Objectives: Up to 30% of the 5 million patients with chronic hepatitis C in the United States have normal serum alanine transaminase (ALT) levels. These individuals have not been treated aggressively, and reported response rates have been low. No study has targeted patients treated in a community practice setting.
Methods: Consecutive patients with chronic hepatitis C with normal or near-normal serum ALT levels seen over a 2-year period in a community gastroenterology-hepatology practice were randomly assigned to receive either 3 MU or 6 MU daily interferon (IFN)-α-2a monotherapy for 12 months.
Results: Sixteen patients (8 in each treatment arm) qualified for study. End-of-treatment response was 87.5% with 6 MU IFN daily and 75% with 3 MU IFN daily, whereas sustained virologic response was 62.5% and 50%, respectively. Genotype 1 patients had an improved outcome with the higher 6 MU dose.
Conclusions: Daily IFN monotherapy achieves high response rates in patients with chronic hepatitis C with normal or near-normal ALT. Present-day pegylated interferon regimes can be expected to be as effective.
* Six MU interferon-α-2a daily is more efficacious than 3 MU daily.
* Genotype 1 infections respond when higher doses of interferon are used.
* No differences in side effects were observed as a function of dose.