LAUSR

Methods: PREVAIL is a randomized controlled trial that enrolled HCV-infected (genotype 1) PWID maintained on OAT, including those actively using drugs. Participants were randomized to one of three models of HCV care delivered on-site in an OAT program: 1) directly observed treatment (DOT), 2) group medical visit (Group), or 3) individual treatment as usual (TAU). Participants received DAAs according to AASLD guidelines: telaprevir/pegylated interferon/ribavirin (TVR/PEG/RBV), sofosbuvir/ribavirin (SOF/RBV), sofosbuvir/pegylated interferon/ribavirin (SOF/PEG/RBV), sofosbuvir/simeprevir (SOF/SMV), or sofosbuvir/ledipasvir (SOF/LDV). The primary outcome was SVR12 and secondary outcomes were end of treatment response (ETR) and SVR12. Drug use (opiates, cocaine, and benzodiazepines) was assessed through urine screens. Differences by arm were tested by a Fisher exact test, and the 95% confidence interval (CI) for virological outcomes were determined by the ClopperPearson method.