Re-treatment of patients with chronic hepatitis C who do not respond to peginterferon-α2b: A randomized trial

Annals of Internal Medicine

Volumn 150, Issue 8, 2009, Pages 528-540

  Jensen, Donald M ^a   Marcellin, Patrick ^b   Freilich, Bradley ^c   Andreone, Pietro ^d   Di Bisceglie, Adrian ^e   Brandão Mello, Carlos E ^f   Reddy, K Rajender ^g   Craxi, Antonio ^h   Martin, Antonio Olveira ⁱ   Teuber, Gerlinde ^j   Messinger, Diethelm ^k   Thommes, James A ^l   Tietz, Andreas ^m  

^a UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^b BEAUJON HOSPITAL   (France)

^c Liver and Pancreas Institute of Kansas City   (United States)

^d UNIVERSITY OF BOLOGNA   (Italy)

^e SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f HOSPITAL UNIVERSITÁRIO GAFFRÉE E GUINLE   (Brazil)

^g HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^h Instituto Di Clinica Medica Policlinico   (Italy)

ⁱ HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^j UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^k IST GmbH   (Germany)

^l HOFFMANN LA ROCHE INC   (United States)

^m F HOFFMANN LA ROCHE LTD   (Switzerland)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; RIBAVIRIN; VIRUS RNA; ALPHA2A INTERFERON; ALPHA2B INTERFERON; ANTIVIRUS AGENT; MACROGOL DERIVATIVE; PEGINTERFERON ALFA-2A; PEGINTERFERON ALFA-2B;

ADULT; ALOPECIA; ANEMIA; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BODY WEIGHT; CHILL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DEPRESSION; DIARRHEA; DIZZINESS; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; DRY SKIN; DYSPNEA; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; GENOTYPE; GEOGRAPHY; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; INSOMNIA; IRRITABILITY; LIVER HISTOLOGY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RETREATMENT; SIDE EFFECT; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; UPPER ABDOMINAL PAIN; VOMITING; XEROSTOMIA; BLOOD; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; DRUG COMBINATION; GENETICS; MIDDLE AGED; TREATMENT FAILURE; VIROLOGY;

ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; INTERFERON ALFA-2A; INTERFERON ALFA-2B; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; RETREATMENT; RIBAVIRIN; RNA, VIRAL; TREATMENT FAILURE;

EID: 65349129985     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-150-8-200904210-00007     Document Type: Article

References (29)

1. Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004;39:ll47-71. [PMID: 15057920]
2. Dienstag JL, McHutchison JG. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology. 2006;130:225-30. [PMID: 16401485]
3. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiftman M, Rein-dollar R, et al. Peginterferon-a2b plus ribavirin compared with interferon-a2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-65. [PMID: 11583749]
4. Dienstag JL, McHutchison JG. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology. 2006;130:225-30. [PMID: 16401485]
5. Marcellin P, Boyer N, Gervais A, Martinot M, Pouteau M, Castelnau C, et al. Long-term histologic improvement and loss of detectable intrahepatic HCV RNA in patients with chronic hepatitis C and sustained response to interferon-alpha therapy. Ann Intern Med. 1997;127:875-81. [PMID: 9382365]
6. Sherman M, Yoshida EM, Deschenes M, Krajden M, Bain VG, Peltelrian K, et al; Canadian Pegasys Study Group. Peginterferon-a2a (40KD) plus ribavirin in chronic hepatitis C patients who failed previous interferon therapy. Gut. 2006; 55:1631-8. [PMID: 16709661]
7. Moucari R, Ripault MP, Oules V, Martinot-Peignoux M, Asselah T, Boyer N, et al. High predictive value of early viral kinetics in retreatment with pegin-terferon and ribavirin of chronic hepatitis C patients non-responders to standard combination therapy. J Hepatol. 2007;46:596-604. [PMID: 17218037]
8. Berg C, Goncales FL Jr, Bernstein DE, Sette H Jr, Rasenack J, Diago M, et al. Re-treatment of chronic hepatitis C patients after relapse: efficacy of peginterferon-a2a (40 kDa) and ribavirin. J Viral Hepat. 2006;13:435-40. [PMID: 16792536]
9. Tong MJ, Blatt LM, Tong LT, Sayadzadeh K, Conrad A. Long-term retreatment in chronic hepatitis C patients who were non-responders to an initial course of interferon-a2b. J Viral Hepat. 1998;5:323-31. [PMID: 9795916]
10. Fried MW, Jensen DM, Rodriguez-Torres M, Nyberg LM, Di Bisceglie AM, Morgan TR, et al. Improved outcomes in patients with hepatitis C with difficult-to-treat characteristics: randomized study of higher doses of peginterferon-a2a and ribavirin. Hepatology. 2008;48:1033-43. [PMID: 18697207]
11. Ferenci P, Stauber R, Steindl-Munda P, Gschwantler M, Fickert P, Datz C, et al; Austrian Hepatitis Study Group. Treatment of patients with chronic hepatitis C not responding to interferon with high-dose interferon α with or without ribavirin: final results of a prospective randomized trial. Austrian Hepatitis Study Group. Eur J Gastroenterol Hepatol. 2001;13:699-705. [PMID: 11434597]
12. Diago M, Crespo J, Olveira A, Perez R, Barcena R, Sanchez-Tapias JM, et al. Clinical trial: pharmacodynamics and pharmacokinetics of re-treatment with fixed-dose induction of peginterferon-a2a in hepatitis C virus genotype 1 true non-responder patients. Aliment Pharmacol Ther. 2007;26:1131-8. [PMID: 17894655]
13. Strader DB, Wright T, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004;39:ll47-71. [PMID: 15057920]
14. Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Tran-section of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973;60: 646-9. [PMID: 4541913]
15. Center for Drug Evaluation and Research. Summary Minutes of the Antiviral Drugs Advisory Committee, 19-20 October 2006. Silver Spring, MD: U.S. Food and Drug Administration; 2006.
16. 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;100:2453-62. [PMID: 16279900]
17. Poynard T, Schiff E, Terg R, Moreno-Otero R, Flamm S, Schmidt W, et al. Sustained viral response (SVR) is dependent on baseline characteristics in the retreatment of previous α interferen/ribavirin (I/R) nonresponders (NR): final results from the EPIC3 program [Abstract 988]. J Hepatol. 2008;48:S369.
18. Peglntron. Summary of Product Characteristics. Revision 12 (3 December 2007). Accessed at www.emea.europa.eu/humandocs/PDFs/EPAR/Pegintron /H-280-PI-en.pdf on 17 October 2008.
19. Pegasys (peginterferon alfa-2a) prescribing information [package insert]. Basel, Switzerland: F. Hoffman-La Roche; 2008. Accessed at www.fda.gov /CDER/foi/label/2002/pegihofl01602LB.htm on 4 March 2009.
20. Fried MW, Shiftman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-82. [PMID: 12324553]
21. Marcellin P, Craxi A, Brandao-Mello E, Di Bisceglie AM, Andreone P, Freilich B, et al. A 72-week treatment duration with peginterferon-a2a (40KD) (Pegasys) plus ribavirin (Copegus) has a favorable risk:benefit ratio in nonresponders to pegylated interferon-a2b (12KD) plus ribavirin: findings of the multinational REPEAT study [Abstract 1873]. Hepa-tology. 2008;48:ll46A-7A.
22. Shiftman ML, Di Bisceglie AM, Lindsay KL, Morishima C, Wright EC, Everson GT, et al; Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial Group. Peginterferon-a2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology. 2004; 126:1015-23; discussion 947. [PMID: 15057741]
23. Herrine SK, Brown RS Jr, Bernstein DE, Ondovik MS, Lentz E, Te H. Peginterferon-a2a combination therapies in chronic hepatitis C patients who relapsed after or had a viral breakthrough on therapy with standard interferon-a2b plus ribavirin: a pilot study of efficacy and safety. Dig Dis Sci. 2005;50:719-26. [PMID: 15844708]
24. Mathew A, Peiffer LP, Rhoades K, McGarrity T. Sustained viral response to pegylated interferon-a2b and ribavirin in chronic hepatitis C refractory to prior treatment. Dig Dis Sci. 2006;51:1956-61. [PMID: 17004124]
25. Bergmann JF, Vrolijk JM, van der Schaar P, Vroom B, van Hoek B, van der Sluys Veer A, et al. y-glutamyltransferase and rapid virological response as predictors of successful treatment with experimental or standard peginterferon-a2b in chronic hepatitis C non-responders. Liver Int. 2007;27:1217-25. [PMID: 17919233]
26. Carr C, Hollinger FB, Yoffe B, Wakil A, Phillips J, Bzowej N, et al. Efficacy of interferon-a2b induction therapy before retreatment for chronic hepatitis C. Liver Int. 2007;27:l 111-8. [PMID: 17845540]
27. Diago M, Crespo J, Olveira A, Perez R, Barcena R, Sanchez-Tapias JM, et al. Clinical trial: pharmacodynamics and pharmacokinetics of re-treatment with fixed-dose induction of peginterferon-a2a in hepatitis C virus genotype 1 true non-responder patients. Aliment Pharmacol Ther. 2007;26:1131-8. [PMID: 17894655]
28. Zeuzem S, Hezode C, Ferenci P, Dusheiko G, Alves K, Bengtsson L, et al. Telaprevir in combination with peginterferon-a2a with or without ribavirin in the treatment of chronic hepatitis C: final results of the PROVE2 study [Abstract 243]. Hepatology. 2008;48:4l8A-9A.
29. McHutchison JG, Shiftman ML, Terrault N, Manns MP, Di Bisceglie AM, Jacobson IM, et al. A phase 2B study of telaprevir with peginterferon-a2a and ribavirin in hepatitis C genotype 1 null and partial responders and relapsers following a prior course of peginterferon-a2a /B and ribavirin therapy: PROVE3 interim results [Abstract]. Hepatology. 2008;48:431A-2A.