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

• Prospective, multicenter RCT. Not placebo controlled.

• 166 pts; post-transfusion, elevated ALT x 1 yr, + liver biopsy (86% of pts subsequently tested were HCV Ab positive).

• 3 treatment arms:

- 3 MU IFN alfa-2b TIW x 24 weeks (58 pts)

- 1 MU IFN alfa-2b TIW x 24 weeks (57 pts)

- No treatment (51 pts)

• Follow up varied; 2 - 46 weeks after treatment.

• Main outcomes were ALT levels, liver histology, and relapses after treatment.

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