November 17, 2020
2 min read
Solomon S. Late-breaking Oral Session 2. Presented at: The Liver Meeting Digital Experience; November 13-16, 2020.
Solomon reports grant or research support from Abbott Diagnostics and Gilead Sciences. This study was supported by Gilead Sciences, which provided study product.
In a minimal monitoring – or “Minmon” – study, patients given a full regimen for hepatitis C virus and then remotely monitored achieved 95% sustained virologic response, according to a presenter at The Liver Meeting Digital Experience.
“Though this trial was designed before the COVID pandemic, I like to think of it as COVID-proof or COVID-friendly even. COVID really has required us to pivot clinical programs to minimizing contact and remote approaches which in theory is the essence of the Minmon strategy,” Sunil Solomon, PhD, MPH, MBBS, from Johns Hopkins, said. “Elimination of genotyping and on-treatment evaluations saves a lot of resources and greatly improves treatment access in low middle-income countries. Integrating Minmon with innovating case finding strategies really can help achieve WHO’s ambitious HCV elimination goals even in the context of the uncertainties we live in currently.”
The Minmon strategy outlined by Solomon employed four tenants: no pre-treatment genotyping, all 84 tablets provided at entry to the study to complete 12 weeks of treatment, no scheduled on-treatment clinic visits or lab requirements and remote contact at weeks 4 and 22. SVR was measured at week 24. The study used Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) for 12 weeks.
“There is an urgent need for simple and safe models,” Solomon said. “We did design this study in 2016 before widescale use of pangenotypics and way before the COVID-19 pandemic that has in some ways normalized the use of telemedicine.”
The 399 treatment-naive participants across five countries included injection drug users (3% current; 31% previous), patients with cirrhosis (9%) and people with HIV co-infection (42%). Researchers excluded people with HBV, decompensated cirrhosis or pregnancy.
“The Minmon strategy, by design, doesn’t allow us to really see what happened during the treatment period but what we do know is that at week 4, almost everyone was contacted,” he said. “Almost all showed up for their SVR assessment.”
Solomon reported that 99% of participants received contact at the week 4 remote contact and 84% received the week 22 outreach. He said there were 21 unplanned visits from 15 participants (3.8%) for adverse events, abnormal lab values or other clinical events. Three participants reported losing medication.
SVR data were available for 396 participants, of whom 379 achieved SVR for a rate of 95% (95% CI, 92.4-96.7).
In the SVR non-responders (n = 20), Solomon noted they were less likely to have 100% adherence (67% vs. 91% in the responders group) and the number included two participants who did not report for their SVR testing.
Fourteen participants reported at least one serious adverse event for a rate of 3.5% (95% CI, 2.1-5.8); five of these occurred while on treatment but investigators did not determine any as related to treatment or cause of discontinuation of treatment.
“We had no visits besides for the baseline entry visits and we used tests that are routinely available in all clinical settings,” Solomon said. “Minmon with sof/vel is a keep it safe and simple approach to HCV care delivery with SVR comparable to current clinical standards in treatment-naive participants with no evidence of decompensated cirrhosis.”