November, 1989: The first RCTs DiBisceglie, et al., N Engl J Med; 321: 1506-10.
- 33% of treated patients had normal ALT levels at end of treatment.
- Data presented as “average percent change”: 62% decrease in ALT in treated group vs. 22% in placebo (p=0.0002).
- Numerical data on placebo pts with ALT normalization not given.
- Only 2/21 treated pts (10%) had normal ALT levels at 6 months.
- Significant improvement in “piecemeal necrosis” and “current hepatic injury” in treatment group over placebo group (p=0.01).
- Side effects of IFN were “usually mild.” There were significant differences in fatigue, wt. loss, decreased WBC and platelets in IFN group vs. placebo.
- Patients with higher pre-treatment ALTs were less likely to have complete response.