Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

"Declarations Ethics approval and consent to participateThe HERO study was approved by the IRBs at each of the study sites listed below, and informed consent to participate was obtained from all study participants.(1) West Virginia University: 1609287809(2) Brown University: 901973-2, 3(3) John Hopkins: 00007239(4) Massachusetts General Hospital: 2016P002442/PHS(5) Montefiore Medical Center: 2015-5723(6) University of California, San Francisco: 16-20016(7) University of New Mexico: 16-235(8) University of Washington: STUDY00002659 Consent for publicationNot Applicable. Competing interestsJF has received research grant support from Gilead Sciences. AYK has served on advisory boards for Biomarin. AHL has served on advisory boards for Gilead Sciences and Merck Pharmaceuticals and received research funding from Gilead Sciences. SHM has received speaker fees from Gilead Sciences. All other authors declare no competing interests. Competing interests JF has received research grant support from Gilead Sciences. AYK has served on advisory boards for Biomarin. AHL has served on advisory boards for Gilead Sciences and Merck Pharmaceuticals and received research funding from Gilead Sciences. SHM has received speaker fees from Gilead Sciences. All other authors declare no competing interests."

"Funding This work was supported by a Patient-Centered Outcomes Research Institute (PCORI) Award [grant number HPC-1503-28122] with additional support by Gilead Sciences, Quest Diagnostics, Monogram Biosciences, and OraSure Technologies."

"This study included a secondary analysis of data from the HERO study (ClinicalTrials.gov, NCT02824640) [, ]. The HERO study was a pragmatic randomized clinical trial conducted across eight opioid treatment programs (OTPs) and fifteen community health centers (CHCs) in eight US states among DAA-naïve PWID with active drug injection use within 90 days of screening. Participants were randomized in a 1:1 ratio to two modes of administration: modified Directly Observed Therapy (mDOT) and Patient Navigation (PN). All participants received a 12-week course of sofosbuvir 400 mg and velpatasvir 100 mg fixed-dose combination therapy in electronic blister packs. Participants were given a maximum compensation of $400 ($20 for completing each of 17 research visits, and $5 for returning the electronic blister packs for each of 12 weeks of treatment). Outcomes included and compared the rates of HCV cure, as well as HCV DAA treatment initiation, completion, and adherence between the two study arms."