Community-Based Point-of-Diagnosis Hepatitis C Treatment for Marginalized Populations

Abstract

ImportanceDisparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors.ObjectiveTo determine the feasibility, acceptability, and safety of HCV treatment at the point of HCV infection diagnosis disclosure in a nonclinical community setting.Design, Setting, and ParticipantsIn this single-arm nonrandomized controlled trial conducted between July 1, 2020, and October 31, 2021, street-outreach recruitment targeted people experiencing homelessness and injecting drugs in an urban US community who were eligible for simplified HCV treatment.InterventionsStudy procedures were designed to reflect the community environment and services needed to provide HCV testing, disclosure, and treatment in a nonclinical site. The test-and-treat No One Waits (NOW) model of care provided a 2-week starter pack of 400 mg of sofosbuvir and 100 mg of velpatasvir at time of HCV RNA results disclosure. Participants were transitioned to insurance-provided sofosbuvir-velpatasvir when feasible to complete a 12-week treatment course.Main Outcomes and MeasuresThe primary end point was sustained virologic response at posttreatment week 12 or later (SVR12). Acceptability end points were treatment initiation and completion. Safety end points were treatment discontinuation because of a late exclusion criterion and adverse events.ResultsOf the 492 people (median [IQR] age, 48 [37-58] years; 62 [71%] male) who underwent anti-HCV testing, 246 (50%) tested anti-HCV positive, and 111 (23%) tested HCV RNA positive and were eligible for simplified HCV treatment. Eighty-nine of the 111 eligible participants (80%) returned for confirmatory RNA results, and 87 (98%) accepted and initiated HCV treatment. Seventy (80%) were currently injecting drugs, 83 (97%) had an income below the poverty line, and 53 (61%) were currently unsheltered. Most had HCV genotype 1a (45 [52%]) or 3 (20 [23%]). Sixty-nine (79%) completed 12 weeks of sofosbuvir-velpatasvir treatment, 2 stopped treatment because of low adherence, and 16 were lost to follow-up. Of the 66 participants who completed treatment and had a successful blood draw, 61 (92%) had undetectable HCV RNA at treatment completion. Of the 87 treated patients, 58 achieved SVR12, leading to a treatment response of 67% (95% CI, 56%-76%) among the intention-to-treat group and 84% (95% CI, 73%-92%) among the per-protocol group. There were no adverse events, late exclusions, or deaths.Conclusions and RelevanceIn this nonrandomized controlled trial of HCV treatment at the point of diagnosis, the NOW model of care reduced steps between HCV testing and treatment initiation and resulted in high levels of treatment initiation, completion, and cure. The NOW model of care can expand the current HCV test-and-treat toolkit by reaching a broader population of marginalized communities and expediting curative therapy.Trial RegistrationClinicalTrials.gov Identifier: NCT03987503

Telehealth to increase healthcare access; perspectives of people who use drugs

“…Participants identi ed that partnerships with PWUD-supportive community organizations equipped with suitable technological infrastructure could address barriers related to accessibility and digital literacy. Morris et al also demonstrated that providing HCV treatment for PWUD experiencing homelessness in community settings is feasible, acceptable, and resulted in high cure rates [54]. Additionally, our study participants requested education and awareness about telehealth.…”

High prevalence of hepatitis B virus susceptibility among persons undergoing community-based hepatitis C virus treatment

“…The DeLIVER Care van is a mobile van offering HCV screening and low-threshold HCV treatment which parks outside various service organizations (e.g., methadone clinics, supportive housing) in San Francisco. The NOW study is a clinical trial investigating a point-of-diagnosis HCV treatment model located at a non-clinical community site in San Francisco [ 9 ]. Both programs (DELIVER Care and NOW) identified participants for HCV screening and confirmatory testing from street-outreach recruitment targeting people experiencing homelessness and people who use drugs in both treatment programs.…”

Staff-Facilitated Telemedicine Care Delivery for Treatment of Hepatitis C Infection among People Who Inject Drugs

“…The No One Waits (NOW) Study is a nonrandomized, single-arm clinical trial measuring the acceptability, feasibility, and efficacy of an urban community-based point-ofdiagnosis HCV treatment initiation model (NCT03987503). A complete description of the NOW Study is published elsewhere [25] Briefly, potential participants are screened for HCV infection, and, if positive, offered HCV treatment with study-provided sofosbuvir/ledipasvir at the time of diagnosis. Prior to treatment initiation, but on the same day, participants complete an initial clinician visit via staff-facilitated telemedicine and a pretreatment blood draw.…”

“…Eligible participants are 18 years or older, who report either injecting drugs in their lifetime or having a blood transfusion in or before 1992, confirmed to have HCV viremia and willing to receive simplified HCV treatment and participate in staff-facilitated telemedicine visits. Additional eligibility criteria were previously described [25].…”

“…Eligible participants are identified through methods previously described [25]. Participants provided written consent prior to the initiation of HCV treatment.…”