Interaction Study of the Combined Use of Paroxetine and Fosamprenavir-Ritonavir in Healthy Subjects
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| Published in | Antimicrobial Agents and Chemotherapy Vol. 51; no. 11; pp. 4098 - 4104 |
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American Society for Microbiology
01.11.2007
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| AbstractList | Human immunodeficiency virus-infected patients have an increased risk for depression. Despite the high potential for drug-drug interactions, limited data on the combined use of antidepressants and antiretrovirals are available. Theoretically, ritonavir-boosted protease inhibitors may inhibit CYP2D6-mediated metabolism of paroxetine. We wanted to determine the effect of fosamprenavir-ritonavir on paroxetine pharmacokinetics and vice versa and to evaluate the safety of the combination. Group A started with 20 mg paroxetine every day for 10 days; after a wash-out period of 16 days, subjects received paroxetine (20 mg every day) plus fosamprenavir-ritonavir (700/100 mg twice a day) from days 28 to 37. Group B received the regimens in reverse order. On days 10 and 37, pharmacokinetic curves were recorded. Twenty-six healthy subjects (18 females, 8 males) were included. Median (range) age and weight were 44.4 (18.2 to 64.3) years and 68.8 (51.0 to 89.4) kg. Three subjects were excluded (two because of adverse events; one for nonadherence). Addition of fosamprenavir-ritonavir to paroxetine resulted in a significant decrease in paroxetine exposure: the geometric mean ratios (90% confidence intervals) of paroxetine plus fosamprenavir-ritonavir to paroxetine alone were 0.45 (0.41 to 0.49) for the area under the concentration-time curve from 0 to 24 h (AUC sub(0-24)), 0.49 (0.45 to 0.53) for the maximum concentration of the drug in plasma (C sub(max)), and 0.75 (0.71 to 0.80) for the apparent elimination half-life (t sub(1/2)). The free fraction of paroxetine showed a median (interquartile range) increase of 30% (18 to 42%) after the addition of fosamprenavir-ritonavir. The AUC sub(0-12), C sub(max), C sub(min), and t sub(1/2) of amprenavir and ritonavir were similar to those of historical controls. No serious adverse events occurred. Fosamprenavir-ritonavir reduced total paroxetine exposure by 55%. This is partly explained by protein displacement of paroxetine. We think that this interaction is clinically relevant and that titration to a higher dose of paroxetine may be necessary to accomplish the needed antidepressant effect. Human immunodeficiency virus-infected patients have an increased risk for depression. Despite the high potential for drug-drug interactions, limited data on the combined use of antidepressants and antiretrovirals are available. Theoretically, ritonavir-boosted protease inhibitors may inhibit CYP2D6-mediated metabolism of paroxetine. We wanted to determine the effect of fosamprenavir-ritonavir on paroxetine pharmacokinetics and vice versa and to evaluate the safety of the combination. Group A started with 20 mg paroxetine every day for 10 days; after a wash-out period of 16 days, subjects received paroxetine (20 mg every day) plus fosamprenavir-ritonavir (700/100 mg twice a day) from days 28 to 37. Group B received the regimens in reverse order. On days 10 and 37, pharmacokinetic curves were recorded. Twenty-six healthy subjects (18 females, 8 males) were included. Median (range) age and weight were 44.4 (18.2 to 64.3) years and 68.8 (51.0 to 89.4) kg. Three subjects were excluded (two because of adverse events; one for nonadherence). Addition of fosamprenavir-ritonavir to paroxetine resulted in a significant decrease in paroxetine exposure: the geometric mean ratios (90% confidence intervals) of paroxetine plus fosamprenavir-ritonavir to paroxetine alone were 0.45 (0.41 to 0.49) for the area under the concentration-time curve from 0 to 24 h (AUC 0-24 ), 0.49 (0.45 to 0.53) for the maximum concentration of the drug in plasma ( C max ), and 0.75 (0.71 to 0.80) for the apparent elimination half-life ( t 1/2 ). The free fraction of paroxetine showed a median (interquartile range) increase of 30% (18 to 42%) after the addition of fosamprenavir-ritonavir. The AUC 0-12 , C max , C min , and t 1/2 of amprenavir and ritonavir were similar to those of historical controls. No serious adverse events occurred. Fosamprenavir-ritonavir reduced total paroxetine exposure by 55%. This is partly explained by protein displacement of paroxetine. We think that this interaction is clinically relevant and that titration to a higher dose of paroxetine may be necessary to accomplish the needed antidepressant effect. ABSTRACT Human immunodeficiency virus-infected patients have an increased risk for depression. Despite the high potential for drug-drug interactions, limited data on the combined use of antidepressants and antiretrovirals are available. Theoretically, ritonavir-boosted protease inhibitors may inhibit CYP2D6-mediated metabolism of paroxetine. We wanted to determine the effect of fosamprenavir-ritonavir on paroxetine pharmacokinetics and vice versa and to evaluate the safety of the combination. Group A started with 20 mg paroxetine every day for 10 days; after a wash-out period of 16 days, subjects received paroxetine (20 mg every day) plus fosamprenavir-ritonavir (700/100 mg twice a day) from days 28 to 37. Group B received the regimens in reverse order. On days 10 and 37, pharmacokinetic curves were recorded. Twenty-six healthy subjects (18 females, 8 males) were included. Median (range) age and weight were 44.4 (18.2 to 64.3) years and 68.8 (51.0 to 89.4) kg. Three subjects were excluded (two because of adverse events; one for nonadherence). Addition of fosamprenavir-ritonavir to paroxetine resulted in a significant decrease in paroxetine exposure: the geometric mean ratios (90% confidence intervals) of paroxetine plus fosamprenavir-ritonavir to paroxetine alone were 0.45 (0.41 to 0.49) for the area under the concentration-time curve from 0 to 24 h (AUC 0-24 ), 0.49 (0.45 to 0.53) for the maximum concentration of the drug in plasma ( C max ), and 0.75 (0.71 to 0.80) for the apparent elimination half-life ( t 1/2 ). The free fraction of paroxetine showed a median (interquartile range) increase of 30% (18 to 42%) after the addition of fosamprenavir-ritonavir. The AUC 0-12 , C max , C min , and t 1/2 of amprenavir and ritonavir were similar to those of historical controls. No serious adverse events occurred. Fosamprenavir-ritonavir reduced total paroxetine exposure by 55%. This is partly explained by protein displacement of paroxetine. We think that this interaction is clinically relevant and that titration to a higher dose of paroxetine may be necessary to accomplish the needed antidepressant effect. Classifications Services AAC Citing Articles Google Scholar PubMed Related Content Social Bookmarking CiteULike Delicious Digg Facebook Google+ Mendeley Reddit StumbleUpon Twitter current issue AAC About AAC Subscribers Authors Reviewers Advertisers Inquiries from the Press Permissions & Commercial Reprints ASM Journals Public Access Policy AAC RSS Feeds 1752 N Street N.W. • Washington DC 20036 202.737.3600 • 202.942.9355 fax • journals@asmusa.org Print ISSN: 0066-4804 Online ISSN: 1098-6596 Copyright © 2014 by the American Society for Microbiology. For an alternate route to AAC .asm.org, visit: AAC Human immunodeficiency virus-infected patients have an increased risk for depression. Despite the high potential for drug-drug interactions, limited data on the combined use of antidepressants and antiretrovirals are available. Theoretically, ritonavir-boosted protease inhibitors may inhibit CYP2D6-mediated metabolism of paroxetine. We wanted to determine the effect of fosamprenavir-ritonavir on paroxetine pharmacokinetics and vice versa and to evaluate the safety of the combination. Group A started with 20 mg paroxetine every day for 10 days; after a wash-out period of 16 days, subjects received paroxetine (20 mg every day) plus fosamprenavir-ritonavir (700/100 mg twice a day) from days 28 to 37. Group B received the regimens in reverse order. On days 10 and 37, pharmacokinetic curves were recorded. Twenty-six healthy subjects (18 females, 8 males) were included. Median (range) age and weight were 44.4 (18.2 to 64.3) years and 68.8 (51.0 to 89.4) kg. Three subjects were excluded (two because of adverse events; one for nonadherence). Addition of fosamprenavir-ritonavir to paroxetine resulted in a significant decrease in paroxetine exposure: the geometric mean ratios (90% confidence intervals) of paroxetine plus fosamprenavir-ritonavir to paroxetine alone were 0.45 (0.41 to 0.49) for the area under the concentration-time curve from 0 to 24 h (AUC(0-24)), 0.49 (0.45 to 0.53) for the maximum concentration of the drug in plasma (C(max)), and 0.75 (0.71 to 0.80) for the apparent elimination half-life (t(1/2)). The free fraction of paroxetine showed a median (interquartile range) increase of 30% (18 to 42%) after the addition of fosamprenavir-ritonavir. The AUC(0-12), C(max), C(min), and t(1/2) of amprenavir and ritonavir were similar to those of historical controls. No serious adverse events occurred. Fosamprenavir-ritonavir reduced total paroxetine exposure by 55%. This is partly explained by protein displacement of paroxetine. We think that this interaction is clinically relevant and that titration to a higher dose of paroxetine may be necessary to accomplish the needed antidepressant effect. Human immunodeficiency virus-infected patients have an increased risk for depression. Despite the high potential for drug-drug interactions, limited data on the combined use of antidepressants and antiretrovirals are available. Theoretically, ritonavir-boosted protease inhibitors may inhibit CYP2D6-mediated metabolism of paroxetine. We wanted to determine the effect of fosamprenavir-ritonavir on paroxetine pharmacokinetics and vice versa and to evaluate the safety of the combination. Group A started with 20 mg paroxetine every day for 10 days; after a wash-out period of 16 days, subjects received paroxetine (20 mg every day) plus fosamprenavir-ritonavir (700/100 mg twice a day) from days 28 to 37. Group B received the regimens in reverse order. On days 10 and 37, pharmacokinetic curves were recorded. Twenty-six healthy subjects (18 females, 8 males) were included. Median (range) age and weight were 44.4 (18.2 to 64.3) years and 68.8 (51.0 to 89.4) kg. Three subjects were excluded (two because of adverse events; one for nonadherence). Addition of fosamprenavir-ritonavir to paroxetine resulted in a significant decrease in paroxetine exposure: the geometric mean ratios (90% confidence intervals) of paroxetine plus fosamprenavir-ritonavir to paroxetine alone were 0.45 (0.41 to 0.49) for the area under the concentration-time curve from 0 to 24 h (AUC0-24), 0.49 (0.45 to 0.53) for the maximum concentration of the drug in plasma (Cmax), and 0.75 (0.71 to 0.80) for the apparent elimination half-life (t1/2). The free fraction of paroxetine showed a median (interquartile range) increase of 30% (18 to 42%) after the addition of fosamprenavir-ritonavir. The AUC0-12, Cmax, Cmin, and t1/2 of amprenavir and ritonavir were similar to those of historical controls. No serious adverse events occurred. Fosamprenavir-ritonavir reduced total paroxetine exposure by 55%. This is partly explained by protein displacement of paroxetine. We think that this interaction is clinically relevant and that titration to a higher dose of paroxetine may be necessary to accomplish the needed antidepressant effect. |
| Author | Cristina Pharo David M. Burger Gerard A. Rongen Audrey A. M. Blenke Corrien P. W. G. M. Verwey-van Wissen Peter P. Koopmans Manon J. van der Lee |
| AuthorAffiliation | Department of Clinical Pharmacy, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, 1 Nijmegen University Centre for Infectious Diseases, Nijmegen, the Netherlands, 2 Clinical Research Centre Nijmegen, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, 3 Department of General Internal Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, 4 GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom 5 |
| AuthorAffiliation_xml | – name: Department of Clinical Pharmacy, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, 1 Nijmegen University Centre for Infectious Diseases, Nijmegen, the Netherlands, 2 Clinical Research Centre Nijmegen, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, 3 Department of General Internal Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, 4 GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom 5 |
| Author_xml | – sequence: 1 givenname: Manon J surname: VAN DER LEE fullname: VAN DER LEE, Manon J organization: Department of Clinical Pharmacy, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands – sequence: 2 givenname: Audrey A. M surname: BLENKE fullname: BLENKE, Audrey A. M organization: Department of Clinical Pharmacy, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands – sequence: 3 givenname: Gerard A surname: RONGEN fullname: RONGEN, Gerard A organization: Clinical Research Centre Nijmegen, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands – sequence: 4 givenname: Corrien P. W. G. M surname: VERWEY-VAN WISSEN fullname: VERWEY-VAN WISSEN, Corrien P. W. G. M organization: Department of Clinical Pharmacy, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands – sequence: 5 givenname: Peter P surname: KOOPMANS fullname: KOOPMANS, Peter P organization: Nijmegen University Centre for Infectious Diseases, Nijmegen, Netherlands – sequence: 6 givenname: Cristina surname: PHARO fullname: PHARO, Cristina organization: GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom – sequence: 7 givenname: David M surname: BURGER fullname: BURGER, David M organization: Department of Clinical Pharmacy, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands |
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| Cites_doi | 10.2165/00003495-200565050-00005 10.1097/00002030-200107060-00010 10.1128/AAC.42.12.3107 10.1345/aph.18240 10.1016/j.clpt.2005.09.001 10.1002/(SICI)1097-0258(19990115)18:1<93::AID-SIM992>3.0.CO;2-8 10.1177/0091270003251864 10.1093/clinchem/44.5.914 10.1093/ajhp/57.4.376 10.1177/009127002762491307 10.1097/01.aids.0000182518.84407.32 10.1097/00007691-200306000-00023 10.1097/00004714-199712000-00003 10.1002/hup.318 10.1093/clinchem/46.8.1072 10.1067/mcp.2000.110561 10.2165/00003495-200464180-00014 10.1177/00912709922007633 10.1097/01.jcp.0000125689.05091.c6 10.2165/00003495-199141020-00007 10.1097/01.qai.0000147524.19122.fd 10.1089/154065802761001301 10.1097/00002030-200404090-00007 10.1111/j.1365-2125.1986.tb02879.x |
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| Keywords | Human Paroxetine Antiretroviral agent Serotonin Healthy subject Enzyme Psychotropic Ritonavir Interaction Enzyme inhibitor Reuptake inhibitor Selective serotonin reuptake inhibitor Peptidases Fosamprenavir Piperidine derivatives Neurotransmitter Hydrolases Antidepressant agent Antiviral Protease inhibitor |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Corresponding author. Mailing address: Department of Clinical Pharmacy, 864 Radboud University Medical Centre Nijmegen, Geert Grooteplein 10, 6525 GA Nijmegen, The Netherlands. Phone: 31 24 3616405. Fax: 31 24 3668755. E-mail: m.vanderlee@akf.umcn.nl Both authors contributed the same amount of work to this paper. |
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| References_xml | – ident: e_1_3_2_3_2 doi: 10.2165/00003495-200565050-00005 – ident: e_1_3_2_10_2 doi: 10.1097/00002030-200107060-00010 – ident: e_1_3_2_22_2 doi: 10.1128/AAC.42.12.3107 – ident: e_1_3_2_26_2 doi: 10.1345/aph.18240 – start-page: 195 year: 1991 ident: e_1_3_2_14_2 publication-title: Biopharmaceutics and clinical pharmacokinetics. – ident: e_1_3_2_2_2 doi: 10.1016/j.clpt.2005.09.001 – ident: e_1_3_2_17_2 doi: 10.1002/(SICI)1097-0258(19990115)18:1<93::AID-SIM992>3.0.CO;2-8 – ident: e_1_3_2_16_2 doi: 10.1177/0091270003251864 – ident: e_1_3_2_25_2 doi: 10.1093/clinchem/44.5.914 – ident: e_1_3_2_23_2 doi: 10.1093/ajhp/57.4.376 – ident: e_1_3_2_5_2 doi: 10.1177/009127002762491307 – ident: e_1_3_2_4_2 doi: 10.1097/01.aids.0000182518.84407.32 – ident: e_1_3_2_11_2 doi: 10.1097/00007691-200306000-00023 – ident: e_1_3_2_21_2 doi: 10.1097/00004714-199712000-00003 – ident: e_1_3_2_24_2 doi: 10.1002/hup.318 – ident: e_1_3_2_18_2 doi: 10.1093/clinchem/46.8.1072 – ident: e_1_3_2_6_2 doi: 10.1067/mcp.2000.110561 – volume: 350 start-page: 60 year: 1989 ident: e_1_3_2_20_2 publication-title: Acta Psychiatr. Scand. Suppl. – ident: e_1_3_2_8_2 doi: 10.2165/00003495-200464180-00014 – ident: e_1_3_2_15_2 doi: 10.1177/00912709922007633 – ident: e_1_3_2_27_2 – ident: e_1_3_2_7_2 doi: 10.1097/01.jcp.0000125689.05091.c6 – ident: e_1_3_2_9_2 doi: 10.2165/00003495-199141020-00007 – ident: e_1_3_2_29_2 doi: 10.1097/01.qai.0000147524.19122.fd – ident: e_1_3_2_13_2 doi: 10.1089/154065802761001301 – ident: e_1_3_2_28_2 doi: 10.1097/00002030-200404090-00007 – ident: e_1_3_2_12_2 doi: 10.1111/j.1365-2125.1986.tb02879.x – volume: 29 start-page: 100 year: 2001 ident: e_1_3_2_19_2 publication-title: Drug Metab. Dispos. |
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Reddit... Human immunodeficiency virus-infected patients have an increased risk for depression. Despite the high potential for drug-drug interactions, limited data on... ABSTRACT Human immunodeficiency virus-infected patients have an increased risk for depression. Despite the high potential for drug-drug interactions, limited... |
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| SubjectTerms | Adolescent Adult Aged Anti-HIV Agents - adverse effects Anti-HIV Agents - pharmacokinetics Antibiotics. Antiinfectious agents. Antiparasitic agents Antidepressive Agents, Second-Generation - adverse effects Antidepressive Agents, Second-Generation - pharmacokinetics Area Under Curve Biological and medical sciences Carbamates Carbamates - adverse effects Carbamates - pharmacokinetics Drug Interactions Female Genotype Humans Male Medical sciences Metabolic Clearance Rate Middle Aged Organophosphates Organophosphates - adverse effects Organophosphates - pharmacokinetics Paroxetine Paroxetine - adverse effects Paroxetine - pharmacokinetics Pharmacology Pharmacology. Drug treatments Ritonavir Ritonavir - adverse effects Ritonavir - pharmacokinetics Sulfonamides Sulfonamides - adverse effects Sulfonamides - pharmacokinetics |
| Title | Interaction Study of the Combined Use of Paroxetine and Fosamprenavir-Ritonavir in Healthy Subjects |
| URI | http://aac.asm.org/content/51/11/4098.abstract https://www.ncbi.nlm.nih.gov/pubmed/17846135 https://journals.asm.org/doi/10.1128/AAC.01243-06 https://search.proquest.com/docview/19976466 https://pubmed.ncbi.nlm.nih.gov/PMC2151442 |
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