A. Bellobuono et al., Early addition of ribavirin to interferon in chronic hepatitis C not responsive to interferon monotherapy, J HEPATOL, 33(3), 2000, pp. 463-468
Background/Aim: Persistence of HCV-RNA in serum early in treatment is a str
ong predictor of failure of alpha-interferon therapy for chronic hepatitis
C, Therefore we compared the efficacy of ribavirin addition to alpha-interf
eron with a doubling of the dosage of alpha-interferon in case of lack of e
arly virological response to alpha-interferon therapy,
Methods: Sixty patients were administered interferon alpha 2b at the dosage
of 3 million units 3 times a week, After the first 4 weeks of therapy, ser
um HCV-RNA was evaluated. The patients with negative HCV-RNA test received
the same treatment for a further 11 months, while those with detectable HCV
-RNA were randomized to receive either the same dosage of alpha-interferon
plus ribavirin (1000 mg/day) or double dosage of alpha-interferon (6 millio
n units tiw) for 11 months, We considered sustained response to be the main
tenance of normal alanine aminotransferase and negativity at HCV-RNA testin
g until the end of a 6-month post-treatment follow-up.
Results: After the first 4 weeks of treatment, 12 (20%) patients showed vir
ological response and 48 patients (80%) remained positive on HCV-RNA testin
g. Sustained response was observed in 5/12 (42%) patients with early virolo
gical response, in 10/24 (42%) patients without early virological response
who were administered ribavirin and alpha-interferon, and in only 1/24 (4%)
patients who were administered the double dosage of alpha-interferon (p=0.
006).
Conclusions: This study shows the efficacy of the addition of ribavirin to
alpha-interferon and the lack of efficacy of doubling the dosage of alpha-i
nterferon in patients without clearance of hepatitis C virus early on in tr
eatment.