Perspectives on Adherence From the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach With 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment.

Abstract

BACKGROUND:

With the advent of efficacious oral direct-acting antivirals (DAAs) for hepatitis C virus (HCV), identification of characteristics associated with adherence is critical to treatment success. We examined correlates of sub-optimal adherence to HCV therapy in a single-arm, multinational, clinical trial.

METHODS:

ACTG A5360 enrolled HCV treatment-naive persons without decompensated cirrhosis from 5 countries. All participants received a 12-weeks course of sofosbuvir/velpatasvir at entry. In-person visits occurred at initiation and week 24, sustained virologic response (SVR) assessment. Adherence at week 4 was collected remotely and was dichotomized optimal (100%, no missed doses) versus sub-optimal (<100%). Correlates of sub-optimal adherence were explored using logistic regression.

RESULTS:

In total, 400 participants enrolled; 399 initiated treatment; 395/397 (99%) reported completing at week 24. Median age was 47 years with 35% female. Among the 368 reporting optimal adherence at week 4 SVR was 96.5% (95% confidence interval [CI] [94.1%, 97.9%]) vs 77.8% (95% CI [59.2%, 89.4%]) P value < .001. In the multivariate model age <30 years and being a US participant were independently associated with early sub-optimal adherence. Participants <30 years were 7.1 times more likely to have early sub-optimal adherence compared to their older counterparts.

CONCLUSIONS:

Self-reported optimal adherence at week 4 was associated with SVR. Early self-reported adherence could be used to identify those at higher risk of treatment failure and may benefit from additional support. Younger individuals <30 years may also be prioritized for additional adherence support. Clinical Trials Registration. NCT03512210.

• Authors: Leonard A Sowah, Laura Smeaton, Irena Brates, Debika Bhattacharya, Benjamin Linas, Bruce Kreter, Sandra Wagner-Cardoso, Sunil Solomon, Mark Sulkowski, Gregory K Robbins
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 76 Issue 11 Pg. 1959-1968 (06 08 2023) ISSN: 1537-6591 [Electronic] United States
• PMID: 36694361 (Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.

Chemical References

• Sofosbuvir
• Antiviral Agents
• velpatasvir

Topics

• Humans
• Female
• Middle Aged
• Adult
• Male
• Sofosbuvir (therapeutic use)
• Hepatitis C, Chronic (complications)
• Antiviral Agents (therapeutic use)
• Hepatitis C (drug therapy)
• Treatment Outcome
• Sustained Virologic Response
• Hepacivirus (genetics)
• Genotype