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There are several barriers that prevent better HCV care, including availability and access to diagnostic and monitoring tests and the requirement for frequent medical visits during treatment.
By taking an approach that limits medical visits, investigators believe they can improve sustained virologic response (SVR) rates for patients with hepatitis C virus (HCV).
A team, led by Sunil S. Solomon, MBBS, Johns Hopkins University School of Medicine, tested an approach to treatment in which each patient receives all the treatment upfront with less frequent medical visits or contact on patients with HCV.
While DAA therapy, including generic formulations, is incredibly successful in treating HCV, there has been limited progress made in the global adoption of HCV treatment. This is likely due to several existing barriers to treatment scale-up, including availability and access to diagnostic and monitoring tests, healthcare infrastructure, and the requirement for frequent medical visits during treatment.
In the phase 4, open-label, single-arm trial dubbed ACTG A5360, the investigators examined patients across 38 sites in Brazil, South Africa, Thailand, Uganda, and the US. Included in the study were adult patients with evidence of an active HCV infection HCV RNA >1000 IU/mL) and HCV-treatment naïve patients. In addition, patients with compensated cirrhosis and HIV and HCV co-infections were also included, but their enrollment was capped.
There were 400 patients enrolled between October 22, 2018 and July 19, 2019, 399 of which initiated treatment.
Each participant received a fixed dose combination or oral sofosbuvir 400 mg and velpatasvir 100 mg once daily for 12 weeks.
The MINMON Approach
The investigators also used the minimal monitoring approach (MINMON), which included no pre-treatment genotyping, the entire treatment course was dispensed at entry, no scheduled visits or laboratory monitoring, and 2 points of remote contact at week 4 for adherence and week 22 to schedule outcome assessment at week 24.
The team also allowed any participant who missed the week 24 outcome assessment to return for a visit at any point before week 72.
The investigators sought primary efficacy outcomes of sustained virological response, which was defined as HCV RNA less than the lower limit of quantification measured at least 22 weeks post-treatment initiation. They also sought primary safety outcomes of serious adverse events.
After assessing SVR, the investigators found 89% (n = 355) of patients reported taking 100% of the trial medication during the 12-week treatment period and 379 patients had an SVR (95%; 95% CI, 92.4-06.7).
They also found 4% (n = 14) participants reported serious adverse events between treatment initiation and week 28, but none were treatment related or led to treatment discontinuation of death. Also 4% (n = 15) participants had unplanned visits, but none were related to treatment.
“In this diverse global population of people with HCV, the MINMON approach with sofosbuvir–velpatasvir treatment was safe and achieved SVR comparable to standard monitoring observed in real-world data,” the authors wrote.“Coupled with innovative case finding strategies, this strategy could be crucial to the global HCV elimination agenda.”
The study, “A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial,” was published online in The Lancet Gastroenterology & Hepatology.