Background: Hepatitis C Virus (HCV) treatment in people who inject drugs (PWID) is a key component of elimination models but PWID face substantial barriers to treatment access. Despite data showing treatment outcomes among PWID on medications for opioid use disorder (MOUD) are similar to non-PWID outcomes, few studies examine PWID treatment outcomes with only syringe services support. Objectives: To evaluate the effect of recruitment for HCV treatment with elbasvir/grazoprevir (E/G) in a syringe services program (SSP) as compared to an MOUD program for people with opioid use disorder. Methods: This real-world, multi-site prospective open-label pilot study compares treatment of PWID with aspartate aminotransferase to platelet ratio (APRI) < 0.7 and genotype 1a, 1b, and 4 HCV with E/G, engaged in MOUD (n = 25) or an SSP (n = 25). The MOUD arm was enrolled through a federally qualified community health center and SSP arm through a nearby SSP. Prospective arms were compared to an academic hepatology clinic group (n = 50). Sustained virologic response at 12 weeks (SVR12), medication adherence, and treatment discontinuation were evaluated. Results: In the MOUD vs SSP arms, substance use throughout treatment was found in 36% (9/25) vs 100% (25/25); good adherence (> 90% pills taken) in 100% (25/25) vs 68% (17/25); treatment completion 100% (25/25) vs 64% (16/25); and SVR12 rates were 96% (24/25) vs 60% (15/25). In the community standard comparison group, SVR12 was achieved in 94% (47/50). There were two virologic failures or re-infections in the SSP group; all other non-responders were due to missing SVR12 data. Conclusions: While recruitment and follow-up are challenging in SSPs, preliminary data suggests adherence, treatment completion, and SVR12 are high in PWID treated with E/G engaging in SSP or MOUD. All metrics are comparable to community standards for non-PWID for treatment of HCV with direct-antiviral drugs.
Real-world evidence for a prescription digital therapeutic to treat opioid use disorder
