Safety of peginterferon alfa-2a (40KD) treatment in patients with chronic hepatitis B infection: an observational, multicenter, open label, non-interventional study in Turkish patients.

Abstract

BACKGROUND/AIMS:

Pegylated alfa interferon is the only immunomodulatory drug licensed for hepatitis B. We evaluated the safety and tolerability of peginterferon alfa-2a (40KD) in patients with chronic hepatitis B.

MATERIALS AND METHODS:

A total of 113 chronic hepatitis B patients under peginterferon alfa-2a (40KD; 180 μg/week) treatment were included in this multicenter, open label, non-interventional study, and 66 patients completed the follow-up period. Vital signs, physical examination and laboratory findings, concomitant medications, and adverse events were recorded. A Quality of Life questionnaire (Short Form-36) was performed twice, at the beginning and at the end of the study.

RESULTS:

There was no significant difference between initial and last visits in terms of physical examination findings and Short Form-36 scores. A total of 27 adverse events were reported in 15 patients (22.7%), with most of them being mild in intensity (70.4%). The rates of the adverse events were similar in the monotherapy and combination therapy groups (peginterferon alfa-2a + lamivudine, peginterferon alfa-2a + adefovir or peginterferon alfa-2a + entecavir therapy groups), at 23.7% and 14.3%, respectively. The dosage of peginterferon had to be reduced in 3 patients (4.5%) due to thrombocytopenia. Overall patient compliance to treatment was detected as 85.9%.

CONCLUSIONS:

Based on the lack of serious adverse events and absence of impairment in Quality of Life, peginterferon alfa-2a (40KD, 180 μg/week, subcutaneously) treatment for 48 weeks led to a high level of patient compliance and was associated with a high degree of safety and tolerability for the treatment of adult patients with chronic hepatitis B in real-life practice.

• Authors: Nurdan Tözün, Orhan Sezgın, Murat Gülşen, Sabite Kacar, Necati Yenıce, Şerif Yilmaz, Saadettin Hülagü, Bülent Kantarçeken, Fahri Yakaryilmaz, Alper Yurcı, Kemal Mustafa Serez, Halil Bahçecıoğlu, Sait Bağci
• Journal: The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology (Turk J Gastroenterol) Vol. 23 Issue 5 Pg. 552-9 ( 2012) ISSN: 2148-5607 [Electronic] Turkey
• PMID: 23161301 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

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

Topics

• Adolescent
• Adult
• Aged
• Antiviral Agents (administration & dosage)
• Dose-Response Relationship, Drug
• Female
• Follow-Up Studies
• Hepatitis B, Chronic (drug therapy, psychology)
• Humans
• Interferon-alpha (administration & dosage)
• Male
• Middle Aged
• Patient Compliance
• Polyethylene Glycols (administration & dosage)
• Quality of Life
• Recombinant Proteins (administration & dosage)
• Retrospective Studies
• Surveys and Questionnaires
• Treatment Outcome
• Young Adult