Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial

The Lancet Gastroenterology and Hepatology

Volumn 3, Issue 3, 2018, Pages 153-161

  Grebely, Jason ^a   Dalgard, Olav ^b   Conway, Brian ^c   Cunningham, Evan B ^a   Bruggmann, Philip ^d   Hajarizadeh, Behzad ^a   Amin, Janaki ^a,e   Bruneau, Julie ^f   Hellard, Margaret ^g,h   Litwin, Alain H ⁱ   Marks, Philippa ^a   Quiene, Sophie ^a   Siriragavan, Sharmila ^a   Applegate, Tanya L ^a   Swan, Tracy ^j   Byrne, Jude ^k   Lacalamita, Melanie ^l   Dunlop, Adrian ^m   Matthews, Gail V ^a,n   Powis, Jeff ^o   Shaw, David ^p   Thurnheer, Maria Christine ^l   Weltman, Martin ^q   Kronborg, Ian ^r   Cooper, Curtis ^s   Feld, Jordan J ^t   Fraser, Chris ^u   Dillon, John F ^v   Read, Phillip ^a,w   Gane, Ed ^x   Dore, Gregory J ^a,n   more..

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b AKERSHUS UNIVERSITY HOSPITAL   (Norway)

^c VANCOUVER INFECTIOUS DISEASES CENTRE   (Canada)

^d Arud Centres for Addiction Medicine   (Switzerland)

^e MACQUARIE UNIVERSITY   (Australia)

^f CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^g BURNET INSTITUTE   (Australia)

^h ALFRED HOSPITAL   (Australia)

ⁱ ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^j International Network on Hepatitis in Substance Users   (United States)

^k Australian Injecting Illicit Drug Users League   (Australia)

^l UNIVERSITY OF BERN   (Switzerland)

^m Newcastle Pharmacotherapy Service   (Australia)

ⁿ ST VINCENT S HOSPITAL   (Australia)

^o South Riverdale Community Health Centre   (Canada)

^p ROYAL ADELAIDE HOSPITAL   (Australia)

^q NEPEAN HOSPITAL   (Australia)

^r WESTERN HOSPITAL   (Australia)

^s OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^t TORONTO GENERAL HOSPITAL   (Canada)

^u Cool Aid Community Health Centre ^*  (Canada)

^v UNIVERSITY OF DUNDEE   (United Kingdom)

^w Kirketon Road Centre ^*  (Australia)

^x AUCKLAND CITY HOSPITAL   (New Zealand)

more..

Author keywords

[No Author keywords available]

Indexed keywords

NONSTRUCTURAL PROTEIN 5A INHIBITOR; SOFOSBUVIR; VELPATASVIR; ANTIVIRUS AGENT; CARBAMIC ACID DERIVATIVE; FUSED HETEROCYCLIC RINGS;

ADULT; ALCOHOL CONSUMPTION; ARTHRALGIA; ARTICLE; BACKACHE; CLINICAL TRIAL; DIARRHEA; DIZZINESS; DRUG USE; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOLLOW UP; GENETIC DISTANCE; HEADACHE; HEPATITIS C; HUMAN; INSOMNIA; LIMIT OF QUANTITATION; LIVER CIRRHOSIS; LIVER FIBROSIS; LIVER STIFFNESS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NAUSEA; OPIATE SUBSTITUTION TREATMENT; PHYSICAL EXAMINATION; PRIORITY JOURNAL; QUESTIONNAIRE; REINFECTION; RHABDOMYOLYSIS; RHINOPHARYNGITIS; SUSTAINED VIROLOGIC RESPONSE; VOMITING; CHRONIC HEPATITIS C; COMPLICATION; DRUG ADMINISTRATION; DRUG PACKAGING; GENETICS; GENOTYPE; HEPACIVIRUS; MEDICATION COMPLIANCE; ORAL DRUG ADMINISTRATION; PHASE 4 CLINICAL TRIAL; RECURRENT DISEASE; RISK FACTOR; SUBSTANCE ABUSE; VIROLOGY;

ADMINISTRATION, ORAL; ADULT; ANTIVIRAL AGENTS; CARBAMATES; DRUG ADMINISTRATION SCHEDULE; DRUG PACKAGING; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HETEROCYCLIC COMPOUNDS, 4 OR MORE RINGS; HUMANS; MALE; MEDICATION ADHERENCE; MIDDLE AGED; RECURRENCE; RISK FACTORS; SOFOSBUVIR; SUBSTANCE ABUSE, INTRAVENOUS; SUSTAINED VIROLOGIC RESPONSE;

EID: 85042350029     PISSN: 24681253     EISSN: None     Source Type: Journal    
DOI: 10.1016/S2468-1253(17)30404-1     Document Type: Article

References (43)

1. Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol 2 (2017), 161–176.
2. Degenhardt, L, Peacock, A, Colledge, S, et al. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health 5 (2017), e1192–e2207.
3. Hajarizadeh, B, Grebely, J, Dore, GJ, Epidemiology and natural history of HCV infection. Nat Rev Gastroenterol Hepatol 10 (2013), 553–562.
4. Nelson, PK, Mathers, BM, Cowie, B, et al. Global epidemiology of hepatitis B and hepatitis C in people who inject drugs: results of systematic reviews. Lancet 378 (2011), 571–583.
5. Grebely, J, Dore, GJ, Zeuzem, S, et al. Efficacy and safety of sofosbuvir/velpatasvir in patients with chronic hepatitis C Virus infection receiving opioid substitution therapy: analysis of phase 3 ASTRAL trials. Clin Infect Dis 63 (2016), 1479–1481.
6. Grebely, J, Mauss, S, Brown, A, et al. Efficacy and safety of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic HCV genotype 1 infection receiving opioid substitution therapy: analysis of phase 3 ION trials. Clin Infect Dis 63 (2016), 1405–1411.
7. Grebely, J, Hajarizadeh, B, Dore, GJ, Direct-acting antiviral agents for HCV infection affecting people who inject drugs. Nat Rev Gastroenterol Hepatol 14 (2017), 641–651.
8. Dore, GJ, Altice, F, Litwin, AH, et al. Elbasvir-grazoprevir to treat hepatitis C virus infection in persons receiving opioid agonist therapy: a randomized trial. Ann Intern Med 165 (2016), 625–634.
9. Lalezari, J, Sullivan, JG, Varunok, P, et al. Ombitasvir/paritaprevir/r and dasabuvir plus ribavirin in HCV genotype 1-infected patients on methadone or buprenorphine. J Hepatol 63 (2015), 364–369.
10. Dore, GJ, Grebely, J, Altice, F, et al. HCV reinfection and injecting risk behavior following elbasvir/grazoprevir treatment in patients on opioid agonist therapy: CO-STAR three year follow-up study. Hepatology, 64, 2016, 431A.
11. Robaeys, G, Bielen, R, Azar, DG, Razavi, H, Nevens, F, Global genotype distribution of hepatitis C viral infection among people who inject drugs. J Hepatol 65 (2016), 1094–1103.
12. Barua, S, Greenwald, R, Grebely, J, Dore, GJ, Swan, T, Taylor, LE, Restrictions for Medicaid reimbursement of sofosbuvir for the treatment of hepatitis C virus infection in the United States. Ann Intern Med 163 (2015), 215–223.
13. Marshall, AD, Cunningham, EB, Nielsen, S, et al. Restrictions for reimbursement of interferon-free direct-acting antiviral drugs for HCV infection in Europe. Lancet Gastroenterol Hepatol, 2017 published online Oct 3. http://dx.doi.org/10.1016/S2468-1253(17)30284-4.
14. Feld, JJ, Jacobson, IM, Hezode, C, et al. Sofosbuvir and velpatasvir for HCV genotype 1, 2, 4, 5, and 6 infection. N Engl J Med 373 (2015), 2599–2607.
15. Foster, GR, Afdhal, N, Roberts, SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med 373 (2015), 2608–2617.
16. Grebely, J, Dalgard, O, Cunningham, EB, et al. Efficacy of response-guided directly observed pegylated interferon and self-administered ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study. Int J Drug Policy 47 (2017), 177–186.
17. Grebely, J, Pham, ST, Matthews, GV, et al. Hepatitis C virus reinfection and superinfection among treated and untreated participants with recent infection. Hepatology 55 (2012), 1058–1069.
18. Lamoury, FM, Jacka, B, Bartlett, S, et al. The Influence of hepatitis C virus genetic region on phylogenetic clustering analysis. PLoS One, 10, 2015, e0131437.
19. Morris, L, Smirnov, A, Kvassay, A, et al. Initial outcomes of integrated community-based hepatitis C treatment for people who inject drugs: findings from the Queensland Injectors' Health Network. Int J Drug Policy 47 (2017), 216–220.
20. Read, P, Lothian, R, Chronister, K, et al. Delivering direct acting antiviral therapy for hepatitis C to highly marginalised and current drug injecting populations in a targeted primary health care setting. Int J Drug Policy 47 (2017), 209–215.
21. Mason, K, Dodd, Z, Guyton, M, et al. Understanding real-world adherence in the directly acting antiviral era: a prospective evaluation of adherence amongst people with a history of drug use at a community-based program in Toronto, Canada. Int J Drug Policy 47 (2017), 202–208.
22. Midgard, H, Bjoro, B, Maeland, A, et al. Hepatitis C reinfection after sustained virological response. J Hepatol 64 (2016), 1020–1026.
23. Alavi, M, Spelman, T, Matthews, GV, et al. Injecting risk behaviours following treatment for hepatitis C virus infection among people who inject drugs: The Australian Trial in Acute Hepatitis C. Int J Drug Policy 26 (2015), 976–983.
24. Artenie, AA, Zang, G, Daniel, M, et al. Short-term injection drug use changes following hepatitis C virus (HCV) assessment and treatment among persons who inject drugs with acute HCV infection. Int J Drug Policy 47 (2017), 239–243.
25. Cunningham, EB, Applegate, TL, Lloyd, AR, Dore, GJ, Grebely, J, Mixed HCV infection and reinfection in people who inject drugs—impact on therapy. Nat Rev Gastroenterol Hepatol 12 (2015), 218–230.
26. Aspinall, EJ, Corson, S, Doyle, JS, et al. Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis 57:suppl 2 (2013), S80–S89.
27. Simmons, B, Saleem, J, Hill, A, Riley, RD, Cooke, GS, Risk of late relapse or reinfection with hepatitis C virus after achieving a sustained virological response: a systematic review and meta-analysis. Clin Infect Dis 62 (2016), 683–694.
28. Young, J, Rossi, C, Gill, J, et al. Risk factors for hepatitis C virus reinfection after sustained virologic response in patients co-infected with HIV. Clin Infect Dis 64 (2017), 1154–1162.
29. Islam, N, Krajden, M, Shoveller, J, et al. Incidence, risk factors, and prevention of hepatitis C reinfection: a population-based cohort study. Lancet Gastroenterol Hepatol 2 (2017), 200–210.
30. Dore, GJ, Grebely, J, Altice, F, et al. Hepatitis C virus (HCV) reinfection and injecting risk behavior following elbasvir (EBR)/grazoprevir (GZR) treatment in participants on opiate agonist therapy (OAT): CO-STAR part B. Hepatology 66 (2017), 112a–113a.
31. Darke, S, Self-report among injecting drug users: a review. Drug Alcohol Depend 51 (1998), 253–263.
32. Islam, MM, Topp, L, Conigrave, KM, et al. The reliability of sensitive information provided by injecting drug users in a clinical setting: clinician-administered versus audio computer-assisted self-interviewing (ACASI). AIDS Care 24 (2012), 1496–1503.
33. Sulkowski, M, Ward, K, Falade-Nwulia, O, et al. Randomized controlled trial of cash incentives or peer mentors to improve HCV linkage and treatment among HIV/HCV coinfected persons who inject drugs: the CHAMPS Study. J Hepatol, 66, 2017, S719.
34. Asher, AK, Portillo, CJ, Cooper, BA, Dawson-Rose, C, Vlahov, D, Page, KA, Clinicians' views of hepatitis C virus treatment candidacy with direct-acting antiviral regimens for people who inject drugs. Substance Use Misuse 51 (2016), 1218–1223.
35. European Association for the Study of the Liver. EASL recommendations on the treatment of hepatitis C 2016. J Hepatol 66 (2017), 153–194.
36. Robaeys, G, Grebely, J, Mauss, S, et al. Recommendations for the management of hepatitis C virus infection among people who inject drugs. Clin Infect Dis 57:suppl 2 (2013), 129–137.
37. American Association for the Study of Liver Diseases/Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. www.hcvguidelines.org/evaluate/when-whom, 2015 (accessed Dec 19, 2017).
38. WHO. Guidelines for the screening, care and treatment of persons with hepatitis C infection. 2014, World Health Organization, Geneva, Switzerland.
39. Grebely, J, Robaeys, G, Bruggmann, P, et al. Recommendations for the management of hepatitis C virus infection among people who inject drugs. Int J Drug Policy 26 (2015), 1028–1038.
40. Martin, NK, Vickerman, P, Grebely, J, et al. Hepatitis C virus treatment for prevention among people who inject drugs: modeling treatment scale-up in the age of direct-acting antivirals. Hepatology 58 (2013), 1598–1609.
41. WHO. Global Hepatitis Report 2017. 2017, World Health Organization, Geneva.
42. Scott, N, McBryde, ES, Thompson, A, Doyle, JS, Hellard, ME, Treatment scale-up to achieve global HCV incidence and mortality elimination targets: a cost-effectiveness model. Gut 66 (2017), 1507–1515.
43. Martin, NK, Vickerman, P, Dore, GJ, et al. Prioritization of HCV treatment in the direct-acting antiviral era: an economic evaluation. J Hepatol 65 (2016), 17–25.