Abstract
Pegylated interferon (PegIFN) and ribavirin therapy is the standard treatment option for patients with chronic hepatitis C. In a multicenter open trial, we assessed the efficacy and tolerability of PegIFN and ribavirin in 72 HIV negative hemophiliacs (age: 21–64 years) with persistently high ALT values. HCV genotype was 1 in 72%, 3 in 14%, 2 in 12% and 4 in 3%. Treatment: PegIFN alpha2b 1.5 mcg/Kg/week for 48 weeks in genotypes 1/4 or 24 weeks in genotypes 2/3 plus ribavirin 800–1200 mg/day based on viral type. Treatment was stopped in patients lacking virological response at month 6. All patients were assessed for 6 months post-treatment. Results: 11 patients withdrew for side-effects (6) or non-compliance (5). Sixteen patients (22%) did not achieve a primary virological response and 4 (6%) had a virological breakthrough. Therefore, 41 patients (57%) had had an end-of-treatment response. Post-treatment follow-up is ongoing in 7 patients. In 65 patients who completed the study, 2 were relapsers and 32 (49%) had a sustained virological response (SVR, 82% of genotypes 2/3 and 38% of genotypes 1/4). Neutropenia (<800 cells), high ALT and diabetes were reasons for treatment interruption. The median fall in hemoglobin levels was 3.1 g/dL. Leucopenia (40%), weight loss (39%), and fatigue (35%) were frequent side-effects. Thirty patients (42%) required dose reduction of ribavirin (21, 29%) and PegIFN (22, 30%). SVR rates were similar in patients who adhered to protocol and those requiring dose reduction (56% vs 45%). Conclusions: combination therapy with PegIFN and ribavirin improves SVR in HIV negative hemophiliacs with chronic hepatitis C.
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