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Background This study investigated adherence and associated factors among people with recent injection drug use (IDU) or current opioid agonist therapy (OAT) and compared once-daily to twice-daily hepatitis C virus (HCV) direct-acting antiviral (DAA) therapy. Methods SIMPLIFY and D3FEAT are international, multicenter studies that recruited participants with recent IDU (previous 6 months; SIMPLIFY, D3FEAT) or current OAT (D3FEAT) between March 2016 and February 2017 in 8 countries. Participants received sofosbuvir/velpatasvir (once daily; SIMPLIFY) or paritaprevir/ritonavir/ombitasvir, dasabuvir (twice daily) ± ribavirin (D3FEAT) for 12 weeks administered in electronic blister packs. We evaluated overall adherence (proportion of prescribed doses taken) and nonadherence ( Results Of 190 participants, 184 (97%) completed treatment. Median adherence was 92%, with higher adherence among those receiving once-daily vs twice-daily therapy (94% vs 87%, P = .005). Overall, 40% of participants (n = 76) were nonadherent ( Conclusions This study demonstrated high adherence to once- and twice-daily DAA therapy among people with recent IDU or currently receiving OAT. Nonadherence described did not impact treatment outcomes, suggesting forgiveness to nonadherence.

Background In many settings, recent or prior injection drug use remains a barrier to accessing direct-acting antiviral treatment (DAA) for hepatitis C virus (HCV) infection. We examined patterns of drug and alcohol use and injection equipment sharing among people with recent injecting drug use or receiving opioid agonist treatment (OAT) during and following DAA-based treatment. Methods SIMPLIFY and D3FEAT are phase 4 trials evaluating the efficacy of DAA among people with past 6-month injecting drug use or receiving OAT through a network of 25 international sites. Enrolled in 2016–2017, participants received sofosbuvir/velpatasvir (SIMPLIFY) or paritaprevir/ritonavir/dasabuvir/ombitasvir ± ribavirin (D3FEAT) for 12 weeks and completed behavioral questionnaires before, during, and up to 2 years posttreatment. The impact of time in HCV treatment and follow-up on longitudinally measured longitudinally measured behaviors was estimated using generalized estimating equations. Results At screening, of 190 participants (mean age, 47 years; 74% male), 62% reported any past-month injecting 16% past-month injection equipment sharing, and 61% current OAT. Median alcohol use was 2 (Alcohol Use Disorders Identification Test–Consumption; range, 1–12). During follow-up, opioid injecting (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.92–0.99) and sharing (OR, 0.87; 95% CI, 0.80–0.94) decreased, whereas no significant changes were observed for stimulant injecting (OR, 0.98; 95% CI, 0.94–1.02) or alcohol use (OR, 0.99; 95% CI, 0.95–1.04). Conclusions Injecting drug use and risk behaviors remained stable or decreased following DAA-based HCV treatment. Findings further support expanding HCV treatment to all, irrespective of injection drug use. Clinical Trials Registration SIMPLIFY, NCT02336139; D3FEAT, NCT02498015.

usc Background: There are close ties between injecting drug use and incarceration as a result of imprisonment for drug-related crimes and therefore Hepatitis C virus (HCV) transmission in prisons is high. The most effective strategies to prevent HCV transmission, including needle-syringe exchange (NSP) and opiate substitution therapies (OST) are commonly unavailable in the prisons. Understanding trends in incidence and associated factors in prisons is crucial for developing and improving HCV prevention and treatment programs in the prison setting. Aims: This study investigated trends in HCV incidence and associated factors among a cohort of prisoners in New South Wales (NSW), Australia. Methods: Data were available from the Hepatitis C Incidence and Transmission Study in prisons (HITS-p) from 2005–2014. Temporal trends in HCV incidence were evaluated. Factors associated with time to HCV seroconversion were assessed using Cox proportional hazards regression. Results: Among 590 participants enrolled, 320 were eligible for inclusion (≥1 follow-up visit, lifetime history of injecting drugs, and HCV antibody/RNA negative at enrolment). The mean age was 26 years, 72% (n=229) were male, 33% (n=104) reported recent injecting drug use, 11% (n=35) reported greater than or equal to weekly injecting since entering prison, and 25% (n=81) reported syringe sharing during follow-up. 93 seroconversions were observed in the overall sample [815 person-years (py) of follow-up] while 32 seroconversions were seen in the continuously imprisoned population (507 py of follow-up). HCV incidence was 11.4/100 p-yrs (95% CI: 9.3–14.0/100 p-yrs) in the overall sample and 6.3/100 p-yrs (95% CI: 4.5–8.9/100 p-yrs) among the continually imprisoned sample. A stable trend in incidence was observed over the study period (Figure 1). In adjusted analyses among the overall sample, greater than or equal to weekly injecting was independently associated with time to HCV seroconversion. In adjusted analyses among the continuously imprisoned population, syringe sharing was independently associated with time to HCV seroconversion. Conclusions: This study demonstrates that current prevention strategies have failed to reduce the incidence of HCV in the Australian prison setting between 2005 and 2014. This study also highlights the need for clean injecting equipment in prison given that needle and syringe sharing was associated with HCV infection among continually imprisoned participants, irrespective of frequency of injecting or the type of drug injected. Prison remains a high risk environment for acquisition of HCV infection and highlights the need for improved harm reduction strategies including NSP and evaluation of interferon-free HCV treatment as prevention strategies in prisons. Refereed/Peer-reviewed