Background/aims: Chronic hepatitis C is widely prevalent and is the commonest indication for liver transplantation in the United States. Standard treatment with interferon-alpha at 3 million units (MU) three times a week for 6-12 months has yielded poor results. The addition of ribavirin has not significantly increased response rates, and at the same time has been associated with both new and enhanced complications.
Methodology: We have used daily interferon-alpha at a dose of 5 MU for at least six months to treat patients with chronic hepatitis C in a community-based practice for the last five years. Treatment virologic response was defined as three consecutive monthly negative HCV-RNA results by RT-PCR. Following this, treatment was continued for an additional six months with a 'maintenance' dose of 2.5-5 MU interferon daily with intent to achieve a sustained response defined as HCV-RNA negativity six months after stopping maintenance therapy. A retrospective analysis of this experience is presented.
Results: Forty-two consecutive patients with chronic hepatitis C were treated. Eight (19%) discontinued treatment prematurely. Twenty-eight of the remaining 34 patients who completed treatment cleared the virus, yielding an end of treatment virologic response rate of 66.6%, based on the intent-to-treat principle. A sustained response was achieved in 15 (35.7%). Statistical analyses revealed maintenance therapy to be the significant variable associated with high sustained response in those patients who completed six months of maintenance therapy did significantly better (sustained response--72.7%) than those who discontinued maintenance therapy (sustained response--50%) (P < 0.05).
Conclusions: High pre-treatment viral loads and normal pre-treatment serum ALT levels did not adversely affect outcomes. Thus, daily therapy at 5 MU interferon until three negative monthly HCV-RNA results are obtained, followed by an additional six months of maintenance therapy yields high end of treatment and sustained response rates. Unlike most studies in the literature these excellent results were achievable in a community-based practice.