Short Course Therapy With Glecaprevir/Pibrentasvir for Early Hepatitis C Virus Infection: PURGE-C.

BACKGROUND: Shorter treatment courses for early hepatitis C virus (HCV) infection could simplify treatment approaches, particularly in key populations. METHODS: PURGE-C (A5380) was a single-arm, multicenter trial evaluating the treatment of early HCV (primary or reinfection) with 4 weeks of glecaprevir/pibrentasvir (G/P). Early HCV was defined as new detectable HCV RNA or alanine aminotransferase (ALT) elevation within 24 weeks of study entry. The primary endpoint was sustained virologic response (SVR) 12 weeks after prescribed treatment completion (SVR12). Re-treatment outcomes were also collected. RESULTS: Forty-five participants (98% male, 51% White, 31% Hispanic, median age 36 years, 51% with human immunodeficiency virus [HIV], 27% self-reported injecting drugs) were enrolled from the United States and Brazil between November 2019 and January 2023. Median time from HCV diagnosis to entry was 31 days (Q1-Q3: 15-49). Median baseline HCV RNA was 5.3 log10 IU/mL (Q1-Q3: 3.3-6.0) and ALT 146 U/L (min-max: 22-3866). Overall, 38 of 45 (84%) participants (90% confidence interval [CI]: 74%-91%) achieved SVR12. All 4 participants who were retreated and had outcome data achieved SVR12. CONCLUSIONS: In this population with elevated risk of onward HCV transmission, 84% were cured with 4 weeks of G/P. Failing this short-course treatment did not compromise retreatment. This study suggests that people with early HCV infection can achieve moderately high cure rates with abbreviated courses of direct-acting antivirals (DAA). Simplified approaches to treatment are critical for HCV elimination and are particularly relevant for populations difficult to retain in care. CLINICAL TRIAL REGISTRATION: NCT04042740.

Duke Scholars

Author Susanna Naggie Medicine, Infectious Diseases