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Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans
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| Veröffentlicht in: | The journal of antimicrobial chemotherapy 71(2016), 8, Seite 2241-2247 |
|---|---|
| Personen und Körperschaften: | , , , , , , , |
| Titel: | Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans/ Nicolas Hohmann, Raphael Reinhard, Sven Schnaidt, Lukas Witt, Alexandra Carls, Jürgen Burhenne, Gerd Mikus and Walter E. Haefeli |
| Format: | E-Book-Kapitel |
| Sprache: | Englisch |
| veröffentlicht: |
May 1, 2016
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| Gesamtaufnahme: |
: The journal of antimicrobial chemotherapy, 71(2016), 8, Seite 2241-2247
, volume:71 |
| Quelle: | Verbunddaten SWB Lizenzfreie Online-Ressourcen |
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| 245 | 1 | 0 | |a Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans |c Nicolas Hohmann, Raphael Reinhard, Sven Schnaidt, Lukas Witt, Alexandra Carls, Jürgen Burhenne, Gerd Mikus and Walter E. Haefeli |
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| 520 | |a Objectives Antiretroviral combination therapy of patients infected with HIV has greatly increased their life expectancy. Hence, the treatment of HIV-related long-term complications and age-related comorbidities has become more important. Reported incidence rates of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH) are increasing in HIV-positive patients, potentially requiring treatment with phosphodiesterase 5 inhibitors such as sildenafil or tadalafil. In vitro, the NNRTI rilpivirine is both a pregnane X receptor agonist and cytochrome P450 (CYP) 3A inhibitor. Clinical data concerning the potential effects of rilpivirine coadministration on the pharmacokinetics of the CYP3A substrate tadalafil are lacking. Methods We enrolled 20 healthy volunteers in an open-label, two-part, one-arm Phase I clinical trial to investigate acute and chronic effects of multiple doses of 25 mg of oral rilpivirine on single-dose and steady-state pharmacokinetics of multiple oral 20 mg doses of tadalafil. CYP3A activity was measured simultaneously with the oral midazolam microdose test. Results We did not observe a change of tadalafil single-dose and steady-state exposure or of CYP3A activity measured at initiation, during maintenance and upon discontinuation of rilpivirine treatment after single-dose and chronic administration of rilpivirine. Conclusions Tadalafil can be combined with rilpivirine without dose adjustment or drug monitoring in HIV patients with ED or PAH. Rilpivirine at daily therapeutic doses of 25 mg does not induce or inhibit CYP3A-dependent drug metabolism. | ||
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| author | Hohmann, Nicolas, Reinhard, Raphael, Schnaidt, Sven, Witt, Lukas, Carls, Alexandra, Burhenne, Jürgen, Mikus, Gerd, Haefeli, Walter E. |
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| contents | Objectives Antiretroviral combination therapy of patients infected with HIV has greatly increased their life expectancy. Hence, the treatment of HIV-related long-term complications and age-related comorbidities has become more important. Reported incidence rates of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH) are increasing in HIV-positive patients, potentially requiring treatment with phosphodiesterase 5 inhibitors such as sildenafil or tadalafil. In vitro, the NNRTI rilpivirine is both a pregnane X receptor agonist and cytochrome P450 (CYP) 3A inhibitor. Clinical data concerning the potential effects of rilpivirine coadministration on the pharmacokinetics of the CYP3A substrate tadalafil are lacking. Methods We enrolled 20 healthy volunteers in an open-label, two-part, one-arm Phase I clinical trial to investigate acute and chronic effects of multiple doses of 25 mg of oral rilpivirine on single-dose and steady-state pharmacokinetics of multiple oral 20 mg doses of tadalafil. CYP3A activity was measured simultaneously with the oral midazolam microdose test. Results We did not observe a change of tadalafil single-dose and steady-state exposure or of CYP3A activity measured at initiation, during maintenance and upon discontinuation of rilpivirine treatment after single-dose and chronic administration of rilpivirine. Conclusions Tadalafil can be combined with rilpivirine without dose adjustment or drug monitoring in HIV patients with ED or PAH. Rilpivirine at daily therapeutic doses of 25 mg does not induce or inhibit CYP3A-dependent drug metabolism. |
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| spelling | Hohmann, Nicolas 1983- VerfasserIn (DE-588)1018788999 (DE-627)683426052 (DE-576)356371816 aut, Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans Nicolas Hohmann, Raphael Reinhard, Sven Schnaidt, Lukas Witt, Alexandra Carls, Jürgen Burhenne, Gerd Mikus and Walter E. Haefeli, May 1, 2016, 7, Text txt rdacontent, Computermedien c rdamedia, Online-Ressource cr rdacarrier, Gesehen am 05.01.2017, Objectives Antiretroviral combination therapy of patients infected with HIV has greatly increased their life expectancy. Hence, the treatment of HIV-related long-term complications and age-related comorbidities has become more important. Reported incidence rates of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH) are increasing in HIV-positive patients, potentially requiring treatment with phosphodiesterase 5 inhibitors such as sildenafil or tadalafil. In vitro, the NNRTI rilpivirine is both a pregnane X receptor agonist and cytochrome P450 (CYP) 3A inhibitor. Clinical data concerning the potential effects of rilpivirine coadministration on the pharmacokinetics of the CYP3A substrate tadalafil are lacking. Methods We enrolled 20 healthy volunteers in an open-label, two-part, one-arm Phase I clinical trial to investigate acute and chronic effects of multiple doses of 25 mg of oral rilpivirine on single-dose and steady-state pharmacokinetics of multiple oral 20 mg doses of tadalafil. CYP3A activity was measured simultaneously with the oral midazolam microdose test. Results We did not observe a change of tadalafil single-dose and steady-state exposure or of CYP3A activity measured at initiation, during maintenance and upon discontinuation of rilpivirine treatment after single-dose and chronic administration of rilpivirine. Conclusions Tadalafil can be combined with rilpivirine without dose adjustment or drug monitoring in HIV patients with ED or PAH. Rilpivirine at daily therapeutic doses of 25 mg does not induce or inhibit CYP3A-dependent drug metabolism., Reinhard, Raphael 1988- VerfasserIn (DE-588)112275499X (DE-627)87613326X (DE-576)481470344 aut, Schnaidt, Sven VerfasserIn (DE-588)1122755198 (DE-627)876133685 (DE-576)322299527 aut, Witt, Lukas 1983- VerfasserIn (DE-588)1046419862 (DE-627)776400533 (DE-576)399746145 aut, Carls, Alexandra VerfasserIn (DE-588)1059566680 (DE-627)798640820 (DE-576)415706254 aut, Burhenne, Jürgen 1963- VerfasserIn (DE-588)1034228889 (DE-627)745126987 (DE-576)381858197 aut, Mikus, Gerd VerfasserIn (DE-588)110903137 (DE-627)691097941 (DE-576)336988710 aut, Haefeli, Walter E. 1958- VerfasserIn (DE-588)124572359 (DE-627)656806141 (DE-576)340514221 aut, Enthalten in The journal of antimicrobial chemotherapy Oxford : Oxford Univ. Press, 1975 71(2016), 8, Seite 2241-2247 Online-Ressource (DE-627)266876838 (DE-600)1467478-6 (DE-576)075144972 1460-2091 nnns, volume:71 year:2016 number:8 pages:2241-2247 extent:7, http://dx.doi.org/10.1093/jac/dkw125 Verlag Resolving-System kostenfrei Volltext, http://jac.oxfordjournals.org/content/71/8/2241 Verlag kostenfrei Volltext, http://dx.doi.org/10.1093/jac/dkw125 LFER, LFER 2017-01-16T00:00:00Z |
| spellingShingle | Hohmann, Nicolas, Reinhard, Raphael, Schnaidt, Sven, Witt, Lukas, Carls, Alexandra, Burhenne, Jürgen, Mikus, Gerd, Haefeli, Walter E., Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans, Objectives Antiretroviral combination therapy of patients infected with HIV has greatly increased their life expectancy. Hence, the treatment of HIV-related long-term complications and age-related comorbidities has become more important. Reported incidence rates of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH) are increasing in HIV-positive patients, potentially requiring treatment with phosphodiesterase 5 inhibitors such as sildenafil or tadalafil. In vitro, the NNRTI rilpivirine is both a pregnane X receptor agonist and cytochrome P450 (CYP) 3A inhibitor. Clinical data concerning the potential effects of rilpivirine coadministration on the pharmacokinetics of the CYP3A substrate tadalafil are lacking. Methods We enrolled 20 healthy volunteers in an open-label, two-part, one-arm Phase I clinical trial to investigate acute and chronic effects of multiple doses of 25 mg of oral rilpivirine on single-dose and steady-state pharmacokinetics of multiple oral 20 mg doses of tadalafil. CYP3A activity was measured simultaneously with the oral midazolam microdose test. Results We did not observe a change of tadalafil single-dose and steady-state exposure or of CYP3A activity measured at initiation, during maintenance and upon discontinuation of rilpivirine treatment after single-dose and chronic administration of rilpivirine. Conclusions Tadalafil can be combined with rilpivirine without dose adjustment or drug monitoring in HIV patients with ED or PAH. Rilpivirine at daily therapeutic doses of 25 mg does not induce or inhibit CYP3A-dependent drug metabolism. |
| swb_id_str | 481470514 |
| title | Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans |
| title_auth | Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans |
| title_full | Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans Nicolas Hohmann, Raphael Reinhard, Sven Schnaidt, Lukas Witt, Alexandra Carls, Jürgen Burhenne, Gerd Mikus and Walter E. Haefeli |
| title_fullStr | Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans Nicolas Hohmann, Raphael Reinhard, Sven Schnaidt, Lukas Witt, Alexandra Carls, Jürgen Burhenne, Gerd Mikus and Walter E. Haefeli |
| title_full_unstemmed | Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans Nicolas Hohmann, Raphael Reinhard, Sven Schnaidt, Lukas Witt, Alexandra Carls, Jürgen Burhenne, Gerd Mikus and Walter E. Haefeli |
| title_in_hierarchy | Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans / Nicolas Hohmann, Raphael Reinhard, Sven Schnaidt, Lukas Witt, Alexandra Carls, Jürgen Burhenne, Gerd Mikus and Walter E. Haefeli, |
| title_short | Treatment with rilpivirine does not alter plasma concentrations of the CYP3A substrates tadalafil and midazolam in humans |
| title_sort | treatment with rilpivirine does not alter plasma concentrations of the cyp3a substrates tadalafil and midazolam in humans |
| url | http://dx.doi.org/10.1093/jac/dkw125, http://jac.oxfordjournals.org/content/71/8/2241 |