Interferon alpha-2b and ribavirin as combined therapy for chronic hepatitis C in Cuba: National Program
Abstract
The treatment of chronic hepatitis C with interferon alpha (IFN-a) is widely used. However, the relapse rate is high, and sustained response is only in 10-20%. A combined treatment based on the synergic antiviral effects described for IFN-a and ribavirin was used as a National Program in Cuba. The study enrolled 357 patients treated during 48 weeks with an injection of IFN-a, 3 times weekly, combined with oral ribavirin in daily doses, the doses adjusted to body weight. Sustained virological response was the efficacy end point, supported by biochemical and histological changes. Normalization in transaminase levels occurs in 60.5% of patients after the first 4 weeks, 71.4% at 26 weeks and 60.2% at the end of treatment. In similar moments, the viral load was undetectable in 42.9%, 42.6% and 37.0% respectively. The implementation of this National Program led to 49.0% and 29.7% of biochemical and virological sustained response respectively. A histological improvement was observed in 53.5% of evaluated patients. The treatment was well tolerated and almost all adverse reactions were attributable to IFN-a. The main adverse reports were: anemia, leucopenia, asthenia, fever, headache, arthralgias, anorexia and myalgia. Anti-interferon antibodies were developed in 38 patients, in 3 of them as neutralizing of antiviral activity. These results confirm the efficacy and security profile of both drugs as combined therapy for the chronic hepatitis C and represent the first clinical data generated from its extensive use in the Cuban general population. The virological response was in agreement with international reports for populations with similar characteristics.
