Efficacy of peginterferon alpha-2b in chronic hepatitis... : Hepatology (original) (raw)

Viral Hepatitis

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

Castelnau, Corinne1; Le Gal, Frédéric2; Ripault, Marie-Pierre1; Gordien, Emmanuel2; Martinot-Peignoux, Michelle1; Boyer, Nathalie1; Pham, Bach-Nga3; Maylin, Sarah3; Bedossa, Pierre4; Dény, Paul2; Marcellin, Patrick1; Gault, Elyanne2,*

1_Service d'Hépatologie, Hôpital Beaujon, AP-HP; INSERM U773 CRB3, Clichy, France_

2_Service de Bactériologie-Virologie-Hygiène, Laboratoire associé au Centre National de Référence des Hépatites B et C, Hôpital Avicenne, AP-HP; Université Paris 13, EA3604, Bobigny, France_

3_Département d'Immunologie Microbiologie des Pathologies Infectieuses, Hôpital Beaujon, AP-HP; INSERM U773 CRB3, Clichy, France_

4_Service d'Anatomie pathologique, Hôpital Beaujon, AP-HP, Clichy; CNRS UMR 8149, Faculté de Pharmacie Paris V, France_

*Laboratoire de Bactériologie-Virologie-Hygiène, Hôpital Avicenne, 125 ave de Stalingrad, 93009 Bobigny Cedex, France

Email:[email protected]

Received 3 May 2006; Accepted 22 June 2006

Published online in Wiley InterScience (www.interscience.wiley.com).

Grant sponsor: Assistance Publique Hôpitaux de Paris: Progrès Médical et Innovation Thérapeutique; Grant sponsor: French Ministère de la Santé.

See Editorial on Page 536

Potential conflict of interest: Nothing to report.

fax number: (33) 1 4895 5911

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 μg/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.