메뉴 건너뛰기




Volumn 165, Issue 9, 2016, Pages 625-634

Elbasvir-grazoprevir to treat hepatitis C virus infection in persons receiving opioid agonist therapy a randomized trial

(22)  Dore, Gregory J a   Altice, Frederick b   Litwin, Alain H c   Dalgard, Olav d   Gane, Edward J e   Shibolet, Oren f   Luetkemeyer, Anne g   Nahass, Ronald h   Peng, Cheng Yuan i   Conway, Brian j   Grebely, Jason a   Howe, Anita Y M k   Gendrano, Isaias N l   Chen, Erluo l   Huang, Hsueh Cheng l   Dutko, Frank J l   Nickle, David C l   Nguyen, Bach Yen l   Wahl, Janice l   Barr, Eliav l   more..


Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BUPRENORPHINE; BUPRENORPHINE PLUS NALOXONE; ELBASVIR PLUS GRAZOPREVIR; METHADONE; OPIATE AGONIST; PLACEBO; ANTIVIRUS AGENT; BENZOFURAN DERIVATIVE; DRUG COMBINATION; ELBASVIR-GRAZOPREVIR DRUG COMBINATION; IMIDAZOLE DERIVATIVE; QUINOXALINE DERIVATIVE;

EID: 84994388425     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M16-0816     Document Type: Article
Times cited : (321)

References (27)
  • 1
    • 84883445154 scopus 로고    scopus 로고
    • Epidemiology and natural history of HCV infection
    • [PMID: 23817321]
    • Hajarizadeh B, Grebely J, Dore GJ. Epidemiology and natural history of HCV infection. Nat Rev Gastroenterol Hepatol. 2013;10:553-62. [PMID: 23817321] doi:10.1038/nrgastro.2013.107
    • (2013) Nat Rev Gastroenterol Hepatol. , vol.10 , pp. 553-562
    • Hajarizadeh, B.1    Grebely, J.2    Dore, G.J.3
  • 2
    • 84871036375 scopus 로고    scopus 로고
    • Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: A systematic analysis for the Global Burden of Disease Study 2010
    • [PMID: 23245604]
    • Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2095-128. [PMID: 23245604] doi:10.1016/S0140-6736(12)61728-0
    • (2012) Lancet. , vol.380 , pp. 2095-2128
    • Lozano, R.1    Naghavi, M.2    Foreman, K.3    Lim, S.4    Shibuya, K.5    Aboyans, V.6
  • 3
    • 80051676859 scopus 로고    scopus 로고
    • Global epidemiology of hepatitis B and hepatitis C in people who inject drugs: Results of systematic reviews
    • [PMID: 21802134]
    • Nelson PK, Mathers BM, Cowie B, Hagan H, Des Jarlais D, Horyn-iak D, et al. Global epidemiology of hepatitis B and hepatitis C in people who inject drugs: results of systematic reviews. Lancet. 2011;378:571-83. [PMID: 21802134] doi:10.1016/S0140-6736 (11)61097-0
    • (2011) Lancet. , vol.378 , pp. 571-583
    • Nelson, P.K.1    Mathers, B.M.2    Cowie, B.3    Hagan, H.4    Des Jarlais, D.5    Horyn-Iak, D.6
  • 4
    • 84940905515 scopus 로고    scopus 로고
    • Ombitasvir/paritaprevir/r and dasabuvir plus ribavirin in HCV genotype 1-infected patients on methadone or buprenorphine
    • [PMID: 25839406]
    • Lalezari J, Sullivan JG, Varunok P, Galen E, Kowdley KV, Rustgi V, et al. Ombitasvir/paritaprevir/r and dasabuvir plus ribavirin in HCV genotype 1-infected patients on methadone or buprenorphine. J Hepatol. 2015;63:364-9. [PMID: 25839406] doi:10.1016/j.jhep.2015.03.029
    • (2015) J Hepatol. , vol.63 , pp. 364-369
    • Lalezari, J.1    Sullivan, J.G.2    Varunok, P.3    Galen, E.4    Kowdley, K.V.5    Rustgi, V.6
  • 6
    • 84864387126 scopus 로고    scopus 로고
    • MK-5172, a selective inhibitor of hepatitis C virus NS3/4a protease with broad activity across genotypes and resistant variants
    • [PMID: 22615282]
    • Summa V, Ludmerer SW, McCauley JA, Fandozzi C, Burlein C, Claudio G, et al. MK-5172, a selective inhibitor of hepatitis C virus NS3/4a protease with broad activity across genotypes and resistant variants. Antimicrob Agents Chemother. 2012;56:4161-7. [PMID: 22615282] doi:10.1128/AAC.00324-12
    • (2012) Antimicrob Agents Chemother. , vol.56 , pp. 4161-4167
    • Summa, V.1    Ludmerer, S.W.2    McCauley, J.A.3    Fandozzi, C.4    Burlein, C.5    Claudio, G.6
  • 7
    • 84889888952 scopus 로고    scopus 로고
    • Discovery of MK-8742: An HCV NS5A inhibitor with broad genotype activity
    • [PMID: 24127258]
    • Coburn CA, Meinke PT, Chang W, Fandozzi CM, Graham DJ, Hu B, et al. Discovery of MK-8742: an HCV NS5A inhibitor with broad genotype activity. ChemMedChem. 2013;8:1930-40. [PMID: 24127258] doi:10.1002/cmdc.201300343
    • (2013) ChemMedChem. , vol.8 , pp. 1930-1940
    • Coburn, C.A.1    Meinke, P.T.2    Chang, W.3    Fandozzi, C.M.4    Graham, D.J.5    Hu, B.6
  • 8
    • 84898407061 scopus 로고    scopus 로고
    • A combination containing MK-5172 (HCV NS3 protease inhibitor) and MK-8742 (HCV NS5A inhibitor) demonstrates high barrier to resistance in vitro in HCV replicons
    • Lahser F, Liu R, Bystol K, Xia E, Raubertas R, Asante-Appiah E, et al. A combination containing MK-5172 (HCV NS3 protease inhibitor) and MK-8742 (HCV NS5A inhibitor) demonstrates high barrier to resistance in vitro in HCV replicons. Hepatology. 2012;56(Suppl S1):236A.
    • (2012) Hepatology. , vol.56 , pp. 236A
    • Lahser, F.1    Liu, R.2    Bystol, K.3    Xia, E.4    Raubertas, R.5    Asante-Appiah, E.6
  • 10
    • 84994450406 scopus 로고    scopus 로고
    • No pharmacokinetic interaction between HCV NS5A inhibitor elbasvir and buprenorphine/naloxone in healthy volunteers
    • Marshall WL, Marenco T, Feng HP, Barbour AM, Gilmartin J, Liu F, et al. No pharmacokinetic interaction between HCV NS5A inhibitor elbasvir and buprenorphine/naloxone in healthy volunteers. Hepatology. 2015;62(Suppl 1):573A.
    • (2015) Hepatology. , vol.62 , pp. 573A
    • Marshall, W.L.1    Marenco, T.2    Feng, H.P.3    Barbour, A.M.4    Gilmartin, J.5    Liu, F.6
  • 11
    • 84994467754 scopus 로고    scopus 로고
    • Pharmacokinetic interaction between the HCV non-structural protein 5A inhibitor MK-8742 and methadone in subjects on stable mainte-nance therapy. Abstract no. 59. HepDART: Frontiers in Drug Devel-opment for Viral Hepatitis, 2013
    • Marshall WL, Caro L, Jumes P, Ma J, Mangin E, Liu Y, et al. Pharmacokinetic interaction between the HCV non-structural protein 5A inhibitor MK-8742 and methadone in subjects on stable mainte-nance therapy. Abstract no. 59. HepDART: Frontiers in Drug Devel-opment for Viral Hepatitis, 2013. Global Antiviral Journal. 2013; 9(Suppl 2):61.
    • (2013) Global Antiviral Journal. , vol.9 , pp. 61
    • Marshall, W.L.1    Caro, L.2    Jumes, P.3    Ma, J.4    Mangin, E.5    Liu, Y.6
  • 12
    • 84925424553 scopus 로고    scopus 로고
    • Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously un-treated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): A randomised, open-label phase 2 trial
    • [PMID: 25467591]
    • Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, et al. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously un-treated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015;385:1075-86. [PMID: 25467591] doi: 10.1016/S0140-6736(14)61795-5
    • (2015) Lancet. , vol.385 , pp. 1075-1086
    • Lawitz, E.1    Gane, E.2    Pearlman, B.3    Tam, E.4    Ghesquiere, W.5    Guyader, D.6
  • 13
    • 84925423399 scopus 로고    scopus 로고
    • Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): A randomised, open-label phase 2 trial
    • [PMID: 25467560]
    • Sulkowski M, Hezode C, Gerstoft J, Vierling JM, Mallolas J, Pol S, et al. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial. Lancet. 2015;385:1087-97. [PMID: 25467560] doi:10.1016/S0140-6736(14)61793-1
    • (2015) Lancet. , vol.385 , pp. 1087-1097
    • Sulkowski, M.1    Hezode, C.2    Gerstoft, J.3    Vierling, J.M.4    Mallolas, J.5    Pol, S.6
  • 14
    • 84946216260 scopus 로고    scopus 로고
    • Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): A non-randomised, open-label trial
    • [PMID: 26423374]
    • Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015;2:e319-27. [PMID: 26423374] doi:10.1016/S2352-3018(15)00114-9
    • (2015) Lancet HIV. , vol.2 , pp. e319-e327
    • Rockstroh, J.K.1    Nelson, M.2    Katlama, C.3    Lalezari, J.4    Mallolas, J.5    Bloch, M.6
  • 15
    • 84937064772 scopus 로고    scopus 로고
    • Grazoprevir-elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1, 4, or 6 infection: A randomized trial
    • [PMID: 25909356]
    • Zeuzem S, Ghalib R, Reddy KR, Pockros PJ, Ben Ari Z, Zhao Y, et al. Grazoprevir-elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1, 4, or 6 infection: a randomized trial. Ann Intern Med. 2015; 163:1-13. [PMID: 25909356] doi:10.7326/M15-0785
    • (2015) Ann Intern Med. , vol.163 , pp. 1-13
    • Zeuzem, S.1    Ghalib, R.2    Reddy, K.R.3    Pockros, P.J.4    Ben Ari, Z.5    Zhao, Y.6
  • 16
    • 0001072895 scopus 로고
    • The use of confidence or fiducial limits illustrated in the case of the binomial
    • Clopper C, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934;26:404-13.
    • (1934) Biometrika , vol.26 , pp. 404-413
    • Clopper, C.1    Pearson, E.S.2
  • 17
    • 0021832508 scopus 로고
    • Comparative analysis of two rates
    • [PMID: 4023479]
    • Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213-26. [PMID: 4023479]
    • (1985) Stat Med. , vol.4 , pp. 213-226
    • Miettinen, O.1    Nurminen, M.2
  • 18
    • 84904570994 scopus 로고    scopus 로고
    • Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection
    • [PMID: 25038354]
    • Sulkowski MS, Naggie S, Lalezari J, Fessel WJ, Mounzer K, Shuhart M, et al; PHOTON-1 Investigators. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312:353-61. [PMID: 25038354] doi:10.1001/jama.2014.7734
    • (2014) JAMA. , vol.312 , pp. 353-361
    • Sulkowski, M.S.1    Naggie, S.2    Lalezari, J.3    Fessel, W.J.4    Mounzer, K.5    Shuhart, M.6
  • 19
    • 84880984985 scopus 로고    scopus 로고
    • Treatment of hepatitis C virus infection among people who are actively injecting drugs: A systematic review and meta-analysis
    • [PMID: 23884071]
    • Aspinall EJ, Corson S, Doyle JS, Grebely J, Hutchinson SJ, Dore GJ, et al. Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis. 2013;57 Suppl 2:S80-9. [PMID: 23884071] doi:10.1093/cid/cit306
    • (2013) Clin Infect Dis. , vol.57 , pp. S80-S89
    • Aspinall, E.J.1    Corson, S.2    Doyle, J.S.3    Grebely, J.4    Hutchinson, S.J.5    Dore, G.J.6
  • 20
    • 84938795806 scopus 로고    scopus 로고
    • Restrictions for Medicaid reimbursement of sofosbuvir for the treatment of hepatitis C virus infection in the United States
    • [PMID: 26120969]
    • 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. 2015;163:215-23. [PMID: 26120969] doi:10.7326/M15-0406
    • (2015) Ann Intern Med. , vol.163 , pp. 215-223
    • Barua, S.1    Greenwald, R.2    Grebely, J.3    Dore, G.J.4    Swan, T.5    Taylor, L.E.6
  • 21
    • 84941805183 scopus 로고    scopus 로고
    • Recommendations for the management of hepatitis C virus infection among people who inject drugs
    • [PMID: 26282715]
    • Grebely J, Robaeys G, Bruggmann P, Aghemo A, Backmund M, Bruneau J, et al; International Network for Hepatitis in Substance Users. Recommendations for the management of hepatitis C virus infection among people who inject drugs. Int J Drug Policy. 2015;26: 1028-38. [PMID: 26282715] doi:10.1016/j.drugpo.2015.07.005
    • (2015) Int J Drug Policy. , vol.26 , pp. 1028-1038
    • Grebely, J.1    Robaeys, G.2    Bruggmann, P.3    Aghemo, A.4    Backmund, M.5    Bruneau, J.6
  • 22
    • 84931560807 scopus 로고    scopus 로고
    • EASL recommendations on treatment of hepatitis C 2015
    • European Association for Study of Liver [PMID: 25911336]
    • European Association for Study of Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol. 2015;63:199-236. [PMID: 25911336] doi:10.1016/j.jhep.2015.03.025
    • (2015) J Hepatol. , vol.63 , pp. 199-236
  • 23
    • 84932085484 scopus 로고    scopus 로고
    • Recommendations for testing, manag-ing, and treating hepatitis C
    • American Association for the Study of Liver Diseases; Infectious Diseases Society of America. on 13 July 2016
    • American Association for the Study of Liver Diseases; Infectious Diseases Society of America. Recommendations for testing, manag-ing, and treating hepatitis C. AASLD guidelines. 2015. Accessed at www.hcvguidelines.org on 13 July 2016.
    • (2015) AASLD Guidelines.
  • 24
    • 84880998115 scopus 로고    scopus 로고
    • Moving the agenda forward: The prevention and management of hepatitis C virus infection among people who inject drugs
    • [PMID: 23884062]
    • Grebely J, Bruggmann P, Backmund M, Dore GJ. Moving the agenda forward: the prevention and management of hepatitis C virus infection among people who inject drugs. Clin Infect Dis. 2013;57 Suppl 2:S29-31. [PMID: 23884062] doi:10.1093/cid/cit264
    • (2013) Clin Infect Dis. , vol.57 , pp. S29-S31
    • Grebely, J.1    Bruggmann, P.2    Backmund, M.3    Dore, G.J.4
  • 25
    • 84155180685 scopus 로고    scopus 로고
    • Cost-effectiveness of hepatitis C virus antiviral treatment for injection drug user populations
    • [PMID: 21898506]
    • Martin NK, Vickerman P, Miners A, Foster GR, Hutchinson SJ, Goldberg DJ, et al. Cost-effectiveness of hepatitis C virus antiviral treatment for injection drug user populations. Hepatology. 2012;55: 49-57. [PMID: 21898506] doi:10.1002/hep.24656
    • (2012) Hepatology. , vol.55 , pp. 49-57
    • Martin, N.K.1    Vickerman, P.2    Miners, A.3    Foster, G.R.4    Hutchinson, S.J.5    Goldberg, D.J.6
  • 26
    • 84906302905 scopus 로고    scopus 로고
    • Restoration of HCV-specific CD8+ T cell function by interferon-free therapy
    • [PMID: 24905492]
    • Martin B, Hennecke N, Lohmann V, Kayser A, Neumann-Haefelin C, Kukolj G, et al. Restoration of HCV-specific CD8+ T cell function by interferon-free therapy. J Hepatol. 2014;61:538-43. [PMID: 24905492] doi:10.1016/j.jhep.2014.05.043
    • (2014) J Hepatol. , vol.61 , pp. 538-543
    • Martin, B.1    Hennecke, N.2    Lohmann, V.3    Kayser, A.4    Neumann-Haefelin, C.5    Kukolj, G.6
  • 27
    • 84931378182 scopus 로고    scopus 로고
    • Successful interferon-free therapy of chronic hepatitis C virus infection normalizes natural killer cell function
    • [PMID: 25754160]
    • Serti E, Chepa-Lotrea X, Kim YJ, Keane M, Fryzek N, Liang TJ, et al. Successful interferon-free therapy of chronic hepatitis C virus infection normalizes natural killer cell function. Gastroenterology. 2015;149:190-200. [PMID: 25754160] doi:10.1053/j.gastro.2015.03.004
    • (2015) Gastroenterology. , vol.149 , pp. 190-200
    • Serti, E.1    Chepa-Lotrea, X.2    Kim, Y.J.3    Keane, M.4    Fryzek, N.5    Liang, T.J.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.