Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects

Hepatology

Volumn 57, Issue 3, 2013, Pages 897-902

  Liu, Jiang ^a   Jadhav, Pravin R ^a   Amur, Shashi ^a   Fleischer, Russell ^a   Hammerstrom, Thomas ^a   Lewis, Linda ^a   Naeger, Lisa ^a   O'Rear, Jule ^a   Pacanowski, Michael ^a   Robertson, Sarah ^a   Seo, Shirley ^a   Soon, Greg ^a   Birnkrant, Debra ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PEGINTERFERON ALPHA; RIBAVIRIN; TELAPREVIR; VIRUS RNA;

ARTICLE; DRUG RESPONSE; FOOD AND DRUG ADMINISTRATION; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROSPECTIVE STUDY; RELAPSE;

ANTIVIRAL AGENTS; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG APPROVAL; DRUG MONITORING; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; EVIDENCE-BASED MEDICINE; HEPATITIS C, CHRONIC; HUMANS; INTERFERON-ALPHA; OLIGOPEPTIDES; RECURRENCE; RIBAVIRIN; UNITED STATES;

EID: 84874467035     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.25764     Document Type: Article

References (22)

1. US Food and Drug Administration, Center for Drug Evaluation and Research. FDA approved drug products. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.
2. Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. HEPATOLOGY 2011; 54: 1433-1444.
3. US Food and Drug Administration, Center for Drug Evaluation and Research. Antiviral Drugs Advisory Committee: advisory committee briefing document for NDA 201-917 telaprevir 375 mg tablets. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252561.pdf.
4. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011; 364: 2405-2416.
5. Sherman KE, Flamm SL, Afdhal NH, Nelson DR, Sulkowski MS, Everson GT, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011; 365: 1014-1024.
6. Shiffman ML. Treatment of hepatitis C in 2011: what can we expect? Curr Gastroenterol Rep 2010; 12: 70-75.
7. Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011; 364: 2417-2428.
8. McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, et al. Telaprevir for previously treated chronic HCV infection. N Engl J Med 2010; 362: 1292-1303.
9. Liu J, Florian J, Birnkrant D, Murray J, Jadhav PR. Interferon responsiveness does not change in experienced hepatitis c subjects: implications for drug development and clinical decisions. In: The 62nd Annual Meeting of the American Association for the Study of Liver Diseases; San Francisco; 2011.
10. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry providing clinical evidence of effectiveness for human drug and biological products. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryinformation/Guidances/ucm078749.pdf.
11. US Food and Drug Administration, Center for Drug Evaluation and Research. Trileptal label. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021014s015s019s022s024s025s027s028, 285s009s013s015s018s019s020s022lbl.pdf.
12. US Food and Drug Administration, Center for Drug Evaluation and Research. Topiramate label. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020505s042, 844s036lbl.pdf.
13. Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J 2005; 7: E503-E512.
14. Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, et al. Impact of pharmacometric reviews on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther 2007; 81: 213-221.
15. Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, et al. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin Pharmacokinet 2011; 50: 627-635.
16. Li F, Nandy P, Chien S, Noel GJ, Tornoe CW. Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children. Antimicrob Agents Chemother 2010; 54: 375-379.
17. Madabushi R, Cox DS, Hossain M, Boyle DA, Patel BR, Young G, et al. Pharmacokinetic and pharmacodynamic basis for effective argatroban dosing in pediatrics. J Clin Pharmacol 2011; 51: 19-28.
18. US Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry chronic hepatitis c virus infection: developing direct-acting antiviral agents for treatment. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf.
19. Sherman M, Yoshida EM, Deschenes M, Krajden M, Bain VG, Peltekian K, et al. Peginterferon alfa-2a (40KD) plus ribavirin in chronic hepatitis C patients who failed previous interferon therapy. Gut 2006; 55: 1631-1638.
20. Jacobson IM, Gonzalez SA, Ahmed F, Lebovics E, Min AD, Bodenheimer HC Jr, et al. A randomized trial of pegylated interferon alpha-2b plus ribavirin in the retreatment of chronic hepatitis C. Am J Gastroenterol 2005; 100: 2453-2462.
21. Lindsay KL, Morishima C, Wright EC, Dienstag JL, Shiffman ML, Everson GT, et al. Blunted cytopenias and weight loss: new correlates of virologic null response to re-treatment of chronic hepatitis C. Clin Gastroenterol Hepatol 2008; 6: 234-241.
22. Poynard T, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, et al. Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy. Gastroenterology 2009; 136: 1618-28.e2.