November, 1989: The first RCTsDavis, et al., N Engl J Med; 321: 1501-6.

• Results:

Complete response (normal ALT at week 24):

3 MU group 22/58 (38%)

1 MU group 9/57 (16%); p=0.01

untreated group 2/51 (4%); p=0.001

- NNT with 3 MU IFN vs. no treatment to achieve complete response at week 24 = 3.

- Histologic improvement in 52% of 3 MU group vs. 29% of 1 MU group, but histological and biochemical response did not correlate.

- 48 % had biochemical relapse by mean f/u of 17 wks.

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