14 Weeks of Treatment with PegIntron plus Ribavirin Is Non-inferior to 24 Weeks in Rapid Responders with HCV Genotype 2 or 3

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14 Weeks of Treatment with PegIntron plus Ribavirin Is Non-inferior to 24 Weeks in Rapid Responders with HCV Genotype 2 or 3By Baker, PhD

In a previous multicenter, non-randomized study conducted in Norway, Denmark, and Sweden, 90% of patients with HCV genotype 2 or 3 and a rapid virological response (RVR) experienced a sustained virological response (SVR) after 14 weeks of treatment with pegylated interferon alfa-2a (PegIntron) plus ribavirin.

To assess the validity of this early study, the researchers conducted the current randomized, non-inferiority trial, the results of which were presented at the 42nd Annual Meeting of the European Association for the Study of Liver Disease this month in Barcelona, Spain.

The investigators enrolled 428 treatment-naive HCV RNA positive patients with genotype 2 or 3. Patients who experienced a RVR (defined as < 50 IU/ml after 4 weeks of treatment) were randomized to receive either 14 weeks (Group A) or 24 weeks (Group of treatment with PegIntron plus ribavirin. The primary endpoint was SVR. The non-inferiority margin was set to be 10% between the 2 groups.

Results

Overall, 298 of 428 patients (70%) achieved RVR and were randomized to Group A (n = 149) or Group B (n = 149). The median age was 38 years, 65% were men, the mean weight was 80 kg, 20% had genotype 2, and 80% had genotype 3. There was no significant difference in the baseline characteristics of the 2 groups. In an intention-to-treat analysis, SVR was observed in 121 of 149 patients (81%) in Group A and in 131 of 149 patients (88%) in Group B.

The difference between the 2 groups was 6.7%. In a per protocol analysis including only those who received more than 80% of each drug for more than 80% of the scheduled time and who had HCV RNA measured 24 weeks post-treatment, 115 of 127 patients (91%) in Group A and 95 of 100 patients (95%) in Group B achieved SVR. The table below shows SVR rates in 227 patients with RVR who received treatment per protocol (Group A, n=127; Group B, n=100) according to genotype and baseline HCV RNA level.

TABLE

Conclusion

Based on their findings, the study authors concluded, “With a 5% significance level, 14 weeks treatment with pegylated interferon alpha-2b and ribavirin is non-inferior to 24 weeks treatment in patients with genotype 2 or 3 and RVR.”

Infectious Disease Department, Ullevål University Hospital, Oslo, Norway; Medical Department, Rikshospitalet, Oslo, Norway; Pharmaceutical Institute, Rigshospitalet, Copenhagen, Denmark; Department of Gastroenterology, Malmø University Hospital, Malmø, Sweden.

04/20/07

ReferenceO Dalgard, K Bjøro, H Ring-Larsen, and H Verbaan. Peginterferon alfa-2b and ribavirin for 14 or 24 weeks in patients with HCV genotype 2 or 3 and rapid virological response. The North-C Trial. 42nd Annual Meeting of the European Association for the Study of Liver Disease. April 11 - 15, 2007, Barcelona, Spain.

http://www.hivandhepatitis.com/2007icr/easl/docs/042007_b.html