TY - JOUR
TI - A randomized trial to assess the efficacy of interferon alpha in
combination with ribavirin in the treatment of interferon alpha
nonresponders with chronic hepatitis C: superior efficacy of high daily
dosage of interferon alpha in genotype 1
AU - Tassopoulos, NC
AU - Tsantoulas, D
AU - Raptopoulou, M
AU - Vassiliadis, T
AU - and Kanatakis, S
AU - Paraskevas, E
AU - Vafiadis, I
AU - Avgerinos, A and
AU - Tzathas, C
AU - Manolakopoulos, S
AU - Ketikoglou, I
AU - Aggelis, P and
AU - Goritsas, K
AU - Giannoulis, G
AU - G, GH
AU - Thomopoulos, K and
AU - Akriviadis, E
AU - Sypsa, V
AU - Hatzakis, A
JO - Journal of Viral Hepatitis
PY - 2003
VL - 10
TODO - 3
SP - 189-196
PB - Wiley
SN - 1352-0504, 1365-2893
TODO - 10.1046/j.1365-2893.2003.00406.x
TODO - chronic hepatitis C; daily interferon; interferon alpha; non-responders;
randomized clinical trial; ribavirin
TODO - A randomized trial was conducted to assess the efficacy of daily (QD) or
thrice weekly (TIW) administration of interferon-alpha (IFN) in high
doses in combination with ribavirin (1.0-1.2 g/day) in patients with
chronic hepatitis C (CHC) who were nonresponders to previous IFN
monotherapy. Interferon was administered as 10 MU IFN (QD or TIW) for 4
weeks, followed by 5 MU IFN (QD or TIW) for 20 weeks, and then by 3 MU
IFN (QD or TIW) for 24 weeks. Sustained virological response (SVR) was
evaluated in 142 patients who received at least one dose of medication.
One-fourth of the patients achieved SVR, 26% of those treated with IFN
QD and 25% of those treated with IFN TIW (P = 0.85). For genotype 1
patients, SVR rates were 32.4 and 15.8% for IFN QD and IFN TIW,
respectively, whereas for genotype non-1 patients the corresponding SVR
rates were 20.6 and 36.4%, respectively (test of homogeneity: P =
0.031). This finding was further confirmed by multivariate logistic
regression analysis where a statistically significant interaction (P =
0.012) was found between treatment and HCV genotype indicating that the
IFN QD regimen was superior to IFN TIW among genotype 1 patients
whereas, among genotype non-1 patients, the two treatments were similar
(odds ratio of SVR in IFN QD vs IFN TIW: 3.33 among genotype 1 patients,
95% CI: 1.00-11.14). In conclusion, re-treatment of patients not
responding to previous IFN monotherapy with a combination of high daily
dose of IFN with ribavirin may be beneficial for genotype 1 infected
patients.
ER -