Safety of telaprevir for chronic hepatitis C virus infection: A meta-analysis of randomized controlled trials

Clinical Drug Investigation

Volumn 32, Issue 10, 2012, Pages 665-672

  Qin, Huimin ^a,b   Li, Hongtao ^c   Zhou, Xiaolin ^a,b   Feng, Fang ^a,b   Shen, Yanbing ^a,b   Tan, Hongku ^a,b   Ye, Feng ^a,b   Xie, Yingchun ^a,b  

^a CHINA THREE GORGES UNIVERSITY   (China)

^b Yichang Central People's Hospital   (China)

^c Department of Oncology   (China)

Author keywords

hepatitis C; Meta analysis; Telaprevir

Indexed keywords

PEGINTERFERON ALPHA2A PLUS RIBAVIRIN; TELAPREVIR;

ANEMIA; ARTHRALGIA; ARTICLE; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEVER; HEADACHE; HEPATITIS C; HUMAN; INSOMNIA; META ANALYSIS; MYALGIA; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; PRURITUS; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; TREATMENT DURATION;

ANTIVIRAL AGENTS; CONFIDENCE INTERVALS; HEPATITIS C, CHRONIC; HUMANS; ODDS RATIO; OLIGOPEPTIDES; PUBLICATION BIAS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TREATMENT OUTCOME; VIRAL LOAD;

EID: 84865454706     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11633240-000000000-00000     Document Type: Article

References (35)

1. Lin C, Lin K, Luong YP, et al. In vitro resistance studies of hepatitis C virus serine protease inhibitors, VX-950 and BILN 2061: structural analysis indicates different resistance mechanisms. J Biol Chem. 2004 Apr 23; 279 (17): 17508-14 (Pubitemid 38560514)
2. Smith LS, Nelson M, Naik S, et al. Telaprevir: an NS3/4A protease inhibitor for the treatment of chronic hepatitis C. Ann Pharmacother. 2011 May; 45 (5): 639-48
3. Hofmann WP, Zeuzem S. A new standard of care for the treatment of chronic HCV infection. Nat Rev Gastroenterol Hepatol 2011 May; 8 (5): 257-64
4. Pawlotsky JM. The results of Phase III clinical trials with telaprevir and boceprevir presented at the Liver Meeting 2010: a new standard of care for hepatitis C virus genotype 1 infection, but with issues still pending. Gastroenterology 2011 Mar; 140 (3): 746-54
5. Burney T, Dusheiko G. Overview of the PROVE studies evaluating the use of telaprevir in chronic hepatitis C genotype 1 patients. Expert Rev Anti Infect Ther 2011 Feb; 9 (2): 151-60
6. McHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med 2009 Apr 30; 360 (18): 1827-38
7. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011 Jun 23; 364 (25): 2405-16
8. Hezode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009 Apr 30; 360 (18): 1839-50
9. Petitti DB. Meta-analysis, decision analysis, and cost effectiveness analysis: methods for quantitative synthesis in medicine(2nded). New York, NY: Oxford University Press; 2000
10. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23; 364 (25): 2417-28
11. Sherman KE, Flamm SL, Afdhal NH, et al. Responseguided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011 Sep 15; 365 (11): 1014-24
12. McHutchison JG, Manns MP, Muir AJ, et al. Telaprevir for previously treated chronic HCV infection. N Engl J Med 2010 Apr 8; 362 (14): 1292-303
13. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996 Feb; 17 (1): 1-12 (Pubitemid 26120810)
14. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959 Apr; 22 (4): 719-48
15. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986 Sep; 7 (3): 177-88 (Pubitemid 17189972)
16. Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ 2003 Sep 6; 327 (7414): 557-60 (Pubitemid 37088507)
17. Cochran WG. The combination of estimates from different experiments. Biometrics 1954; 10 (1): 101-29
18. Tobias A. Assessing the influence of a single study in the meta-analysis estimate. Stata Tech Bull 1999; 8: 15-7
19. Kumada H, Toyota J, Okanoue T, et al. Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan. J Hepatol 2012 Jan; 56 (1): 78-84
20. Marcellin P, Forns X, Goeser T, et al. Telaprevir is effective given every 8 or 12 hours with ribavirin and peginterferon alfa-2a or-2b to patients with chronic hepatitis C. Gastroenterology 2011 Feb; 140 (2): 459-8 e1; quiz e14
21. Foster GR, Hezode C, Bronowicki JP, et al. Telaprevir alone or with peginterferon and ribavirin reduces HCV RNA in patients with chronic genotype 2 but not genotype 3 infections. Gastroenterology 2011 Sep; 141 (3): 881-9 e1
22. Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med 2001 Jul 5; 345 (1): 41-52 (Pubitemid 32634271)
23. Blonski W, Reddy KR. Hepatitis C virus infection and hepatocellular carcinoma. Clin Liver Dis 2008 Aug; 12 (3): 661-74, x (Pubitemid 351952471)
24. Asselah T. Realize the advance in HCV treatment, but remain cautious. J Hepatol 2011 Dec; 55 (6): 1457-60
25. Cacoub P, Bourliere M, Lubbe J, et al. Dermatological side effects of hepatitis C and its treatment: patient management in the era of direct-acting antivirals. J Hepatol 2012 Feb; 56 (2): 455-63
26. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011 Apr; 64 (4): 383-94
27. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008 Apr 26; 336 (7650): 924-6 (Pubitemid 351632017)
28. Ramachandran P, Fraser A, Agarwal K, et al. UK consensus guidelines for the use of the protease inhibitors boceprevir and telaprevir in genotype 1 chronic hepatitis C infected patients. Aliment Pharmacol Ther 2012 Mar; 35 (6): 647-62
29. Liapakis A, Jacobson I. Telaprevir user's guide. Clin Liver Dis 2011 Aug; 15 (3): 555-71
30. Soriano V, Vispo E, Poveda E, et al. Treatment failure with new hepatitis C drugs. Expert Opin Pharmacother 2012 Feb; 13 (3): 313-23
31. Kwo PY. Phase III results in Genotype 1 naive patients: predictors of response with boceprevir and telaprevir combined with pegylated interferon and ribavirin. Liver Int 2012 Feb; 32 Suppl. 1: 39-43
32. Ahlenstiel G, Booth DR, George J. IL28B in hepatitis C virus infection: translating pharmacogenomics into clinical practice. J Gastroenterol 2010 Sep; 45 (9): 903-10
33. Akuta N, Suzuki F, Hirakawa M, et al. Amino acid substitution in hepatitis C virus core region and genetic variation near the interleukin 28B gene predict viral response to telaprevir with peginterferon and ribavirin. Hepatology 2010 Aug; 52 (2): 421-9
34. Scott JD, Gretch DR. Molecular diagnostics of hepatitis C virus infection: a systematic review. JAMA 2007 Feb 21; 297 (7): 724-32 (Pubitemid 46294562)
35. Imhof I, Simmonds P. Genotype differences in susceptibility and resistance development of hepatitis C virus to protease inhibitors telaprevir (VX-950) and danoprevir (ITMN-191). Hepatology 2011 Apr; 53 (4): 1090-9