Table 1.
Summary of the effect of demographic factors/disease/food on doravirine pharmacokinetics
| Factor | Dosing | Comparison | Doravirine GMR (90% CI) | Reference | |||
|---|---|---|---|---|---|---|---|
| AUC0–∞ | AUC0–24 | Cmax | C24 | ||||
| Age | Doravirine 100 mg SD | Elderly men/young men | 0.85 (0.67–1.10) | – | 0.92 (0.73–1.16) | 0.81 (0.59–1.11) | [22] |
| Doravirine 100 mg SD | Elderly women/young women | 0.97 (0.79–1.19) | – | 1.18 (0.98–1.42) | 0.94 (0.72–1.21) | [22] | |
| Gender | Doravirine 100 mg SD | Women/men | 1.20 (1.03–1.40) | – | 1.42 (1.23–1.64) | 1.02 (0.84–1.24) | [22] |
| Hepatic impairment | Doravirine 100 mg SD | Moderate hepatic impairment/normal hepatic function | 0.99 (0.72–1.35) | 0.93 (0.74–1.18) | 0.90 (0.66–1.24) | 0.99 (0.74–1.33) | [25] |
| Renal impairment | Doravirine 100 mg SD | Severe renal impairment/normal renal function | 1.43 (1.00–2.04) | – | 0.83 (0.61–1.15) | 1.38 (0.99–1.92) | [24] |
| Food | Doravirine 100 mg SD | Fed/fasted | 1.16 (1.06–1.26) | – | 1.03 (0.89–1.19) | 1.36 (1.19–1.55) | [23] |
| Doravirine 100 mg/lamivudine 300 mg/TDF 300 mg SD | Fed/fasted | 1.10 (1.01–1.20) | – | 0.95 (0.80–1.12) | 1.26 (1.13–1.41) | [23] | |
AUC0–24 area under the concentration–time curve from time zero to 24 h, AUC0–∞ area under the concentration–time curve from time zero to infinity, C24 plasma concentration 24 h post-dose, CI confidence interval, Cmax maximum plasma concentration, GMR geometric mean ratio, SD single dose, TDF tenofovir disoproxil fumarate