BACKGROUND/AIMS: The antiviral agent amantadine may have activity against the hepatitis C virus. To determine whether the combination of interferon-alpha plus amantadine was more effective than interferon monotherapy we conducted a multicentre clinical trial in untreated patients with chronic hepatitis C infection. METHODS: We performed a pilot study in two centres (36 patients) to determine the number needed for a statistically significant clinical trial and then conducted a multicentre, randomized controlled clinical trial involving 14 centres and 143 patients. RESULTS: There was no significant difference in sustained response rates in patients receiving interferon and amantadine compared to those receiving interferon alone. The on treatment response rate at 3 months was 65% on combination vs. 49% on interferon alone (P = 0.05) while the sustained response was 18 and 15%, respectively. CONCLUSIONS: Combination therapy with interferon plus amantadine does not lead to a significant increase in sustained response rates when compared to interferon monotherapy.
RCT Entities:
BACKGROUND/AIMS: The antiviral agent amantadine may have activity against the hepatitis C virus. To determine whether the combination of interferon-alpha plus amantadine was more effective than interferon monotherapy we conducted a multicentre clinical trial in untreated patients with chronic hepatitis C infection. METHODS: We performed a pilot study in two centres (36 patients) to determine the number needed for a statistically significant clinical trial and then conducted a multicentre, randomized controlled clinical trial involving 14 centres and 143 patients. RESULTS: There was no significant difference in sustained response rates in patients receiving interferon and amantadine compared to those receiving interferon alone. The on treatment response rate at 3 months was 65% on combination vs. 49% on interferon alone (P = 0.05) while the sustained response was 18 and 15%, respectively. CONCLUSIONS: Combination therapy with interferon plus amantadine does not lead to a significant increase in sustained response rates when compared to interferon monotherapy.
Authors: Rudolf E Stauber; Harald Hofer; Franz Hackl; Kurt Schütze; Christian Datz; Karin Hegenbarth; Wolfgang Jessner; Petra Steindl-Munda; Ferenci Peter Journal: Wien Klin Wochenschr Date: 2004-08-31 Impact factor: 1.704
Authors: P J Thuluvath; A Maheshwari; J Mehdi; K D Fairbanks; L L-W Wu; L G Gelrud; M J Ryan; F A Anania; I F Lobis; M Black Journal: Gut Date: 2004-01 Impact factor: 23.059
Authors: Steven K Herrine; Robert S Brown; David E Bernstein; Michael S Ondovik; Ellen Lentz; Helen Te Journal: Dig Dis Sci Date: 2005-04 Impact factor: 3.487