Efficacy, tolerability and predictive factors for early and sustained virologic response in patients treated with weight-based dosing regimen of PegIFN α-2b and ribavirin in real-life healthcare setting

Journal of Gastrointestinal and Liver Diseases

Volumn 16, Issue 1, 2007, Pages 23-29

  Gheorghe, Liana ^a,d   Iacob, Speranta ^a   Sporea, Ioan ^b   Grigorescu, Mircea ^c   Sirli, Roxana ^b   Damian, Dana ^c   Gheorghe, Cristian ^a   Iacob, Razvan ^a  

^a CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^b VICTOR BABES UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^c IULIU HATIEGANU UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^d FUNDENI CLINICAL INSTITUTE   (Romania)

Author keywords

Chronic hepatitis C; Early virologic response; PegIFN 2b; Sustained virologic response; Weight based dosing regimen

Indexed keywords

PEGINTERFERON ALPHA2B; RIBAVIRIN;

ABDOMINAL PAIN; ADULT; ALOPECIA; ANEMIA; APPETITE; ARTHRALGIA; ARTICLE; BLOOD TOXICITY; CHILL; CONTROLLED STUDY; COUGHING; DEPRESSION; DERMATITIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MECHANISM; DRUG RESPONSE; DRUG TOLERABILITY; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; HEADACHE; HEPATITIS C; HUMAN; INJECTION SITE INFLAMMATION; INJECTION SITE REACTION; INSOMNIA; IRRITABILITY; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; MENTAL CONCENTRATION; MYALGIA; NAUSEA; NEUTROPENIA; PRURITUS; RASH; SIDE EFFECT; THROMBOCYTOPENIA; VISUAL DISORDER; VOMITING; WEIGHT REDUCTION; XEROSTOMIA;

EID: 34047266160     PISSN: 18418724     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. National Institutes of Health Consensus Development Conference Statement. Management of hepatitis C. Hepatology 2002; 36 (Suppl 1): S3-S20
2. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon α-2b plus ribavirin compared with interferon α-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomized trial. Lancet 2001; 358: 958-965
3. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alpha 2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002; 347: 975-982
4. Hadziyannis SJ, Sette H Jr, Morgan TR, et al. Pegasys International Study Group. Peginterferon α-2a and ribavirin combination therapy in chronic hepatitis C. A randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004; 140: 346-355
5. Zeuzem S, Pawlotsky J-M, Lukasiewicz E, et al. DITTO-HCV Study Group. International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C. J Hepatol 2005; 43: 250-257
6. Zeuzem S, Hultcrantz R, Bourliere M, et al. Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in previously untreated patients infected with HCV genotypes 2 or 3. J Hepatol 2004; 40: 993-999
7. Zeuzem S. Heterogeneous virologic response rates to interferon-based therapy in patients with chronic hepatitis C: who respond less well? Ann Intern Med 2004; 140: 370-381
8. Craxi A, Camma C. Treating patients with HCV genotype land low viraemia: more than meets the eye. J Hepatol 2006;44:4-7
9. Jacobson I, Brown Jr R, Freilich B, et al. for the WIN-R Study Group. Weight based ribavirin dosing (WBD) increases sustained viral response (SVR) in patients with chronic hepatitis C (CHC): final results of the WIN-R study, a U.S.-community-based trial. Hepatology 2005; 42: 749A (LB 03)
10. Abadir N, Marotta P, Feinman SV, et al. Pegetron prospective optima weight-based dosing response program (POWER): Preliminary results. Hepatology 2005; 42: 693A (Abstr 1256)
11. Shehab TM, Sonnad SS, Lok AS. Management of hepatitis C patients by primary care physicians in the USA: results of a national survey. J Viral Hepat 2001; 8: 377-383
12. Shehab TM, Fontana RJ, Oberhelman K, Marrero JA, Su GL, Lok ASF. Effectiveness of interferon α-2b and ribavirin combination therapy in the treatment of naïve chronic hepatitis C patients in clinical practice. Clin Gastroenterol Hepatol 2004: 425-431
13. Gheorghe L, Grigorescu M, Iacob S, et al. Effectiveness and tolerability of PegIFN α-2a and ribavirin combination therapy in Romanian patients with chronic hepatitis C: from clinical trials to clinical practice. Rom J Gastroenterol 2005; 14: 109-115
14. Monitorul Oficial al Romaniei, Partea I, Nr. 269/17.04.2003: Ordin privind criteriile de selectie a pacientilor si schema terapeutica pentru tratamentul antiviral in hepatita cronica cu virus B si C
15. Knodell RG, Ishak KG, Black WC, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1981; 1: 431-435
16. Grigorescu M, Radu C, Pascu O, et al. Etiological profile of chronic hepatitis and liver cirrhosis in Romania - a multicentre study. Rom J Gastroenterol 2001; 10: 199-204
17. Sulkowski MS. Management of the hematologic complications of hepatitis C therapy. Clin Liver Dis 2005; 9: 601-616
18. Curry MP, Afdhal NH. Use of growth factors with antiviral therapy for chronic hepatitis C. Clin Liver Dis 2005; 9: 439-451
19. Aspinall RJ, Pockros PJ. Review article: the management of side effects during therapy for hepatitis C. Aliment Pharmacol Ther 2004; 20: 917-929
20. Fontana RJ. Optimizing outcomes in hepatitis C: Is treatment beyond 48 weeks ever justified? Gastroenterology 2006; 130: 1357-1362
21. Berg T, von Wagner M, Nasser S, et al. Extended treatment duration for hepatitis C virus type 1: comparing 48 versus 72 weeks of peginterferon α-2a plus ribavirin. Gastroenterology 2006; 130: 1086-1097
22. Zeuzem S, Buti M, Ferenci P, et al. Efficacy of 24 weeks treatment with peginterferon α-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J Hepatol 2006; 44: 97-103
23. Taliani G, Gemignani G, Ferrari C, et al and the Non-Responders Retreatment Group. PegIFN α-2b plus ribavirin in the retreatment of interferon-ribavirin nonresponder patients. Gastroenterology 2006; 130: 1098-1106
24. FDA Advisory Committee Briefing Document. Food and Drug Administration Website. At: http://www.fda.gov/ohrms/dockets/ac/02/briefing/3819B1_02_FDA- Clinical briefing.pdf Accessed January 28, 2003
25. Heathcote EJ, Shiffman ML, Cooksley WG, et al. Peginterferon α-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med 2000; 343: 1673-1680
26. Fried MW. Side effects of therapy of hepatitis C and their management. Hepatology 2002; 36: S237-S244
27. McHutchison JG, Manns M, Patel K, et al. International Hepatitis Interventional Therapy Group. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology 2002; 123: 1061-1069
28. Ferenci P, Shiffman M, Fried MW, et al. Early prediction of response to 40kDa peginterferon α-2a (Pegasys) plus ribavirin (RBV) in patients with chronic hepatitis C (CHC). Hepatology 2001; 34: 351A