COVID-19 has further highlighted the need for innovative models that minimize face-to-face contact in HCV treatment.
The Hepatitis C virus (HCV) is one of the most common blood-borne infections in the world. The infection, which attacks the liver and causes inflammation, presents a serious burden on health care globally. People who contract the virus often go on to develop chronic illness and there is currently no vaccine for the disease.
There are roughly 71 million people who have HCV around the planet. In order to achieve the broad goal of eliminating the virus by 2030, 80% of those with HCV will need to be treated. This means a simplification of treatment delivery and associated laboratory monitoring without compromising efficacy or safety is needed.
A recent study, conducted by investigators from the Johns Hopkins University School of Medicine, has focused on a way to do this. The data was presented during the Conference on Retroviruses and Opportunistic Infections (CROI) 2021 virtual sessions.
The study, a single-arm, open-label trial named ACTG A5360, evaluated the safety and efficacy of a minimal monitoring (MINMON) approach to HCV therapy in treatment-naïve persons with no evidence of decompensated cirrhosis. Included in the trial were 400 participants from 38 sites in 5 countries across 4 continents. The participants received a single-tablet, fixed-dose regimen of sofosbuvir/velpatasvir for 12 weeks.
Of the 399 who initiated treatment, the median age was 47, with (35% being cisgender women, 22 self-identifying across the transgender spectrum, and 166 being White. The MINMON approach included no genotyping, all tablets being dispensed at entry, no on-treatment visits/labs and 2 remote contacts at Weeks 4 (adherence assessment) and 22 (scheduling sustained virology response [SVR] visit).
Findings from the study showed that the remote contact was successful at weeks 4 for 99% of the participants and successful at weeks 22 for 84% of the participants. Additionally, 95% of the participants achieved SVR.
“In a diverse, global patient population, the MINMON approach to HCV treatment delivery was safe and achieved SVR comparable to current standards,” the authors wrote. “Wider adoption of this approach coupled with innovative case-finding strategies may facilitate HCV elimination while minimizing in-person appointments and resource use.”