PEGASYS Regimen Provides Higher Sustained Virological Response Rates For Hepatitis C Patients
A new, independently-conducted study being presented at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) shows that PEGASYS (peginterferon alfa-2a) treatment regimens result in higher sustained virological response (SVR) rates for hepatitis C patients as compared to regimens with another pegylated interferon.(1)
Comparing Today's Standard Treatment Regimens: The Milan Safety Tolerability Study
The Milan Safety Tolerability Study (MIST) randomly assigned 431 patients to receive PEGASYS or PegIntronTM, both in combination with ribavirin. In the PEGASYS group, the daily ribavirin dose for genotype 1 and 4 patients was 1000-1200 mg based on weight, while patients with genotype 2 or 3 received a fixed dose of ribavirin (800 mg). In the PegIntron group, ribavirin doses ranged from 800 mg to 1400 mg based on a patient's weight in all genotypes. The primary endpoint was to compare the safety and tolerability. The secondary endpoint was to compare efficacy.
Professor Colombo, Head of the 1st Division of Gastroenterology and A.M. Migliavacca Center for Liver Disease at the University of Milan, and colleagues will present the results of a study, which found significantly higher SVR rates in patients treated with PEGASYS/ribavirin as compared to those treated with peginterferon alfa-2b (PegIntron)/ribavirin (66 percent vs. 54 percent, p=0.02). The difference was sustained in patients with the most difficult to treat forms of the virus, those infected with genotypes 1 or 4 (48 percent vs. 32 percent, p=0.02). The two regimens showed a similar safety and tolerability profile, with similar rates of serious adverse events (2 percent in both arms) and drop outs for side effects (7 percent vs. 6 percent).
"Our study combines the rigor of a randomized, controlled trial with the general applicability of a 'real-world' study, since it included all patients at our clinic who initiated hepatitis C treatment and met basic eligibility criteria," said Professor Colombo. "The results from this study prove that treatment success rates in the real world can be comparable to those achieved in clinical trials. The study also demonstrates that PEGASYS regimens enable significantly more patients to achieve a SVR."