1995: RCTs of dose and duration Lin, et al., J Hepatology; 23: 487-96.
Prospective, multicenter, open-label RCT.
230 patients with elevated ALT (or AST in 29 pts) x 6 months; + liver biopsy; all pts HCV Ab +.
Randomized to 3 treatment arms:
Group a: 3 MU IFN alfa-2b TIW x 6 months (72 pts).
Group b: 5 MU TIW x 6 months (75 pts).
Group c: 3 MU TIW x 2 years (80 pts; 40 completed trial).
Follow up for 6 months after treatment ended.
Outcomes were ALT/AST levels at end of treatment and 6 months, relapses, and histology.