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FIELD-BASED DELIVERY OF HCV THERAPY WITH MINIMAL MONITORING TO PWID IN CHENNAI, INDIA
Sunil S. Solomon1, Amrose Pradeep2, Mark Sulkowski1, Aylur K. Srikrishnan2, Nandagopal Paneerselvam2, Shanmugam Saravanan2, Santhanam Anand2, Muniratnam S. Kumar2, David Thomas1, Shruti H. Mehta3
1Johns Hopkins Univ Sch of Med, Baltimore, MD, USA,2YR Gaitonde Cntr for AIDS Rsr and Educ, Chennai, India,3Johns Hopkins Univ, Baltimore, USA
In 2016, WHO released elimination targets for hepatitis C virus (HCV), but for these to be achieved, strategies must target those hardest-to-treat in low-and-middle-income countries (LMICs) such as people who inject drugs (PWID). Access in LMICs has improved with generic antivirals (~$200/28 days) but monitoring remains expensive (HCV RNA=$80; genotype=$90). We evaluated the feasibility of field-based directly observed therapy (DOT) with minimal molecular monitoring for delivery of HCV therapy to current and former PWID in Chennai, India, where genotype (GT) 3 or 1 infections are common.
From 9/2015 – 3/2016, 50 PWID were randomized 1:1 to Arm 1: Sofosbuvir+Peginterferon+Ribavirin (SOF+PR) for 12 weeks or Arm 2: Sofosbuvir+Ribavirin (SOF/RBV) for 24 weeks. HCV RNA testing was done at baseline and 12 weeks after the end of treatment (EOT) to measure sustained virologic response 12 (SVR; HCV RNA
All were male; median age was 46; 2 were HIV co-infected and 20% had an elastography score >12.3 kPA (cirrhosis). Six discontinued (3 per arm) – none due to side effects (treatment completion in each arm: 88%). Of 44 who completed treatment, median missed doses were 2 with SOF+PR (range: 0-18) and 6 (range: 0-39) with SOF/RBV. All 22 who completed treatment with SOF+PR achieved SVR (88%: [22/25]). Of the 16 who completed SOF/RBV treatment and had SVR data at abstract submission, 11 achieved SVR (58% [11/19]). Of the HCV failures with SOF/RBV, 2 had GT1a and 3 GT3a infection; 4 had HCV RNA
Field-based DOT of HCV therapy without real-time molecular monitoring was logistically feasible; however achieving 100% adherence was challenging. SOF+PR appeared superior to SOF/RBV in achieving SVR, especially in those who missed doses with no discontinuations due to side effects. In settings where injections are perceived more effective than pills and adherence may be challenging, there may remain a role for peginterferon in combination with oral direct acting antivirals for short treatment durations.