Minimal monitoring feasible in HCV patients on SOF/VEL

Minimal monitoring is feasible in patients with active hepatitis C virus (HCV) infection treated with sofosbuvir/velpatasvir (SOF/VEL), with high rates of sustained virologic response (SVR) reported, including in patients with novel HCV subtypes, according to new data from the phase IV MINMON study presented at IDDF 2023.

“High costs of pretreatment genotyping and on-treatment monitoring as well as overloaded healthcare systems represent major barriers to HCV elimination,” said Dr Sunil Solomon of the Division of Infectious Diseases, Johns Hopkins University, Maryland, US. “The COVID-19 pandemic further highlights the need for [treatment] simplification.”

The open-label, multi-country, single-arm phase IV MINMON study was conducted to evaluate the efficacy and safety of a minimal monitoring approach to HCV treatment delivery. Treatment-naïve patients with active HCV infection (n=377; median age, 47 years; female sex at birth, 35 percent) were given a full regimen of SOF/VEL (400/100 mg QD, 84 tablets for 12 weeks) at study entry and then remotely contacted at week 4 and week 22, without pretreatment genotyping and on-treatment clinic or lab visits. SVR was measured at week 24. [Lancet Gastroenterol Hepatol 2022;7:307-317]

Overall, 95 percent of patients who initiated treatment achieved SVR, while 89 percent of patients reported 100 percent adherence (ie, completion of the whole regimen). “Importantly, comparable SVR rates were seen across most subgroups, regardless of HIV coinfection status [HIV coinfection, 95.3 percent; no HIV coinfection, 94.6 percent] and history of substance use [current, 94.6 percent; previous, 94.1 percent; never, 95.9 percent],” pointed out Solomon.

These results prompted the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) to update their HCV treatment guidelines. Patients with HIV coinfection, who accounted for 42 percent of MINMON’s overall population, are now eligible for the minimal monitoring approach. [Clin Infect Dis 2023;doi:10.1093/cid/ciad319; Lancet Gastroenterol Hepatol 2022;7:307-317]

“The only subgroup who did not show comparable SVR rates was patients aged 20–29 [SVR, 84.8 percent], who also represent a challenging group in the HIV population,” reported Solomon.

Identification of the new HCV genotype (GT) 7c and novel GT4 subtypes highlights greater genetic diversity of HCV than previously recognized. In MINMON, SOF/VEL demonstrated efficacy against these novel strains, with 100 percent SVR rates. [Han WM, et al, CROI 2023, abstract 596]

“Notably, self-reported optimal adherence at week 4 was associated with a better SVR rate vs suboptimal adherence [96.5 percent vs 77.8 percent; p<0.001], indicating that week 4 is a time point to identify those at higher risk of treatment failure who may benefit from additional adherence support,” said Solomon. As patients aged <30 years were seven times more likely to have early suboptimal adherence vs their older counterparts (odds ratio, 7.12; 95 percent confidence interval, 2.53–19.6; p<0.01), this younger patient group should be prioritized for additional adherence support. [Clin Infect Dis 2023;76:1959-1968]

Fourteen patients (3.5 percent) in MINMON reported ≥1 serious adverse event, but none were related to SOF/VEL. No treatment discontinuation or death was reported through week 28.

“MINMON suggests that simplified HCV treatment is feasible, with SVR rates comparable to current clinical standards in treatment-naïve patients,” Solomon summarized.