Drug intelligence / Profile preview

simeprevir + peginterferon alfa-2a + ribavirin

Development stage
Phase 3
Lead developer
Johnson & Johnson
Modality
Small Molecules, Recombinant Proteins and Enzymes
Administration
Oral, Subcutaneous
01

Overview

A fixed-duration oral and injectable **combination antiviral regimen** for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection, especially in treatment-naive or previously untreated patients. - **Simeprevir** is a once-daily NS3/4A serine protease inhibitor (small molecule) that directly interrupts HCV replication by inhibiting viral polyprotein processing. - **Peginterferon alfa-2a** is a pegylated, recombinant type I interferon (protein) that stimulates the host immune response against HCV. - **Ribavirin** is a guanosine analogue antiviral (small molecule) thought to contribute to viral clearance primarily via immunomodulatory effects and inhibition of viral RNA synthesis. Used together, this triple therapy increases rates of sustained virologic response (SVR12) compared to peginterferon and ribavirin alone, without substantially increasing the overall adverse event profile, though skin rashes and photosensitivity are more common. Response-guided therapy is often used to tailor treatment duration (typically 24 to 48 weeks) based on virologic milestones[1][2][3][5][6]. Developed and first approved in the early 2010s, it was previously a first-line regimen, but has largely been replaced by newer direct-acting antiviral (DAA) combination therapies.

Brand names
Olysio + Pegasys + CopegusOlysio + Pegasys + Rebetol
Other names
simeprevir + peginterferon alpha-2a + ribavirinsimeprevir + pegylated interferon alfa-2a + ribavirin
02

Targets

NS3/4A (Hepatitis C virus nonstructural protein 3/4A serine protease)NS5B (Hepatitis C virus non-structural protein 5B (NS5B) RNA-dependent RNA polymerase)IFNAR (Immune system modulation via type I interferon receptor)

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