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This drug is a **combination oral regimen for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection**, consisting of: - BI 201335 (faldaprevir), an **NS3/4A protease inhibitor**, - BI 207127 (deleobuvir), a **NS5B non-nucleoside polymerase inhibitor**, and - ribavirin, an antiviral nucleoside analogue. The combination was designed as an *interferon-free direct-acting antiviral (DAA) regimen*, aiming to rapidly suppress and clear HCV RNA. BI 201335 targets the HCV NS3/4A protease, preventing viral polyprotein cleavage, while BI 207127 inhibits the NS5B polymerase at the thumb-pocket 1, halting RNA replication. Ribavirin complements this activity by increasing error rates during viral replication and enhancing immune clearance. Clinical trials have demonstrated **high rates of rapid virological response and sustained virological response (SVR)** in treatment-naïve genotype 1 patients, including those with cirrhosis, with a generally favorable safety profile and no severe adverse events[1][2][3][4][5][7][8][10]. The regimen was tested in the SOUND-C series of studies (C1, C2, C3) and showed most benefit in patients with genotype 1b and favorable IL28B genetic patterns.
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