Roferon (alpha interferon 2A) for the treatment of hepatitis C infected patients with cirrhosis: A pilot study

Purpose: At the present time, a growing number of HCV infected patients have evidence of cirrhosis at initial presentation. To date, the efficacy of therapy with Alpha Interferon 2A (Roferon, Roche Labs, Nutley, NJ) in patients with compensated cirrhosis has not been assessed. Methods: 9 patients (6 men, 3 women) with compensated cirrhosis due to HCV were enrolled. The mean patient age was 54. The mean pre-treatment Childs -Turcotte-Pugh score was 5. HCV genotypes were 1A (3 patients) 1B (3 patients) 2B (1 patient) and unknown (1 patient). Patients were scheduled to complete 48 weeks of treatment with 3 million units(mu)of Roferon three days a week. Treatment was initiated at 500,000 units per week, and the dose was escalated as tolerated. Endpoints of treatment were normalization of serum ALT, and clearance of serum HCV by qualitative and quantitative PCR. Treatment was discontinued in the event of side effects or if HCV viral titers remained positive at 12 weeks. Results: 5 of 9 patients were able to tolerate a Roferon dose of 3 mu. The dose could not be increased or had to be decreased to less than 3 million units in 4 patients. Patients were treated for a mean of 22 weeks. 0 of 9 patients normalized serum transaminases or cleared HCV with therapy. The mean ALT was 186 prior to therapy, and 133 at the time treatment was discontinued. The mean percent reduction in ALT was 27%. The mean pre-treatment HCV titer was 3.2 million, and 1.3 million at the time therapy was discontinued. The mean percent reduction in HCV viral titer was 60%. 1 patient developed worsening of ascites, and 1 developed refractory encephalopathy during treatment. In both patients, treatment was discontinued, and the patients recovered. Conclusions: In this population of HCV infected patients with compensated cirrhosis, therapy with Roferon did not normalize serum transaminases or eradicate HCV viremia. Side effects necessitating the discontinuation of therapy occurred in 2 patients. Larger trials are required to determine if Interferon therapy has any long term benefit, slows progression to cirrhosis or hepatoma, and improves histology in HCV induced cirrhosis.