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Higher Fixed Dosing with PEGASYS in Difficult-to-Treat Patients
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Roche Press Announcement
The results of another study presented at AASLD show that intensifying treatment with a higher fixed dose of PEGASYS along with a higher dose of COPEGUS may yield higher response rates in patients with several characteristics that make hepatitis C more difficult-to-treat.
It is well recognized that response rates to treatment can be significantly lower in patients who have these specific characteristics together, such as infection with genotype 1, high levels of virus in the blood and heavy bodyweight.
"We have known for some time that certain patients have characteristics that make their disease more difficult to treat, and improving their treatment success rates with currently available medications is an urgent need," said Michael W. Fried, M.D., Professor of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill. "If strategies using intensified treatment with peginterferon alfa-2a and ribavirin are validated in larger studies, these findings suggest that even more patients living with chronic hepatitis C can
have treatment success."
This randomized, double-blind study enrolled 188 adults with previously untreated genotype 1 chronic hepatitis C infection, a bodyweight of more than 85 kg and high blood levels of hepatitis C (HCV RNA level greater than 800,000 IU/mL). Patients received 48 weeks of treatment with PEGASYS at either the standard fixed dose of 180_g/week or a higher fixed dose of 270_g/week, plus COPEGUS (ribavirin) at the standard dose of 1200mg/day or a higher dose
of 1600mg/day, as follows:
- peginterferon alfa-2a (40KD) 180_g/week plus ribavirin 1200mg/day (Group A)
- peginterferon alfa-2a (40KD) 180_g/week plus ribavirin 1600mg/day (Group B)
- peginterferon alfa-2a (40KD) 270_g/week plus ribavirin 1200mg/day (Group C)
- peginterferon alfa-2a (40KD) 270_g/week plus ribavirin 1600mg/day (Group D)
It was the group receiving a combination of a higher dose of PEGASYS and a higher dose of COPEGUS (group D) which achieved the highest rate of SVR versus the current standard regimen (47 percent vs. 28 percent). This result also highlights the important role that COPEGUS plays in achieving an SVR.
The use of higher doses of PEGASYS and COPEGUS together was associated with an increase in the rate of serious adverse events compared with standard doses (up to 13 percent vs. 9 percent), an increase in the incidence of hematological abnormalities, including anemia, and an increase in premature withdrawals due to safety reasons.
"These two clinical trials underscore the commitment of Roche to finding better
treatment solutions for patients living with chronic hepatitis C," said Thomas Klein, Vice President, Hepatology, Roche. "It is this commitment that has led to the status of PEGASYS as the most broadly-studied pegylated interferon, and which drives our extensive research efforts to develop new compounds and treatment strategies for hepatitis C."
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of cirrhosis, liver cancer and the need for liver transplants. According to the Centers for Disease Control and Prevention (CDC), an estimated 4.1 million Americans (1.6 percent) have been infected with hepatitis C; 3.2 million are chronically infected. The number of new infections per year has declined from an average of 240,000 in the 1980s to about 26,000 in 2004. CDC estimates the number of hepatitis C-related deaths could increase to 38,000 annually by the year 2010,
surpassing annual HIV/AIDS deaths.
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