Rapid HCV-RNA Decline With Once Daily TMC435: A Phase I Study in Healthy Volunteers and Hepatitis C Patients

Design of the TMC435350-C101 trial.

Mean plasma concentration-time profile during 5-day TMC435 in hepatitis C patients (•, 200 mg QD) and in healthy volunteers (▼, 100 mg QD; ♦, 200 mg QD; ▲, 400 mg QD).

Change in plasma HCV-RNA (log₁₀ IU/mL) from baseline observed in 6 hepatitis C patients receiving 5 days, dosing of TMC435 200 mg QD. Four patients indicated in purple had genotype 1a HCV infection (■, patient 173; ▲, patient 175; •, patient 176; ♦, patient 177), whereas 2 patients indicated in olive were infected with HCV genotype 1b (■, patient 174; ▲, patient 178). Median values (•) are shown in orange. Follow-up times were day 18 and day 34 (patient 173), day 18 and day 34 (patient 174), day 14 and day 24 (patient 175), day 14 and day 39 (patient 176), day 14 and day 35 (patient 177), day 14 and day 35 (patient 178).