High sustained response to daily dosing of interferon with ribavirin in chronic hepatitis C patients naïve to therapy

Abstract

Background: : Viral kinetics suggests that daily administration of alpha-interferon (IFN) will clear hepatitis C virus (HCV) RNA earlier and more frequently compared with standard t.i.w. To reduce the likelihood of viral replication, mutation and subsequent development of resistance, daily dosing with IFN may be appropriate. To determine the safety and efficacy of daily IFN with ribavirin in chronic HCV infection we performed a prospective study.

Methods: : Thirty-five naïve adult HCV-positive patients (25 male/10 female) were treated with IFN-alpha2b; 5 MU daily for 2 weeks followed by 3 MU daily for 22 weeks and ribavirin 800-1200 mg/day depending on weight. Liver biopsy, performed in 25 patients, showed mild to moderate activity in 19 patients (76%) and severe activity in six patients (24%). Two patients showed staged IV fibrosis. Serotyping was performed in 29 patients by an enzyme immunoassay-based Murex assay. Type 3 was the predominant serotype, present in 14 cases. Hepatitis C virus RNA was measured by the Chiron bDNA assay.

Results: : Mean baseline HCV-RNA level was 14.2 +/- 18.7 MEq/mL (median 6.09; range 0.2-92.5), which became undetectable in all but three patients at week 4. Normalization of alanine aminotransferase (ALT) at week 4 was seen in 27 patients. Three patients withdrew due to non-compliance. Thirty-two patients completed 24 weeks of therapy as per the protocol. At the end of treatment, the HCV-RNA level was negative in 29 of 32 patients (90.6%) and ALT was normal in 31 of 32 patients (97%). Sustained viral response at 6 months follow up was seen in 28 of 32 patients (88%). The ALT level was normal in 28 of 32 patients (88%).

Conclusion: : Daily administration of IFN with ribavirin is well tolerated in the majority of patients. There is rapid elimination of virus with normalization of ALT and a significantly high sustained viral response.