by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
January 30, 2024
Heo M, Norton BL, Pericot-Valverde I, et al. the HERO Study Group, National Stakeholder Advisory Board, Optimal Hepatitis C Treatment Adherence Patterns and Sustained Virologic Response among People Who Inject Drugs: THE HERO Study. J Hepatol. 2024 Jan 17: S0168-8278(23)05374-6. doi: 10.1016/j.jhep.2023.12.020. PMID: 38242324.
This study describes various medication adherence patterns and SVR outcomes among treatment naïve, non-pregnant adult PWID enrolled in the HERO Study (a U.S. trial comparing modified DOT and patient navigation across eight opioid treatment programs and fifteen community health centers) who initiated sofosbuvir/velpatasvir (x12 weeks). Electronic blister pack and SVR data were available for 496 participants, which comprised the per-protocol sample. Adherence was summarized according to various patterns, such as total adherent days, consecutive missed/non-adherent days, and early discontinuations. Multivariate models accounted for several factors including study site/setting, age, employment, injection frequency and recency, and urine drug screen results. The median total adherent days was 63 (75%) per 84-day treatment course, and observed SVR rate was 460/496 (92.7%). Participants with early or premature medication discontinuation (i.e., 1st– and 2nd-month discontinuation) were less likely to achieve SVR. Participants who missed more than 14 consecutive adherent days had a significantly smaller chance of achieving SVR compared to people who missed ≤ 7 consecutive days (regardless of when it occurred). Greater total adherent days were significantly associated with SVR only among the subgroup with < 50% adherence rate. Overall, greater total adherent days, longer consecutive adherent days, and shorter consecutive missed days were all associated with 90% or higher SVR rate.
Recommendations on managing incomplete HCV treatment adherence were a welcome addition to clinical guidelines, however they were based on limited data and ultimately reflected expert opinion of AASLD-IDSA HCV Treatment Guidance Panel members. These results from the HERO Study, which include an extensive and detailed characterization of adherence patterns across a large group of participants, offer much needed information to refine our understanding of how different patterns of DAA adherence (including number of missed days as well as timing of discontinuations) affect treatment outcomes. Although these findings involve only a single 12-week DAA regimen, and some cases classified as treatment failures might have actually represented reinfections, these results can help potentially identify which adherence interventions might be most useful to offer, and when to implement them, to ensure optimal patient and community level HCV treatment outcomes.
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