Should patients with early loss of serum HCV-RNA during alpha interferon therapy for chronic hepatitis C be treated for 6 or 12 months?

• Published in: Journal of hepatology Vol. 30; no. 1; pp. 8 - 13
• Main Authors: Bellobuono, Antonio, Mondazzi, Luca, Tempini, Silvana, Chiodo, Federico, Magliano, Enrico, Mondini, Chiara, Idéo, Gaetano
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier B.V 1999; Elsevier
• Subjects: Adult; Alanine Transaminase - blood; Antiviral therapy; Biological and medical sciences; Drug Administration Schedule; Female; Hepacivirus - genetics; Hepatitis C virus; Hepatitis C, Chronic - therapy; Human viral diseases; Humans; Infectious diseases; Interferon-alpha - administration & dosage; Interferon-alpha - therapeutic use; Male; Medical sciences; Middle Aged; Prognosis; Prospective Studies; Reference Values; Reverse Transcriptase Polymerase Chain Reaction; RNA, Viral - blood; Viral diseases; Viral hepatitis; Hepatitis C virus; Antiviral therapy; Viral hepatitis; Human; Immunopathology; Evaluation; Alpha interferon; Treatment efficiency; Cytokine; Hepatic disease; Serology; Infection; Response; Chronic; Follow up study; Viral disease; Digestive diseases; Predictive factor; Comparative study; Viral hepatitis C
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/S0168-8278(99)80002-6

Background/Aims: Retrospective studies have suggested that early loss of serum HCV-RNA predicts sustained response to α-interferon treatment in chronic hepatitis C, but the optimal duration of therapy after loss of HCV-RNA is not known. The aims of this study were: a) to prospectively evaluate the effectiveness of HCV-RNA testing after 1 month of α-interferon treatment in the prediction of sustained response, and b) to compare the efficacy of 6 and 12 months of therapy in patients with a negative serum HCV-RNA test after the first month of treatment. Methods: One hundred and thirty patients were administered interferon α-2b at doses related to body weight (< or ≥ 60 kg) and to HCV genotype: 5 or 8 MU tiw for type 1, and 3 or 5 MU tiw for genotypes non-1. Serum HCV-RNA testing was performed using in-house nested RT-PCR at month 1, at the end of treatment and 6 months afterwards. We considered sustained response to be the maintenance of normal alanine aminotransferase and negativity at serum HCV-RNA testing until the end of follow-up. Results: Sustained response was observed in 2/72 (2.8%) patients with detectable HCV-RNA after the initial month of therapy, in 8/30 (26.7%) patients with early loss of HCV-RNA treated for 6 months and in 20/28 (71.4%) patients treated for 12 months ( p<0.01). Conclusions: Serum HCV-RNA detectability after the first month is strongly associated with a very poor chance of sustained response, and these cases should be offered other treatments. Patients with early loss of HCV-RNA should complete a 12-month treatment, which appeared more effective than a 6-month treatment.