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01 May 2004

Safety and tolerability of the combination therapy with pegylatedinterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in patientswith chronic hepatitis C in Poland – interim analysis of data fromEAP program

Marta Wawrzynowicz-Syczewska, Marek Wasilewski, Hanna Trocha, Ewa Topczewska-Staubach, Krzysztof Tomasiewicz, Katarzyna Świętek, Katarzyna Szamotulska, Katarzyna Sikorska, Andrzej Horban, Marek Beniowski, Hanna Berak, Beata Bolewska, Anna Boroń-Kaczmarska, Janusz Cianciara, Andrzej Cieśla, Jacek Gąsiorowski, Andrzej Gietka, Ewa Gliwińska, Andrzej Gładysz, Zbigniew Gonciarz, Waldemar Halota, Małgorzata Inglot, Urszula Janas-Skulina, Ewa Janczewska-Kazek, Jolanta Jaskowska, Krzysztof Jurczyk, Jacek Juszczyk, Brygida Knysz, Wiesław Kryczka, Jan Kuydowicz, Anna Lakomy, Beata Logiewa-Bazger, Małgorzata Zejc-Bajsarowicz, Dorota Zarębska-Michaluk, Witold Wrodycki, Anna Łyczak, Tomasz Mach, Włodzimierz Mazur, Zofia Michalska, Roma Modrzewska, Khalil Nazzal, Paweł Pabjan, Anna Piekarska, Paweł Piszko

Med Sci Monit 2004; 10(1): 12-16 :: ID: 11832

Abstract

Open-label, multicenter extended availability program with peginterferon alfa-2a used in combination with ribavirin in patients with CHC in Poland was analysed. Finally, 572 patients were enrolled. The interim analysis of safety and tolerability was performed in 190 patients whose data were available after 72 weeks of observation. Mean hemoglobin level was 14.8 g/dl and decreased to week 24, then remain stable until the end of therapy and returned to the baseline value. Lekocytes level in week 2 decreased, reach a plateau in week 8 and return to baseline values at end observation. Similar phenomenon was observed with neutrophils. Platelet count during the treatment fell gradually in week 8 and remained stable. Reported adverse events requiring PEGASYS® or COPEGUS
® dose reduction were also analyzed. The most frequent adverse effect leading to the reduction of peginterferon alfa-2a dose was reduction. It was noted in 16 patients out of 18, who had the doses reduced because of adverse effects. Only in 5 patients, the dose was reduced because of depression or anxiety. Combined therapy was generally well-tolerated, preliminary analysis data confirms similar tolerability profile to that observed in phase III clinical trials.

Keywords: combination therapy with pegylated interferon alfa-2a and ribavirin, safety and tolerability, chronic hepatitis C

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750