Study Shows 12 Weeks of Peginterferon Alfa-2b and Ribavirin Combination Therapy as Effective as 24 Weeks in Certain Hepatitis C Patients With Genotype 2 or 3 Virus Results Published in New England Journal of Medicine Support Shorter Course of Therapy Based on Predictability of Response at Week 4 of Treatment SAN GIOVANNI ROTONDO, Italy, June 22 /PRNewswire-FirstCall/ -- Results of a new study published in the current issue of the New England Journal of Medicine show that a shorter, 12-week course of therapy with peginterferon alfa-2b and ribavirin combination therapy was as effective as a 24-week course for patients with hepatitis C virus (HCV) genotype 2 or 3 who had an early response to treatment, defined as HCV RNA negative at 4 weeks. The shorter regimen was not only highly effective in these patients, with 85 percent achieving a sustained virological response, but it also was associated with fewer side effects and, consequently, less frequent withdrawals from therapy. Moreover, patients assigned to 12 weeks of treatment were less likely to require a dose reduction. Maintaining the therapeutic dose is important for achieving an sustained virological response. "Our findings suggest that patients with chronic hepatitis C genotype 2 or 3 infection who have undetectable virus after 4 weeks of treatment with peginterferon alfa-2b and ribavirin achieve high response rates with only 12 weeks of therapy and do not require 24 weeks of treatment," said Alessandra Mangia, M.D., Gastroenterology Unit, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo. "Tailoring treatment so that those with an early response are given a shorter course may make therapy more appealing to patients, sparing the expense and inconvenience of extended treatment, without adversely affecting outcomes." Most patients treated today for chronic HCV genotype 2 or 3 receive 24 or 48 weeks of therapy. Although these schedules are effective, side effects increase with the length of treatment. Study and Results This open-label clinical trial was conducted in 14 centers in Italy as an investigator-sponsored study without financial support from industry. Patients were randomly assigned to receive weight-based peginterferon alfa-2b (PegIntron, Schering-Plough) at a dose of 1.0 mcg per kilogram of body weight weekly plus oral ribavirin (Rebetol, Schering-Plough) at a dose of 1000 mg (for those with a weight of less than 75 kg) or 1200 mg (for those with a weight of greater than or equal to 75 kg) daily, administered either for the standard period of 24 weeks (in the control standard-duration group of 70 patients) or for a variable duration of 12 or 24 weeks (in the variable duration group of 213 patients), depending on whether tests for HCV RNA were negative or positive at week 4. The primary measure of efficacy was sustained virological response (SVR), defined as HCV RNA that was undetectable in the serum 24 weeks after treatment was stopped. Patients in the two treatment arms were well matched for baseline characteristics. Peginterferon alfa-2b and ribavirin combination therapy was shown to be effective in eliciting an early response, with 64 percent of patients in the standard-duration group and 62 percent in the variable-duration group having undetectable virus (HCV RNA negative) at week 4. Early response was highly predictive of sustained virological response, with 91 percent and 85 percent of patients, respectively, achieving SVR. Overall, 76 percent of patients in the standard-duration group and 77 percent in the variable-duration group achieved SVR. Fewer patients receiving the 12-week regimen had adverse events and withdrew from treatment than in the group receiving the 24-week regimen (P=0.049). Among patients with HCV genotype 2, the overall rate of sustained virological response was 80 percent compared to 66 percent among those with genotype 3 (P less than 0.001). The study findings suggest that stopping therapy after 12 weeks in patients with a response at 4 weeks is appropriate for patients with either genotype, because the rates of sustained virological response were similar in patients with genotype 2 or 3 who had an early response and who were treated for 12 or 24 weeks. Importantly, the rate of relapse (defined as undetectable HCV at the end of treatment but detectable at the end of follow-up) in the group treated for 12 weeks was not different from that among patients in the standard-duration group with an early response (P=0.19). Patients in the 12-week group who did relapse were offered re-treatment with the same dose of peginterferon alfa-2b and ribavirin for an additional 12 weeks. Nine of 10 of these patients achieved an SVR. Therefore, even taking into consideration the rate of relapse, treatment for 12 weeks rather than 24 weeks appears to be appropriate for patients with an early response. DATASOURCE: Alessandra Mangia, M.D. CONTACT: Europe: Colin Martin of Ritz Communications, +44-20-8994-1639, Cell: +44-7931-560-141; or United States: Elaine Metcalf of Chandler Chicco Agency, +1-212-229-8431 Company News On-Call: http://www.prnewswire.com/comp/777050.html

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