Clinical Trial Update - MINMON Study Fully Enrolled

In November 2018, the ACTG launched enrollment for A5360: A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations who are HCV Treatment Naïve with Evidence of Active HCV Infection or The MINMON Study. Globally, nearly 71 million people have chronic HCV, of whom an estimated 4-5 million also have HIV. In this context, there is an urgent need for advances in treatment delivery. In some parts of the world, the healthcare system itself - through requiring frequent visits and laboratory monitoring during HCV treatment - can lead to barriers to HCV treatment with the new easy-to-take once a day treatments for HCV cure. The basic premise of the study is to eradicate all of these healthcare system barriers. In A5360, patients (n=400) will be provided HCV treatment with sofosbuvir/velpatasvir (Epclusa) for 12 weeks without any traditional laboratory or clinical monitoring or planned visits.

We would like to announce now that MINMON is fully enrolled! Enrolling sites are in Africa, Brazil, India, Thailand, and the United States. Following HCV treatment, participants will be followed for an additional 72 weeks to assess the long-term outcomes related to HCV and liver disease, including the incidence of HCV reinfection. Study investigators hypothesize that this “minimal monitoring” for HCV treatment outcomes will result in more cost-efficient and effective paradigms in HCV treatment management, expanding the number of people who can achieve HCV cure worldwide.