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TITLE: High-dose (9 MU) long-term (60 weeks) alfa-interferon
therapy for chronic hepatitis patients infected with HCV genotype
1b.
Efficacy of standard regimens (e.g., 3-6 MU for 24 weeks) of
alfa-IFN therapy for chronic hepatitis C has been limited,
particularly in patients with HCV/1b. To see if higher-dose longer
term treatment is more effective, we tried a 9 MU 60-week regimen.
HCV/1b-infected chronic hepatitis patients received 9 MU IFN alpha
2a everyday but Sunday for 2 weeks and thrice a week for next 10
weeks, and 76 patients became HCV RNA-negative while 81 remained
positive. The RNA-negative patients were then randomized to receive
3 MU (group I, n = 37) or 9 MU (group II, n = 39) for 48 weeks. Of
the RNA-positive patients, only those with normal ALT received
another 9 MU 48-week treatment (group III, n = 45). Sustained
responders (SR) were defined as those with negative RNA and normal
ALT 6 months after the therapy. SR rates based on intent-to-treat
principle did not differ significantly between groups I and II (30%
vs 41%), but those based on the protocol-compatible cases showed a
significantly lower than those in group II. Adverse effects of IFN,
developed more frequently in groups II and III than in group I,
were mostly reversible. In conclusion, our results encourage 9 MU
60-week IFN alpha treatment in HCV/1b-infected patients with
careful attention to adverse effects, and suggest that the
treatment should be discontinued if HCV RNA does not disappear
within 12 weeks.
AUTHOR: Kanai K, Kako M, Kumada T, Tsubouchi H, Aikawa T,
Kojima M, Harada H, Kawasaki T, Nakashima M, Okamoto H, Mishiro S
Department of Gastroenterology, Toshiba General Hospital, Tokyo,
Japan.
SOURCE: Arch Virol 1998;143(8):1545-54
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