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

AbstractBACKGROUND & 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 mug/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.
AuthorsStefan 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,
JournalGastroenterology (Gastroenterology) Vol. 127 Issue 6 Pg. 1724-32 (Dec 2004) ISSN: 0016-5085 [Print] United States
PMID15578510 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antiviral Agents
  • Interferon-alpha
  • RNA, Viral
  • Recombinant Proteins
  • peginterferon alfa-2a
  • Polyethylene Glycols
  • Ribavirin
  • interferon alfa-2a
  • Alanine Transaminase
Topics
  • Adult
  • Alanine Transaminase (blood)
  • Antiviral Agents (administration & dosage, adverse effects)
  • Drug Therapy, Combination
  • Female
  • Hepatitis C, Chronic (drug therapy)
  • Humans
  • Injections, Subcutaneous
  • Interferon-alpha (administration & dosage, adverse effects)
  • Male
  • Middle Aged
  • Polyethylene Glycols (administration & dosage, adverse effects)
  • RNA, Viral (analysis)
  • Recombinant Proteins
  • Ribavirin (administration & dosage)
  • Treatment Outcome

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