The study results showed that TMC435 was safe and well-tolerated with no clinically relevant differences in adverse events between treatment groups and standard of care.
In the treatment arm, 83% of patients were able to stop all therapy at week 24.
Patients in the treatment arm demonstrated potent and consistent antiviral efficacy, with sustained virologic response (SVR) rates of up to 84%
The phase 2b response guided study enrolled 386 treatment-naïve patients who were grouped into treatment arm or placebo arm.
Patients in the treatment arm received TMC435, 75mg or 150mg, in combination with ribavirin and pegIFNalpha-2A, the current standard of care (SoC), while patients in the placebo arm received SoC plus placebo.