Longer IFN Therapy in HCV Infection Is Beneficial. Part 1
Several studies reaffirmed the benefits of longer-term IFN therapy on sustained response rates and liver histology.
Bellobuono and colleagues (Milan, Italy) compared six and twelve months of IFN alfa-2b therapy in men with an unknown serum HCV RNA after one month of treatment. One hundred thirty patients with biopsy-proven chronic hepatitis C without cirrhosis received IFN alfa-2b 5-8 MU TIW (genotype 1 a or 1b) or 3-5 MU TIW (genotype 2a or 3a) for 1 month. Of these patients, 58 with normal ALT and undetectable serum HCV RNA after the first month of therapy were randomized to complete 6 (n-30) or 12 (n-28) months of treatment. There was no difference between treatment groups with regard to pretreatment liver histology; however, 32% of patients treated for 12 months were infected with HCV genotype 1a or 1b compared with 23% of patients treated for 6 months. The sustained response rate (defined as maintenance of normal ALT and undetectable serum HCV RNA during treatment and for at least 6 months after the end of therapy) was significantly higher in patients treated for 12 months compared with those treated for 6 months (72% vs 27%; P
Bellobuono A, Tempini S, Vicari F, Chiodo F, Id?o G. Should patients with undetectable serum HCVRNA 1 month after interferon alpha therapy be treated for 6 or 12 months? J Hepatol. 1997;26 (suppl 1):77. Abstract P/C01/02.
In a similar study, Aguilar-Reina et al (Sevilla, Spain) treated 70 patients with biopsyproven chronic hepatitis C with IFN alfa-2b 3 MU TIW for 12 months, regardless of biochemical response to therapy, in order to measure the effect of therapy on liver histology. One year after therapy completion, all patients underwent a second biopsy. The changes between the two biopsies in terms of histologic diagnosis and Knodell index score were measured and correlated with biochemical and virologic parameters also obtained at the time of the second biopsy. Diagnoses at the first and second biopsies were minimal changes/normal: 0/16; chronic persistent hepatitis: 17/15; moderate chronic active hepatitis (CAH): 13/11; severe CAH: 28/17; bridging CAH: 10/8; and cirrhosis: 2/3. Overall Knodell index improvement was observed in 47 patients, worsening in 6, and no change in 17. Overall Knodell index improvement was 2.7 ± 3.5 points.
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