Studies Showed Higher SVR For PEGASYS Plus Ribavirin Successful In Treating Hepatitis C
Roche's three studies indicate that chronic hepatitis C patients who received PEGASYS (peginterferon alfa-2a) plus ribavirin had a greater chance of achieving a sustained virological response (SVR) than patients on peginterferon alfa-2b. Results from the studies were presented this week at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) in Milan, Italy, adding to the robust body of evidence supporting PEGASYS as an effective treatment choice for treating patients with hepatitis C.
Ascione, et al: A Prospective, Randomized, Investigator-Initiated Head-to-Head Trial
Results of the Peginterferon Alpha-2a Plus Ribavirin Versus Peginterferon Alpha-2b Plus Ribavirin in Naive Patients with Chronic Hepatitis C Virus Infection Study: Results of a Prospective Randomized Trial, an independently-conducted study, were presented by Professor Antonio Ascione, Director of the Department of Gastroenterology Liver Unit at Cardarelli Hospital in Naples, Italy, in the oral late-breaker session at EASL. It is a prospective, randomized, investigator-initiated head-to-head trial designed to directly compare PEGASYS with peginterferon alfa-2b, each in combination with ribavirin. Enrolling 320 patients in Italy, of all genotypes, the study randomized patients to receive either PEGASYS 180 mcg/week or peginterferon alfa-2b 1.5 mcg/kg/week. Importantly, patients received equivalent starting doses of ribavirin (either 1,000 or 1,200 mg ribavirin per day based on body weight), and the process for ribavirin dose reduction was the same for all patients.
The results showed that overall 68.7 percent (110/186) of hepatitis C patients who were treated with PEGASYS achieved SVR, defined by undetectable hepatitis C virus (HCV) RNA in the blood 24 weeks after the end of treatment, compared to 54.4 percent (87/134) of patients who received peginterferon alfa-2b (p=0.008). Furthermore, in genotypes 1 and 4 -- the most difficult-to-treat patient group -- 51 patients (54.8 percent) taking PEGASYS achieved SVR, compared to 37 patients (39.8 percent) in the peginterferon alfa-2b group (p=0.04). In genotypes 2 and 3; 59 patients (88.1 percent) taking PEGASYS achieved SVR, compared to 50 patients (74.6 percent) taking peginterferon alfa-2b (p=0.046). Side effects were similar, although there were more withdrawals for side effects in the peginterferon alfa-2b group.
T. Witthoeft, et al: Hepatitis C Treatment in Real-Life PRACTICE in Germany
Another study presented at EASL, a retrospective analysis called The PRACTICE Study, analyzed the response of 3,470 patients of all genotypes, to hepatitis C treatment between 2000 and 2007 in 23 German treatment centers with a high volume of patients. Patients were matched with regard to key baseline characteristics, including viral load, prior treatment history, body mass index, history of drug addiction, HIV co-infection as well as those who received a similar cumulative ribavirin dose. Among these matched pairs, significantly more patients treated with PEGASYS plus ribavirin achieved SVR compared to those treated with peginterferon alfa-2b and ribavirin (59.3 percent (N=848) vs. 53.0 percent (N=848) [p = 0.008]).
A. Craxi, et al: PROBE Compares The Pegylated Interferons
The PROBE study, an observational study, was designed to prospectively evaluate the efficacy of the pegylated interferons in real-life practice. The study enrolled 6,644 patients with genotype 1 virus at 167 treatment centers in Italy. The analysis included 1,351 patients of whom 887 received peginterferon alfa-2a and 464 received peginterferon alfa-2b. The study reflected "real-life" clinical settings by including patients with comorbidities, including obesity, diabetes, advanced age, psychiatric disorders, methadone use, thyreopathy and autoimmunity. Again, the trial found a greater chance of achieving SVR in patients treated with PEGASYS combination therapy compared to those treated with peginterferon alfa-2b combination therapy (SVR rates of 41 percent (360/887) vs. 34 percent (156/464), respectively [p = 0.004]).
"The outcomes of the three studies presented at EASL, comparing PEGASYS to peginterferon alfa-2b, contribute to a growing body of evidence that PEGASYS provides a successful outcome for many patients with hepatitis C," said Steven C. Sembler, vice president of Commercial Operations, Roche. "We are committed to further advancing the treatment of hepatitis C. Reflecting Roche's leadership in this area, our comprehensive clinical trials program aims to optimize treatment with PEGASYS and COPEGUS in the hope of bringing treatment success to even more patients."
Roche Comments on Schering-Plough "IDEAL" Study
Roche reiterated its position on the design of the Schering-Plough sponsored "IDEAL" study results, which were also presented at EASL. Clear biases in the design of this study that may have favored patients receiving peginterferon alfa-2b regimens prevent any direct comparison of the pegylated interferons. These biases include: