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| |  DDW: Pegasys (Pegylated IFN Alpha-2a) Shown Effective, Safe And Tolerable For Chronic Hepatitis C By Bruce Wilson Special to DG News
ATLANTA, GA -- May 24, 2001 -- In the treatment of chronic hepatitis C, pegylated (40 kDa) interferon (IFN) alpha-2a (PEG, Pegasys®) is associated with fewer adverse events, better tolerability, and a better quality of life than IFN alpha-2b/ribavirin, according to a study presented yesterday at Digestive Disease Week. Reporting on behalf of his colleagues, Dr. Kenneth D. Rothstein, Albert Einstein Medical Center, Philadelphia, Pennsylvania, said the study has important implications when considering an antiviral treatment for chronic hepatitis C patients. "Tolerability and quality of life are critical aspects of the treatment of hepatitis C but are rarely assessed in large clinical trials," Dr. Rothstein told delegates. Prior studies have shown that the sustained virological response (SVR) of PEG is better than that of IFN alpha-2a therapy (30-39 percent versus 10-19 percent). "Standard-of-care" combination therapy with IFN alpha-2b/ribavirin is associated with a similar improved SVR but more significant adverse events when compared to IFN monotherapy. In this trial, 412 treatment-naïve patients with chronic hepatitis C were randomized to PEG or IFN alpha-2b/ribavirin for 48 weeks followed by a 24-week treatment-free period. Twenty-five percent had cirrhosis or were in transition to cirrhosis, Dr. Rothstein indicated. Virological response was defined as Hepatitis C virus RNA below the level of detection by Roche AMPLICOR™ v. 2.0. Quality of life was assessed by administration of the Hepatitis Quality of Life Questionnaire (HQLQ: SF-36 plus 4 additional hepatitis-specific domains). Safety and tolerability were assessed by the incidence of adverse events and patient discontinuation/withdrawal rates, respectively. According to Dr. Rothstein, the virological responses in the two treatment arms were practically equivalent at weeks 4, 12 and 24, with an increase over time. There was a clinically significant difference between patients receiving PEG and those on IFN alpha-2b/ribavirin for several adverse events including anemia (2.0 percent versus 32.4 percent), dyspnea (9.5 percent versus 18.1 percent), nausea (33.6 percent versus 45.9 percent) and pruritus (6.7 percent versus 17.5 percent). At weeks 4 and 12, patients in the PEG group compared to those in the IFN alpha-2b/ribavirin group had more favorable quality of life scores in all eight SF-36 domains, plus both physical and mental summary scores, and four additional hepatitis-specific domains (p<0.05). PEG showed significantly better scores than IFN alpha-2b/ribavirin on the Work Productivity and Activity Impairment (WPAI) instrument in scales of impairment, work impairment and activity impairment at weeks 4 and 12. Also, significantly fewer patients in the PEG arm went from being employed to unemployed. Twenty-six patients (13.4 percent) on IFN/ribavirin and 11 patients (5.6 percent) on PEG have discontinued therapy to date. Further follow-up is in progress, Dr. Rothstein said.
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