A randomized controlled trial of recombinant interferon-alpha in chronic hepatitis C in hemophiliacs

Abstract

Chronic liver disease associated with hepatitis C virus (HCV) is an important cause of morbidity and mortality in hemophilia. We have used recombinant interferon alpha-2b (IFN alpha-2b) in a randomized controlled liver biopsy trial to treat hemophiliacs with chronic hepatitis. Eighteen patients entered the study, 16 of whom were subsequently shown to have antibodies to the HCV. All underwent liver biopsy at entry and were randomized to either treatment with self- administered IFN alpha-2b, 3 million units subcutaneously thrice weekly (n = 10) or no treatment (control group) (n = 8). Nine subjects had chronic active hepatitis, seven had chronic persistent hepatitis, and two had cirrhosis. Twelve months after entry into the study 17 patients underwent a second liver biopsy. All biopsies were coded, assessed, and scored according to the histologic severity of the liver disease. Ten patients were administered IFN for 1 year, and in four patients normalization of alanine aminotransferase (ALT) occurred compared with none in the untreated group. After the second liver biopsy, six of the eight initial no-treatment patients were treated with interferon 3 million units thrice weekly for 6 months, and normalization of ALT was seen in five patients. Biochemical relapse within 4 months of stopping IFN occurred in one of four patients treated for 1 year and in four of five patients treated for 6 months. IFN treatment was well tolerated. Although the histologic scores of the two groups were similar at entry into the study, after 12 months the biopsy appearances in the treated group were significantly improved compared with the controls (P less than .01). Histologic improvement was noted in the three interferon- treated human immunodeficiency virus antibody-positive patients and also in other patients who had no biochemical response. We conclude that low-dose recombinant IFN alpha is effective in normalizing transaminases and improving the histologic appearances in at least 50% of hemophiliacs with chronic hepatitis C.

Hepatitis C infection and outcomes in the Scottish haemophilia population

“…The natural clearance rate of 17.4% is similar to that observed in non-haemophilia cohorts, the slightly lower level possibly reflects the preponderance of males in our study [4]. Previous data report lower rates of SVR for monotherapy in PWH compared with other HCV-infected groups [16][17][18][19] and our SVR (14.5%) is consistent with this. Combination therapy with interferon-alpha and ribavirin produces higher SVR in the non-haemophilia population with levels of 55% using pegylated interferon-alpha and ribavirin [20].…”

A study of anti‐hepatitis C positive blood donors: the first year of screening

“…There may, however, be some benefits for donors knowing their HCV status in that prophylactic treatment, e.g. reduction in alcohol intake (and interferon therapy, which Makris et al (1991) showed to have a beneficial effect in at least 50% of haemophiliacs infected with HCV) can be instituted early. As yet the extent of secondary transmission of HCV is still unclear; the potential benefits of awareness of HCV infection in this respect cannot therefore be estimated.…”

Virological characteristics of HCV infection in Japanese haemophiliacs

“…The number of HCV-RNA copies in patients with genotype 2a was significantly lower than in those with genotype 1a (P = 0.0007), 1b (P = 0.0009) or combined 1a/1b (P = 0.0019) by ANOVA (Bonferroni/ Dunn test). (*) HIV-Ab(+), (*) HIV-Ab(7).…”