The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related child's class a cirrhosis

Gastroenterology

Volumn 148, Issue 4, 2015, Pages 762-770.e2

  Pearlman, Brian L ^a,b,c   Ehleben, Carole ^a   Perrys, Michael ^c  

^a ATLANTA MEDICAL CENTER   (United States)

^b MEDICAL COLLEGE OF GEORGIA   (United States)

^c EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Drug Clinical Trial; HCV; Liver Fibrosis

Indexed keywords

BILIRUBIN; PEGINTERFERON ALPHA2B; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; VIRUS RNA; ALPHA INTERFERON; ANTIVIRUS AGENT; FUSED HETEROCYCLIC RINGS; MACROGOL DERIVATIVE; RECOMBINANT PROTEIN; SULFONAMIDE; URIDINE PHOSPHATE;

ADULT; ANEMIA; ARTICLE; ASTHENIA; BACKACHE; BILIRUBIN BLOOD LEVEL; CHRONIC DISEASE; CLINICAL FEATURE; DECOMPENSATED LIVER CIRRHOSIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; HEPATITIS C; HEPATITIS C VIRUS SUBTYPE 1A; HUMAN; HUMAN TISSUE; HYPERAMYLASEMIA; HYPERBILIRUBINEMIA; INSOMNIA; IRRITABILITY; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA; NEUTROPENIA; OPEN STUDY; OUTCOME ASSESSMENT; PHOTOSENSITIVITY; PRIORITY JOURNAL; PROSPECTIVE STUDY; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT DURATION; ANALOGS AND DERIVATIVES; BLOOD; CLASSIFICATION; COMPARATIVE STUDY; COMPLICATION; CONTROLLED STUDY; DRUG COMBINATION; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; LIVER CIRRHOSIS; MIDDLE AGED; TREATMENT OUTCOME; VIRUS LOAD;

ADULT; ANTIVIRAL AGENTS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HETEROCYCLIC COMPOUNDS, 3-RING; HUMANS; INTERFERON-ALPHA; LIVER CIRRHOSIS; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; RIBAVIRIN; RNA, VIRAL; SULFONAMIDES; TREATMENT OUTCOME; URIDINE MONOPHOSPHATE; VIRAL LOAD;

EID: 84925411319     PISSN: 00165085     EISSN: 15280012     Source Type: Journal    
DOI: 10.1053/j.gastro.2014.12.027     Document Type: Article

References (27)

1. D. Lavanchy Evolving epidemiology of hepatitis C virus Clin Microbiol Infect 17 2011 107 115
2. World Health Organization. Hepatitis C. Available at: http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed July 24, 2014.
3. A.J. Van der Meer, B.J. Veldt, and J.J. Feld Association between sustained virologic response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis JAMA 308 2012 2584 2593
4. J.M. Pawlotsky New hepatitis C therapies; the toolbox, strategies, and challenges Gastroenterology 146 2014 1176 1192
5. I.M. Jacobson, G.J. Dore, and G.R. Foster Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomized, double-blind, placebo-controlled trial Lancet 384 2014 403 413
6. E. Lawitz, A. Mangia, and D. Wyles Sofosbuvir for previously untreated chronic hepatitis C infection N Engl J Med 368 2013 1878 1887
7. Gilead Sciences, Foster City, CA. Available at: http://www.gilead.com/∼/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi-pi.pdf. Accessed July 24, 2014.
8. E. Lawitz, M.S. Sulkowski, and M. Rodriquez-Torres Simeprevir plus sofosbuvir with/without ribavirin for treating chronic HCV genotype 1 infection in prior null-responders to peginterferon/ribavirin and treatment-naive patients (COSMOS) Lancet 384 2014 1756 1765
9. American Association for the Study of Liver Diseases. Recommendations for testing, managing, and treating hepatitis C. Available at: http://www.hcvguidelines.org. Accessed July 24, 2014.
10. Z.M. Younossi, G. Guyatt, and M. Kiwi Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease Gut 45 1999 295 300
11. D. Ge, J. Fellay, and A.J. Thompson Genetic variation in IL28B predicts hepatitis C treatment-induced clearance Nature 461 2009 399 401
12. A.J. Thompson, A.J. Muir, and M.S. Sulkowski Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus Gastroenterology 139 2010 120 129
13. F. Poordad, C. Hezode, and R. Trinh ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis N Engl J Med 370 2014 1973 1982
14. N. Afdhal, S. Zeuzem, and P. Kwo Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection N Engl J Med 370 2014 1889 1898
15. O.V. Nainan, M.J. Alter, and D. Kruszon-Moran Hepatitis C virus genotypes and viral concentrations in participants of a general population survey in the United States Gastroenterology 131 2006 478 484
16. C. Sarrazin, and S. Zeuzem Resistance to direct antiviral agents in patients with hepatitis C infection Gastroenterology 138 2010 447 462
17. S. Zeuzem, V. Soriano, and T. Asselah Faldaprevir and deleobuvir for HCV genotype 1 infection N Engl J Med 369 2013 630 639
18. P. Ferenci, D. Bernstein, and J. Lalezari ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV N Engl J Med 370 2014 1983 1992
19. N. Afdhal, R. Reddy, and D.R. Nelson Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection N Engl J Med 370 2014 1483 1493
20. C. Hezode, H. Fontaine, and C. Dorival Effectiveness of telaprevir and boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis Gastroenterology 147 2014 132 142
21. M. Manns, P. Marcellin, and F. Poordad Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomized, double-blind, placebo-controlled phase 3 trial Lancet 384 2014 414 426
22. S.S. Choe, J.M. Volpe, and D. Jacqueline Cross-sectional assessment of 1500 clinical samples submitted for HCV NS3/4A protease inhibitor drug resistance testing in the US (abstr) Hepatology 58 2013 1500
23. A. Bae, S.C. Sun, and X. Qi Susceptibility of treatment-naive hepatitis C virus clinical isolates to HCV protease inhibitors Antimicrob Agents Chemother 54 2010 5288 5297
24. B.L. Pearlman Hepatitis C virus infection in African Americans Clin Infect Dis 42 2006 963 971
25. J.G. McHutchison, E.J. Lawitz, and M.L. Shiffman IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection N Engl J Med 361 2009 580 593
26. L.M. Hagan, Z. Yang, and M. Ehteshami All-oral, interferon-free treatment for chronic hepatitis C: cost effectiveness analysis J Viral Hep 20 2013 847 857
27. L.M. Hagan, M.S. Sulkowski, and R.F. Schinazi Cost analysis of sofosbuvir/simeprevir for genotype 1 hepatitis C virus in interferon-ineligible/intolerant individuals Hepatology 60 2014 37 45