1995: RCTs of dose and duration Poynard, et al., N Engl J Med; 332: 1457-62
Prospective, blinded RCT.
329 consecutive pts with NANB hepatitis; elevated ALT x 1yr; + liver biopsy (88% subsequently tested HCV Ab +).
All pts treated for 6 months with 3 MU TIW x 6 months; 303 then randomized to 3 treatment arms:
- Group 1: 3 MU TIW for 12 more months (103 pts).
- Group 2: 1 MU TIW for 12 more months (101 pts).
- Group 3: No further treatment (complex protocol for pts in this group with elevated ALT for 3 consecutive months; most of these were re-treated with initial regimen).
Followed for a total of 2 yrs after treatment.