Randomised Controlled Trial Conducted in Injecting Equipment Provision Sites to Compare the Effectiveness of Different Hepatitis C Treatment Regimens in People Who Inject Drugs: A Direct ObserVed TherApy Versus FortNightly CollEction Study for HCV...

Overview

Journal BMJ Open

Specialty General Medicine

Date 2019 Aug 11

PMID 31399460

Citations 7

Authors

Sarah K Inglis

Lewis Jz Beer

Christopher Byrne

Amy Malaguti

Emma Robinson

Christian Sharkey

Kirsty Gillings

Brian Stephens

John F Dillon

Affiliations

Soon will be listed here.

Abstract

Introduction: Hepatitis C is a blood-borne virus (HCV) that can seriously damage the liver and is spread mainly through blood-to-blood contact with an infected person. Over 85% of individuals who have HCV in Scotland became infected following injecting drug use. Since people who inject drugs (PWID) are the main source of new infections, theoretical modelling has suggested that treatment of HCV infection in PWID may effectively reduce HCV prevalence and accomplish elimination. This protocol describes a clinical trial delivering HCV treatment within injecting equipment provision sites (IEPS) in Tayside, Scotland.

Methods And Analysis: PWID attending IEPS are tested for HCV and, if they are chronically infected with HCV and eligible, invited to receive treatment within the IEPS. They are randomised to one of three treatment regimens; daily observed treatment, treatment dispensed every 2 weeks and treatment dispensed every 2 weeks together with an adherence psychological intervention (administered before treatment begins). The primary outcome is comparison of the rate of successful treatment (SVR) in each treatment group. Secondary analyses include assessment of adherence, reinfection rates, viral resistance to treatment and interaction of the treatment with illicit drugs.

Ethics And Dissemination: The ADVANCE (A Direct obserVed therApy versus fortNightly CollEction) HCV trial was given favourable opinion by East of Scotland Research Ethics Committee (LR/17/ES/0089) prior to commencement.

Trial Registration Numbers: European Clinical Trials Database (EudraCT) (2017-001039-38) and ClinicalTrials.gov (NCT03236506).

Citing Articles

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Robinson E, Byrne C, Carberry J, Radley A, Beer L, Inglis S BMC Public Health. 2023; 23(1):54.

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Randomized clinical trial: Direct-acting antivirals as treatment for hepatitis C in people who inject drugs: Delivered in needle and syringe programs via directly observed therapy versus fortnightly collection.

Beer L, Inglis S, Malaguti A, Byrne C, Sharkey C, Robinson E J Viral Hepat. 2022; 29(8):646-653.

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Real-world outcomes of rapid regional hepatitis C virus treatment scale-up among people who inject drugs in Tayside, Scotland.

Byrne C, Beer L, Inglis S, Robinson E, Radley A, Goldberg D Aliment Pharmacol Ther. 2021; 55(5):568-579.

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Khalsa J, Mathur P Viruses. 2021; 13(7).

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References

Bruggmann P . Accessing Hepatitis C patients who are difficult to reach: it is time to overcome barriers. J Viral Hepat. 2012; 19(12):829-35. DOI: 10.1111/jvh.12008. View

Bonkovsky H, Mehta S . Hepatitis C: a review and update. J Am Acad Dermatol. 2001; 44(2):159-82. DOI: 10.1067/mjd.2001.109311. View

Bourliere M, Gordon S, Flamm S, Cooper C, Ramji A, Tong M . Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated HCV Infection. N Engl J Med. 2017; 376(22):2134-2146. DOI: 10.1056/NEJMoa1613512. View

Roy K, Hutchinson S, Wadd S, Taylor A, Cameron S, Burns S . Hepatitis C virus infection among injecting drug users in Scotland: a review of prevalence and incidence data and the methods used to generate them. Epidemiol Infect. 2006; 135(3):433-42. PMC: 2870592. DOI: 10.1017/S0950268806007035. View

Schulkind J, Stephens B, Ahmad F, Johnston L, Hutchinson S, Thain D . High response and re-infection rates among people who inject drugs treated for hepatitis C in a community needle and syringe programme. J Viral Hepat. 2018; 26(5):519-528. DOI: 10.1111/jvh.13035. View

Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M . Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014; 370(20):1889-98. DOI: 10.1056/NEJMoa1402454. View

Innes H, Goldberg D, Dillon J, Hutchinson S . Strategies for the treatment of Hepatitis C in an era of interferon-free therapies: what public health outcomes do we value most?. Gut. 2014; 64(11):1800-9. DOI: 10.1136/gutjnl-2014-308166. View

Sagnelli E, Starace M, Minichini C, Pisaturo M, Macera M, Sagnelli C . Resistance detection and re-treatment options in hepatitis C virus-related chronic liver diseases after DAA-treatment failure. Infection. 2018; 46(6):761-783. DOI: 10.1007/s15010-018-1188-3. View

Poordad F, Felizarta F, Asatryan A, Sulkowski M, Reindollar R, Landis C . Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology. 2017; 66(2):389-397. PMC: 5573922. DOI: 10.1002/hep.29081. View

10.

Montaner J . Treatment as prevention--a double hat-trick. Lancet. 2011; 378(9787):208-9. DOI: 10.1016/S0140-6736(11)60821-0. View

11.

Chikovani I, Ompad D, Uchaneishvili M, Sulaberidze L, Sikharulidze K, Hagan H . On the way to Hepatitis C elimination in the Republic of Georgia-Barriers and facilitators for people who inject drugs for engaging in the treatment program: A formative qualitative study. PLoS One. 2019; 14(4):e0216123. PMC: 6488087. DOI: 10.1371/journal.pone.0216123. View

12.

Radley A, de Bruin M, Inglis S, Donnan P, Dillon J . Clinical effectiveness of pharmacy-led versus conventionally delivered antiviral treatment for hepatitis C in patients receiving opioid substitution therapy: a study protocol for a pragmatic cluster randomised trial. BMJ Open. 2018; 8(12):e021443. PMC: 6303565. DOI: 10.1136/bmjopen-2017-021443. View

13.

Lawitz E, Poordad F, Gutierrez J, Wells J, Landaverde C, Evans B . Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial. Hepatology. 2016; 65(2):439-450. DOI: 10.1002/hep.28877. View

14.

Montaner J, Lima V, Harrigan P, Lourenco L, Yip B, Nosyk B . Expansion of HAART coverage is associated with sustained decreases in HIV/AIDS morbidity, mortality and HIV transmission: the "HIV Treatment as Prevention" experience in a Canadian setting. PLoS One. 2014; 9(2):e87872. PMC: 3922718. DOI: 10.1371/journal.pone.0087872. View

15.

Wolfe D, Luhmann N, Harris M, Momenghalibaf A, Albers E, Byrne J . Human rights and access to hepatitis C treatment for people who inject drugs. Int J Drug Policy. 2015; 26(11):1072-80. DOI: 10.1016/j.drugpo.2015.05.007. View

16.

Altice F, Maru D, Bruce R, Springer S, Friedland G . Superiority of directly administered antiretroviral therapy over self-administered therapy among HIV-infected drug users: a prospective, randomized, controlled trial. Clin Infect Dis. 2007; 45(6):770-8. PMC: 2693907. DOI: 10.1086/521166. View

17.

Swan D, Long J, Carr O, Flanagan J, Irish H, Keating S . Barriers to and facilitators of hepatitis C testing, management, and treatment among current and former injecting drug users: a qualitative exploration. AIDS Patient Care STDS. 2010; 24(12):753-62. DOI: 10.1089/apc.2010.0142. View

18.

Harris R, Thomas B, Griffiths J, Costella A, Chapman R, Ramsay M . Increased uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease in England: modelling the predicted impact of treatment under different scenarios. J Hepatol. 2014; 61(3):530-7. DOI: 10.1016/j.jhep.2014.05.008. View

19.

Hutchinson S, Roy K, Wadd S, Bird S, Taylor A, Anderson E . Hepatitis C virus infection in Scotland: epidemiological review and public health challenges. Scott Med J. 2006; 51(2):8-15. DOI: 10.1258/RSMSMJ.51.2.8. View

20.

Martin N, Vickerman P, Foster G, Hutchinson S, Goldberg D, Hickman M . Can antiviral therapy for hepatitis C reduce the prevalence of HCV among injecting drug user populations? A modeling analysis of its prevention utility. J Hepatol. 2010; 54(6):1137-44. DOI: 10.1016/j.jhep.2010.08.029. View