Pegylated interferon alpha-2b as monotherapy or in combination with ribavirin in chronic hepatitis delta
Articolo
Data di Pubblicazione:
2006
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 g/kg) alone as monotherapy (n 16) or in combination
with ribavirin (n22), 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.HDVRNA 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.
Tipologia CRIS:
03A-Articolo su Rivista
Elenco autori:
NIRO GA; CIANCIO A; GAETA GB; SMEDILE A; MARRONE A; OLIVERO A; STANZIONE M; DAVID E; BRANCACCIO G; FONTANA R; PERRI F; ANDRIULLI A; RIZZETTO M
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