Thevenot T{1}, Mathurin P{1}, Perrin M{1}, Plassar F{2}, Blot C{1}, Opolon P{1}, Poynard T{1}. 1Services d'Hepato-Gastroenterologie et 2d' Anatomopathologie, Hopital Pitie Salpetriere, Paris, France.
Patients and method: 41 consecutive patients (18 men and 23 women), mean age 53 years (range 29-74), 17 with cirrhosis, were treated with R at an initially dose of 800mg/day to 1,200mg/day and were followed monthly. Indication for R was either a contrindication (n=15), either an intolerance (n=11), either a non response to interferon (n=15). R was combined to IFN 3 MU TIW for 14 patients and to azathioprine for 5 transplanted patients. Results: The mean duration of treatment was 4,3 months (range 1-18). 14 therapy out of 47 (30%) were stopped for suspicion of side effects. 7 patients stopped 8 treatments at 1,2 month (1-3) for a drop of hemoglobin of 4,6 points in mean (2,7-5,9); according to the rule of international protocol, only 5 treatments (2 of whom under azathioprine) with a hemoglobin level inferior to 8,5gr/dl should have stopped. 4 treatments were stopped for vomiting (6%), 3 in the two first weeks. 2 treatments were stopped for a depression in the fourth month, and for somnolence in the third month. Surprisingly, although levels were similar, the decrease of hemoglobin was less fast in patients treated with IFN plus R (M0=13.37±1gr/dl, M1=12.07±1.46, M2=11.69±1.53, M3=11.69±1.28) than in patients treated with R alone (M0=13.34±1.51gr/dl, M1=10.7±2.2, M2=11.72±1.17, M3=11.7±1.1). The signification of the matched Mann- Whitney test was respectively at M1 p=0.006, M2 and M3 p=NS. Although levels were lower, the decrease of hemoglobin was less important among patients with cirrhosis (M0=12.9±1.4gr/dl, M1=11.3±2.6, M2=11.6±1.3, M3=12.2±1.1) than among patients without cirrhosis (M0=3.6±1.3gr/dl, M1=11.1±1.7, M2=11.6±1.3, M3=11.4±1.1). The signification of the matched Mann-Whitney test was respectively at M1 p=0.003, M2=NS and M3 p=0.01 The mean volum of red globul was similar before treatment among patients without (M0=93.2±1.3) or with cirrhosis (M0=95.8±1.7) and increased during the first 3 month of R among patients without cirrhosis (M1=96.8±1.6, M2=97.8±1.3, M3=100.2±1.3) while it was stable at M3 (95.2±1.6) among patients wih cirrhosis Conclusions: Anemia <8,5 gr/dl was present in 10%, perhaps worsen by azathioprine, and vomiting in 6% of patients treated with R. In contrary to expected, combination of IFN and R or a cirrhosis did not seem to worsen the risk of anemia.
Source: American Association for the Study of Liver Diseases - 1996 Annual Meeting