Pegylated interferon alfa-2a plus ribavirin therapy induces sustained virological response rates up to 63% in randomized-controlled trials.
Dr Lee and colleagues from Canada examined the efficacy and safety of this therapy in routine clinical practice.
The research team conducted a prospective open-label programme.
The researchers gave treatment-naive patients with chronic Hepatitis C pegylated interferon alfa-2a 180 μg/week plus ribavirin 800 mg/day for 24 or 48 weeks.
|The negative predictive value of an early virological response at week 12 was 94%|
|Alimentary Pharmacology & Therapeutics|
In total, 508 patients were enrolled, of which 334 were non-cirrhotic, and 174 were cirrhotic.
In genotype 1 patients treated for 48 weeks, sustained virological response rates were 41% in non-cirrhotics and 34% in cirrhotics.
The team noted that sustained virological response rates in genotype 2 or 3 non-cirrhotics were 79% and 72%, respectively.
The researchers found that the corresponding values for cirrhotic genotype 2 and 3 were 66% and 44%.
The negative predictive value of an early virological response at week 12 was 94%.
Predictive factors for sustained virological response on multivariate analysis were genotype 2 and 3, and low viral load and degree of fibrosis.
The team observed that the rates of serious adverse events and adverse events inducing withdrawal were comparable with the phase III trials.
Dr Lee's team concludes, “Efficacy and safety of pegylated interferon alfa-2a plus ribavirin in clinical practice is comparable with results of randomized-controlled trials.”