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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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
Pages (from-to)1724-1732
Number of pages9
JournalGastroenterology
Volume127
Issue number6
DOIs
StatePublished - Dec 1 2004

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Ribavirin
Chronic Hepatitis C
Transaminases
Alanine Transaminase
Hepacivirus
Therapeutics
peginterferon alfa-2a
Genotype
Safety
DNA-Directed RNA Polymerases
Hepatitis C
Antiviral Agents
RNA
Polymerase Chain Reaction

ASJC Scopus subject areas

  • Gastroenterology

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Peginterferon alfa-2a (40 kilodaltons) and ribavirin in patients with chronic hepatitis C and normal aminotransferase levels. / Zeuzem, Stefan; Diago, Moisés; Gane, Edward; Reddy, K. Rajender; Pockros, Paul; Prati, Daniele; Shiffman, Mitchell; Farci, Patrizia; Gitlin, Norman; O'Brien, Christopher B; Lamour, François; Lardelli, Pilar.

In: Gastroenterology, Vol. 127, No. 6, 01.12.2004, p. 1724-1732.

Research output: Contribution to journalArticle

Zeuzem, S, Diago, M, Gane, E, Reddy, KR, Pockros, P, Prati, D, Shiffman, M, Farci, P, Gitlin, N, O'Brien, CB, Lamour, F & Lardelli, P 2004, 'Peginterferon alfa-2a (40 kilodaltons) and ribavirin in patients with chronic hepatitis C and normal aminotransferase levels', Gastroenterology, vol. 127, no. 6, pp. 1724-1732. https://doi.org/10.1053/j.gastro.2004.09.050
Zeuzem, Stefan ; Diago, Moisés ; Gane, Edward ; Reddy, K. Rajender ; Pockros, Paul ; Prati, Daniele ; Shiffman, Mitchell ; Farci, Patrizia ; Gitlin, Norman ; O'Brien, Christopher B ; Lamour, François ; Lardelli, Pilar. / Peginterferon alfa-2a (40 kilodaltons) and ribavirin in patients with chronic hepatitis C and normal aminotransferase levels. In: Gastroenterology. 2004 ; Vol. 127, No. 6. pp. 1724-1732.
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T1 - Peginterferon alfa-2a (40 kilodaltons) and ribavirin in patients with chronic hepatitis C and normal aminotransferase levels

AU - Zeuzem, Stefan

AU - Diago, Moisés

AU - Gane, Edward

AU - Reddy, K. Rajender

AU - Pockros, Paul

AU - Prati, Daniele

AU - Shiffman, Mitchell

AU - Farci, Patrizia

AU - Gitlin, Norman

AU - O'Brien, Christopher B

AU - Lamour, François

AU - Lardelli, Pilar

PY - 2004/12/1

Y1 - 2004/12/1

N2 - 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.

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