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  Česky / Czech version Čes. a Slov. Gastroent., 56, 2002, No. 3, p. 106-111
 
Combination Therapy with Interferon alpha-2b and Ribavirin of Patients with Chronic Hepatitis C –Results of Czech Multicentre trial 
Husa P.1 ,Krtek V.2 ,Švejda J.3 ,Stránský J.4 ,Cieslarová B.4 ,Nádvorník V.5 ,Ehrmann J.6 ,Urbánek P.7 ,Volfová M.8 ,Svobodník A.9 a další účastníci multicentrické studie * 

1 Klinika infekčních chorob FN,Brno 2 II.interní klinika Fakultní Thomayerovy nemocnice,Praha 3 Sdružení privátních lékařů,Ústí nad Labem 4 I.interní klinika FNKV,Praha 5 Infekční oddělení ÚVN,Praha 6 II.interní klinika LF UP,Olomouc 7 I.interní klinika VFN,Praha 8 I.interní klinika FN,Hradec Králové 9 Centrum informatiky a analýz UOC,LF MU,Brno
 


Summary:

       Objective:To evaluate combination treatment with interferon (IFN)alpha-2b and ribavirin in the treatment of patients with chronic hepatitis C.To compare whether the therapeutic results differ between naive patients relapsers after IFN monotherapy and non-responders to IFN monotherapy.To evaluate the frequency of adverse therapeutic events such as anaemia,leukopenia and thrombocytopenia and the reversibility of chan- ges of haematological parameters.To evaluate in what proportion of patients it was necessary to reduce the original IFN and/or ribavirin doses because of adverse events. Method:Retrospective evaluation of results and safety of treatment of 173 patients with chronic hepatitis C,incl.41 IFN naive patients,47 relapsers after IFN monotherapy and 85 non-responders IFN monotherapy.Statistical evaluation of the different success rate in different patient groups (chi 2 test)and frequency of adverse events of treatment (Wilcoxon ´s test). Results:Saustained virological and biochemical responses were achieved after a 6-month interval following termination of one-year combined therapy with IFN alpa-2b (3 MU three times per week)and ribavirin (1000 –1200 mg/day)in 42%and 46%naive patients,in 45%and 43%relapsers and 25%and 26%non-respon- ders.Sustained biochemical response in patients not responding to IFN was significantly worse than in the other two groups (p 0.05).From the aspect of a sustained virological response the authors recorded also poorer results in patients who did not respond to previous treatment,in relapsing patients the difference is evaluated as statistically significant (p =0.019),in untreated patients at the borderline of statistical significance (p = 0.058).During treatment a significant decline of the haemoglobin level occurred as well as of the number of leucocytes and thrombocytes (p 0.001)as compared with baseline values),but before the end of the investigati- on all values reached normal levels.On account of leukopenia and/or neutropenia the dose of IFN alpha-2b had to be reduced in 8%patients,on account of serious anaemia the ribavirin dose was reduced in 21% patients. Conclusion:Combination treatment with IFN alpha-2b and ribavirin is effective in a significant proportion of patients with chronic hepatitis C.Treatment is always associated with anaemia,leukopenia and thrombocyto- penia which are however completely reversible after termination of treatment.

        Key words: chronic hepatitis C –interferon alpha 2b –ribavirin –adverse events
       

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