Results of Combination Interferon alfa-2b + Ribavirin

Patrice Couzigou, MD, is Head of the Hepatogastroenterology Department of Haut Leveque Hospital (Pessac-Bordeaux) and Professor of Medicine at the University Victor Segalen of Bordeaux in France.

Dr. Couzigou received his medical degree from the University of Breast and went on to complete postgraduate training in hepatogastroenterology and pharmacology at Bordeaux University. He is a member of the French Association for the Study of Liver Disease, the French National Society of Gastroenterology, the European Association for the Study of the Liver, the European Society for Biochemical Research on Alcoholism, the International Society for biochemical Research on Alcoholism. He has published more than 150 articles in peer-reviewed journals.

His main areas of expertise and scientific interests are viral hepatitis C (transmission route and counselling patients, antiviral therapy) genetics factors and alcohol, especially alcoholic liver disease.

Results of Combination Interferon alfa-2b + Ribavirin
Regimens vs. Interferon Monotherapy in Non-Responders
Patrice Couzigou, MD

Viral kinetics studies have shown very rapid HCV production with replication half-life of around three hours. Twenty-four hours after subcutaneous interferon administration, exogenous interferon is not detectable and viremia starts to increase. Daily interferon administration could induce a better virological response than interferon administered three times a week.

A randomized prospective study is in progress in patients non responders (NR) to a first administration of interferon, defined by the absence of transaminases normalisation after three months of treatment.

398 NR patients have been enrolled in three arms:

– Group A received 6 MU IFN alfa 2 b tiw for 24 weeks then 3 MU tiw for 24 weeks
– Group B received 6 MU IFN alfa 2b tiw for 24 weeks then 3 MU tiw for 24 weeks plus ribavirin 1000 mg daily
– Group C received 3 MU daily of interferon alfa 2b for 24 weeks followed by 3 MU tiw for 24 weeks. Ribavirin at the standard dose (1,000-1,200 mg) per day was used for the entire 48 weeks.

The objectives of this study are to:
1. Test the therapeutic effect of the addition of ribavirin to interferon alfa 2b
2. Test the effects of daily interferon alfa 2b therapy with a similar total interferon dose administration
At inclusion no significant difference was observed between the three arms for age, sex, contamination route, duration of contamination, body mass index, transaminase levels, Metavir score for activity and fibrosis, genotype and viral load.

After 12 weeks of treatment, side effects are more frequent in groups B and C for hematological, psychiatric, dermatological and pulmonary events with no significant differences between groups B and C.

After 12 weeks treatment, in group A, B and C respectively, the biochemical response is 29,9% (n = 87) 42,7% (n=89) and 48,4% (n=91) (p<0,05) and for the virological response 31%m 38,2% and 47,2% (NS).

In genotype 1 patients, the virological response at three months is 21,6% (group A), 22,2% (group B) and 40,7% (group C) p <0,05. In genotype non-1 patients, no statistical difference was observed.

Interim results of this ongoing trial favor the daily administration of interferon with ribavirin for a similar total dose interferon administered. It remains to be seen if the effect of daily administration has a beneficial effect on long term response to therapy.

Patrice Couzigou, MD

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