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Single-center, fixed-sequence, 3-period, open-label, drug interaction study in 20 healthy subjects. Period 1: BOC (boceprevir) 800mg three times daily from day 1 through the morning of day 6. Followed by a 7 day washout. Period 2: RPV (rilpivirine) 25mg once daily from day 1 through day 11, followed immediately by Period 3, concomitant BOC 800mg three times daily and RPV 25mg once daily from day 1 through day 11. Blood samples were collected for BOC and RPV PK in each period.
RPV and BOC coadministration increased RPV exposures but not to a clinically significant extent. GMR (90% CI) for RPV AUC(0-24h), Cmax, and C24h were 1.39 (1.27, 1.52), 1.15 (1.04, 1.28), and 1.51 (1.36, 1.68), respectively. BOC PK was not affected. GMR (90% CI) for BOC AUC(0-8h), Cmax, and C8h were 0.94 (0.88, 1.00), 0.98 (0.89, 1.08), and 1.04 (0.93, 1.16), respectively. BOC and RPV co-administration was well-tolerated.
E Rhee, H-P Feng, F Xuan, W Lin, C Smith, Y Zhu, J Butterton. Absence of significant pharmacokinetic interaction between the hepatitis c virus protease inhibitor boceprevir and hiv-1 nnrti rilpivirine. 20th Conference On Retroviruses And Opportunistic Infections. Atlanta, Georgia, USA. ; 2013.