Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study

Snehal S Lopes; Irene Pericot-Valverde; Julia Arnsten; Paula J Lum; Lynn E Taylor; Shruti H Mehta; Judith I Tsui; Judith Feinberg; Arthur Y Kim; Brianna L Norton; Kimberly Page; Cristina Murray-Krezan; Jessica Anderson; Phillip Moschella; Moonseong Heo; Alain H Litwin

doi:10.1016/j.drugpo.2023.104288

Self-reported and measured adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs: The HERO study

Int J Drug Policy. 2024 Jan:123:104288. doi: 10.1016/j.drugpo.2023.104288. Epub 2023 Dec 15.

Authors

Snehal S Lopes¹, Irene Pericot-Valverde², Julia Arnsten³, Paula J Lum⁴, Lynn E Taylor⁵, Shruti H Mehta⁶, Judith I Tsui⁷, Judith Feinberg⁸, Arthur Y Kim⁹, Brianna L Norton³, Kimberly Page¹⁰, Cristina Murray-Krezan¹¹, Jessica Anderson¹⁰, Phillip Moschella¹², Moonseong Heo¹, Alain H Litwin¹³

Affiliations

¹ Department of Public Health Sciences, Clemson University, Clemson, SC 29634, USA.
² Department of Psychology, College of Behavioral, Social, and Health Sciences, Clemson University, Clemson, SC 29634, USA.
³ Albert Einstein College of Medicine, Bronx, NY 10461, USA; Department of Medicine, Montefiore Medical Center, Bronx, NY 10467, USA.
⁴ Department of Medicine, University of California, 1001 Potrero Ave, San Francisco, CA 94110, USA.
⁵ College of Pharmacy, University of Rhode Island, 7 Greenhouse Road, Kingston, RI 02881, USA.
⁶ Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615N. Wolfe Street, Room E6546, Baltimore, MD 21205, USA.
⁷ Department of Medicine, University of Washington, 325 9th Ave., Seattle, WA 98104, USA.
⁸ Department of Behavioral Medicine and Psychiatry, West Virginia University School of Medicine, 930 Chestnut Ridge Road, Morgantown, WV 26505, USA; Department of Medicine, Section of Infectious Diseases, West Virginia University School of Medicine, 930 Chestnut Ridge Road, Morgantown, WV 26505, USA.
⁹ Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit St., Boston, MA 02114, USA; Harvard Medical School, Boston, MA 02115, USA.
¹⁰ Department of Internal Medicine, University of New Mexico Health Sciences Center, University of New Mexico MSC 10 5550, Albuquerque, NM 87131, USA.
¹¹ Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
¹² Department of Emergency Medicine, Prisma Health, Greenville, SC, USA; School of Health Research, Clemson University, Clemson, SC, USA; Department of Medicine, University of South Carolina School of Medicine, 876W Faris Rd, Greenville, SC 29605, USA.
¹³ School of Health Research, Clemson University, Clemson, SC, USA; Department of Medicine, University of South Carolina School of Medicine, 876W Faris Rd, Greenville, SC 29605, USA; Department of Medicine, Prisma Health, Greenville, SC, USA. Electronic address: [email protected].

PMID: 38103458
DOI: 10.1016/j.drugpo.2023.104288

Abstract

Background: Objective adherence measures, such as electronic blister pack (BP), for direct-acting antivirals (DAAs) for hepatitis C virus (HCV) treatment have high accuracy, but their use is limited in real practice settings. We examined the association of self-reported adherence using a visual analogue scale (VAS) with objective BP adherence and sustained virologic response (SVR) among people who inject drugs.

Methods: We conducted secondary analyses using a subset of participants (N = 493) from the per-protocol sample of the HERO study, a pragmatic randomized trial of HCV treatment interventions that used both VAS and BP to measure adherence to a 12-week sofosbuvir/velpatasvir DAA regimen. Multivariable mixed-effects regression models tested the association of self-report adherence level with longitudinal weekly objective adherence. Multivariable logistic regression tested the association of self-report adherence with SVR.

Results: The average VAS and BP adherences were 95.1 % (SD = 8.9 %) and 76.0 % (16.0 %), respectively, and the proportion of the participants achieving SVR was 92.9 %. The estimated adjusted mean objective adherence was significantly different (-16 %; 95 % CI: -22 %, -11 %, p < .001) between participants with 100 % and <80 % VAS adherence. The likelihood of SVR was significantly lower for those with <80 % VAS adherence [adjusted OR = 0.07; 95 % CI: 0.02, 0.24; p < .001] compared to those with 100 %.

Conclusion: Self-reported adherence overestimated objective adherence. However, higher self-report adherence was significantly associated with higher objective adherence. Also, self-reported adherence ≥80 % was significantly associated with SVR. Thus, the self-report measure has utility as a monitoring tool for adherence during DAA treatment.

Keywords: Direct-acting antiviral medication; Electronic blister pack adherence; Hepatitis C; People who inject drugs; Self-report adherence.

Publication types

Pragmatic Clinical Trial

MeSH terms

Antiviral Agents
Drug Users*
Hepacivirus
Hepatitis C* / complications
Hepatitis C* / drug therapy
Hepatitis C, Chronic* / drug therapy
Humans
Self Report
Sustained Virologic Response

Substances

Antiviral Agents