LONG-TERM TITRATED RECOMBINANT INTERFERON-ALPHA-2 A IN CHRONIC HEPATITIS-C - A RANDOMIZED CONTROLLED TRIAL

The efficacy and tolerability of 12-month treatment with titrated dose s of recombinant interferon-alpha 2 alpha (IFN-alpha 2 alpha) in chron ic hepatitis C were studied in 67 consecutively recruited patients ran domly assigned either to a starting dose of IFN-alpha 2 alpha 6 MU, su bsequently adjusted to the serum alanine aminotransferase (ALT) respon se (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 ne sted polymerase chain reaction (PCR) in 17 (49%) treated patients comp ared to none of the controls (P < 0.001), During the 12 months after s topping treatment the number of patients who remained in remission was eight (23%) and one respectively (4%) (P = 0.031), Follow-up liver bi opsy showed reduced hepatic inflammation in 80% of treated patients an d 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 neutralizi ng anti-bodys (13% vs 19%). Absence of cirrhosis was the only independ ent pretreatment parameter that predicted a sustained response. In con clusion, a mean cumulative dose of IFN 549 MU, titrated over 12 months , was well tolerated, and resulted in the long-term clearance of HCV R NA and normal ALT levels in 23% of patients.