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Long‐term titrated recombinant interferon‐α2a in chronic hepatitis C: a randomized controlled trial
Author(s) -
Rumi M. G.,
Ninno E.,
Parravicini M. L.,
Romeo R.,
Soffredini R.,
Donate M. F.,
Zahm F.,
Colombo M.
Publication year - 1995
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/j.1365-2893.1995.tb00009.x
Subject(s) - medicine , gastroenterology , tolerability , cirrhosis , interferon , randomized controlled trial , hepatitis c , hepatitis c virus , alpha interferon , immunology , adverse effect , virus
Summary. The efficacy and tolerability of 12‐month treatment with titrated doses of recombinant interferon‐α2a (IFN‐α2a) in chronic hepatitis C were studied in 67 consecutively recruited patients randomly assigned either to a starting dose of IFN‐α2a 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 2 7 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 anti‐bodys (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.