Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

Summary

HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide. Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.

Timeline

Start

2021-08-24

Primary completion

2024-09-17

Completion

2024-09-17

Publications

• Boesecke C, Workowski K, Gordon SC, Cave B, Marcinak J, Miller MG, Semizarov D, Welhaven A, Baumgarten A. Glecaprevir/Pibrentasvir for Acute Hepatitis C Virus Infection in Individuals with a History of Prior Hepatitis C Infection. Infect Dis Ther. 2026 Jun 24. doi: 10.1007/s40121-026-01381-w. Online ahead of print.
• Llibre JM, Boesecke C, Moon J, Lank PM, Miller MG, Fredrick LM, Welhaven A, Semizarov D, Marcinak J, Gentile I, Reiberger T, Puoti M. A single-arm phase IIIb study of 8-week glecaprevir/pibrentasvir treatment in adults with acute hepatitis C. J Hepatol. 2026 Apr;84(4):702-712. doi: 10.1016/j.jhep.2025.11.009. Epub 2025 Nov 24.

Drugs

Indications