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

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 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.

• Authors: 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, PEGASYS Study NR16071 Investigator Group
• Journal: Gastroenterology (Gastroenterology) Vol. 127 Issue 6 Pg. 1724-32 (Dec 2004) ISSN: 0016-5085 [Print] United States
• PMID: 15578510 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• Alanine Transaminase
• peginterferon alfa-2a

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-2
• 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