A minimal monitoring approach for delivering sofosbuvir-velpatasvir treatment in patients with nondecompensated cirrhosis and hepatitis C virus (HCV) infection is safe and achieved sustained virological response (SVR) comparable with standard monitoring, according to a study in the Lancet Gastroenterology & Hepatology.

The phase 4, international AIDS Clinical Trials Group (ACTG) A5360 Minimal Monitoring (MINMON) trial assessed the efficacy and safety of a minimal monitoring approach of delivering interferon-free and ribavirin-free, pangenotypic direct-acting antivirals to HCV treatment-naive participants with active HCV infection (RNA >1000 IU/mL within 35 days before study entry).

Eligible participants were aged ≥18 years and received a single-tablet fixed dose combination of 400 mg of sofosbuvir and 100 mg of velpatasvir once daily for 12 weeks.


Continue Reading

The MINMON intervention included the following: (1) no pretreatment HCV genotype assessment, (2) dispensation of the entire treatment course at entry (3 bottles of 28 tablets each), (3) no scheduled clinic or laboratory monitoring visits before the efficacy outcome assessment, and (4) 2 points of remote contact — week 4 post-treatment initiation to assess adherence and update contact information and week 22 to update contact information and schedule the outcome assessment visit at week 24.

Participants were followed for 72 weeks after treatment initiation. SVR was the primary efficacy outcome and was defined as HCV RNA less than the lower limit of quantification, measured at least 22 weeks after treatment initiation. Serious adverse events were the primary safety outcome.

A total of 400 participants were enrolled from October 22, 2018, through July 19, 2019. Their median age was 47 years, 65% were men, and 22 (6%) identified across the transgender spectrum.

Overall, 355 (89%) of 397 individuals self-reported taking 100% of medications within the treatment period at week 24. Among the 399 patients who started treatment, 379 (95.0%; 95% CI, 92.4-96.7) had an SVR. The rates of SVR ranged from 92.4% (95% CI, 86.5-95.8) in the United States to 100% (95% CI, 75.8-100) in South Africa and 100% (95% CI, 79.6-100) in Uganda. Of 166 participants living with HIV, 94.6% (95% CI, 90.0-97.1) achieved an SVR.

A total of 14 (4%) of 397 participants had at least 1 serious adverse event, and 23 (6%) patients reported 28 adverse events, including diarrhea, headache, and fatigue.

Investigators noted the findings were limited by the absence of a concurrent comparator group, and the small number of participants in certain subgroups which limited the ability to make strong conclusions. Additionally, the trial was implemented at NIH-certified research sites, which may not be representative of care in other settings.

“Given the challenges with access to HCV genotyping and barriers associated with medication refill fulfilment, these data support the guidance to eliminate pre-treatment genotyping when using pangenotypic regimens, and suggest dispensation of the entire study treatment at initiation without compromising patient safety or treatment efficacy,” the researchers commented. “Collectively these data support and provide added evidence for the use of simplified protocols for the delivery of HCV care.”

Disclosure: This research was funded in part by Gilead Sciences. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Solomon SS, Wagner-Cardoso S, Smeaton L, et al. A minimal monitoring approach for the treatment of hepatitis C virus infection (ACTG A5360 [MINMON]): a phase 4, open-label, single-arm trial. Lancet Gastroenterol Hepatol. Published online January 10, 2022. doi: 10.1016/S2468-1253(21)00397-6