• Jason Grebely, Gregory J Dore, Frederick L Altice, Brian Conway, Alain H Litwin, Brianna L Norton, Olav Dalgard, Edward J Gane, Oren Shibolet, Ronald Nahass, Anne F Luetkemeyer, Cheng-Yuan Peng, David Iser, Isaias Noel Gendrano, Michelle M Kelly, Peggy Hwang, Ernest Asante-Appiah, Barbara A Haber, Eliav Barr, Michael N Robertson, and Heather Platt.
• The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia (J.G., G.J.D.).
• Ann. Intern. Med. 2022 Sep 1; 175 (9): 1221-1229.

BackgroundHepatitis C virus (HCV) reinfection after successful treatment may reduce the benefits of cure among people who inject drugs.ObjectiveTo evaluate the rate of HCV reinfection for 3 years after successful treatment among people receiving opioid agonist therapy (OAT).DesignA 3-year, long-term, extension study of persons enrolled in the CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) study (ClinicalTrials.gov: NCT02105688).Setting55 clinical trial sites in 13 countries.PatientsAged 18 years and older with chronic HCV infection with genotypes 1, 4, or 6 receiving stable OAT.InterventionNo treatments were administered.MeasurementsSerum samples were assessed for HCV reinfection. Urine drug screening was performed.ResultsAmong 296 participants who received treatment, 286 were evaluable for reinfection and 199 were enrolled in the long-term extension study. The rate of HCV reinfection was 1.7 [95% CI, 0.8 to 3.0] per 100 person-years; 604 person-years of follow-up). A higher rate of reinfection was seen among people with recent injecting drug use (1.9 [95% CI, 0.5 to 4.8] per 100 person-years; 212 person-years). Ongoing drug use and injecting drug use were reported by 59% and 21% of participants, respectively, at the 6-month follow-up visit and remained stable during 3 years of follow-up.LimitationsParticipants were required to be 80% adherent to OAT at baseline and may represent a population with higher stability and lower risk for HCV reinfection. Rate of reinfection may be underestimated because all participants did not continue in the long-term extension study; whether participants who discontinued were at higher risk for reinfection is unknown.ConclusionReinfection with HCV was low but was highest in the first 24 weeks after treatment completion and among people with ongoing injecting drug use and needle-syringe sharing.Primary Funding SourceMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

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