To evaluate an efficacy and safety profile of simeprevir (NS3/4A protease inhibitor) in difficult-to-treat patients infected with hepatitis C virus (HCV).
Material and methods
Ten patients with chronic hepatitis C (8 male, average age 46,8±12,4 years) were treated with simeprevir (150 mg once daily, orally) and pegylated interferon (peg-INF) alfa 2a/ribavirin for 12 weeks followed by 12 weeks (in 8 patients) or 36 weeks (in 2 patients) treatment with peg-INF alfa-2a and ribavirin. A triple therapy was prescribed because of inefficacy of previous antiviral therapy course and/or compensated cirrhosis.
Sustained virological response (SVR) was achieved in 8 (80%) patients, including 7 (87%) patients with GT1b, 6 (75%) patients with cirrhosis and 6 (100%) patients with relapse after previous treatment (peg-INF/ ribavirin). SVR was associated with decrease in liver stiffness by 9.33±6.3 kPa (p<0.005). The most frequent adverse events were flu-like symptoms, weight loss and blood changes.
Simeprevir in combination with peg-INF and ribavirin is effective and safe in patients with cirrhosis or relapse after previous antiviral therapy, and remains relevant in the era of INF-free regimens.
Cirrhosis, hepatitis C virus infection, simeprevir, protease inhibitor.