Comparative evaluation of the safety and efficacy of recombinant FVIII in severe hemophilia A patients

OBJECTIVE: This study compared the safety and efficacy of Safacto(®) versus xyntha(®) in patients with severe hemophilia A. METHODS: Thirty-three male patients with severe hemophilia A were randomly divided into two groups. Seventeen patients received Safacto(®) and 16 patients received Xyntha(®) for four consecutive times. The dosage of FVIII was 40–50 IU/kg for each injection. Plasma level of FVIII activity was evaluated before every injection, 15 minutes after the injection and one month after the start of the trial. The rate of factor VIII activity, pain and joint motion were also assessed before and after the treatment. RESULTS: Plasma level of FVIII clotting activity in Safacto(®) and Xyntha(®) were 1.96±0.5 IU/dl and 1.63±0.5 IU/dl and increased to 88.84±25.2 IU/dl and 100.09±17.8 IU/dl, respectively (P<0.001). Pain score and range of motion improvement were 9.3±0.9 and 8.7±0.1 in Safacto(®) (P=0.17); and 9.4±0.8 and 8.8±0.3 in Xyntha(®) (P=0.35), respectively. No allergic or other unfavorable reactions was observed with either of the preparations. CONCLUSION: This study showed that Safacto(®) has a favorable efficacy and safety profile.