Development of novel direct acting antivirals (DAAs) has led to > 95% sustained virological response rates (SVR12) in patients with hepatitis C virus (HCV) in controlled clinical trials.
The purpose of this study was to evaluate the safety and efficacy of DAAs in a non-controlled setting.
This retrospective cohort included patients who initiated on DAAs between May 2014 and May 2018. The primary endpoint was SVR12. Descriptive statistics were used to analyze the results. Bivariate associations between patients achieving treatment success and demographic and clinical variables were conducted using chi-square, Fisher's exact test, and independent samples t-test with a two-sided alpha value of 0.05.
Of the 50 patients with HCV who were initiated on DAAs, 3 were lost to follow-up and 1 died during treatment. SVR12 was achieved in 42 of 50 (84%) patients by ITT analysis and in 42 of 45 (93%) patients by the per-protocol analysis. Two patients died and 3 were lost to follow-up (LTFU). All 3 patients LTFU had a history of heroin use; this was the only demographic factor significantly associated with treatment failure (Fisher's exact p = 0.02).
Findings from our cohort indicate that SVR12 rates based on ITT analysis are lower than the > 95% rates seen in large controlled clinical trials, mainly due to patients being lost to follow-up. These findings suggest that a gap remains in the HCV treatment cascade, especially in the underserved populations and persons with a history of drug use.