Nonadherence to Ledipasvir/Sofosbuvir Did Not Predict Sustained Virologic Response in a Randomized Controlled Trial of Human Immunodeficiency Virus/Hepatitis C Virus Coinfected Persons Who Use Drugs

J Infect Dis. 2022 Mar 2;225(5):903-911. doi: 10.1093/infdis/jiab477.

Abstract

Background: Eliminating hepatitis C virus (HCV) will require effective treatment delivery to persons with substance use disorders (SUDs). We evaluated the relationship between ledipasvir/sofosbuvir treatment persistence (receiving 84 tablets), adherence, and sustained virologic response (SVR) in persons with human immunodeficiency virus (HIV)/HCV coinfection.

Methods: Of the 144 participants with HIV/HCV and SUDs, 110 initiated a 12-week treatment course under 1 of 3 conditions (usual care, peer mentors, and cash incentives). We used self-report, pharmacy pill counts, and expected date of refill to examine adherence. Persistent participants were categorized as high adherence (taking ≥90% of doses) or low adherence (taking <90% of doses).

Results: Most participants persisted on treatment after initiation (n = 105), with 95% (n = 100) achieving SVR. One third (34%) of participants had moderate/heavy alcohol use by the biomarker phosphatidylethanol ([Peth] ≥50 ng/mL), and 44% had urine toxicology positive for cocaine or heroin at enrollment. The proportion of persons with high adherence was 72% (n = 76), and the proportion of persons with low adherence was 28%. Although low adherence was associated with moderate/heavy alcohol use by PEth (relative risk = 2.77; 95% confidence interval, 1.50-5.12), SVR did not vary according to adherence (P = .702), and most participants (97%) with low adherence achieved SVR.

Conclusions: Treatment persistence led to high SVR rates among persons with HIV/HCV, despite imperfect adherence and SUDs.

Keywords: adherence; direct-acting antivirals; hepatitis C virus; substance use disorders; sustained virologic response.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Antiviral Agents / pharmacology
  • Antiviral Agents / therapeutic use
  • Benzimidazoles
  • Coinfection*
  • Fluorenes
  • HIV
  • HIV Infections* / complications
  • HIV Infections* / drug therapy
  • Hepacivirus
  • Hepatitis C* / complications
  • Hepatitis C* / drug therapy
  • Hepatitis C, Chronic* / complications
  • Hepatitis C, Chronic* / drug therapy
  • Humans
  • Pharmaceutical Preparations
  • Sofosbuvir / therapeutic use
  • Substance-Related Disorders* / complications
  • Substance-Related Disorders* / drug therapy
  • Sustained Virologic Response
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Benzimidazoles
  • Fluorenes
  • Pharmaceutical Preparations
  • ledipasvir
  • Sofosbuvir