Darunavir 800 + 100 10 once trial 10 1.42 1.06 NC ritonavir (0.84, once daily 1.35)e 50 once daily 10 once daily 10 1.24 1.19 NC (0.96, 1.48) Efavirenz 600 once 40 once 11 0.78 0.86 NC daily dailyc (0.72, 1.02) Lopinavir 800/200 10 once 10 2.19 1.47 NC ritonavir daily (1.17, once daily 1.85) Rilpivirine 25 once 25 once trial 17 1.01 1.01 NC daily (0.94, 4, 1.09) Sertraline 50 once 10 once 19 1.00 0.96 NC daily daily 16) NC = Not Calculated. a. All interaction studies conducted in healthy volunteers. b. All No Effect Boundaries are 70% -143% unless otherwise specified. c. Study conducted with DESCOVY (FTC/TAF). d. Mean ratio of tenofovir PK parameters (90% CI) was 3.16 (3.00, 3.33) for Cmax, 3.24 (3.02, 3.47) for AUC, and 3.21 (2.90, 3.54) for Cmin. e. Mean ratio of tenofovir PK parameters (90% CI) was 2.42 (1.98, 2.95) for Cmax, 2.43 (2.07, 2.84) for AUClast. f. Study conducted with Genvoya. There appears to be no apparent interaction between TAF and the commonly administered agents, such that the PK values of these agents remain unchanged in the presence of TAF. See table below:
Darunavir 800 + 100 ritonavir once daily 10 once 10 1.42 1.06 (0.84, 1.35)e NC 50 once daily 10 once daily 10 1.24 1.19 (0.96, 1.48) NC Efavirenz 600 once daily 40 once dailyc 11 0.78 0.86 (0.72, 1.02) NC Lopinavir 800/200 ritonavir once daily 10 once daily 10 2.19 1.47 (1.17, 1.85) NC Rilpivirine 25 once daily 25 once 17 1.01 1.01 (0.94, 1.09) NC Sertraline 50 once daily 10 once daily 19 1.00 0.96 NC NC = Not Calculated. a. All interaction studies conducted in healthy volunteers. b. All No Effect Boundaries are 70% -143% unless otherwise specified. c. Study conducted with DESCOVY (FTC/TAF). d. Mean ratio of tenofovir PK parameters (90% CI) was 3.16 (3.00, 3.33) for Cmax, 3.24 (3.02, 3.47) for AUC, and 3.21 (2.90, 3.54) for Cmin. e. Mean ratio of tenofovir PK parameters (90% CI) was 2.42 (1.98, 2.95) for Cmax, 2.43 (2.07, 2.84) for AUClast. f. Study conducted with Genvoya. There appears to be no apparent interaction between TAF and the commonly administered agents, such that the PK values of these agents remain unchanged in the presence of TAF. See table below: trial 4, 16) trial
auspar-emtricitabine-161220-cer.docx