Peginterferon alfa-2a (40 kilodaltons) and ribavirin in patients with chronic hepatitis C and normal aminotransferase levels

Stefan Zeuzem, Moisés Diago, Edward Gane, K. Rajender Reddy, Paul Pockros, Daniele Prati, Mitchell Shiffman, Patrizia Farci, Norman Gitlin, Christopher B. O'Brien, François Lamour, Pilar Lardelli

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237 Scopus citations

Abstract

Background & Aims: Patients with chronic hepatitis C and persistently normal alanine aminotransferase (ALT) levels have been routinely excluded from large randomized treatment trials; consequently, the efficacy and safety of antiviral therapy in this population are unknown. Methods: Patients with at least 3 normal ALT values over an 18-month period were randomized (3:3:1) to treatment with peginterferon alfa-2a 180 μg/wk plus ribavirin 800 mg/day for 24 weeks (212 patients), the same combination for 48 weeks (210 patients), or no treatment (69 patients) in a multinational study. All patients were monitored for 72 weeks. The primary measure of efficacy was sustained virologic response (SVR), defined as undetectable serum hepatitis C virus (HCV) RNA by qualitative polymerase chain reaction at the end of 24 weeks of untreated follow-up. Results: No patient cleared HCV RNA in the untreated control group. SVR rates of 30% and 52% were obtained in the 24- and 48-week treatment groups, respectively. In patients infected with HCV genotype 1, SVR rates of 13% and 40% were obtained with 24 and 48 weeks of treatment, respectively (P <. 0001). In patients infected with genotypes 2 or 3, SVR rates were 72% and 78% with 24 and 48 weeks of treatment, respectively (P =. 452). Treatment-related flares in ALT activity were not observed. Conclusions: The efficacy and safety of peginterferon alfa-2a and ribavirin combination therapy in patients with chronic hepatitis C and persistently normal ALT levels are similar to that in patients with elevated ALT levels. The indication for treatment of hepatitis C can be evaluated independently from baseline ALT activity.

Original languageEnglish (US)
Pages (from-to)1724-1732
Number of pages9
JournalGastroenterology
Volume127
Issue number6
DOIs
StatePublished - Dec 2004

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Zeuzem, S., Diago, M., Gane, E., Reddy, K. R., Pockros, P., Prati, D., Shiffman, M., Farci, P., Gitlin, N., O'Brien, C. B., Lamour, F., & Lardelli, P. (2004). Peginterferon alfa-2a (40 kilodaltons) and ribavirin in patients with chronic hepatitis C and normal aminotransferase levels. Gastroenterology, 127(6), 1724-1732. https://doi.org/10.1053/j.gastro.2004.09.050