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Author: O ReichardØ{1}, G NorkransØ{2}, A FrydenØ{3}, J-H BraconierØ{4}, A AlaeusØ{1}, H GlaumannØ{5}, R SchvarczØ{5}, A SonnerborgØ{5}, R WejstalØ{2}, O WeilandØ{5} Danderyd HospitalØ{1}, and Huddinge University HospitalØ{5}, Karolinska Institute, Stockholm; East Hospital, GothenburgØ{2}; University Hospital, LinkopingØ{3}; University Hospital, LundØ{4}.

A few small and uncontrolled studies have reported promising results with the interferon/ribavirin (IFN/Rib) combination as therapy for chronic hepatitis C; especially among patients with a previous non-sustained or non-response to IFN alone. We have evaluated the efficacy and safety of a 24 week IFN/Rib course, compared to IFN/placebo. 100 patients, previously not treated with IFN, ribavirin or any other antiviral drug for hepatitis C, were randomized in a double-blinded fashion to receive IFN alpha-2b 3 MU subcutaneously thrice weekly in combination with either oral ribavirin, at a dose of 1000-1200 mg/day (50 patients), or placebo (50 patients). Follow-up after treatment cessation was for 24 weeks. The study groups were comparable with regard to age, gender, mode of acquisition, liver histology, pretreatment ALT level, pretreatment HCV RNA level and genotype.

There was no significant difference in biochemical or virological response at treatment cessation. Thus, a biochemical response with normalization of ALT was seen in 32/50 patients (64%) in the IFN/Rib group, and in 28/50 patients (56%) in the IFN/placebo group. The virological response, with eradication of viremia, was 26/50 (52%) for both study groups. In contrast, at the end of follow-up, a sustained biochemical response was seen in 23/50 patients (46%) in the IFN/Rib group, and in 11/50 patients (22%) in the IFN/placebo group (p<0.05). Furthermore, in sera analyzed so far, the sustained virological response was 20/44 (45%) and 10/43 (23%) in the IFN/Rib and IFN/placebo groups, respectively (p<0.05). The sustained virological response rate for genotype 3a was significantly better than for genotype 1a and 1b (50% vs 19 and 18% respectively in the total study population; p<0.05). Age, gender, liver histology and pretreatment ALT and HCV RNA levels did not affect treatment outcome. Four patients discontinued treatment due to side-effects; all in the IFN/Rib study group. Patients who received IFN/Rib had lower haemoglobin (p=0.0001) and higher uric acid levels (p<0.05) than IFN/placebo patients at treatment cessation. The changes were reversible after treatment cessation.

In conclusion, IFN/Rib combination treatment was significantly better than IFN alone to produce a sustained biochemical and virological response in previously untreated hepatitis C patients.

Source: American Association for the Study of Liver Diseases - 1996 Annual Meeting

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