메뉴 건너뛰기




Volumn 1, Issue 2, 2016, Pages 97-104

Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study

(25)  Lau, George a,b   Benhamou, Yves c   Chen, Guofeng b   Li, Jin b   Shao, Qing b   Ji, Dong b   Li, Fan b   Li, Bing b   Liu, Jialiang b   Hou, Jinlin d   Sun, Jian d   Wang, Cheng a,d   Chen, Jing a   Wu, Vanessa a   Wong, April a   Wong, Chris L P e   Tsang, Stella T Y e   Wang, Yudong a   Bassit, Leda f   Tao, Sijia f   more..


Author keywords

[No Author keywords available]

Indexed keywords

ASUNAPREVIR; DACLATASVIR; LEDIPASVIR; SIMEPREVIR; SOFOSBUVIR; ANTIVIRUS AGENT; BENZIMIDAZOLE DERIVATIVE; BMS-790052; FLUORENE DERIVATIVE; IMIDAZOLE DERIVATIVE; ISOQUINOLINE DERIVATIVE; SULFONAMIDE;

EID: 84995756438     PISSN: 24681253     EISSN: None     Source Type: Journal    
DOI: 10.1016/S2468-1253(16)30015-2     Document Type: Article
Times cited : (76)

References (34)
  • 1
    • 84939653819 scopus 로고    scopus 로고
    • Hepatitis C guidance: AASLD–IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus
    • 1 AASLD–IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD–IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology 62 (2015), 932–954.
    • (2015) Hepatology , vol.62 , pp. 932-954
  • 2
    • 84931560807 scopus 로고    scopus 로고
    • EASL recommendations on treatment of hepatitis C 2015
    • 2 European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol 63 (2015), 199–236.
    • (2015) J Hepatol , vol.63 , pp. 199-236
  • 3
    • 84900339263 scopus 로고    scopus 로고
    • Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection
    • 3 Afdhal, N, Zeuzem, S, Kwo, P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 370 (2014), 1889–1898.
    • (2014) N Engl J Med , vol.370 , pp. 1889-1898
    • Afdhal, N.1    Zeuzem, S.2    Kwo, P.3
  • 4
    • 84898669547 scopus 로고    scopus 로고
    • Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection
    • 4 Afdhal, N, Reddy, KR, Nelson, DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 370 (2014), 1483–1493.
    • (2014) N Engl J Med , vol.370 , pp. 1483-1493
    • Afdhal, N.1    Reddy, K.R.2    Nelson, D.R.3
  • 5
    • 84900326091 scopus 로고    scopus 로고
    • Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis
    • 5 Kowdley, KV, Gordon, SC, Reddy, KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 370 (2014), 1879–1888.
    • (2014) N Engl J Med , vol.370 , pp. 1879-1888
    • Kowdley, K.V.1    Gordon, S.C.2    Reddy, K.R.3
  • 6
    • 84892619580 scopus 로고    scopus 로고
    • Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection
    • 6 Sulkowski, MS, Gardiner, DF, Rodriguez-Torres, M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 370 (2014), 211–221.
    • (2014) N Engl J Med , vol.370 , pp. 211-221
    • Sulkowski, M.S.1    Gardiner, D.F.2    Rodriguez-Torres, M.3
  • 8
    • 84934325371 scopus 로고    scopus 로고
    • Fake medicines are undermining global efforts to combat infectious disease, says US journal
    • 8 McCarthy, M, Fake medicines are undermining global efforts to combat infectious disease, says US journal. BMJ, 350, 2015, h2137.
    • (2015) BMJ , vol.350 , pp. h2137
    • McCarthy, M.1
  • 9
    • 84964697428 scopus 로고    scopus 로고
    • Stopping murder by medicine: introducing the Model Law on Medicine Crime
    • 9 Attaran, A, Stopping murder by medicine: introducing the Model Law on Medicine Crime. Am J Trop Med Hyg 92:6 suppl (2015), 127–132.
    • (2015) Am J Trop Med Hyg , vol.92 , Issue.6 , pp. 127-132
    • Attaran, A.1
  • 10
    • 84903132956 scopus 로고    scopus 로고
    • Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 hepatitis C virus in interferon-ineligible/intolerant individuals
    • 10 Hagan, LM, Sulkowski, MS, Schinazi, RF, Cost analysis of sofosbuvir/ribavirin versus sofosbuvir/simeprevir for genotype 1 hepatitis C virus in interferon-ineligible/intolerant individuals. Hepatology 60 (2014), 37–45.
    • (2014) Hepatology , vol.60 , pp. 37-45
    • Hagan, L.M.1    Sulkowski, M.S.2    Schinazi, R.F.3
  • 11
    • 84896449505 scopus 로고    scopus 로고
    • Minimum costs for producing hepatitis C direct-acting antivirals for use in large-scale treatment access programs in developing countries
    • 11 Hill, A, Khoo, S, Fortunak, J, Simmons, B, Ford, N, Minimum costs for producing hepatitis C direct-acting antivirals for use in large-scale treatment access programs in developing countries. Clin Infect Dis 58 (2014), 928–936.
    • (2014) Clin Infect Dis , vol.58 , pp. 928-936
    • Hill, A.1    Khoo, S.2    Fortunak, J.3    Simmons, B.4    Ford, N.5
  • 12
    • 84894297488 scopus 로고    scopus 로고
    • Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection
    • 12 Gane, EJ, Stedman, CA, Hyland, RH, et al. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology 146 (2014), 736–743.
    • (2014) Gastroenterology , vol.146 , pp. 736-743
    • Gane, E.J.1    Stedman, C.A.2    Hyland, R.H.3
  • 13
    • 84925607745 scopus 로고    scopus 로고
    • Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study
    • 13 Kohli, A, Osinusi, A, Sims, Z, et al. Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Lancet 385 (2015), 1107–1113.
    • (2015) Lancet , vol.385 , pp. 1107-1113
    • Kohli, A.1    Osinusi, A.2    Sims, Z.3
  • 14
    • 84938751694 scopus 로고    scopus 로고
    • Modelling hepatitis C therapy—predicting effects of treatment
    • 14 Perelson, AS, Guedj, J, Modelling hepatitis C therapy—predicting effects of treatment. Nat Rev Gastroenterol Hepatol 12 (2015), 437–445.
    • (2015) Nat Rev Gastroenterol Hepatol , vol.12 , pp. 437-445
    • Perelson, A.S.1    Guedj, J.2
  • 15
    • 84863396230 scopus 로고    scopus 로고
    • Hepatitis C viral kinetics with the nucleoside polymerase inhibitor mericitabine (RG7128)
    • 15 Guedj, J, Dahari, H, Shudo, E, Smith, P, Perelson, AS, Hepatitis C viral kinetics with the nucleoside polymerase inhibitor mericitabine (RG7128). Hepatolgy 55 (2012), 1030–1037.
    • (2012) Hepatolgy , vol.55 , pp. 1030-1037
    • Guedj, J.1    Dahari, H.2    Shudo, E.3    Smith, P.4    Perelson, A.S.5
  • 16
    • 84898603709 scopus 로고    scopus 로고
    • Analysis of hepatitis C viral kinetics during administration of two nucleotide analogues: sofosbuvir (GS-7977) and GS-0938
    • 16 Guedj, J, Pang, PS, Denning, J, et al. Analysis of hepatitis C viral kinetics during administration of two nucleotide analogues: sofosbuvir (GS-7977) and GS-0938. Antivir Ther 19 (2014), 211–220.
    • (2014) Antivir Ther , vol.19 , pp. 211-220
    • Guedj, J.1    Pang, P.S.2    Denning, J.3
  • 17
    • 79957448889 scopus 로고    scopus 로고
    • Second-phase hepatitis C virus RNA decline during telaprevir-based therapy increases with drug effectiveness: implications for treatment duration
    • 17 Guedj, J, Perelson, AS, Second-phase hepatitis C virus RNA decline during telaprevir-based therapy increases with drug effectiveness: implications for treatment duration. Hepatology 53 (2011), 1801–1808.
    • (2011) Hepatology , vol.53 , pp. 1801-1808
    • Guedj, J.1    Perelson, A.S.2
  • 18
    • 84921060015 scopus 로고    scopus 로고
    • Global distribution and prevalence of hepatitis C virus genotypes
    • 18 Messina, JP, Humphreys, I, Flaxman, A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 61 (2015), 77–87.
    • (2015) Hepatology , vol.61 , pp. 77-87
    • Messina, J.P.1    Humphreys, I.2    Flaxman, A.3
  • 19
    • 84899660159 scopus 로고    scopus 로고
    • Nanomedicines in the treatment of hepatitis C virus infection in Asian patients: optimizing use of peginterferon alfa
    • 19 Liu, CH, Kao, JH, Nanomedicines in the treatment of hepatitis C virus infection in Asian patients: optimizing use of peginterferon alfa. Int J Nanomed 9 (2014), 2051–2067.
    • (2014) Int J Nanomed , vol.9 , pp. 2051-2067
    • Liu, C.H.1    Kao, J.H.2
  • 20
    • 84946488527 scopus 로고    scopus 로고
    • Emergence of hepatitis C virus NS5A L31V plus Y93H variant upon treatment failure of daclatasvir and asunaprevir is relatively resistant to ledipasvir and NS5B polymerase nucleotide inhibitor GS-558093 in human hepatocyte chimeric mice
    • 20 Kai, Y, Hikita, H, Tatsumi, T, et al. Emergence of hepatitis C virus NS5A L31V plus Y93H variant upon treatment failure of daclatasvir and asunaprevir is relatively resistant to ledipasvir and NS5B polymerase nucleotide inhibitor GS-558093 in human hepatocyte chimeric mice. J Gastroenterol 50 (2015), 1145–1151.
    • (2015) J Gastroenterol , vol.50 , pp. 1145-1151
    • Kai, Y.1    Hikita, H.2    Tatsumi, T.3
  • 21
    • 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
    • 21 Sulkowski, M, Hezode, C, Gerstoft, J, 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 385 (2015), 1087–1097.
    • (2015) Lancet , vol.385 , pp. 1087-1097
    • Sulkowski, M.1    Hezode, C.2    Gerstoft, J.3
  • 22
    • 84874644131 scopus 로고    scopus 로고
    • Modeling shows that the NS5A inhibitor daclatasvir has two modes of action and yields a shorter estimate of the hepatitis C virus half-life
    • 22 Guedj, J, Dahari, H, Rong, L, et al. Modeling shows that the NS5A inhibitor daclatasvir has two modes of action and yields a shorter estimate of the hepatitis C virus half-life. Proc Natl Acad Sci U S A 110 (2013), 3991–3996.
    • (2013) Proc Natl Acad Sci U S A , vol.110 , pp. 3991-3996
    • Guedj, J.1    Dahari, H.2    Rong, L.3
  • 23
    • 84876003551 scopus 로고    scopus 로고
    • Analysis of hepatitis C virus decline during treatment with the protease inhibitor danoprevir using a multiscale model
    • 23 Rong, L, Guedj, J, Dahari, H, et al. Analysis of hepatitis C virus decline during treatment with the protease inhibitor danoprevir using a multiscale model. PLoS Comput Biol, 9, 2013, e1002959.
    • (2013) PLoS Comput Biol , vol.9 , pp. e1002959
    • Rong, L.1    Guedj, J.2    Dahari, H.3
  • 24
    • 84901595218 scopus 로고    scopus 로고
    • Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection
    • 24 Kumada, H, Suzuki, Y, Ikeda, K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 59 (2014), 2083–2091.
    • (2014) Hepatology , vol.59 , pp. 2083-2091
    • Kumada, H.1    Suzuki, Y.2    Ikeda, K.3
  • 25
    • 84964691124 scopus 로고    scopus 로고
    • APASL consensus statements and recommendation on treatment of hepatitis C
    • published online April 29.
    • 25 Omata, M, Kanda, T, Wei, L, et al. APASL consensus statements and recommendation on treatment of hepatitis C. Hepatol Intl, 2016, 10.1007/s12072-016-9717-6 published online April 29.
    • (2016) Hepatol Intl
    • Omata, M.1    Kanda, T.2    Wei, L.3
  • 26
    • 84934286397 scopus 로고    scopus 로고
    • C-swift: grazoprevir/elbasvir + sofosbuvir in cirrhotic and noncirrhotic, treatment-naive patients with hepatitis C virus genotype 1 infection, for durations of 4, 6 or 8 weeks and genotype 3 infection for durations of 8 or 12 weeks
    • 26 Poordad, F, Lawitz, E, Gutierrez, JA, et al. C-swift: grazoprevir/elbasvir + sofosbuvir in cirrhotic and noncirrhotic, treatment-naive patients with hepatitis C virus genotype 1 infection, for durations of 4, 6 or 8 weeks and genotype 3 infection for durations of 8 or 12 weeks. J Hepatol 62 (2015), S192–S193.
    • (2015) J Hepatol , vol.62 , pp. S192-S193
    • Poordad, F.1    Lawitz, E.2    Gutierrez, J.A.3
  • 27
    • 84939259594 scopus 로고    scopus 로고
    • Predictors of sustained viral response to 4–6 week duration therapy with ledipasvir + sofosbuvir + GS-9451 +/− GS-9669 in early and advanced fibrosis (NIH/UMD synergy trial)
    • 27 Kattakuzhy, S, Sidharthan, S, Wilson, E, et al. Predictors of sustained viral response to 4–6 week duration therapy with ledipasvir + sofosbuvir + GS-9451 +/− GS-9669 in early and advanced fibrosis (NIH/UMD synergy trial). J Hepatol, 62, 2015, S669.
    • (2015) J Hepatol , vol.62 , pp. S669
    • Kattakuzhy, S.1    Sidharthan, S.2    Wilson, E.3
  • 28
    • 84862684876 scopus 로고    scopus 로고
    • A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C
    • 28 Lawitz, EJ, Gruener, D, Hill, JM, et al. A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C. J Hepatol 57 (2012), 24–31.
    • (2012) J Hepatol , vol.57 , pp. 24-31
    • Lawitz, E.J.1    Gruener, D.2    Hill, J.M.3
  • 29
    • 84921276609 scopus 로고    scopus 로고
    • Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subjects treated with sofosbuvir in phase 2 and 3 clinical trials
    • 29 Svarovskaia, ES, Dvory-Sobol, H, Parkin, N, et al. Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subjects treated with sofosbuvir in phase 2 and 3 clinical trials. Clin Infect Dis 59 (2014), 1666–1674.
    • (2014) Clin Infect Dis , vol.59 , pp. 1666-1674
    • Svarovskaia, E.S.1    Dvory-Sobol, H.2    Parkin, N.3
  • 30
    • 84969812045 scopus 로고    scopus 로고
    • Daclatasvir + asunaprevir versus sofosbuvir/ledipasvir for hepatitis C genotype 1 in Japanese patients: an indirect comparison
    • 30 Swallow, E, Kelley, C, Signorovitch, J, Wygant, G, McPhee, F, Daclatasvir + asunaprevir versus sofosbuvir/ledipasvir for hepatitis C genotype 1 in Japanese patients: an indirect comparison. J Comp Eff Res 5 (2016), 273–279.
    • (2016) J Comp Eff Res , vol.5 , pp. 273-279
    • Swallow, E.1    Kelley, C.2    Signorovitch, J.3    Wygant, G.4    McPhee, F.5
  • 31
    • 77952581566 scopus 로고    scopus 로고
    • A comprehensive hepatitis C viral kinetic model explaining cure
    • 31 Snoeck, E, Chanu, P, Lavielle, M, et al. A comprehensive hepatitis C viral kinetic model explaining cure. Clin Pharmacol Ther 87 (2010), 706–713.
    • (2010) Clin Pharmacol Ther , vol.87 , pp. 706-713
    • Snoeck, E.1    Chanu, P.2    Lavielle, M.3
  • 32
    • 84991593714 scopus 로고    scopus 로고
    • Unexpected early tumor recurrence in patients with hepatitis C virus-related hepatocellular carcinoma undergoing interferon-free therapy: a note of caution
    • published online April 12.
    • 32 Reig, M, Marino, Z, Perello, C, et al. Unexpected early tumor recurrence in patients with hepatitis C virus-related hepatocellular carcinoma undergoing interferon-free therapy: a note of caution. J Hepatol, 2016, 10.1016/j.jhep.2016.04.008 published online April 12.
    • (2016) J Hepatol
    • Reig, M.1    Marino, Z.2    Perello, C.3
  • 33
    • 84876471176 scopus 로고    scopus 로고
    • Systematic review: Asian patients with chronic hepatitis C infection
    • 33 Nguyen, LH, Nguyen, MH, Systematic review: Asian patients with chronic hepatitis C infection. Aliment Pharmacol Ther 37 (2013), 921–936.
    • (2013) Aliment Pharmacol Ther , vol.37 , pp. 921-936
    • Nguyen, L.H.1    Nguyen, M.H.2
  • 34
    • 84880414695 scopus 로고    scopus 로고
    • Prevalence of HCV viral and host IL28B genotypes in China
    • 34 Wei, L, Lopez-Talavera, J, Roa, H, et al. Prevalence of HCV viral and host IL28B genotypes in China. Hepatology 54 (2011), 563A–5664.
    • (2011) Hepatology , vol.54 , pp. 563A-5664
    • Wei, L.1    Lopez-Talavera, J.2    Roa, H.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.