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. 2025 Jul 30:ciaf305.
doi: 10.1093/cid/ciaf305. Online ahead of print.

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

Arthur Y Kim  1 , Minhee Kang  2 , Triin Umbleja  2 , Estevão P Nunes  3 , Kristen M Marks  4 , Anne F Luetkemeyer  5 , Carrington Koebele  6 , Chanelle Wimbish  7 , Daniel S Fierer  8 , Dimas A Kliemann  9 , Sunil S Solomon  10 , Jens Kort  11 , Jennifer J Kiser  12 , Georg M Lauer  1 , Raymond T Chung  1 , Leonard A Sowah  13 , Beverly L Alston-Smith  13 , David L Wyles  14 , Susanna Naggie  15 ; A5380 Study Team
Collaborators, Affiliations

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

Arthur Y Kim et al. Clin Infect Dis. .

Abstract

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.

Keywords: acute infection; direct acting antivirals; human immunodeficiency virus; interferon-free; interferon-sparing.

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Conflict of interest statement

Potential conflicts of interest. A. Y. K. has served on a data monitoring committee for Shionogi, Inc.(Osaka, Japan). K. M. M. reports serving on a data monitoring committee for Immorna and Novo Nordisk and grants to her institution from Gilead and GlaxoSmithKline. A. F. L. reports grants to her institution from Gilead, GlaxoSmithKline, Merck, and Cepheid. D. S. F. reports grants to his institution from Merck and Gilead Pharmaceuticals. S. S. S. reports grants to his institution and honoraria from Abbott Laboratories and Gilead Sciences. J. K. is an employee and shareholder of AbbVie, Inc. (North Chicago, Illinois, USA). J. J. K. is an employee and shareholder of Merck & Co. Inc. (Rahway, New Jersey, USA). R. T. C. reports grants to his institution from Bristol-Myers Squibb, AbbVie, Boehringer, Janssen, Gilead, Merck, Roche, GSK, and Salix. L. A. S. is a former employee and current shareholder of Gilead Sciences (Foster City, California, USA). S. N. has grants to her institution from Abbott Laboratories and Gilead Sciences and is a current shareholder in Vir (San Francisco, California, USA). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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