Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

Summary

To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the \~71 million people with chronic HCV infection will need to be treated, necessitating simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety. The COVID-19 pandemic has further highlighted the need for innovative models of health care delivery that minimize face-to-face patient-provider contact. The purpose of this study was to evaluate the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy to deliver interferon- and RBV-free, pan-genotypic DAA therapy to treat active HCV in HCV treatment naïve participants.

Timeline

Start

2018-10-22

Primary completion

2020-07-30

Completion

2021-02-28

Publications

• Torres TS, Saha PT, Smeaton L, Wimbish C, Kliemann DA, Avihingsanon A, Kityo C, Bennet JA, Van Schalkwyk M, Linas B, Nunes EP, Robbins GK, Wyles D, Naggie S, Sulkowski M, Cardoso SW, Solomon S. Impact of a minimal monitoring HCV treatment approach on Health-Related Quality of Life. Qual Life Res. 2025 Jun;34(6):1683-1694. doi: 10.1007/s11136-025-03922-1. Epub 2025 Feb 28.
• Han WM, Solomon SS, Smeaton L, Avihingsanon A, Wagner Cardoso S, Li J, Parvangada A, Sulkowski M, Naggie S, Martin R, Mo H, Maiorova E, Wyles D. Reinfection and Resistance Associated Substitutions Following a Minimal Monitoring Approach for Hepatitis C Virus Treatment in MINMON Trial. Clin Infect Dis. 2025 Jul 18;80(6):1293-1301. doi: 10.1093/cid/ciae627.
• Sowah LA, Smeaton L, Brates I, Bhattacharya D, Linas B, Kreter B, Wagner-Cardoso S, Solomon S, Sulkowski M, Robbins GK. Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment. Clin Infect Dis. 2023 Jun 8;76(11):1959-1968. doi: 10.1093/cid/ciad034.
• Solomon SS, Wagner-Cardoso S, Smeaton L, Sowah LA, Wimbish C, Robbins G, Brates I, Scello C, Son A, Avihingsanon A, Linas B, Anthony D, Nunes EP, Kliemann DA, Supparatpinyo K, Kityo C, Tebas P, Bennet JA, Santana-Bagur J, Benson CA, Van Schalkwyk M, Cheinquer N, Naggie S, Wyles D, Sulkowski M. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):307-317. doi: 10.1016/S2468-1253(21)00397-6. Epub 2022 Jan 10.

Drugs

Indications