BACKGROUND
The hepatitis C virus infection is estimated to affect 170 million people around the world. For many patients, the infection can go on for years without the patient feeling ill. The hepatitis C virus can evade the body’s natural immune system, thus becoming a chronic hepatitis C condition after many years. The traditional therapy for chronic hepatitis C is interferon therapy. Interferon is a natural protein produced by the body to combat infections. In the case of hepatitis C, synthetic interferon gives the body an extra boost to help it fight the hepatitis C virus.
In Japan, Interferon (IFN) therapy has been the approved treatment in since 1992. This treatment has been improved with the development of new types of Interferon therapy. Studies have also shown that combination IFN treatment is quite effective in treating chronic patients. One such combination treatment is with pegylated IFN (Peg-IFN) and ribavirin (RBV) for at least one year for difficult to treat patients.
Another recently developed treatment is Consensus IFN (CIFN), also referred to as IFN alfacon-1. CIFN has demonstrated higher antiviral effects than many other Interferon treatments. The results of previous studies in Japan have demonstrated that CIFN at a dose of 18 MU is effective and tolerable in patients with chronic HCV and a high viral load.(7)
Meanwhile, another type of Interferon treatment, IFN-ß, was reported to have a higher response rate if administered twice daily instead of once a day. The twice daily administration is thought to compensate for the short half-life of compounds in IFN-ß.
On the basis of these findings, researchers from Keio University and thirteen other affiliated hospitals tested the effectiveness of combination treatment for chronic hepatitis C with CIFN and induction therapy with twice-daily IFN-ß as opposed to the traditional once a day CIFN therapy, also known as CIFN monotherapy. The researchers aim was to analyse if the new induction therapy with twice-daily IFN-ß is better than once a day CIFN therapy for a period of 6-months for chronic hepatitis C.
THE STUDY AND RESULTS
They analyzed the efficacy and tolerability of this induction therapy in a multicenter, randomized, open-trial. Patients with chronic hepatitis C who visited these hospitals from March 2002 to September 2003 were enrolled in this study. Patients were randomly assigned to monotherapy without (group I, n=16) and with induction therapy (group II, n=12). The mean age of group II was older than that of group I, and other baseline condition was not statistically significant.
Their results suggest that induction therapy with twice-daily IFN-ß has no beneficial effect on the efficacy of monotherapy with consensus interferon. However, this could be due to the high drop-out rates and incidence of adverse reactions with induction therapy (Group II). The only significant difference between the two groups was the age; the mean age was greater in group II than in group I (56.2 vs 45.8 year old).
In conclusion, their results suggest that induction therapy with twice-daily IFN-ß is not much superior to the therapeutic efficacy of CIFN monotherapy, and a large study may clarify whether the induction therapy improves efficacy.
################
Acknowledgment: This study was conducted among Department of Internal Medicine of Keio affiliated hospitals; Keio University Hospital, Eiju General Hospital, Fussa Hospital, Kawasaki City Kawasaki Hospital, Keiyu Hospital, Kitasato Institute Hospital, Minami-Tama Hospital, National Saitama Hospital, Nihon Kohkan Hospital, Saitama Social Insurance Hospital, Tachikawa Hospital, TEPCO Hospital,
Tokyo Dental Collage Ichikawa General Hospital, Tokyo Medical Center, Yokohama City Hospital, Tokyo Metropolitan Hiroo Hospital, Tokyo Metropolitan Ohtsuka Hospital, and Metropolitan Saisei-Kai Central Hospital, Tokyo.
Title of paper: Induction therapy with twice-daily interferon-beta does not improve the therapeutic efficacy of consensus interferon monotherapy for chronic hepatitis C
Authors: Hidetsugu Saito, (1) Shinichiro Tada, (1) Hirotoshi Ebinuma, (1) Hiromasa Ishii, (1) Kazuo Kashiwazaki, (2) Jiro Nishida, (3) Takeshi Yoshida, (4) Shigeyuki Zeki, (5) Hideo Yoshida, (6) Masahiro Yoshioka, (7) Yasutaka Inagaki, (8) Naoki Kumagai, (9) and Toshifumi Hibi (1)
Department of Internal Medicine, (1) School of Medicine, Keio University, Tokyo; (2) Tachikawa Hospital, Tokyo; (3) Tokyo Dental Collage Ichikawa General Hospital, Chiba; (4) Saitama Social Insurance Hospital, Saitama; (5) Keiyu Hospital, Kanagawa; (6) Eiju General Hospital, Tokyo; (7) Minami-Tama Hospital, Tokyo; (8) Nihon Kohkan Hospital, Kanagawa; (9) Kitasato Institute Hospital, Tokyo, Japan
