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

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.
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.
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.
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
  • 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

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research network!

Choose Username:
Verify Password: