New Study Shows That Pegasys Regimen Provides Higher Cure Rates For Hepatitis C Patients

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Nov 2008 - 0:00 PDT

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A new, independently-conducted study being presented at AASLD shows that PEGASYS(R) (peginterferon alfa-2a (40KD)) regimens result in higher cure rates for hepatitis C patients compared to regimens with another pegylated interferon.(1)

Comparing Today's Standard Treatment Regimens: The Milan Safety Tolerability Study

Prof. 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 cure rates in patients treated with Pegasys/ribavirin compared to those treated with peginterferon alfa-2b (PegIntron(TM)))/ribavirin (66% vs. 54%, p=0.02). The difference was even more pronounced in patients with the most difficult-to-treat forms of the virus, those infected with genotypes 1 or 4 (48% vs. 32%, p=0.02). The two regimens showed a similar safety and tolerability profile, with similar rates of serious adverse events (2% in both arms) and drop outs for side effects (7% vs. 6%).(1)

"Our study combines the rigor of a randomised, 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 Prof Colombo. "The results from this study prove that treatment success rates in the real world can be comparable to those achieved in clinical trials, and the study also demonstrates that Pegasys regimens enable significantly more patients to achieve a cure."

The Milan Safety Tolerability (MIST) Study randomly assigned 431 patients to receive Pegasys or peginterferon alfa-2b, both in combination with ribavirin. In the Pegasys group, the daily ribavirin dose for genotype 1 and 4 patients was 1,000-1,200 mg based on weight, while patients with genotype 2 or 3 received a fixed dose of ribavirin (800 mg). In the peginterferon alfa-2b group, ribavirin doses ranged from 800 mg to 1,400 mg based on a patient's weight in all genotypes.

Since the study used different ribavirin dosing in the treatment arms, it cannot provide a direct, head-to-head comparison between Pegasys and peginterferon alfa-2b, but instead offers comparisons between the specific combination regimens.

About Chronic Hepatitis C

Hepatitis C (HCV), the most common chronic blood-borne infection, is transmitted primarily through blood or blood products. HCV chronically affects 180 million people worldwide, which makes it over four times more prevalent than HIV. It is a leading cause of cirrhosis, liver cancer and liver failure, despite the fact that many patients can be cured.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.

References:

1) Rumi M, Aghemo A, Prati G, et al. Randomized study comparing peginterferon-alfa-2a plus ribavirin and peginterferon-alfa2b plu s ribavirin in naïve patients with chronic hepatitis C: final results of the Milan Safety Tolerability Study. Abstract presented at the American Association for the Study of Liver Disease; 31 October 2008; San Francisco, California, USA.