A MULTICENTER CONTROLLED, RANDOMIZED, OPEN TRIAL OF INTERFERON-ALPHA-2B TREATMENT OF ANTI-HUMAN IMMUNODEFICIENCY VIRUS-NEGATIVE HEMOPHILIC PATIENTS WITH CHRONIC HEPATITIS-C

There is limited information about the long-term efficacy of prolonged therapy (more than 6 months) with interferon alpha in hemophilic pati ents with chronic hepatitis C who are not coinfected with the human im munodeficiency virus (HIV-1). One hundred and seven hemophiliacs were randomly assigned to 3 million U of interferon alpha 2b three times we ekly for 12 months or no therapy, The patients were followed up for at least 12 months posttreatment. Response was assessed by both serial a lanine aminotransferase (ALT) levels and hepatitis C virus (HCV)-RNA m easured by reverse transcribed polymerase chain reaction (RT-PCR) meth od. Before treatment, serum levels of HCV-RNA were measured quantitati vely by second generation branched-DNA assay and the HCV genotype was determined by RT-PCR, Serum HGV-RNA, a marker of infection with the he patitis G virus, was also measured by RT-PCR. Normalization of ALT was sustained and serum HCV-RNA was cleared in 6 of 45 treated patients, compared with none of the 50 untreated controls (13% v 0% P<.01). Low pretreatment viremia was the only feature that was associated with an increased likelihood of sustained response (P <.01). This study shows that multitransfused hemophiliacs with chronic hepatitis C not coinfec ted with HIV-1 respond at low rates to prolonged interferon therapy. ( C) 1997 by The American Society of Hematology.