Theme: Clinical Research Year: 2018
All-oral therapy has turned HCV into an easily curable disease, with trial data showing SVR
rates of > 90%. However, real-life SVR rates are slight lower in intent-to-treat (ITT) analyses.
While per-protocol SVR rates remain high (highlighting treatment efficacy), LTFU may reduce
the overall cure rate. The aim of this study was to evaluate the impact of LTFU on ITT SVR
rates in a population of people who drug users (PWUD) actively.
A retrospective analysis was performed on all HCV-infected patients who were treated at our
centre from May 2014-Dec 2017. All subjects were enrolled in a multidisciplinary model of care,
addressing medical, psychologic, social, and addiction-related needs. The primary outcome was
SVR12 and occurrence LTFU in the active PWUD sub-group.
At data-lock, 229 individuals had completed all-oral therapy: mean age of 54 years, 27% female,
46% active PWUD (drug use < 6 months, 82% opiate use), 63% HCV GT1a, and 22% cirrhotic. The ITT SVR rate was 90% while the modified ITT (mITT) SVR rate was 94%, with 7 relapses, 13 LTFU, and 2 discontinuations. Stratified ITT SVR rates show that active PWUD were significantly less likely to achieve SVR (84% ITT SVR) (p=0.0185). Active PWUD accounted for 70% of LTFU and 100% of discontinuations. The mITT SVR in was 88% in this cohort. Comparing mITT rates of active and the remaining population showed no significant difference in cure rates (p=0.1157). All individuals that were LTFU (4) after the end of treatment had undetectable HCV RNA. Conclusion: While it may seem that active PWUD are less likely to cure HCV compared to the general population, this is mainly driven by LTFU. It will be important to develop strategies to address the LTFU rate in this population and document their virologic outcomes within the context of WHO HCV elimination goals. Conflicts: AA– Travel grants from AbbVie and Merck & Co. JH – Nothing to declare YR – Nothing to declare AT – Nothing to declare DT – Honoraria from Merck & Co. BC – Grants, honoraria, travel funding, and advisory board positions with AbbVie, Merck & Co, Gilead Sciences, and ViiV.