TY - JOUR
T1 - Hepatitis c treatment among people who use drugs in an office-based opioid treatment program versus a syringe exchange program
T2 - A real-world prospective clinical trial
AU - Seaman, Andrew
AU - Ronan, Wren
AU - Myers, Lauren
AU - Wheelock, Haven
AU - Butler, Melinda
AU - Nelson, Lisa
AU - Williams, Beth E.
AU - Zaman, Atif
N1 - Funding Information:
Authors’ Contribution: Study concept and design, A.Z., and A.S.; Acquisition of data, A.S., W.R., L.M., H.W., M.B., and L.N.; Analysis and interpretation of data, A.S., H.W., and A.Z.; Drafting of the manuscript, A.S.; Critical revision of the manuscript for important intellectual contribution, A.S., H.W., and A.Z.; Statistical analysis, A.S. and A.Z.; Study supervision and administrative support, A.S. and A.Z. Clinical Trial Registration Code: NCT03093415 Conflict of Interests: There are no financial conflicts of interests. Andrew Seaman, Wren Ronan, Lisa Nelson, and Melinda Butler received partial research support by Merck Pharmaceuticals for this study. Dr. Seaman has also received research funding from the Gilead FOCUS foundation unrelated to the content of this work. All protocol development, analysis, and writing were the responsibility of the authors. The funders had no role in approval of the final analysis or manuscript development. Data Reproducibility: The data presented in this study are openly available in one of the repositories or will be available on request from the corresponding author by this journal representative at any time during submission or after publication. Otherwise, all consequences of possible withdrawal or future retraction will be with the corresponding author.
Publisher Copyright:
© 2021, Kowsar Medical Institute. All rights reserved.
PY - 2021/8
Y1 - 2021/8
N2 - 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 aminotrans-ferase 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.
AB - 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 aminotrans-ferase 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.
KW - Communicable Diseases
KW - Hepatitis C
KW - Needle-Exchange Programs
KW - Opiate Substitution Treatment
KW - Opioid-Related Disorders
KW - Substance-Related Disorders
UR - http://www.scopus.com/inward/record.url?scp=85121384467&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85121384467&partnerID=8YFLogxK
U2 - 10.5812/hepatmon.114781
DO - 10.5812/hepatmon.114781
M3 - Article
AN - SCOPUS:85121384467
SN - 1735-143X
VL - 21
SP - NA
JO - Hepatitis Monthly
JF - Hepatitis Monthly
IS - 8
M1 - e114781
ER -