title: 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.affiliation: Service d'Hépatologie, Hôpital Beaujon, AP-HP; INSERM U773 CRB3, Clichy, and Université Paris 13, Bobigny, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Castelnau
authors.forename: Frédéric
authors.initials: F
authors.lastname: Le Gal
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Ripault
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Gordien
authors.forename: Michelle
authors.initials: M
authors.lastname: Martinot-Peignoux
authors.forename: Nathalie
authors.initials: N
authors.lastname: Boyer
authors.forename: Bach-Nga
authors.initials: BN
authors.lastname: Pham
authors.forename: Sarah
authors.initials: S
authors.lastname: Maylin
authors.forename: Pierre
authors.initials: P
authors.lastname: Bedossa
authors.forename: Paul
authors.initials: P
authors.lastname: Dény
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
authors.forename: Elyanne
authors.initials: E
authors.lastname: Gault
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004337:Drug Carriers; D005260:Female; D005500:Follow-Up Studies; D019701:Hepatitis D, Chronic / Q000188:drug therapy* / Q000821:virology; D003698:Hepatitis Delta Virus / Q000187:drug effects / Q000235:genetics*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D012367:RNA, Viral / Q000235:genetics*; D011994:Recombinant Proteins; D012189:Retrospective Studies; D020133:Reverse Transcriptase Polymerase Chain Reaction; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b