Long-term titrated recombinant interferon-alpha 2a in chronic hepatitis C: a randomized controlled trial.

M. G. Rumi, E. del Ninno, M. L. Parravicini, R. Romeo, R. Soffredini, M. F. Donato, F. Zahm, M. Colombo

Research output: Contribution to journalArticle

Abstract

The efficacy and tolerability of 12-month treatment with titrated doses of recombinant interferon-alpha 2a (IFN-alpha 2a) in chronic hepatitis C were studied in 67 consecutively recruited patients randomly assigned either to a starting dose of IFN-alpha 2a 6 MU, subsequently adjusted to the serum alanine aminotransferase (ALT) response (n = 35), or to no therapy (n = 32; controls). End-of-treatment ALT levels were normal and hepatitis C virus (HCV) RNA was negative by nested polymerase chain reaction (PCR) in 17 (49%) treated patients compared to none of the controls (P <0.001). During the 12 months after stopping treatment the number of patients who remained in remission was eight (23%) and one respectively (4%) (P = 0.031). Follow-up liver biopsy showed reduced hepatic inflammation in 80% of treated patients and in 29% of controls (P <0.001). The eight sustained responders and 27 non-responders or relapsers received similar mean total doses of IFN (565 MU vs 545 MU) and had a similar incidence of anti-IFN neutralizing antibodys (13% vs 19%). Absence of cirrhosis was the only independent pretreatment parameter that predicted a sustained response. In conclusion, a mean cumulative dose of IFN 549 MU, titrated over 12 months, was well tolerated, and resulted in the long-term clearance of HCV RNA and normal ALT levels in 23% of patients.

Original languageEnglish
Pages (from-to)73-76
Number of pages4
JournalJournal of Viral Hepatitis
Volume2
Issue number2
Publication statusPublished - 1995

ASJC Scopus subject areas

  • Hepatology
  • Virology

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