Comparing the safety, tolerability and quality of life in patients with chronic hepatitis B vs chronic hepatitis C treated with peginterferon alpha-2a.

Abstract

BACKGROUND/AIMS:

Hepatitis B and C viruses (HBV and HCV) are two clinically distinct but related diseases. Pooled data from five studies of peginterferon alpha-2a in patients with chronic HCV infection (CHC) were compared with two studies of the drug in patients with chronic HBV infection (CHB).

METHOD:

The HBV studies included both hepatitis B e antigen (HBeAg)-positive (n=271) and HBeAg-negative (n=177) patients; 791 patients took part in the HCV trials. In all studies, patients were treated with 180 microg peginterferon alpha-2a monotherapy once weekly for 48 weeks. The number of adverse events (AEs), discontinuations and dose modifications were documented. Health-related quality of life (HRQL) was assessed using the Short-Form 36 questionnaire. Safety was assessed throughout the treatment period. A 24-week treatment-free follow-up period was also included.

RESULTS:

Differences (HBV vs HCV) were observed in the incidence of AEs (88-89 vs 96-100%), serious AEs (4-5 vs 7-16%) and treatment withdrawals (6-8 vs 17-33%). The frequency of depression-related events was lower in CHB patients (4 vs 22%, P<0.001), as was the impact of treatment on HRQL.

CONCLUSIONS:

The safety and tolerability of peginterferon alpha-2a in patients with CHB compares favourably with that observed in CHC patients, with a lower incidence of common interferon-related AEs and a significantly lower incidence of depression.

• Authors: Patrick Marcellin, George K K Lau, Stefan Zeuzem, E Jenny Heathcote, Paul J Pockros, K Rajender Reddy, Teerha Piratvisuth, Patrizia Farci, Wan-Cheng Chow, Ji-Dong Jia, Woon Paik, Neil Wintfeld, Nigel Pluck
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 28 Issue 4 Pg. 477-85 (Apr 2008) ISSN: 1478-3231 [Electronic] United States
• PMID: 18339074 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Interferon alpha-2
• Interferon-alpha
• Recombinant Proteins
• Polyethylene Glycols
• peginterferon alfa-2a

Topics

• Adult
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Drug-Related Side Effects and Adverse Reactions
• Female
• Hepatitis B, Chronic (diagnosis, drug therapy, mortality)
• Hepatitis C, Chronic (diagnosis, drug therapy, mortality)
• Humans
• Interferon alpha-2
• Interferon-alpha (administration & dosage, adverse effects)
• Liver Function Tests
• Male
• Maximum Tolerated Dose
• Middle Aged
• Multicenter Studies as Topic
• Polyethylene Glycols (administration & dosage, adverse effects)
• Probability
• Prognosis
• Quality of Life
• Randomized Controlled Trials as Topic
• Recombinant Proteins
• Reference Values
• Risk Assessment
• Severity of Illness Index
• Survival Rate
• Treatment Outcome