Pegylated Interferon and Ribavirin Anti-hepatitis C Therapy in Patients with Hemophilia Is as Effective and Safe as in Non-hemophilic Patients

Abstract number: P0218

ME¹ Mancuso, E¹ Santagostino, MG² Rumi, F² De Filippi, S³ Linari, A³ Coppola, A³ Rocino, A³ Iorio, A³ Dragani, G³ Barillari, G³ Tagariello, R³ Nicolin, M² Colombo, PM¹ Mannucci

¹¹Angelo Bianchi Bonomi Hemophilia & Thrombosis Center, IRCCS Maggiore Hospital, Milan, Italy ¹¹Angelo Bianchi Bonomi Hemophilia & Thrombosis Center, IRCCS Maggiore Hospital, Milan, Italy ²²Hepatology Department, IRCCS Maggiore Hospital, Milan, Italy ³³Hepatitis Study Group of the Association of Italian Hemophilia Centers

Pegylated interferon (Peg-IFN) plus ribavirin is the standard treatment for patients with chronic hepatitis C. In a multicenter open trial, we assessed the efficacy and tolerability of this treatment in 78 HIV negative hemophiliacs (age: 21–64 years) with persistently high transaminase values. Cirrhosis was clinically detected in 12 patients (15%). HCV genotype was 1 in 69%, 2a/c in 14%, 3a in 14% and 4 in 3%. PegIFNa-2b was given at doses of 1.5 mcg/Kg/week for 48 weeks in genotypes 1/4 and for 24 weeks in 2/3. Ribavirin 800–1200 mg/day based on body weight. Treatment was stopped in patients with polymerase chain reaction positive HCV-RNA at month 6.

Results:  11 patients (14%) withdrew for side-effects (4) or non-compliance (7). Fifteen (19%) did not eradicate HCV-RNA at month 6; 5 (6%) had a virological breakthrough; 47 (60%) had had an end-of-treatment response. At the end of 6-month follow-up, 43 (55%) had a sustained response (SVR: 86% genotypes 2/3; 43% genotypes 1/4) while 4 (5%) relapsed. Neutropenia (<500 cells), ALT flares, diabetes and vomiting were reasons for treatment interruption. The median fall in hemoglobin levels was 3.1 g/dL. Leucopenia (<3000 cells, 88%), weight loss (38%), and fatigue (33%) were frequent side-effects. Thirty-two patients (41%) required dose reduction of ribavirin (23, 29%) or PegIFN (20, 26%). SVR rates were similar in patients compliant to full-dose treatment and those requiring dose reduction (51% vs 49%). The median values of pre-treatment ALT was lower and cirrhosis more prevalent in non responders than in patients with SVR (77 vs 110 IU/L, P= 0.04; 31% vs 2%, P= 0.001, respectively).

Conclusions:  PegIFN and ribavirin therapy is as effective and well-tolerated in HIV-negative hemophiliacs as in ordinary HCV patients.