by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
February 1, 2022
Solomon SS, Wagner-Cardoso S, Smeaton L, et. al. 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 Jan 10: S2468-1253(21)00397-6. doi: 10.1016/S2468-1253(21)00397-6. Online ahead of print. PMID: 35026142
The MINMON trial examined efficacy and safety of a minimal monitoring strategy for delivering HCV treatment to a diverse, global population of treatment-naïve participants. 400 HBsAg-negative adults seen at infectious disease clinics—most affiliated with universities—in Brazil, South Africa, Thailand, Uganda, and the U.S. were staged based on FIB-4 index (no pre-treatment HCV genotype assessment was performed): compensated cirrhosis was defined as FIB-4 ≥ 3.25 and Child-Pugh score ≤ 6. Enrollment occurred between October 2018 and July 2019: over 40% of participants were living with HIV (99% were receiving suppressive non-efavirenz based ART). 12 weeks of sofosbuvir/velpatasvir was dispensed at study entry, and no scheduled clinic or laboratory monitoring visits were conducted before the 24-week efficacy outcome assessment. Remote contact occurred at: (a) week 4 to assess adherence, and (b) week 22 to schedule outcome assessment visit (participant contact information was updated at both points). 91% of participants self-reported completing all study medications at the expected 84-day timepoint (+/- 1 week). 89% reported taking 100% of medications within the treatment period and 8% reported taking 90-99%. Overall, 95% experienced SVR: subgroup analyses indicated lower SVR rates among participants with cirrhosis (88.2% vs. 95.6%), participants < 30 years of age (84.8% vs. 95.9%), and participants with genotype 3. SVR was > 94% for participants with current or previous history of substance use. 4% experienced at least one serious adverse event, and 6% experienced non-serious events: 5 cases of non-serious events were attributed to study medication.
Findings of this trial, shared at the 2020 AASLD Liver Meeting, are highly encouraging and especially relevant given the clinical evaluation and follow-up modifications that some practices have explored or adopted to maintain delivery of HCV services during the COVID-19 pandemic. High rates of participant follow-up and SVR were observed using the MINMON intervention model that included baseline dispensation of the full 12-week treatment course and elimination of all scheduled on-treatment in-person clinical and laboratory monitoring visits. As authors note, changes in such medication dispensing and monitoring workflows “reduce patient, provider, and health system costs”. Additional studies exploring other HCV treatment regimens and also outcomes for specific subgroups (i.e. younger individuals as well as people with genotype 3, cirrhosis, and/or prior HCV treatment experience) will shed further light on new approaches to HCV care delivery that balance safety, efficacy, patient/provider experience, and health system resources.
The author has no conflicts of interest to disclose.
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