Pegylated interferon alpha-2b as monotherapy or in... : Hepatology (original) (raw)

Viral Hepatitis

Pegylated interferon alpha-2b as monotherapy or in combination with ribavirin in chronic hepatitis delta

Niro, Grazia Anna1,*; Ciancio, Alessia2; Gaeta, Giovanni Battista3; Smedile, Antonina2; Marrone, Aldo4; Olivero, Antonella2; Stanzione, Maria3; David, Ezio5; Brancaccio, Giuseppina3; Fontana, Rosanna1; Perri, Francesco1; Andriulli, Angelo1; Rizzetto, Mario2

1_Gastroenterology CSS Hospital, S.Giovanni Rotondo, Italy_

2_Gastroenterology Molinette Hospital and University, Turin, Italy_

3_Department of Infectious Diseases, Second University of Naples, Italy_

4_Department of Internal Medicine and Hepatology, Second University of Naples, Italy_

5_Department of Pathology, Molinette Hospital, Turin, Italy_

*Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, Viale Cappuccini, 71013 San Giovanni Rotondo (FG), Italy

Email:[email protected]

Received 9 April 2006; Accepted 7 June 2006

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

See Editorial on Page 536

Potential conflict of interest: Nothing to report.

fax: (39) 411879

Abstract

Therapy of chronic hepatitis delta with standard interferon therapy has met with limited efficacy. This study was designed to examine the efficacy and safety of peginterferon with or without ribavirin. Thirty-eight serum hepatitis B surface antigen- and HDV RNA-positive patients with alanine aminotransferase (ALT) more than 1.5 times the upper normal limit received peginterferon alpha-2b (1.5 μg/kg) alone as monotherapy (n = 16) or in combination with ribavirin (n = 22), for 48 weeks. Thereafter, all the patients were maintained on peginterferon for 24 weeks and followed for 24 weeks off therapy. The primary end point studied was the virological and biochemical response at the end of follow-up. HDV RNA was determined by single or nested polymerase chain reaction assays. Twenty-seven patients (71%), 11 receiving monotherapy and 16 receiving the combination treatment, completed the follow-up. At the end of treatment, a virological response was observed in 3 of the patients treated with peginterferon (19%) and in 2 of the patients treated with combination therapy (9%), and a biochemical response was observed in 6 (37.5%) and 9 patients (41%), respectively. In nonresponders, ALT diminished from a mean of 174 ± 53 to 86 ± 41 IU/L. At the end of follow-up, serum HDV RNA was negative in 8 patients (21%), and a biochemical response was detected in 10 patients (26%). Treatment was discontinued in 25% of the patients, and dosing was modified in 58%. In conclusion , a prolonged course of peginterferon alpha-2b resulted in clearance of serum HDV RNA and ALT normalization in a fifth of patients with chronic hepatitis D, while ribavirin had no effect on the viral clearance rate. Overall tolerance of therapy was poor.