November, 1989: The first RCTsDiBisceglie, et al., N Engl J Med; 321: 1506-10.

• Prospective, dbl-blinded, placebo-controlled RCT.

• 41 pts; h/o blood product exposure, ALT 2x nl for 2 years, + liver biopsy. (90% subsequently HCV AB +)

• 22% hepatitis Bs or core Ab positive.

• 2 groups:

- 1 MU IFN alfa-2b QD x 1wk, then 2 MU TIW x 23 wks.

- placebo injections by same schedule.

• Follow up for at least 6 months after treatment.

• Outcomes were ALT levels during and after treatment, histology, side effects, and pre-treatment predictors of response.

Previous slide

Next slide

Back to first slide

View graphic version