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. 2021 Apr 8;60(7):835–853. doi: 10.1007/s40262-021-01005-1

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© The Author(s) 2021

Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

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Fig. 3 — a Impact of oral rilpivirine on co-medication pharmacokinetics from drug–drug interaction crossover studies in healthy volunteers. 1. Period 1: Atorvastatin 40 mg daily for 4 days. Period 2: Rilpivirine 150 mg daily for 15 days + atorvastatin 40 mg daily days 12–15 (n = 16). 2. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Darunavir/ritonavir 800/100 mg daily for 22 days + rilpivirine 150 mg daily day 12–22 (n = 16). 3a. Period 1: Cabotegravir 30 mg daily for 12 days. Period 2: Rilpivirine 25 mg daily for 11 or 12 days. Period 3: Cabotegravir 30 mg daily + rilpivirine 25 mg daily, for 12 days (n = 11). 3b. Period 1: Dolutegravir 50 mg daily for 5 days. Period 2: Rilpivirine 25 mg daily for 11 or 12 days. Period 3: Dolutegravir 50 daily + rilpivirine 25 mg daily for 5 days (n = 16). 4. Period 1: Grazoprevir/elbasvir 200/50 mg daily for 8 days. Period 2: Rilpivirine 25 mg daily for 11 days. Period 3: Grazoprevir/elbasvir 200/50 mg daily + rilpivirine 25 mg daily for 9 days (n = 20). 5. Period 1: Rilpivirine 150 mg daily for 8 days. Period 2: Tenofovir disoproxil fumarate 300 mg daily for 16 days + rilpivirine 150 mg daily either days 1–8 or days 9–16 (n = 15). 6. Period 1: Norethindrone/ethinylestradiol 1/0.035 mg in three 21-day cycles + rilpivirine 25 mg daily on days 1–15 of the third cycle (n = 18). 7. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Ketoconazole 400 mg daily for 22 days + rilpivirine 150 mg daily days 12–22. 8. Period 1: Rilpivirine 150 mg daily for 10 days. Period 2: Lopinavir/ritonavir 400/100 mg twice daily for 20 days + rilpivirine 150 mg days 11–20 (n = 14). 9. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Omeprazole 20 mg daily for 22 days + rilpivirine 150 mg on days 12–22 (n = 16). 10. Period 1: Paracetamol 500 mg, single dose. Period 2: Rilpivirine 150 mg daily for 12 days + paracetamol 500 mg single dose on day 11 (n = 16). 11. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Rifabutin 300 mg daily for 11 days. Period 3: Rilpivirine 150 mg + rifabutin 300 mg daily for 11 days (n = 18). 12. Period 1: Sildenafil 50 mg, single dose. Period 2: Rilpivirine 75 mg daily for 12 days + sildenafil 50 mg single dose on day 12 (n = 16). 13. Period 1: Sofosbuvir/velpatasvir 400/100 mg daily for 8 days. Period 2: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate 200/25/300 mg + sofosbuvir/velpatasvir 400/100 mg daily for 8 days (n = 24). 14. Period 1: Rilpivirine 25 mg daily for 14 days. Period 2: Tenofovir alafenamide fumarate 25 mg daily for 14 days. Period 3: Rilpivirine 25 mg + tenofovir alafenamide fumarate 25 mg daily, for 14 days (n = 17). 15. Stable methadone dose (60–150 mg daily) for 25 days + rilpivirine 25 mg daily on days 15–25 (n = 13). (b) Impact of co-medications on oral rilpivirine pharmacokinetics from drug–drug interaction crossover studies in healthy volunteers. 1. Period 1: Atorvastatin 40 mg daily for 4 days. Period 2: Rilpivirine 150 mg daily for 15 days + atorvastatin 40 mg daily days 12–15 (n = 16). 2. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Darunavir/ritonavir 800/100 mg daily for 22 days + rilpivirine 150 mg daily days 12–22 (n = 16). 3a. Period 1: Cabotegravir 30 mg daily for 12 days. Period 2: Rilpivirine 25 mg daily for 11 or 12 days. Period 3: Cabotegravir 30 mg daily + rilpivirine 25 mg daily for 12 days (n = 11). 3b. Period 1: Dolutegravir 50 mg daily for 5 days. Period 2: Rilpivirine 25 mg daily for 11 or 12 days. Period 3: Dolutegravir 50 daily + rilpivirine 25 mg daily for 5 days (n = 16). 4. Period 1: Grazoprevir/elbasvir 200/50 mg daily for 8 days. Period 2: Rilpivirine 25 mg daily for 11 days. Period 3: Grazoprevir/elbasvir 200/50 mg daily + rilpivirine 25 mg daily for 9 days (n = 20). 5. Period 1: Rilpivirine 150 mg daily for 8 days. Period 2: Tenofovir disoproxil fumarate 300 mg daily for 16 days + rilpivirine 150 mg daily either days 1–8 or days 9–16 (n = 15). 6. Period 1: Rilpivirine 150 mg single dose. Period 2: Rilpivirine 150 mg single dose 2 h after famotidine 40 mg single dose (n = 24). 7. Period 1: Rilpivirine 150 mg daily. Period 2: Ketoconazole 400 mg daily for 22 days + rilpivirine 150 mg daily days 12–22 (n = 14). 8. Period 1: Rilpivirine 150 mg daily for 10 days. Period 2: Lopinavir/ritonavir 400/100 mg twice daily for 20 days + rilpivirine 150 mg days 11–20 (n = 14). 9. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Omeprazole 20 mg daily for 22 days + rilpivirine 150 mg on days 12–22 (n = 16). 10. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Rifabutin 300 mg daily for 11 days. Period 3: Rilpivirine 150 mg + rifabutin 300 mg daily for 11 days (n = 18). 11. Period 1: Rilpivirine 150 mg daily. Period 2: Rilpivirine 150 mg daily + rifampicin 600 mg daily (n = 16). 12. Period 1: Sildenafil 50 mg, single dose. Period 2: rilpivirine 75 mg daily for 12 days + sildenafil 50 mg single dose on day 12 (n = 16). 13. Period 1: Sofosbuvir/velpatasvir 400/100 mg daily for 8 days. Period 2: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate 200/25/300 mg + sofosbuvir/velpatasvir 400/100 mg daily for 8 days (n = 24). Data are presented as area under the curve (squares) and trough plasma concentration (triangles) geometric mean ratios + 90% confidence intervals for rilpivirine with and without co-medication. The bioequivalence margin (0.8–1.25) is indicated by dashed vertical lines. CAB cabotegravir, DRV/RTV darunavir/ritonavir, DTG dolutegravir, GS-331007 metabolite of sofosbuvir, GZR/EBR grazoprevir/elbasvir, LPV/RTV lopinavir/ritonavir, NOR/EE norgestrel/ethinylestradiol, RPV rilpivirine, sd single dose, SOF/VEL sofosbuvir/velpatasvir, TAF tenofovir alafenamide, TDF tenofovir disoproxil fumarate [49, 71–83, 88, 95, 96].

Fig. 3 — a Impact of oral rilpivirine on co-medication pharmacokinetics from drug–drug interaction crossover studies in healthy volunteers. 1. Period 1: Atorvastatin 40 mg daily for 4 days. Period 2: Rilpivirine 150 mg daily for 15 days + atorvastatin 40 mg daily days 12–15 (n = 16). 2. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Darunavir/ritonavir 800/100 mg daily for 22 days + rilpivirine 150 mg daily day 12–22 (n = 16). 3a. Period 1: Cabotegravir 30 mg daily for 12 days. Period 2: Rilpivirine 25 mg daily for 11 or 12 days. Period 3: Cabotegravir 30 mg daily + rilpivirine 25 mg daily, for 12 days (n = 11). 3b. Period 1: Dolutegravir 50 mg daily for 5 days. Period 2: Rilpivirine 25 mg daily for 11 or 12 days. Period 3: Dolutegravir 50 daily + rilpivirine 25 mg daily for 5 days (n = 16). 4. Period 1: Grazoprevir/elbasvir 200/50 mg daily for 8 days. Period 2: Rilpivirine 25 mg daily for 11 days. Period 3: Grazoprevir/elbasvir 200/50 mg daily + rilpivirine 25 mg daily for 9 days (n = 20). 5. Period 1: Rilpivirine 150 mg daily for 8 days. Period 2: Tenofovir disoproxil fumarate 300 mg daily for 16 days + rilpivirine 150 mg daily either days 1–8 or days 9–16 (n = 15). 6. Period 1: Norethindrone/ethinylestradiol 1/0.035 mg in three 21-day cycles + rilpivirine 25 mg daily on days 1–15 of the third cycle (n = 18). 7. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Ketoconazole 400 mg daily for 22 days + rilpivirine 150 mg daily days 12–22. 8. Period 1: Rilpivirine 150 mg daily for 10 days. Period 2: Lopinavir/ritonavir 400/100 mg twice daily for 20 days + rilpivirine 150 mg days 11–20 (n = 14). 9. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Omeprazole 20 mg daily for 22 days + rilpivirine 150 mg on days 12–22 (n = 16). 10. Period 1: Paracetamol 500 mg, single dose. Period 2: Rilpivirine 150 mg daily for 12 days + paracetamol 500 mg single dose on day 11 (n = 16). 11. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Rifabutin 300 mg daily for 11 days. Period 3: Rilpivirine 150 mg + rifabutin 300 mg daily for 11 days (n = 18). 12. Period 1: Sildenafil 50 mg, single dose. Period 2: Rilpivirine 75 mg daily for 12 days + sildenafil 50 mg single dose on day 12 (n = 16). 13. Period 1: Sofosbuvir/velpatasvir 400/100 mg daily for 8 days. Period 2: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate 200/25/300 mg + sofosbuvir/velpatasvir 400/100 mg daily for 8 days (n = 24). 14. Period 1: Rilpivirine 25 mg daily for 14 days. Period 2: Tenofovir alafenamide fumarate 25 mg daily for 14 days. Period 3: Rilpivirine 25 mg + tenofovir alafenamide fumarate 25 mg daily, for 14 days (n = 17). 15. Stable methadone dose (60–150 mg daily) for 25 days + rilpivirine 25 mg daily on days 15–25 (n = 13). (b) Impact of co-medications on oral rilpivirine pharmacokinetics from drug–drug interaction crossover studies in healthy volunteers. 1. Period 1: Atorvastatin 40 mg daily for 4 days. Period 2: Rilpivirine 150 mg daily for 15 days + atorvastatin 40 mg daily days 12–15 (n = 16). 2. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Darunavir/ritonavir 800/100 mg daily for 22 days + rilpivirine 150 mg daily days 12–22 (n = 16). 3a. Period 1: Cabotegravir 30 mg daily for 12 days. Period 2: Rilpivirine 25 mg daily for 11 or 12 days. Period 3: Cabotegravir 30 mg daily + rilpivirine 25 mg daily for 12 days (n = 11). 3b. Period 1: Dolutegravir 50 mg daily for 5 days. Period 2: Rilpivirine 25 mg daily for 11 or 12 days. Period 3: Dolutegravir 50 daily + rilpivirine 25 mg daily for 5 days (n = 16). 4. Period 1: Grazoprevir/elbasvir 200/50 mg daily for 8 days. Period 2: Rilpivirine 25 mg daily for 11 days. Period 3: Grazoprevir/elbasvir 200/50 mg daily + rilpivirine 25 mg daily for 9 days (n = 20). 5. Period 1: Rilpivirine 150 mg daily for 8 days. Period 2: Tenofovir disoproxil fumarate 300 mg daily for 16 days + rilpivirine 150 mg daily either days 1–8 or days 9–16 (n = 15). 6. Period 1: Rilpivirine 150 mg single dose. Period 2: Rilpivirine 150 mg single dose 2 h after famotidine 40 mg single dose (n = 24). 7. Period 1: Rilpivirine 150 mg daily. Period 2: Ketoconazole 400 mg daily for 22 days + rilpivirine 150 mg daily days 12–22 (n = 14). 8. Period 1: Rilpivirine 150 mg daily for 10 days. Period 2: Lopinavir/ritonavir 400/100 mg twice daily for 20 days + rilpivirine 150 mg days 11–20 (n = 14). 9. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Omeprazole 20 mg daily for 22 days + rilpivirine 150 mg on days 12–22 (n = 16). 10. Period 1: Rilpivirine 150 mg daily for 11 days. Period 2: Rifabutin 300 mg daily for 11 days. Period 3: Rilpivirine 150 mg + rifabutin 300 mg daily for 11 days (n = 18). 11. Period 1: Rilpivirine 150 mg daily. Period 2: Rilpivirine 150 mg daily + rifampicin 600 mg daily (n = 16). 12. Period 1: Sildenafil 50 mg, single dose. Period 2: rilpivirine 75 mg daily for 12 days + sildenafil 50 mg single dose on day 12 (n = 16). 13. Period 1: Sofosbuvir/velpatasvir 400/100 mg daily for 8 days. Period 2: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate 200/25/300 mg + sofosbuvir/velpatasvir 400/100 mg daily for 8 days (n = 24). Data are presented as area under the curve (squares) and trough plasma concentration (triangles) geometric mean ratios + 90% confidence intervals for rilpivirine with and without co-medication. The bioequivalence margin (0.8–1.25) is indicated by dashed vertical lines. CAB cabotegravir, DRV/RTV darunavir/ritonavir, DTG dolutegravir, GS-331007 metabolite of sofosbuvir, GZR/EBR grazoprevir/elbasvir, LPV/RTV lopinavir/ritonavir, NOR/EE norgestrel/ethinylestradiol, RPV rilpivirine, sd single dose, SOF/VEL sofosbuvir/velpatasvir, TAF tenofovir alafenamide, TDF tenofovir disoproxil fumarate [49, 71–83, 88, 95, 96].