Clinical Study

Effect of Food on the Steady-State Pharmacokinetics of Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults

Table 2

Pharmacokinetic parameters and comparisons during tenofovir and emtricitabine plus efavirenz administration in the fasting (Day 1) and fed (Day 8) states.

ParameterGM (95% CI)GMR (90% CI)
Fasting*FedFed/Fasting

(ng/mL)169 (137–255)175 (136–275)1.04 (0.84–1.27)
Tenofovir (ng·h/mL)1316 (1117–1748)1568 (1369–2032)1.19 (1.10–1.29)
(ng/mL)27 (23–39)27 (23–34)0.99 (0.82–1.19)
(L/h)186 (168–231)156 (139–198)0.84 (0.78–0.91)

(ng/mL)1043 (935–1233)870 (789–1016)0.83 (0.76–0.92)
Emtricitabine (ng·h/mL)7029 (6300–8313)6115 (5642–6846)0.87 (0.78–0.97)
(ng/mL)67 (57–92)61 (53–81)0.91 (0.73–1.14)
(L/h)28 (26–33)33 (30–37)0.89 (0.80–0.99)

(ng/mL)3128 (2678–4203)4611 (3961–6037)1.47 (1.24–1.75)
Efavirenz (ng·h/mL)46299 (37411–69475)52194 (41827–76643)1.13 (1.03–1.23)
(ng/mL)1395 (1082–2335)1408 (1073–2448)1.01 (0.91–1.11)
(L/h)13 (11.6–17.3)12 (10.5–14.4)0.89 (0.81–0.97)

GM: geometric means; GMR: geometric mean ratio; CI: confidence intervals, : maximum concentration; : concentration 24 hours after dosing; : area under the concentration-time curve; CL/F: clearance.
*reference.