November 17, 2020
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Solomon S. Late End Oral Session 2. Presentation: The Liver Meeting Digital Experience; November 13-16, 2020.
Solomon receives a grant or research grant from Abbott Diagnostics and Gilead Sciences. This study was supported by Gilead Sciences by providing a product for the study.
In a minimal monitor – or “Minmon” – study, patients were given a complete 95% control of the hepatitis C virus regimen and then achieved a remote virological response that was remotely monitored, according to a presenter at The Liver Meeting Digital Experience.
“Although this trial was designed before the COVID pandemic, I like to think of COVID as evidence or a respectable COVID. COVID has really asked us to focus clinical programs on minimizing contact and remote approaches, which is theoretically the essence of the Minmon strategy.” Sunil Solomon, PhD, MPH, MBBS, From Johns Hopkins, he said. “Eliminating genotyping and treatment assessments saves a lot of resources and greatly improves access to treatment in low-income countries. Integrating Minmon’s case-finding strategies with innovative strategies can help achieve the WHO’s ambitious goals of eliminating HCV in the context of the uncertainties we face today. “
The Minmon strategy defined by Solomon employed four tenants: no pre-treatment genotype, 84 pills given at the entrance to the research to complete the 12-week treatment, scheduled clinical treatment visits or laboratory requirements, and remote contact at 4 to 22 weeks SVR was measured at 24 weeks. The study used Epclusa (sofosbuvir / velpatasvir, Gilead Sciences) for 12 weeks.
“There is an urgent need for simple and safe models,” Solomon said. “We designed this study in 2016 before the widespread use of pangenotypes and before the COVID-19 pandemic that somehow normalized the use of telemedicine.”
399 naive treatments in five countries were injecting drug users (3% current; 31% previous), patients with cirrhosis (9%) and people with HIV co-infection (42%). Researchers have ruled out people with HBV, decompensated cirrhosis, or pregnancy.
“Minmon’s strategy, by design, doesn’t allow us to really see what happened during treatment, but what we do know is that we can get in touch with almost everyone in week 4,” he said. “Almost all of them showed up for the SVR assessment.”
Solomon reported that 99% of participants received a long-term relationship at 4 weeks and 84% at 22 weeks. According to him, there were 21 unplanned visits from 15 participants (3.8%) to adverse events, abnormal laboratory values or other clinical events. All three participants reported losing their medications.
Data on 396 participants were available, of which 379 achieved a 95% rate (95% CI, 92.4–96.7).
In the unresponsive SVR (n = 20), Solomon indicated that they were less likely to have 100% adherence (67% vs. 91% responded in the group) and the number included two participants who were not reported for their SVR examination.
Fourteen participants reported at least one serious adverse event with a rate of 3.5% (95% CI, 2.1–5.8); five of these occurred while they were in treatment, but the researchers did not determine the reason for the treatment or discontinuation of treatment.
“We did not make any basic entry visits and used the tests available in all the usual clinical settings,” Solomon said. “The safe and simple approach to HCV surveillance with Minmon sof / vel is comparable to current clinical standards that have no evidence of decompensated cirrhosis of naïve treatment participants with SVR.”