Theme: Clinical Research Year: 2024
Background: Opioid treatment programs (OTPs) in North America are government-regulated facilities which provide opioid use disorder treatment. The optimal approach to HCV care among people who use drugs (PWUD) enrolled in North American OTPs is unknown.
Methods: We conducted a pragmatic randomized controlled trial (clinicaltrials.gov NCT04677153) at 5 OTPs in the United States and Canada. PWUD with HCV were enrolled at OTPs and randomized (1:1) to on-site HCV treatment by OTP staff with support from peer OTP clients (TT) or standard of care off-site referral for HCV treatment (SOC). After randomization, participants underwent eligibility assessment for glecaprevir/pibrentasvir (G/P) per AASLD/IDSA simplified treatment algorithm. OTPs had access to a local specialist to tailor their HCV test and treat approach to local context. The primary outcome was HCV treatment initiation within 12 weeks; secondary outcomes were time to treatment initiation and sustained virologic response at 12 weeks (SVR12). Analyses were conducted within the modified intention-to-treat (mITT) population (randomized participants eligible for G/P).
Results: Among 182 participants randomized between August 2021-November 2023 to TT (N=91) or SOC (N=91), 58 were study protocol G/P ineligible (38 undetectable HCV RNA, 14 platelet count <150,000/mL, 5 missing blood work, 1 withdrew) and 2 were excluded from analyses. In the mITT sample (n=122; median age 49 [IQR:38-58]), most were white (58%) and male (60%). Overall, 59/66 (89%) in the TT and 12/56 (21%) in the SOC groups initiated treatment [p=<0.001], with median time-to-initiation 19 days [IQR:11-34] in the TT vs 50 days [IQR:32-57] in the SOC group [p=<0.001]. Treatment discontinuation was noted in 6/59 (10%) of TT and 2/12 (16%) of SOC participants. SVR outcomes are pending and will be available prior to the conference date.
Conclusion: HCV test and treat with peer-support at OTPs is associated with increased HCV treatment among PWUD.
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