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

摘要

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.