Multicenter randomized study comparing initial daily induction with high dose lymphoblastoid interferon vs. standard interferon treatment for chronic hepatitis c

One hundred fifty‐five chronic hepatitis C patients were assigned at random to receive natural lymphoblastoid interferon (IFN)α‐n1, s.c., for 13 months in one of three treatment regimens: initial daily induction with 10 million units (MU) followed (group 1, n = 50) or not (group 2, n = 52) by 1 month of rest and then three times weekly 10 MU (2 months), 5 MU (2 months), and 3 MU (8 months); group 3 (n = 53) received tiw 5 MU (2 months) followed by 3 MU (11 months). By intention‐to‐treat analysis, ALT normalization at completion of treatment was greater in patients who received continuous IFNα‐n1 therapy with initial daily induction (group 2: 24/52, 46%) compared with those given intermittent therapy with initial daily induction (group 1: 17/50, 34%) and those who received standard IFNα‐n1 therapy (group 3, 18/53, 34%; P not significant). The sustained ALT response was 26%, 27% and 21% and the sustained virological response was 20%, 27%, and 19%, in groups 1, 2, and 3, respectively. A trend was observed towards a higher biochemical and virological end‐of‐treatment response in patients given induction therapy (17%) compared with standard therapy (6%, P  =  0.053). Sustained biochemical and virological responses were 20%, 27%, and 17% in groups 1, 2, and 3, respectively. Platelet and leukocyte counts decreased following daily high‐dose treatment and remained low until therapy cessation ( P < 0.001). The data suggest that daily s.c. induction with 10 MU IFNα‐n1 followed by intermittent or continuous maintenance therapy for 1 year does not improve the results achieved with the standard 1‐year IFNα course in the treatment of chronic hepatitis C patients. J. Med. Virol. 64:460–465, 2001. © 2001 Wiley‐Liss, Inc.