Longer IFN Therapy in HCV Infection Is Beneficial. Part 2
At the time of the second biopsy, 50% of patients had normal GPT, 41% had negative HCV RNA, and 36% had normal GPT and negative HCV RNA. Each of these changes was associated with a statistically significant improvement in Knodell index score compared with continued abnormal GPT or positive HCV RNA. The researchers concluded that IFN alfa-2b therapy for 12 months can result in resolution of pathologic changes in patients with chronic hepatitis C without a complete virologic and/or biochemical response and that hepatic lesions, including fibrosis, show improvement in nonresponders.
Aguilar-Reina J, Rometro M, G?mez L, Otero F, Gavil?n F, Hern?ndez A. Pathological changes one year after the end of 12-month interferon therapy in patients with chronic hepatitis C. J Hepatol. 1997;26 (suppl 1):202. Abstract C01/97.
In an ongoing multicenter, randomized, controlled trial, Damen and colleagues (Amsterdam, The Netherlands) are evaluating the effect of up to 3 years of IFN therapy in patients with chronic HCV infection. Patients receive IFN 5 MU TIW for 8 weeks and then 2.5 MU TIW for 16 weeks. Patients who respond to this regimen stop therapy. Relapsers and nonresponders continue therapy for up to 3 years. Of the 103 patients enrolled, 78 patients were evaluable at week 48 (33 controls, 45 treated) and 39 patients have completed the study (19 controls, 20 treated). After 48 weeks, 8 of 45 treated patients (18%) had a sustained virologic response, 40% (18/45) were considered nonresponders, and 42% (19/45) relapsed after a primary response. Of the 20 treated patients who were evaluable at the end of 3 years, the 3 responders maintained their response, 7 nonresponders remained nonresponders, and 7/10 relapsers became sustained virologic responders with long-term treatment. The overall sustained response after 48 weeks of standard treatment was 15% (3/20; 95% confidence interval [CI]: 3% to 38%). After 3 years of treatment, sustained response increased to 55% (11/20; 95% CI: 32% to 77%). The investigators concluded that 3 years of IFN treatment increases the likelihood of a sustained virologic response for patients who relapse following 6 months of therapy.
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