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

Study validity:

• Strengths

- large size; good randomization with equal distribution of variables; intention to treat (ITT) analysis; biopsy comparisons blinded.

- Lack of placebo probably did not affect outcomes measured.

• Weaknesses

- Almost 15% of pts HCV Ab negative (should be accounted for by adequate randomization).

- ? significance of “near-complete” responders.

- ? clinical importance of outcomes.

- Supported by Schering-Plough (???).

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