Efficacy of peginterferon alpha-2b in chronic hepatitis delta: relevance of quantitative RT-PCR for follow-up.

Abstract

Hepatitis delta virus (HDV) can cause severe acute and chronic liver disease in patients infected by hepatitis B virus. Interferon alpha at high doses, although poorly efficient, is the only treatment reported to provide some benefit in chronic hepatitis delta. Pegylated interferon alpha (PEG-IFN) has not yet been evaluated. Treatment is usually monitored by the qualitative detection of HDV-RNA in serum. In this study, safety and efficacy of PEG-IFN were assessed in chronic hepatitis delta, and serum HDV-RNA kinetics were determined using quantitative RT-PCR. Fourteen patients with chronic hepatitis delta received subcutaneous PEG-IFN alpha-2b during 12 months (1.5 microg/kg per week). Serum HDV-RNA was quantified at initiation and during the course of therapy, and during the posttreatment follow-up period, which ranged from 6 to 42 months (median 16 months). PEG-IFN alpha-2b was well tolerated, inducing no serious adverse effect. Sustained biochemical response was obtained in 8 patients (57%). At the end of treatment, 8 patients (57%) had achieved virological response (undetectable HDV-RNA). Sustained virological response throughout the posttreatment follow-up period was observed in 6 patients (43%). HDV-RNA kinetics were predictive of the response: after 3 months of PEG-IFN, HDV-RNA levels were significantly lower in the responders than in the nonresponders group (P=.018). After 6 months of therapy, a negative HDV-RNA was predictive of sustained response (P=.021). In conclusion, this preliminary study indicates that PEG-IFN alpha-2b is safe and efficient for treatment of chronic hepatitis delta. The follow-up of HDV-RNA levels during therapy, which allows the differentiation of various profiles of virological responses, improves treatment monitoring.

• Authors: Corinne Castelnau, Frédéric Le Gal, Marie-Pierre Ripault, Emmanuel Gordien, Michelle Martinot-Peignoux, Nathalie Boyer, Bach-Nga Pham, Sarah Maylin, Pierre Bedossa, Paul Dény, Patrick Marcellin, Elyanne Gault
• Journal: Hepatology (Baltimore, Md.) (Hepatology) Vol. 44 Issue 3 Pg. 728-35 (Sep 2006) ISSN: 0270-9139 [Print] United States
• PMID: 16941695 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Drug Carriers
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• peginterferon alfa-2b

Topics

• Adult
• Antiviral Agents (therapeutic use)
• Drug Carriers
• Female
• Follow-Up Studies
• Hepatitis D, Chronic (drug therapy, virology)
• Hepatitis Delta Virus (drug effects, genetics)
• Humans
• Interferon alpha-2
• Interferon-alpha (therapeutic use)
• Male
• Middle Aged
• Polyethylene Glycols
• RNA, Viral (genetics)
• Recombinant Proteins
• Retrospective Studies
• Reverse Transcriptase Polymerase Chain Reaction
• Treatment Outcome