Head-to-Head Studies Identify Best Treatment Regimen for Hepatitis C
BETHESDA, Md -- January 4, 2010 -- In patients with chronic hepatitis C virus (HCV), treatment with peginterferon alfa-2a (PEG-IFN-2a) plus ribavirin (RBV) better suppresses the virus to undetectable levels in the blood than treatment with PEG-IFN-2b plus RBV, according to 2 head-to-head studies published in the journal Gastroenterology.
While previous trials have demonstrated that both pegylated interferons are effective and safe when administered with RBV, only 2 randomised studies have compared the efficacy of the peginterferon formulations, neither of which was sufficiently powered to detect a statistically significant difference in sustained virological response (SVR) rates.
"Head-to-head trials comparing the efficacy and safety of PEG-IFN-2a or PEG-IFN-2b in combination with RBV in the treatment of patients with chronic hepatitis C are needed," said author of one of the studies Massimo Colombo, MD, University of Milan, Milan, Italy. "There is insufficient evidence to support conclusions that one therapeutic regimen is superior to the other one."
In the first study, previously untreated patients with chronic HCV were randomised after stratification for HCV genotype to either RBV combined with PEG-IFN-2a or PEG-IFN-2b for 24 or 48 weeks, according to virus genotype. Researchers found that overall, the SVR rate was significantly higher in the PEG-IFN-2a group compared with the PEG-IFN-2b group (66% vs 54%).
"Whether our strategy of RBV dosing, which is at variance with the standard of care for PEG-IFN-2a treatment, is indeed cost-effective, needs to be prospectively assessed through a pharmaco-economy study," added Dr. Colombo.
Similar results were reported in the second study in which 320 consecutive, treatment-naïve, HCV-RNA-positive patients with chronic HCV were randomly assigned to groups given once-weekly subcutaneous PEG-IFN-2a or PEG-IFN-2b plus RBV 1,000 mg/day or 1,200 mg/day for 48 weeks or 24 weeks. More patients in the PEG-IFN-2a group than the PEG-IFN-2b group achieved SVR (68.8% vs 54.4%).
The study authors found that in patients with chronic HCV infection, treatment with PEG-IFN-2a plus RBV produced a significantly higher SVR rate than treatment with PEG-IFN-2b plus RBV; the safety profile of the 2 regimens were similar.
"The fact that both of these studies yielded similar and significant results confirms the potential advantages of PEG-IFN-2a plus RBV versus PEG-IFN-2b plus RBV," said lead author Antonio Ascione, MD, Fatebenefratelli Hospital in Naples. "These advantages may translate to the development of promising new direct anti-viral drugs against HCV."
SOURCE: American Gastroenterological Association