Paritaprevir, ritonavir, ombitasvir, and dasabuvir with and without ribavirin in people with HCV genotype 1 and recent injecting drug use or receiving opioid substitution therapy

International Journal of Drug Policy

Volumn 62, Issue , 2018, Pages 94-103

  Grebely, Jason ^a   Conway, Brian ^b   Cunningham, Evan B ^a   Fraser, Chris ^c   Moriggia, Alberto ^d   Gane, Ed ^e   Stedman, Catherine ^f   Cooper, Curtis ^g   Castro, Erika ^h   Schmid, Patrick ⁱ   Petoumenos, Kathy ^b   Hajarizadeh, Behzad ^b   Marks, Phillipa ^b   Erratt, Amanda ^b   Dalgard, Olav ^j   Lacombe, Karine ^k   Feld, Jordan J ^l   Bruneau, Julie ^m   Daulouede, Jean Pierre ⁿ   Powis, Jeff ^o   Bruggmann, Philip ^p   Matthews, Gail V ^b,q   Kronborg, Ian ^r   Shaw, David ^s   Dunlop, Adrian ^t   Hellard, Margaret ^u   Applegate, Tanya L ^b   Crawford, Sione ^v   Dore, Gregory J ^b,k   more..

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b VANCOUVER INFECTIOUS DISEASES CENTRE   (Canada)

^c Coolaid Community Health Centre ^*  (Canada)

^d Epatocentro Ticino   (Switzerland)

^e AUCKLAND CITY HOSPITAL   (New Zealand)

^f UNIVERSITY OF OTAGO   (New Zealand)

^g OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^h LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

ⁱ CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^j AKERSHUS UNIVERSITY HOSPITAL   (Norway)

^k HÔPITAL SAINT ANTOINE   (France)

^l TORONTO GENERAL HOSPITAL   (Canada)

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

ⁿ Ctr Toxicomanes Prog M M R   (France)

^o South Riverdale Community Health Centre   (Canada)

^p Arud Centres for Addiction Medicine   (Switzerland)

^q ST VINCENT S HOSPITAL   (Australia)

^r WESTERN HOSPITAL   (Australia)

^s ROYAL ADELAIDE HOSPITAL   (Australia)

^t Newcastle Pharmacotherapy Service   (Australia)

^u BURNET INSTITUTE   (Australia)

^v Harm Reduction Victoria Inc   (Australia)

more..

Author keywords

DAA; Drug use; Hepatitis C; Injecting drug users; PWID; Treatment

Indexed keywords

DASABUVIR; DASABUVIR PLUS OMBITASVIR PLUS PARITAPREVIR PLUS RITONAVIR; OMBITASVIR; PARITAPREVIR; RIBAVIRIN; RITONAVIR; ABT-267; ABT-333; ABT-450; ANILIDE; ANTIVIRUS AGENT; CARBAMIC ACID DERIVATIVE; MACROCYCLIC COMPOUND; SULFONAMIDE; URACIL; VIRUS RNA;

ADULT; ADVERSE OUTCOME; ANEMIA; ARTICLE; ASTHENIA; CHRONIC HEPATITIS C; CLINICAL EFFECTIVENESS; DECREASED APPETITE; DIZZINESS; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FATIGUE; FEMALE; FOLLOW UP; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; HYPERHIDROSIS; INJECTION DRUG USER; INSOMNIA; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; MYOCLONUS; NAUSEA; OPIATE SUBSTITUTION TREATMENT; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; PRISONER; PRURITUS; RELAPSE; TREATMENT DURATION; TREATMENT WITHDRAWAL; VOMITING; COMBINATION DRUG THERAPY; DRUG ADMINISTRATION; EPIDEMIOLOGY; GENETICS; HEPACIVIRUS; MEDICATION COMPLIANCE; PROCEDURES; QUALITATIVE RESEARCH; SUBSTANCE ABUSE; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME; VIROLOGY;

ADULT; ANILIDES; ANTIVIRAL AGENTS; CARBAMATES; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; MACROCYCLIC COMPOUNDS; MALE; MEDICATION ADHERENCE; MIDDLE AGED; OPIATE SUBSTITUTION TREATMENT; QUALITATIVE RESEARCH; RIBAVIRIN; RITONAVIR; RNA, VIRAL; SUBSTANCE ABUSE, INTRAVENOUS; SULFONAMIDES; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME; URACIL;

EID: 85055474586     PISSN: 09553959     EISSN: 18734758     Source Type: Journal    
DOI: 10.1016/j.drugpo.2018.10.004     Document Type: Article

References (57)

1. AASLD/IDSA, Recommendations for testing, managing, and treating hepatitis C. Retrieved January 18 2015 from, 2015 www.hcvguidelines.org.
2. Agarwal, K., Dumas, E.O., Gaeta, G.B., Lee, S., Streinu-Cercel, A., Schott, E., et al. Long-term clinical outcomes in HCV genotype 1-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir ± ribavirin: First interim safety and efficacy results from TOPAZ-I. Hepatology, 64, 2016, 427A.
3. Alavi, M., Spelman, T., Matthews, G.V., Haber, P.S., Day, C., van Beek, I., et al. Injecting risk behaviours following treatment for hepatitis C virus infection among people who inject drugs: The Australian trial in acute hepatitis C. International Journal on Drug Policy 26 (2015), 976–983.
4. Alvarez-Uria, G., Day, J.N., Nasir, A.J., Russell, S.K., Vilar, F.J., Factors associated with treatment failure of patients with psychiatric diseases and injecting drug users in the treatment of genotype 2 or 3 hepatitis C chronic infection. Liver International 29 (2009), 1051–1055.
5. Andreone, P., Colombo, M.G., Enejosa, J.V., Koksal, I., Ferenci, P., Maieron, A., et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology, 147(359–365), 2014, e351.
6. Artenie, A.A., Zang, G., Daniel, M., Fortier, E., Jutras-Aswad, D., Puzhko, S., 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. International Journal on Drug Policy 47:September (2017), 239–243, 10.1016/j.drugpo.2017.05.033 Epub 2017 Jun 4.
7. Aspinall, E.J., Corson, S., Doyle, J.S., Grebely, J., Hutchinson, S.J., Dore, G.J., et al. Treatment of hepatitis C virus infection among people who are actively injecting drugs: A systematic review and meta-analysis. Clinical Infectious Diseases 57:Suppl. 2 (2013), S80–89.
8. Boglione, L., Mornese Pinna, S., De Nicolò A., Cusato, J., Cariti, G., Di Perri, G., et al. Treatment with direct-acting antiviral agents of hepatitis C virus infection in injecting drug users: A prospective study. Journal of Viral Hepatitis 24:Oct. (10) (2017), 850–857, 10.1111/jvh.12711 Epub 2017 Apr 25.
9. Bush, K., Kivlahan, D.R., McDonell, M.B., Fihn, S.D., Bradley, K.A., The AUDIT alcohol consumption questions (AUDIT-C): An effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Archives of Internal Medicine 158 (1998), 1789–1795.
10. Castera, L., Vergniol, J., Foucher, J., Le Bail, B., Chanteloup, E., Haaser, M., et al. Prospective comparison of transient elastography, fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology 128 (2005), 343–350.
11. Cunningham, E.B., Applegate, T.L., Lloyd, A.R., Dore, G.J., Grebely, J., Mixed HCV infection and reinfection in people who inject drugs–impact on therapy. Nature Reviews Gastroenterology and Hepatology 12 (2015), 218–230.
12. Degenhardt, L., Peacock, A., Colledge, S., Leung, J., Grebely, J., Vickerman, P., 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 Global Health 5:Dec. (12) (2017), e1192–e1207, 10.1016/S2214-109X(17)30375-3 Epub 2017 Oct 23. Review.
13. Dore, G.J., Altice, F., Litwin, A.H., Dalgard, O., Gane, E.J., Shibolet, O., et al. Elbasvir/grazoprevir to treat HCV infection in persons receiving opioid agonist therapy: A randomized controlled trial (C-EDGE CO-STAR). Annals of Internal Medicine, 2016 In Press.
14. Dore, G.J., Altice, F., Litwin, A.H., Dalgard, O., Gane, E.J., Shibolet, O., et al. Elbasvir-grazoprevir to treat hepatitis C virus infection in persons receiving opioid agonist therapy: A randomized trial. Annals of Internal Medicine 165 (2016), 625–634.
15. Dore, G.J., Grebely, J., Altice, F., Litwin, A.H., Dalgard, O., Gane, E.J., 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.
16. Dore, G.J., Grebely, J., Altice, F., Litwin, A.H., Dalgard, O., Gane, E.J., 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.
17. European Association for the Study of the Liver, EASL Recommendations on Treatment of Hepatitis C 2018. Journal of Hepatology 69:Aug. (2) (2018), 461–511, 10.1016/j.jhep.2018.03.026 Epub 2018 Apr 9. No abstract available.
18. Feld, J.J., Kowdley, K.V., Coakley, E., Sigal, S., Nelson, D.R., Crawford, D., et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. New England Journal of Medicine 370 (2014), 1594–1603.
19. Feld, J.J., Moreno, C., Trinh, R., Tam, E., Bourgeois, S., Horsmans, Y., et al. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. Journal of Hepatology 64 (2016), 301–307.
20. Ferenci, P., Bernstein, D., Lalezari, J., Cohen, D., Luo, Y., Cooper, C., et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. New England Journal of Medicine 370 (2014), 1983–1992.
21. Fuchs, M., Morgan, T.R., Charafeddine, M., Bräu, N., Schmidt, W.N., Kozal, M., et al. An open-label, multicenter study of ombitasvir/parita-previr/ritonavir and dasabuvir with or without ribavi-rin in US veterans with genotype 1 chronic hepatitis C infection: Efficacy and safety results of TOPAZ-VA. Hepatology, 64, 2016, 488A.
22. Grebely, J., Alavi, M., Micallef, M., Dunlop, A.J., Balcomb, A.C., Phung, N., et al. Treatment for hepatitis C virus infection among people who inject drugs attending opioid substitution treatment and community health clinics: The ETHOS Study. Addiction 111 (2016), 311–319.
23. Grebely, J., Dalgard, O., Conway, B., Cunningham, E.B., Bruggmann, P., Hajarizadeh, B., 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 & Hepatology 3:Mar. (3) (2018), 153–161, 10.1016/S2468-1253(17)30404-1 Epub 2018 Jan 6.
24. Grebely, J., Dalgard, O., Cunningham, E.B., Hajarizadeh, B., Foster, G.R., Bruggmann, P., 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. International Journal on Drug Policy 47:September (2017), 177–186, 10.1016/j.drugpo.2017.05.020 Epub 2017 Jun 16.
25. Grebely, J., Dore, G.J., Zeuzem, S., Aspinall, R.J., Fox, R., Han, L., 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. Clinical Infectious Diseases 63 (2016), 1479–1481.
26. Grebely, J., Hajarizadeh, B., Dore, G.J., Direct-acting antiviral agents for HCV infection affecting people who inject drugs. Nature Reviews Gastroenterology & Hepatology 14:Nov. (11) (2017), 641–651, 10.1038/nrgastro.2017.106 Epub 2017 Aug 23. Review.
27. Grebely, J., Jacobson, I.M., Kayali, Z., Verna, E.C., Shiffman, M.L., Hyland, R.H., et al. SOF/VEL/VOX for 8 or 12 weeks Is Well tolerated and results in high SVR12 rates in patients receiving opioid substitution therapy. Journal of Hepatology, 66, 2017, S513.
28. Grebely, J., Larney, S., Peacock, A., Colledge, S., Leung, J., Hickman, M., et al. Global, regional, and country-level estimates of hepatitis C infection among people who have recently injected drugs. Addiction(July), 2018, 10.1111/add.14393 [Epub ahead of print].
29. Grebely, J., Mauss, S., Brown, A., Bronowicki, J.P., Puoti, M., Wyles, D., 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. Clinical Infectious Diseases 63 (2016), 1405–1411.
30. Grebely, J., Puoti, M., Wedemeyer, H., Cooper, C.S., Sulkowski, M.S., Foster, G.F., et al. Safety and efficacy of ombitasvir, Paritaprevir/Ritonavir and dasabuvir with or without ribavirin in chronic hepatitis C patients receiving opioid substitution therapy: A pooled analysis across 12 clinical trials. Journal of Hepatology, 66, 2017, S514.
31. Grebely, J., Robaeys, G., Bruggmann, P., Aghemo, A., Backmund, M., Bruneau, J., et al. Recommendations for the management of hepatitis C virus infection among people who inject drugs. International Journal on Drug Policy 26 (2015), 1028–1038.
32. Hajarizadeh, B., Cunningham, E.B., Reid, H., Law, M., Dore, G.J., Grebely, J., Direct-acting antiviral treatment for hepatitis C among people who use or inject drugs: A systematic review and meta-analysis. The Lancet Gastroenterology & Hepatology(September), 2018, 10.1016/S2468-1253(18)30304-2 pii: S2468-1253(18)30304-2. [Epub ahead of print].
33. Hales, G., Roth, N., Smith, D., Possible fatal interaction between protease inhibitors and methamphetamine. Antiviral Therapy, 5, 2000, 19.
34. Islam, N., Krajden, M., Shoveller, J., Gustafson, P., Gilbert, M., Buxton, J.A., et al. Incidence, risk factors, and prevention of hepatitis C reinfection: A population-based cohort study. The Lancet Gastroenterology & Hepatology 2 (2017), 200–210.
35. Lalezari, J., Sullivan, J.G., Varunok, P., Galen, E., Kowdley, K.V., Rustgi, V., et al. Ombitasvir/paritaprevir/r and dasabuvir plus ribavirin in HCV genotype 1-infected patients on methadone or buprenorphine. Journal of Hepatology 63 (2015), 364–369.
36. Lamoury, F.M., Jacka, B., Bartlett, S., Bull, R.A., Wong, A., Amin, J., et al. The influence of hepatitis C virus genetic region on phylogenetic clustering analysis. PLoS One, 10, 2015, e0131437.
37. Larney, S., Grebely, J., Hickman, M., De Angelis, D., Dore, G.J., Degenhardt, L., Defining populations and injecting parameters among people who inject drugs: Implications for the assessment of hepatitis C treatment programs. International Journal on Drug Policy 26 (2015), 950–957.
38. Martin, N.K., Vickerman, P., Dore, G.J., Grebely, J., Miners, A., Cairns, J., et al. Prioritization of HCV treatment in the direct-acting antiviral era: An economic evaluation. Journal of Hepatology 65 (2016), 17–25.
39. Martin, N.K., Vickerman, P., Grebely, J., Hellard, M., Hutchinson, S.J., Lima, V.D., 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.
40. Mason, K., Dodd, Z., Guyton, M., Tookey, P., Lettner, B., Matelski, J., et al. 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. International Journal on Drug Policy 47:September (2017), 202–208, 10.1016/j.drugpo.2017.05.025 Epub 2017 Jun 12.
41. Midgard, H., Bjoro, B., Maeland, A., Konopski, Z., Kileng, H., Damas, J.K., et al. Hepatitis C reinfection after sustained virological response. Journal of Hepatology 64 (2016), 1020–1026.
42. Nachega, J.B., Parienti, J.J., Uthman, O.A., Gross, R., Dowdy, D.W., Sax, P.E., et al. Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials. Clinical Infectious Diseases 58 (2014), 1297–1307.
43. Norton, B.L., Fleming, J., Bachhuber, M.A., Steinman, M., DeLuca, J., Cunningham, C.O., et al. High HCV cure rates for people who use drugs treated with direct acting antiviral therapy at an urban primary care clinic. International Journal on Drug Policy 47 (2017), 196–201.
44. Poordad, F., Hezode, C., Trinh, R., Kowdley, K.V., Zeuzem, S., Agarwal, K., et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. New England Journal of Medicine 370 (2014), 1973–1982.
45. Puoti, M., Cooper, C., Sulkowski, M.S., Foster, G.R., Berg, T., Villa, E., et al. ABT-450/r/ombitasvir plus dasabuvir with or without ribavirin in HCV genotype 1-infected patients receiving stable opioid substitution treatment: Pooled analysis of efficacy and safety in phase 2 and phase 3 trials. Hepatology 60 (2014), 1135a–1136a.
46. Read, P., Lothian, R., Chronister, K., Gilliver, R., Kearley, J., Dore, G.J., 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. International Journal on Drug Policy 47:September (2017), 209–215, 10.1016/j.drugpo.2017.05.032 Epub 2017 Jun 4.
47. Reau, N., Poordad, F., Enejosa, J., Siddique, A., Aguilar, H.I., Lalezari, J.P., et al. Preliminary safety and efficacy results from TOPAZ-II: A phase 3b study evaluating long-term clinical out-comes in HCV genotype 1-infected patients receiving ombitasvir/paritaprevir/r and dasabuvir +/-ribavirin. Hepatology, 62, 2015, 732A.
48. Robaeys, G., Grebely, J., Mauss, S., Bruggmann, P., Moussalli, J., De Gottardi, A., et al. Recommendations for the management of hepatitis C virus infection among people who inject drugs. Clinical Infectious Diseases 57:Suppl. 2 (2013), S129–137.
49. Scott, N., McBryde, E.S., Thompson, A., Doyle, J.S., Hellard, M.E., Treatment scale-up to achieve global HCV incidence and mortality elimination targets: A cost-effectiveness model. Gut 66:Aug. (8) (2017), 1507–1515, 10.1136/gutjnl-2016-311504 Epub 2016 Apr 12.
50. Simmons, B., Saleem, J., Heath, K., Cooke, G.S., Hill, A., Long-term treatment outcomes of patients infected with hepatitis C virus: A systematic review and meta-analysis of the survival benefit of achieving a sustained virological response. Clinical Infectious Diseases 61 (2015), 730–740.
51. Sulkowski, M., Ward, K., Falade-Nwulia, O., Moon, J., Sutcliffe, C., Brinkley, S., 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. Journal of Hepatology, 66, 2017, S719.
52. Sulkowski, M.S., Eron, J.J., Wyles, D., Trinh, R., Lalezari, J., Wang, C., et al. Ombitasvir, paritaprevir co-dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: A randomized trial. JAMA 313 (2015), 1223–1231.
53. The Polaris Observatory, Global prevalence and genotype distribution of hepatitis C virus infection in 2015: A modelling study. The Lancet Gastroenterology & Hepatology 2 (2017), 161–166.
54. WHO, Guidelines for the screening, care and treatment of persons with hepatitis C infection. 2014, World Health Organization, Geneva, Switzerland.
55. WHO, Organization, W.H., (eds.) Global hepatitis report 2017, 2017, World Health Organization, Geneva.
56. Young, J., Rossi, C., Gill, J., Walmsley, S., Cooper, C., Cox, J., et al. Risk factors for hepatitis C virus reinfection after sustained virologic response in patients co-infected with HIV. Clinical Infectious Diseases 64:May (9) (2017), 1154–1162, 10.1093/cid/cix126.
57. Zeuzem, S., Jacobson, I.M., Baykal, T., Marinho, R.T., Poordad, F., Bourliere, M., et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. New England Journal of Medicine 370 (2014), 1604–1614.