowski, Pradeep Amrose, Aylur K Srikrishnan, Allison M McFall, Balakrishnan Ramasamy, Muniratnam S Kumar, Santhanam Anand, David L Thomas, Shruti H Mehta

Theme: Clinical Research Year: 2017

Background: We assessed the feasibility of field-based directly observed therapy (DOT) with minimal monitoring to deliver HCV treatment to people who use drugs in Chennai, India.

Methods: C-DOT was a randomized, open-label trial of sofosbuvir + peginterferon alfa 2a + ribavirin (SOF+PR) for 12 weeks vs. sofosbuvir + ribavirin (SOF+R) for 24 weeks. 50 participants were randomized 1:1. Sofosbuvir and ribavirin were delivered daily at participant chosen venues and weekly peginterferon injections at a study clinic. HCV RNA testing was done to confirm active HCV infection and sustained virologic response 12 weeks after treatment completion (SVR12). No baseline genotyping or on-treatment viral loads were performed. The primary outcome was treatment completion. Primary analyses were intention-to-treat (ITT); per-protocol (PP) analyses were also conducted.

Results: Median age was 46. All were male, 54% had 10% of doses were missed with no discontinuations due to side effects. Further exploration of short duration treatment with peginterferon plus direct acting antivirals is warranted.

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