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Maintenance Therapy with Pegasys Monotherapy or Pegasys + Ribavirin in Genotype 1 HCV Patients After 24-Week Response
Recent clinical studies have shown that patients infected with HCV genotype 1 derive significant benefit from combination therapy with peginterferon plus ribavirin (RBV) given for 48 weeks. However, ribavirin may have severe side effects that lead to discontinuation in approximately 18% of patients after 24 weeks of treatment.
The aim of the current study was to determine whether or not shorter RBV administration could improve tolerance (i.e., adherence and quality of life) without altering efficacy in patients infected with HCV genotype 1 who respond to combination therapy.
524 previously untreated patients with HCV genotype 1 infection, biopsy-proven chronic hepatitis C, persistently elevated ALT levels and detectable HCV RNA were included between January 2001 and January 2002. They received Pegasys (peginterferon alfa-2a (40KD) 180mcg/week plus RBV (800mg/day) for 24 weeks.
The responders at week 24 (undetectable HCV-RNA in the Roche AmplicorTM HCV test, lower limit of detection 50UI/ml) were randomized at week 26 into Group A, Pegasys plus ribavirin, or group B, Pegasys alone for 22 additional weeks.
Qualitative HCV-RNA detection (Roche AmplicorTM) was performed at weeks 30, 36, 42, 48, 52, 60 and 72 in each group. Results of preliminary analysis: Among the 524 patients , 59.4% were males, the mean age was 46.3 years, the mean body weight was 70.7 kg and 8.6% had cirrhosis ;44.3% had a viral load > 800,000 UI /ml.
345 patients have responded at week 24 (HCV RNA < 50 IU/ml) and have been randomized. 127 of them reached week 36 of follow-up (still on treatment) and were tested for HCV RNA. 6.2% patients (4/ 64) relapsed during therapy in group A vs 11.3% (6/53) in group B (p=NS).
Conclusions: The results of this preliminary analysis suggest that RBV withdrawal after week 24 is not associated with more frequent breakthrough during therapy than continuation of Pegasys-ribavirin combination treatment. The influence of ribavirin withdrawal on the sustained virological response is currently under study in these patients.
01/24/03
Reference
JP Bronowicki and others. EFFICACY AND SAFETY OF 22 WEEKS OF MAINTENANCE THERAPY WITH PEGINTERFERON ALFA-2A(40KD)(PEGASYS)ALONE VERSUS PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN NAIVE PATIENTS WITH CHRONIC HEPATITIS C AND GENOTYPE 1 WHO RESPOND TO A 24 WEEK COURSE THERAPY OF PEGINTERFERON ALFA-2A PLUS RIBAVIRIN: PRELIMINARY RESULTS OF AN OPEN, MULTICENTER,RANDOMIZED TRIAL. Abstract 520. 53rd AASLD. November 1-5, 2002. Boston, MA. Hepatology 2002: Vol 36 No 4, Pt 2 of 2.
