REDUCTION IN THE POPULATION PREVALENCE OF HCV VIRAEMIA AMONG PEOPLE WHO INJECT DRUGS ASSOCIATED WITH SCALE-UP OF DIRECT-ACTING ANTIVIRAL THERAPY IN COMMUNITY DRUG SERVICES: REAL WORLD DATA.

BACKGROUND AND AIMS There has been little empirical evidence to show the 'real world' impact of scaling-up direct-acting antiviral (DAA) treatment among people who inject drugs (PWID) on hepatitis C virus (HCV) viraemia at a population level. We aimed to assess the population impact of rapid DAA scale-up to PWID delivered through community services - including drug treatment, pharmacies, needle exchanges, and prisons - in the Tayside region of Scotland, compared with Greater Glasgow & Clyde (GGC) and the Rest of Scotland (RoS). DESIGN Natural experiment, evaluated using data from national biennial surveys of PWID and national clinical data. SETTING Services providing injecting equipment (2010-2018) and HCV treatment clinics (2017-2018) across Scotland. PARTICIPANTS 12,492 PWID who completed a questionnaire and provided a blood spot (tested for HCV-antibodies and RNA); 4,105 individuals who initiated HCV treatment. INTERVENTION AND COMPARATOR The intervention was rapid DAA scale-up among PWID, which occurred in Tayside. The comparator was GGC/RoS. MEASUREMENTS Trends in HCV viraemia and uptake of HCV therapy over time; sustained viral response (SVR) rates to therapy by region and treatment setting FINDINGS: Uptake of HCV therapy (last year) among PWID between 2013-14 and 2017-18 increased from 15% to 43% in Tayside, 6% to 16% in GGC and 11% to 23% in RoS. Between 2010 and 2017-18, the prevalence of HCV viraemia (among antibody-positives) declined from 73% to 44% in Tayside, 67% to 58% in GGC and 64% to 55% in RoS. The decline in viraemia was greater in Tayside (2017-18 AOR 0·47, 95% CI 0·30-0·75, p=0.001) than elsewhere in Scotland (2017-18 AOR 0·89, 95% CI 0·74-1·07, p=0.220) relative to the baseline of 2013-14 in RoS (including GGC). Per-protocol SVR rates among PWID treated in community sites did not differ from those treated in hospital sites in Tayside (97·4% vs 100·0%, p=0·099). CONCLUSIONS Scale-up of direct-acting antiviral treatment among people who inject drugs can be achieved through hepatitis C virus (HCV) testing and treatment in community drug services whilst maintaining high sustained viral response rates and, in the Tayside region of Scotland, has led to a substantial reduction in chronic HCV in the population.

[1]  L. Tavoschi,et al.  HCV micro‐elimination in two prisons in Milan, Italy: A model of care , 2020, Journal of viral hepatitis.

[2]  Z. Butt,et al.  Real-world Effectiveness of Sofosbuvir/Velpatasvir for Treatment of Chronic Hepatitis C in British Columbia, Canada: A Population-Based Cohort Study , 2020, Open forum infectious diseases.

[3]  H. Gage,et al.  ITTREAT (Integrated Community Test ‐ Stage ‐ TREAT) Hepatitis C service for people who use drugs: Real‐world outcomes , 2020, Liver international : official journal of the International Association for the Study of the Liver.

[4]  M. Deutsch,et al.  Direct-acting antiviral treatment for chronic hepatitis C in people who use drugs in a real-world setting , 2020, Annals of gastroenterology.

[5]  P. Hayes,et al.  Real‐world impact following initiation of interferon‐free hepatitis C regimens on liver‐related outcomes and all‐cause mortality among patients with compensated cirrhosis , 2019, Journal of viral hepatitis.

[6]  P. Read,et al.  Treatment adherence and support for people who inject drugs taking direct‐acting antiviral therapy for hepatitis C infection , 2019, Journal of viral hepatitis.

[7]  Rachel Glass,et al.  Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) – a natural experiment (protocol) , 2019, BMJ Open.

[8]  G. Dore,et al.  Association between rapid utilisation of direct hepatitis C antivirals and decline in the prevalence of viremia among people who inject drugs in Australia. , 2019, Journal of hepatology.

[9]  P. Vickerman,et al.  High response and re‐infection rates among people who inject drugs treated for hepatitis C in a community needle and syringe programme , 2018, Journal of viral hepatitis.

[10]  J. Leung,et al.  Global, regional, and country‐level estimates of hepatitis C infection among people who have recently injected drugs , 2018, Addiction.

[11]  J. Dillon,et al.  DOT-C: A cluster randomised feasibility trial evaluating directly observed anti-HCV therapy in a population receiving opioid substitute therapy from community pharmacy. , 2017, The International journal on drug policy.

[12]  G. Dore,et al.  Direct-acting antiviral agents for HCV infection affecting people who inject drugs , 2017, Nature Reviews Gastroenterology & Hepatology.

[13]  J. Cairns,et al.  Prioritization of HCV treatment in the direct-acting antiviral era: An economic evaluation , 2016, Journal of hepatology.

[14]  M. Pedrosa,et al.  Early View of the Effectiveness of New Direct-Acting Antiviral (DAA) Regimens in Patients with Hepatitis C Virus (HCV) , 2015, Advances in Therapy.

[15]  G. Dore,et al.  Hepatitis C virus therapeutic development: in pursuit of "perfectovir". , 2015, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[16]  C. Archibald,et al.  Key findings from a national enhanced HIV surveillance system: 2010 - 2012. , 2014, Canada communicable disease report = Releve des maladies transmissibles au Canada.

[17]  H. Innes,et al.  Strategies for the treatment of Hepatitis C in an era of interferon-free therapies: what public health outcomes do we value most? , 2014, Gut.

[18]  S. Hutchinson,et al.  Rapid Decline in HCV Incidence among People Who Inject Drugs Associated with National Scale-Up in Coverage of a Combination of Harm Reduction Interventions , 2014, PloS one.

[19]  J. Lazarus,et al.  Hepatitis C Virus Infection Epidemiology among People Who Inject Drugs in Europe: A Systematic Review of Data for Scaling Up Treatment and Prevention , 2014, PloS one.

[20]  P. Hayes,et al.  Attendance at specialist hepatitis clinics and initiation of antiviral treatment among persons chronically infected with hepatitis C: examining the early impact of Scotland's Hepatitis C Action Plan , 2014, Journal of viral hepatitis.

[21]  J. Pawlotsky,et al.  EASL recommendations on treatment of hepatitis C 2014. , 2014, Journal of hepatology.

[22]  P. Vickerman,et al.  Combination Interventions to Prevent HCV Transmission Among People Who Inject Drugs: Modeling the Impact of Antiviral Treatment, Needle and Syringe Programs, and Opiate Substitution Therapy , 2013, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[23]  P. Vickerman,et al.  Can needle and syringe programmes and opiate substitution therapy achieve substantial reductions in hepatitis C virus prevalence? Model projections for different epidemic settings. , 2012, Addiction.

[24]  S. Hutchinson,et al.  Detection of hepatitis C virus RNA in dried blood spots. , 2012, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[25]  Patrick Royston,et al.  Multiple imputation using chained equations: Issues and guidance for practice , 2011, Statistics in medicine.

[26]  J. Parry,et al.  Evaluation of a modified commercial assay in detecting antibody to hepatitis C virus in oral fluids and dried blood spots , 2003, Journal of medical virology.