Minimal monitoring induces sustained virological response in HCV

Among patients treated with sofosbuvir and velpatasvir for hepatitis C virus, the minimal monitoring approach achieved sustained virological response similar to standard monitoring, according to research.

“In low-income and middle-income countries, where over 80% of individuals with chronic HCV reside, costs associated with recommended diagnostics such as pretreatment genotyping and on-treatment monitoring can be higher than the cost of medications or are often unavailable. Additionally, overburdened health care infrastructure is a key challenge to expanded access to HCV treatment,” Sunil S. Solomon, MBBS, PhD, MPH, associate professor of medicine in the infectious diseases department at The Johns Hopkins University School of Medicine, and colleagues wrote. “The AIDS Clinical Trials Group Minimal Monitoring (ACTG A5360 [MINMON]) trial examined the efficacy and safety of a minimal (in-person) monitoring strategy of HCV treatment delivery in a diverse global population living with HCV.”

In a phase 4, international, open-label trial, researchers enrolled 400 treatment-naive patients with HCV infection from 38 sites in Brazil, South Africa, Thailand, Uganda and the United States. Patients received a fixed dose combination of 400 mg sofosbuvir and 100 mg velpatasvir once daily for 12 weeks. The primary outcome was SVR of HCV RNA less than the lower limit of quantification measures at least 22 weeks posttreatment initiation. Researchers defined the MINMON in four components: no pretreatment genotyping, 84-tablet treatment course dispensed at entry, no scheduled visits or lab monitoring and two points of remote contact at week 4 and week 22.

Of 399 patients (median age, 47 years; 35% assigned female sex at birth; 6% identified across the transgender spectrum; 34% cirrhosis) who initiated treatment, 95% achieved SVR (95% CI, 92.4-96.7) with 89% reporting 100% treatment adherence. Further analysis revealed 88.2% of patients with cirrhosis and 95.6% of patients without cirrhosis also achieved SVR. Also, in 166 patients with HCV/HIV-coinfection, 94.6% achieved SVR. Serious adverse events occurred in 4% of patients.

“The MINMON approach with sofosbuvir-velpatasvir used in this study is a simple, safe and efficacious way to deliver treatment globally to HCV-treatment-naive or HCV/HIV-coinfected individuals without evidence of decompensated cirrhosis,” Solomon and colleagues concluded. “Coupled with innovative case finding strategies and point-of-care diagnostics, this streamlined approach could have a crucial role in achieving global HCV elimination.”