Hepatitis C Treatment In People Who Inject Drugs On Medication Assisted Therapy Versus People Attending A Needle Exchange Program NCT03093415

Author: Seaman A, Witkowska M, Ronan W, Myers, L, Nelson L, Butler M, Wheelock H,Hutchison R, Williams B, Zaman A

Theme: Clinical Research Year: 2018

HCV treatment in people who inject drugs (PWIDs) is a key component of eradication models
but PWIDs face substantial barriers to treatment access. Despite data showing treatment
outcomes among PWIDs on medication-assisted therapy (MAT) with buprenorphine or
methadone are similar to non-PWID outcomes, few investigations examine PWID treatment
outcomes with only harm reduction support.
This real-world, multi-site prospective open-label pilot study compares treatment of PWIDs with
APRI < 0.7 and genotype 1a, 1b, and 4 HCV with Elbasvir/Grazoprevir (E/G), engaged in MAT or a needle exchange program (NEP). The MAT arm was enrolled through a federally qualified community health center (FQHC) while the NEP arm was enrolled through a NEP associated with a separate FQHC. Prospective arms were compared to a retrospective FQHC control group (n=50) and a separate community standard group at an academic hepatology clinic (n=50). SVR12, SVR48, reinfection at 48 weeks, medication adherence, and substance use were evaluated. Outcome: At the time of abstract submission, 25/25 MAT arm PWID and 19/25 NEP arm PWID were enrolled. In the MAT vs NEP arms substance use throughout treatment was found in 36% (9/25) vs 100% (19/19); good adherence (missing ≤7 doses) in 92% (23/25) vs 82% (13/16); treatment completion (among those due for completion) was 96% (24/25) vs 80% (12/15); and SVR12 rates were 88% (21/24) vs 44% (4/9). In the community standard comparison group, SVR12 was achieved in 95% (40/42). There were no virologic failures or re-infections; all nonresponders were due to missing SVR12 data. Conclusion: While recruitment and follow-up is challenging in NEPs, preliminary data suggests adherence, treatment completion, and SVR12 are high in PWID treated with E/G engaging in NEP or MAT. All metrics are comparable to community standards for non-PWID for treatment of HCV with direct-antiviral drugs. Disclosure of Interest Statement: This is an investigator-initiated, Merck & Company funded study with limited FTE support for the primary author, site directors, clinical pharmacist, and study coordinators. The authors maintained full control over the data analysis and interpretation and content of the final manuscript.

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