메뉴 건너뛰기




Volumn 45, Issue 3, 2017, Pages 468-475

Simeprevir in combination with sofosbuvir in treatment-naïve and -experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open-label, single-arm study (PLUTO)

(15)  Buti, M a   Calleja, J L b   Lens, S c   Diago, M d   Ortega, E e   Crespo, J f   Planas, R g   Romero Gomez M h   Rodriguez F G i   Pascasio, J M j   Fevery, B k   Kurland, D l   Corbett, C k   Kalmeijer, R l   Jessner, W k  


Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; AMYLASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; PEGINTERFERON; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; TRIACYLGLYCEROL LIPASE; VIRUS RNA; ALPHA INTERFERON; ANTIVIRUS AGENT;

EID: 85006262160     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.13883     Document Type: Article
Times cited : (27)

References (30)
  • 1
    • 84945183985 scopus 로고    scopus 로고
    • Strategies for treating chronic HCV infection in patients with cirrhosis: latest evidence and clinical outcomes
    • Wilder JM, Muir AJ. Strategies for treating chronic HCV infection in patients with cirrhosis: latest evidence and clinical outcomes. Ther Adv Chronic Dis 2015; 6: 314–27.
    • (2015) Ther Adv Chronic Dis , vol.6 , pp. 314-327
    • Wilder, J.M.1    Muir, A.J.2
  • 2
    • 0004016899 scopus 로고    scopus 로고
    • (accessed 29 June 2016)
    • World Health Organization. Hepatitis C, 2015. Available at: http://www.who.int/mediacentre/factsheets/fs164/en/ (accessed 29 June 2016).
    • (2015) Hepatitis C
  • 3
    • 84928193501 scopus 로고    scopus 로고
    • Management of hepatitis C infection before and after liver transplantation
    • Fagiuoli S, Ravasio R, Lucà MG, et al. Management of hepatitis C infection before and after liver transplantation. World J Gastroenterol 2015; 21: 4447–56.
    • (2015) World J Gastroenterol , vol.21 , pp. 4447-4456
    • Fagiuoli, S.1    Ravasio, R.2    Lucà, M.G.3
  • 4
    • 84993949847 scopus 로고    scopus 로고
    • NS3 protease polymorphisms and genetic barrier to drug resistance of distinct hepatitis C virus genotypes from worldwide treatment-naive subjects
    • Vidal LL, Soares MA, Santos AF. NS3 protease polymorphisms and genetic barrier to drug resistance of distinct hepatitis C virus genotypes from worldwide treatment-naive subjects. J Viral Hepatol 2016; 23: 840–9.
    • (2016) J Viral Hepatol , vol.23 , pp. 840-849
    • Vidal, L.L.1    Soares, M.A.2    Santos, A.F.3
  • 5
    • 42249110672 scopus 로고    scopus 로고
    • Hepatitis C genotype 4: what we know and what we don't yet know
    • Kamal SM, Nasser IA. Hepatitis C genotype 4: what we know and what we don't yet know. Hepatology 2008; 47: 1371–83.
    • (2008) Hepatology , vol.47 , pp. 1371-1383
    • Kamal, S.M.1    Nasser, I.A.2
  • 6
    • 78650852334 scopus 로고    scopus 로고
    • Hepatitis C virus genotype 4 therapy: progress and challenges
    • Kamal SM. Hepatitis C virus genotype 4 therapy: progress and challenges. Liver Int 2011; 31(Suppl. 1): 45–52.
    • (2011) Liver Int , vol.31 , pp. 45-52
    • Kamal, S.M.1
  • 7
    • 84890528431 scopus 로고    scopus 로고
    • Review article: the epidemiology and therapy of chronic hepatitis C genotypes 4, 5 and 6
    • Wantuck JM, Ahmed A, Nguyen MH. Review article: the epidemiology and therapy of chronic hepatitis C genotypes 4, 5 and 6. Aliment Pharmacol Ther 2014; 39: 137–47.
    • (2014) Aliment Pharmacol Ther , vol.39 , pp. 137-147
    • Wantuck, J.M.1    Ahmed, A.2    Nguyen, M.H.3
  • 8
    • 84939653819 scopus 로고    scopus 로고
    • Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus
    • AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology 2015; 62: 932–54.
    • (2015) Hepatology , vol.62 , pp. 932-954
  • 9
    • 84931560807 scopus 로고    scopus 로고
    • EASL recommendations on treatment of hepatitis C 2015
    • European Association for Study of Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol 2015; 63: 199–236.
    • (2015) J Hepatol , vol.63 , pp. 199-236
  • 10
    • 84925619517 scopus 로고    scopus 로고
    • Efficacy and safety of simeprevir with PegIFN/ribavirin in naive or experienced patients infected with chronic HCV genotype 4
    • Moreno C, Hezode C, Marcellin P, et al. Efficacy and safety of simeprevir with PegIFN/ribavirin in naive or experienced patients infected with chronic HCV genotype 4. J Hepatol 2015; 62: 1047–55.
    • (2015) J Hepatol , vol.62 , pp. 1047-1055
    • Moreno, C.1    Hezode, C.2    Marcellin, P.3
  • 11
    • 85030236554 scopus 로고    scopus 로고
    • (accessed 23 June 2016)
    • Gilead. SOVALDI Highlights of Prescribing Information. 2015. Available at: http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf (accessed 23 June 2016).
    • (2015) SOVALDI Highlights of Prescribing Information
  • 12
    • 84978953939 scopus 로고    scopus 로고
    • Simeprevir plus sofosbuvir (12 and 8 weeks) in HCV genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study
    • Kwo P, Gitlin N, Nahass R, et al. Simeprevir plus sofosbuvir (12 and 8 weeks) in HCV genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology 2016; 64: 370–80.
    • (2016) Hepatology , vol.64 , pp. 370-380
    • Kwo, P.1    Gitlin, N.2    Nahass, R.3
  • 13
    • 84979066379 scopus 로고    scopus 로고
    • Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: a phase 3 study (OPTIMIST-2)
    • Lawitz E, Matusow G, DeJesus E, et al. Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: a phase 3 study (OPTIMIST-2). Hepatology 2016; 64: 360–9.
    • (2016) Hepatology , vol.64 , pp. 360-369
    • Lawitz, E.1    Matusow, G.2    DeJesus, E.3
  • 14
    • 84857359539 scopus 로고    scopus 로고
    • IL28B polymorphism is associated with treatment response in patients with genotype 4 chronic hepatitis C
    • Asselah T, De Muynck S, Broët P, et al. IL28B polymorphism is associated with treatment response in patients with genotype 4 chronic hepatitis C. J Hepatol 2012; 56: 527–32.
    • (2012) J Hepatol , vol.56 , pp. 527-532
    • Asselah, T.1    De Muynck, S.2    Broët, P.3
  • 16
    • 85008413911 scopus 로고    scopus 로고
    • Sofosbuvir plus simeprevir in treatment-naive and treatment-experienced Egyptian patients with hepatitis C virus infection: a real life experience
    • Esmat G, Eldeen HG, El Kassas M, et al. Sofosbuvir plus simeprevir in treatment-naive and treatment-experienced Egyptian patients with hepatitis C virus infection: a real life experience. J Hepatol 2016; 64: abs SAT-160.
    • (2016) J Hepatol , vol.64
    • Esmat, G.1    Eldeen, H.G.2    El Kassas, M.3
  • 17
    • 85029558000 scopus 로고    scopus 로고
    • 12 W of sofosbuvir/simeprevir in genotypes 1 and 4 in HCV, cirrhotic patients: Qatar experience
    • Derbala M, Alkaabi S, Sultan K, et al. 12 W of sofosbuvir/simeprevir in genotypes 1 and 4 in HCV, cirrhotic patients: Qatar experience. Hepatol Int 2016; 10 (Suppl. 1): abs O–022.
    • (2016) Hepatol Int , vol.10 , pp. abs O-022
    • Derbala, M.1    Alkaabi, S.2    Sultan, K.3
  • 18
    • 85032045370 scopus 로고    scopus 로고
    • Sofosbuvir in combination with simeprevir +/- ribavirin in genotype 4 hepatitis C patients with advanced fibrosis or cirrhosis: real-life experience from Belgium
    • Moreno C, Lasser L, Delwaide J, et al. Sofosbuvir in combination with simeprevir +/- ribavirin in genotype 4 hepatitis C patients with advanced fibrosis or cirrhosis: real-life experience from Belgium. Hepatology 2015; 62 (Suppl. S1): abs 1091.
    • (2015) Hepatology , vol.62 , pp. abs 1091
    • Moreno, C.1    Lasser, L.2    Delwaide, J.3
  • 19
    • 85008312981 scopus 로고    scopus 로고
    • Oral presentation presented at the 50th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, 22–26 April 2015., (accessed 21 November 2016)
    • Abergel A, Loustaud-Ratti V, Metivier S, et al. Ledipasvir/Sofosbuvir for the treatment of patients with chronic genotype 4 or 5 HCV infection. Oral presentation presented at the 50th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, 22–26 April 2015. Available at: http://natap.org/2015/EASL/EASL_80.htm (accessed 21 November 2016).
    • Ledipasvir/Sofosbuvir for the treatment of patients with chronic genotype 4 or 5 HCV infection
    • Abergel, A.1    Loustaud-Ratti, V.2    Metivier, S.3
  • 20
    • 84976260348 scopus 로고    scopus 로고
    • Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial
    • Manns M, Samuel D, Gane EJ, et al. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis 2016; 16: 685–97.
    • (2016) Lancet Infect Dis , vol.16 , pp. 685-697
    • Manns, M.1    Samuel, D.2    Gane, E.J.3
  • 21
    • 84931569160 scopus 로고    scopus 로고
    • Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial
    • Hézode C, Asselah T, Reddy KR, et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet 2015; 385: 2502–9.
    • (2015) Lancet , vol.385 , pp. 2502-2509
    • Hézode, C.1    Asselah, T.2    Reddy, K.R.3
  • 22
    • 84980728956 scopus 로고    scopus 로고
    • Ombitasvir, paritaprevir, and ritonavir plus ribavirin in adults with hepatitis C virus infection and cirrhosis (AGATE-I): a multicentre, phase 3, randomised open-label trial
    • Asselah T, Hézode C, Qaqish RB, et al. Ombitasvir, paritaprevir, and ritonavir plus ribavirin in adults with hepatitis C virus infection and cirrhosis (AGATE-I): a multicentre, phase 3, randomised open-label trial. Lancet Gastroenterol Hepatol 2016; 1: 25–35.
    • (2016) Lancet Gastroenterol Hepatol , vol.1 , pp. 25-35
    • Asselah, T.1    Hézode, C.2    Qaqish, R.B.3
  • 23
    • 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
    • Zeuzem S, Ghalib R, Reddy KR, 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.
    • (2015) Ann Intern Med , vol.163 , pp. 1-13
    • Zeuzem, S.1    Ghalib, R.2    Reddy, K.R.3
  • 25
    • 84963894597 scopus 로고    scopus 로고
    • Systematic review: current concepts and challenges for the direct-acting antiviral era in hepatitis C cirrhosis
    • MajuMD.ar A, Kitson MT, Roberts SK. Systematic review: current concepts and challenges for the direct-acting antiviral era in hepatitis C cirrhosis. Aliment Pharmacol Ther 2016; 43: 1276–92.
    • (2016) Aliment Pharmacol Ther , vol.43 , pp. 1276-1292
    • MajuMD.ar, A.1    Kitson, M.T.2    Roberts, S.K.3
  • 26
    • 84958595162 scopus 로고    scopus 로고
    • Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy
    • Banerjee D, Reddy KR. Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy. Aliment Pharmacol Ther 2016; 43: 674–96.
    • (2016) Aliment Pharmacol Ther , vol.43 , pp. 674-696
    • Banerjee, D.1    Reddy, K.R.2
  • 27
    • 84961891957 scopus 로고    scopus 로고
    • An in-depth analysis of patient-reported outcomes in patients with chronic hepatitis C treated with different anti-viral regimens
    • Younossi ZM, Stepanova M, Henry L, Nader F, Hunt S. An in-depth analysis of patient-reported outcomes in patients with chronic hepatitis C treated with different anti-viral regimens. Am J Gastroenterol 2016; 111: 808–16.
    • (2016) Am J Gastroenterol , vol.111 , pp. 808-816
    • Younossi, Z.M.1    Stepanova, M.2    Henry, L.3    Nader, F.4    Hunt, S.5
  • 28
    • 84942552026 scopus 로고    scopus 로고
    • Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: scientific and regulatory approaches to clinical trial designs
    • Mishra P, Murray J, Birnkrant D. Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: scientific and regulatory approaches to clinical trial designs. Hepatology 2015; 62: 1298–303.
    • (2015) Hepatology , vol.62 , pp. 1298-1303
    • Mishra, P.1    Murray, J.2    Birnkrant, D.3
  • 30
    • 84999059792 scopus 로고    scopus 로고
    • 1998., (accessed 7 June 2016)
    • European Medicines Agency. General considerations for clinical trials. 1998. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002877.pdf (accessed 7 June 2016).
    • General considerations for clinical trials


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.