Rapid hepatitis C virus point-of-care RNA testing and treatment at an integrated supervised consumption service in Toronto, Canada: a prospective, observational cohort study.

Background: Despite high burden of Hepatitis C (HCV) among people who inject drugs, significant barriers to care persist. The aim of this study was to evaluate the provision of rapid, low-barrier point-of-care (POC) HCV RNA testing and linkage to care among clients of a supervised consumption service (SCS) located within a community health centre in Toronto, Canada. Secondary aims included measuring HCV RNA prevalence at baseline, HCV incidence during follow-up and exploring factors associated with HCV RNA positivity and treatment uptake. Methods: Participants were enrolled in a prospective, observational cohort from August 13, 2018 to September 30, 2021. Those with positive HCV RNA tests were offered immediate referral to onsite treatment. Those with negative results were offered repeat testing every three months for up to four visits. HCV incidence was estimated as the number of incident HCV infections per 100 person-years at risk, among those HCV RNA negative at baseline who returned for ≥1 follow-up visit. Missing data were reported when present. Findings: 128 participants were enrolled with four later removed due to ineligibility. At baseline, 54 of 124 eligible participants (43.5%) tested HCV RNA positive. HCV incidence was 35.1 cases per 100 person-years (95% CI: 18.9-65.3) with a cumulative incidence of 38.3% at 15 months of follow-up. Among participants HCV RNA positive at baseline or follow-up (n = 64), 67.2% (n = 43) were linked to HCV care and treatment was initiated among 67.4% (n = 29/43). Interpretation: High HCV RNA prevalence and incidence demonstrate that the SCS serves a high-risk population for HCV. Testing acceptance was high, as was treatment engagement. POC HCV RNA testing positions SCSs as an important point of HCV care access. Funding: HCV Micro-Elimination Grant, Gilead Sciences Canada; in-kind support from Cepheid.

Integrated supervised consumption services and hepatitis C testing and treatment among people who inject drugs in Toronto, Canada: A cross-sectional analysis.

Despite the availability of publicly funded hepatitis C (HCV) treatment in Canada, treatment gaps persist, particularly among people who inject drugs. We estimate correlates of HCV care cascade engagement (testing, diagnosis, and treatment) among people who inject drugs in Toronto, Canada and examine the effect of accessing differing supervised consumption service (SCS) models on self-reported HCV testing and treatment. This is a cross-sectional baseline analysis of 701 people who inject drugs surveyed in the Toronto, Ontario integrated Supervised Injection Services (OiSIS-Toronto) study between November 2018 and March 2020. We examine correlates of self-reported HCV care cascade outcomes including SCS model, demographic, socio-structural, drug use, and harm reduction characteristics. Overall, 647 participants (92%) reported ever receiving HCV testing, of whom 336 (52%) had been diagnosed with HCV. Among participants who reported ever being diagnosed with HCV, 281 (84%) reported chronic HCV, of whom 130 (46%) reported HCV treatment uptake and 151 (54%) remained untreated. Compared to those with no SCS use, participants who had ever injected at an integrated SCS model with co-located HCV care had greater prevalence of both ever receiving HCV testing (adjusted prevalence ratio [aPR]: 1.12, 95% confidence interval [CI]: 1.02-1.24) and ever receiving HCV treatment (aPR: 1.67, 95% CI: 1.04-2.69). Over half of participants diagnosed with chronic HCV reported remaining untreated. Our findings suggest that integrated SCS models with co-located HCV care represent key strategies for linkage to HCV care, but that more is needed to support scale-up.

Peer outreach point-of-care testing as a bridge to hepatitis C care for people who inject drugs in Toronto, Canada.

BACKGROUND: People who inject drugs have high rates of hepatitis C (HCV) and yet many remain undiagnosed and untreated. HCV treatment guidelines and elimination strategies recommend task-shifting to expand where, and by whom, HCV testing and care is delivered. METHODS: A randomized controlled trial design was used to evaluate if point-of-care (POC) HCV antibody testing by peer outreach workers outside of health and social service spaces would improve engagement in HCV care. People with a lifetime history of injection drug use without prior knowledge of HCV antibody status were randomized to receive HCV outreach plus either POC or referral to community-based HCV program for testing as usual. The study was co-designed by people with lived experience of HCV. RESULTS: 920 people were approached to participate over 14 weeks. After refusals, withdrawals and removal of duplicates, there were 380 study participants. Outreach took place primarily in public spaces (66%) such as parks, coffee shops and apartment lobbies. Participants reported very high rates of poverty, housing instability and recent injection drug use. Despite being at high risk for HCV, 61% had no history or knowledge of past HCV testing (n = 230). Of those who received a POC test 77/195 (39%) were positive for HCV antibodies. There was no change in rates of engagement in HCV care among those who received the POC (n = 6; 3%) compared to those who did not (n = 5; 3%). CONCLUSION: Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing. This improved participants' knowledge of their HCV antibody status, but that knowledge in itself did not lead to any change in participant's subsequent engagement in HCV care. Future work is required to evaluate strategies such as incentives or peer navigators to improve linkage to HCV care after diagnosis.

Impact of comprehensive care on health care use among a cohort of marginalized people living with hepatitis C in Toronto.

Background: The majority of new hepatitis C (HCV) cases occur among people who inject drugs. In recent years, multidisciplinary models of HCV treatment have emerged that demonstrate successful treatment outcomes for this population, as well as broad positive individual- and system-level impacts. Our objective was to evaluate changes in health care use among a cohort of people living with HCV before and after engagement with one such program. Methods: Program data were uniquely linked to provincial health administrative databases. Rates of emergency department (ED) visits and hospital admissions of clients from 2011 through 2015 (N = 103) were evaluated using linkages with administrative data for the 2 years before and after program initiation. Data were evaluated using negative binomial regression models with a covariance structure to account for within-individual correlations. Results: Of participants, 72.8% were men (mean age 47 years), and 38% experienced high rates of physical and mental health comorbidity (Aggregated Diagnosis Group score ≥10). Female clients had significantly fewer ED visits 2 years after program initiation (5.04 versus 3.12; risk ratio [RR] 0.61 [95% CI 0.44% to 0.86%]). ED visits for infectious diseases and soft tissue injury were significantly lower for the cohort overall (RRs 0.58 0.51 [95% CIs 0.35% to 0.95% and 0.29% to 0.90%], respectively). Conclusion: Co-locating HCV treatment within comprehensive primary care and harm reduction services appears to have benefits beyond HCV, including a reduction in ED visits among women and a decrease in ED visits for soft tissue infections for all participants.

Understanding real-world adherence in the directly acting antiviral era: A prospective evaluation of adherence among people with a history of drug use at a community-based program in Toronto, Canada.

BACKGROUND: Direct acting antiviral (DAA) treatments for Hepatitis C (HCV) are now widely available with sustained virologic response (SVR) rates of >90%. A major predictor of response to DAAs is adherence, yet few real-world studies evaluating adherence among marginalized people who use drugs and/or alcohol exist. This study evaluates patterns and factors associated with non-adherence among marginalized people with a history of drug use who were receiving care through a primary care, community-based HCV treatment program where opiate substitution is not offered on-site. METHODS: Prospective evaluation of chronic HCV patients initiating DAA treatment. Self-report medication adherence questionnaires were completed weekly. Pre/post treatment questionnaires examined socio-demographics, program engagement and substance use. Missing adherence data was counted as a missed dose. RESULTS: Of the 74 participants, who initiated treatment, 76% were male, the average age was 54 years, 69% reported income from disability benefits, 30% did not have stable housing and only 24% received opiate substitution therapy. Substance use was common in the month prior to treatment initiation with, 11% reported injection drug use, 30% reported non-injection drug use and 18% moderate to heavy alcohol use. The majority (85%) were treatment naïve, with 76% receiving sofosbuvir/ledipasvir (8-24 weeks) and 22% Sofosbuvir/Ribarvin (12-24 weeks). The intention to treat proportion with SVR12 was 87% (60/69). In a modified ITT analysis (excluding those with undetectable RNA at end of treatment), 91% (60/66) achieved SVR12. Overall, 89% of treatment weeks had no missed doses. 41% of participants had at least one missed dose. In multivariate analysis the only factor independently associated with weeks with missed doses was moderate to heavy alcohol use (p=0.05). CONCLUSION: This study demonstrates that strong adherence and SVR with DAAs is achievable, with appropriate supports, even in the context of substance use, and complex health/social issues.