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Pharmacokinetic interaction between rifampicin and the once-daily combination of saquinavir and low-dose ritonavir in HIV-infected patients with tuberculosis

Objectives To assess plasma steady-state pharmacokinetics (PK) of rifampicin, isoniazid, saquinavir and ritonavir in HIV and tuberculosis (TB) co-infected patients, and investigate potential interactions between TB drugs and protease inhibitors (PIs). Methods Open-label, single-arm, sequential PK st...

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Published in:Journal of antimicrobial chemotherapy 2007-04, Vol.59 (4), p.690-697
Main Authors: Ribera, Esteban, Azuaje, Carlos, Lopez, Rosa M., Domingo, Pere, Curran, Adria, Feijoo, Maria, Pou, Leonor, Sánchez, Paquita, Sambeat, Maria Antonia, Colomer, Joan, Lopez-Colomes, Josep Lluis, Crespo, Manuel, Falcó, Vicenç, Ocaña, Imma, Pahissa, Albert
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HIV
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cited_by cdi_FETCH-LOGICAL-c502t-4edc82fb99b1283fd106c636422d1a5c773b0afe09de5b39c5e74f3dba6748bd3
cites cdi_FETCH-LOGICAL-c502t-4edc82fb99b1283fd106c636422d1a5c773b0afe09de5b39c5e74f3dba6748bd3
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container_issue 4
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container_title Journal of antimicrobial chemotherapy
container_volume 59
creator Ribera, Esteban
Azuaje, Carlos
Lopez, Rosa M.
Domingo, Pere
Curran, Adria
Feijoo, Maria
Pou, Leonor
Sánchez, Paquita
Sambeat, Maria Antonia
Colomer, Joan
Lopez-Colomes, Josep Lluis
Crespo, Manuel
Falcó, Vicenç
Ocaña, Imma
Pahissa, Albert
description Objectives To assess plasma steady-state pharmacokinetics (PK) of rifampicin, isoniazid, saquinavir and ritonavir in HIV and tuberculosis (TB) co-infected patients, and investigate potential interactions between TB drugs and protease inhibitors (PIs). Methods Open-label, single-arm, sequential PK study including 22 patients with HIV infection and TB. During the first 2 months, patients received rifampicin, isoniazid and pyrazinamide, with or without ethambutol (first PK study, n = 22). Then patients stopped pyrazinamide and ethambutol and started once-daily antiretroviral therapy (ART) with didanosine, lamivudine, ritonavir (200 mg) and saquinavir (1600 mg) (second PK study, n = 18). Patients stopped all TB drugs after 9 months continuing the same ART (third PK study, n = 15). Differences between TB drug parameters in the first and second PK studies, and between PI parameters in the second and third PK studies were used to assess interactions. Results Rifampicin and isoniazid pharmacokinetics did not change substantially with saquinavir and ritonavir. A significant 39.5%, 34.9% and 48.7% reduction in median saquinavir AUC0–24, Cmax and Ctrough, respectively, was seen with rifampicin and isoniazid. Ritonavir AUC0–24, Cmax and Ctrough decreased 42.5%, 49.6% and 64.3%, respectively, with rifampicin and isoniazid. Conclusions There was a significant interaction between saquinavir, ritonavir and rifampicin, with reduction in median plasma concentrations of saquinavir and ritonavir. Saquinavir should be given with caution in patients receiving rifampicin. Twice-daily dosing or higher saquinavir doses in once-daily administration should be tested to obtain more appropriate plasma levels.
doi_str_mv 10.1093/jac/dkl552
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Methods Open-label, single-arm, sequential PK study including 22 patients with HIV infection and TB. During the first 2 months, patients received rifampicin, isoniazid and pyrazinamide, with or without ethambutol (first PK study, n = 22). Then patients stopped pyrazinamide and ethambutol and started once-daily antiretroviral therapy (ART) with didanosine, lamivudine, ritonavir (200 mg) and saquinavir (1600 mg) (second PK study, n = 18). Patients stopped all TB drugs after 9 months continuing the same ART (third PK study, n = 15). Differences between TB drug parameters in the first and second PK studies, and between PI parameters in the second and third PK studies were used to assess interactions. Results Rifampicin and isoniazid pharmacokinetics did not change substantially with saquinavir and ritonavir. A significant 39.5%, 34.9% and 48.7% reduction in median saquinavir AUC0–24, Cmax and Ctrough, respectively, was seen with rifampicin and isoniazid. Ritonavir AUC0–24, Cmax and Ctrough decreased 42.5%, 49.6% and 64.3%, respectively, with rifampicin and isoniazid. Conclusions There was a significant interaction between saquinavir, ritonavir and rifampicin, with reduction in median plasma concentrations of saquinavir and ritonavir. Saquinavir should be given with caution in patients receiving rifampicin. Twice-daily dosing or higher saquinavir doses in once-daily administration should be tested to obtain more appropriate plasma levels.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkl552</identifier><identifier>PMID: 17307771</identifier><identifier>CODEN: JACHDX</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Adult ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - pharmacokinetics ; Anti-HIV Agents - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiretroviral drugs ; antiretroviral therapy ; Antitubercular Agents - adverse effects ; Antitubercular Agents - pharmacokinetics ; Antitubercular Agents - therapeutic use ; Area Under Curve ; Bacterial diseases ; Biological and medical sciences ; Chromatography, High Pressure Liquid ; Drug Interactions ; Female ; HIV ; HIV infection ; HIV Infections - complications ; HIV Infections - drug therapy ; HIV Infections - metabolism ; HIV Protease Inhibitors - adverse effects ; HIV Protease Inhibitors - pharmacokinetics ; HIV Protease Inhibitors - therapeutic use ; Human bacterial diseases ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infectious diseases ; Male ; Medical sciences ; Models, Statistical ; Pharmacology ; Pharmacology. Drug treatments ; Protease inhibitors ; Rifampin - adverse effects ; Rifampin - pharmacokinetics ; Rifampin - therapeutic use ; Ritonavir - adverse effects ; Ritonavir - pharmacokinetics ; Ritonavir - therapeutic use ; Saquinavir - adverse effects ; Saquinavir - pharmacokinetics ; Saquinavir - therapeutic use ; Spectrophotometry, Ultraviolet ; Tuberculosis ; Tuberculosis - complications ; Tuberculosis - drug therapy ; Tuberculosis - metabolism ; Tuberculosis and atypical mycobacterial infections ; tuberculosis therapy ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids</subject><ispartof>Journal of antimicrobial chemotherapy, 2007-04, Vol.59 (4), p.690-697</ispartof><rights>The Author 2007. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org 2007</rights><rights>2007 INIST-CNRS</rights><rights>The Author 2007. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c502t-4edc82fb99b1283fd106c636422d1a5c773b0afe09de5b39c5e74f3dba6748bd3</citedby><cites>FETCH-LOGICAL-c502t-4edc82fb99b1283fd106c636422d1a5c773b0afe09de5b39c5e74f3dba6748bd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=18688057$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17307771$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ribera, Esteban</creatorcontrib><creatorcontrib>Azuaje, Carlos</creatorcontrib><creatorcontrib>Lopez, Rosa M.</creatorcontrib><creatorcontrib>Domingo, Pere</creatorcontrib><creatorcontrib>Curran, Adria</creatorcontrib><creatorcontrib>Feijoo, Maria</creatorcontrib><creatorcontrib>Pou, Leonor</creatorcontrib><creatorcontrib>Sánchez, Paquita</creatorcontrib><creatorcontrib>Sambeat, Maria Antonia</creatorcontrib><creatorcontrib>Colomer, Joan</creatorcontrib><creatorcontrib>Lopez-Colomes, Josep Lluis</creatorcontrib><creatorcontrib>Crespo, Manuel</creatorcontrib><creatorcontrib>Falcó, Vicenç</creatorcontrib><creatorcontrib>Ocaña, Imma</creatorcontrib><creatorcontrib>Pahissa, Albert</creatorcontrib><title>Pharmacokinetic interaction between rifampicin and the once-daily combination of saquinavir and low-dose ritonavir in HIV-infected patients with tuberculosis</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Objectives To assess plasma steady-state pharmacokinetics (PK) of rifampicin, isoniazid, saquinavir and ritonavir in HIV and tuberculosis (TB) co-infected patients, and investigate potential interactions between TB drugs and protease inhibitors (PIs). Methods Open-label, single-arm, sequential PK study including 22 patients with HIV infection and TB. During the first 2 months, patients received rifampicin, isoniazid and pyrazinamide, with or without ethambutol (first PK study, n = 22). Then patients stopped pyrazinamide and ethambutol and started once-daily antiretroviral therapy (ART) with didanosine, lamivudine, ritonavir (200 mg) and saquinavir (1600 mg) (second PK study, n = 18). Patients stopped all TB drugs after 9 months continuing the same ART (third PK study, n = 15). Differences between TB drug parameters in the first and second PK studies, and between PI parameters in the second and third PK studies were used to assess interactions. Results Rifampicin and isoniazid pharmacokinetics did not change substantially with saquinavir and ritonavir. A significant 39.5%, 34.9% and 48.7% reduction in median saquinavir AUC0–24, Cmax and Ctrough, respectively, was seen with rifampicin and isoniazid. Ritonavir AUC0–24, Cmax and Ctrough decreased 42.5%, 49.6% and 64.3%, respectively, with rifampicin and isoniazid. Conclusions There was a significant interaction between saquinavir, ritonavir and rifampicin, with reduction in median plasma concentrations of saquinavir and ritonavir. Saquinavir should be given with caution in patients receiving rifampicin. Twice-daily dosing or higher saquinavir doses in once-daily administration should be tested to obtain more appropriate plasma levels.</description><subject>Adult</subject><subject>Anti-HIV Agents - adverse effects</subject><subject>Anti-HIV Agents - pharmacokinetics</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiretroviral drugs</subject><subject>antiretroviral therapy</subject><subject>Antitubercular Agents - adverse effects</subject><subject>Antitubercular Agents - pharmacokinetics</subject><subject>Antitubercular Agents - therapeutic use</subject><subject>Area Under Curve</subject><subject>Bacterial diseases</subject><subject>Biological and medical sciences</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Drug Interactions</subject><subject>Female</subject><subject>HIV</subject><subject>HIV infection</subject><subject>HIV Infections - complications</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - metabolism</subject><subject>HIV Protease Inhibitors - adverse effects</subject><subject>HIV Protease Inhibitors - pharmacokinetics</subject><subject>HIV Protease Inhibitors - therapeutic use</subject><subject>Human bacterial diseases</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Models, Statistical</subject><subject>Pharmacology</subject><subject>Pharmacology. Drug treatments</subject><subject>Protease inhibitors</subject><subject>Rifampin - adverse effects</subject><subject>Rifampin - pharmacokinetics</subject><subject>Rifampin - therapeutic use</subject><subject>Ritonavir - adverse effects</subject><subject>Ritonavir - pharmacokinetics</subject><subject>Ritonavir - therapeutic use</subject><subject>Saquinavir - adverse effects</subject><subject>Saquinavir - pharmacokinetics</subject><subject>Saquinavir - therapeutic use</subject><subject>Spectrophotometry, Ultraviolet</subject><subject>Tuberculosis</subject><subject>Tuberculosis - complications</subject><subject>Tuberculosis - drug therapy</subject><subject>Tuberculosis - metabolism</subject><subject>Tuberculosis and atypical mycobacterial infections</subject><subject>tuberculosis therapy</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. 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Aids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ribera, Esteban</creatorcontrib><creatorcontrib>Azuaje, Carlos</creatorcontrib><creatorcontrib>Lopez, Rosa M.</creatorcontrib><creatorcontrib>Domingo, Pere</creatorcontrib><creatorcontrib>Curran, Adria</creatorcontrib><creatorcontrib>Feijoo, Maria</creatorcontrib><creatorcontrib>Pou, Leonor</creatorcontrib><creatorcontrib>Sánchez, Paquita</creatorcontrib><creatorcontrib>Sambeat, Maria Antonia</creatorcontrib><creatorcontrib>Colomer, Joan</creatorcontrib><creatorcontrib>Lopez-Colomes, Josep Lluis</creatorcontrib><creatorcontrib>Crespo, Manuel</creatorcontrib><creatorcontrib>Falcó, Vicenç</creatorcontrib><creatorcontrib>Ocaña, Imma</creatorcontrib><creatorcontrib>Pahissa, Albert</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ribera, Esteban</au><au>Azuaje, Carlos</au><au>Lopez, Rosa M.</au><au>Domingo, Pere</au><au>Curran, Adria</au><au>Feijoo, Maria</au><au>Pou, Leonor</au><au>Sánchez, Paquita</au><au>Sambeat, Maria Antonia</au><au>Colomer, Joan</au><au>Lopez-Colomes, Josep Lluis</au><au>Crespo, Manuel</au><au>Falcó, Vicenç</au><au>Ocaña, Imma</au><au>Pahissa, Albert</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacokinetic interaction between rifampicin and the once-daily combination of saquinavir and low-dose ritonavir in HIV-infected patients with tuberculosis</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2007-04-01</date><risdate>2007</risdate><volume>59</volume><issue>4</issue><spage>690</spage><epage>697</epage><pages>690-697</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><coden>JACHDX</coden><abstract>Objectives To assess plasma steady-state pharmacokinetics (PK) of rifampicin, isoniazid, saquinavir and ritonavir in HIV and tuberculosis (TB) co-infected patients, and investigate potential interactions between TB drugs and protease inhibitors (PIs). Methods Open-label, single-arm, sequential PK study including 22 patients with HIV infection and TB. During the first 2 months, patients received rifampicin, isoniazid and pyrazinamide, with or without ethambutol (first PK study, n = 22). Then patients stopped pyrazinamide and ethambutol and started once-daily antiretroviral therapy (ART) with didanosine, lamivudine, ritonavir (200 mg) and saquinavir (1600 mg) (second PK study, n = 18). Patients stopped all TB drugs after 9 months continuing the same ART (third PK study, n = 15). Differences between TB drug parameters in the first and second PK studies, and between PI parameters in the second and third PK studies were used to assess interactions. Results Rifampicin and isoniazid pharmacokinetics did not change substantially with saquinavir and ritonavir. A significant 39.5%, 34.9% and 48.7% reduction in median saquinavir AUC0–24, Cmax and Ctrough, respectively, was seen with rifampicin and isoniazid. Ritonavir AUC0–24, Cmax and Ctrough decreased 42.5%, 49.6% and 64.3%, respectively, with rifampicin and isoniazid. Conclusions There was a significant interaction between saquinavir, ritonavir and rifampicin, with reduction in median plasma concentrations of saquinavir and ritonavir. Saquinavir should be given with caution in patients receiving rifampicin. Twice-daily dosing or higher saquinavir doses in once-daily administration should be tested to obtain more appropriate plasma levels.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>17307771</pmid><doi>10.1093/jac/dkl552</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record>
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ispartof Journal of antimicrobial chemotherapy, 2007-04, Vol.59 (4), p.690-697
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1460-2091
language eng
recordid cdi_proquest_miscellaneous_19658719
source Oxford Journals Online
subjects Adult
Anti-HIV Agents - adverse effects
Anti-HIV Agents - pharmacokinetics
Anti-HIV Agents - therapeutic use
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiretroviral drugs
antiretroviral therapy
Antitubercular Agents - adverse effects
Antitubercular Agents - pharmacokinetics
Antitubercular Agents - therapeutic use
Area Under Curve
Bacterial diseases
Biological and medical sciences
Chromatography, High Pressure Liquid
Drug Interactions
Female
HIV
HIV infection
HIV Infections - complications
HIV Infections - drug therapy
HIV Infections - metabolism
HIV Protease Inhibitors - adverse effects
HIV Protease Inhibitors - pharmacokinetics
HIV Protease Inhibitors - therapeutic use
Human bacterial diseases
Human immunodeficiency virus
Human viral diseases
Humans
Immunodeficiencies
Immunodeficiencies. Immunoglobulinopathies
Immunopathology
Infectious diseases
Male
Medical sciences
Models, Statistical
Pharmacology
Pharmacology. Drug treatments
Protease inhibitors
Rifampin - adverse effects
Rifampin - pharmacokinetics
Rifampin - therapeutic use
Ritonavir - adverse effects
Ritonavir - pharmacokinetics
Ritonavir - therapeutic use
Saquinavir - adverse effects
Saquinavir - pharmacokinetics
Saquinavir - therapeutic use
Spectrophotometry, Ultraviolet
Tuberculosis
Tuberculosis - complications
Tuberculosis - drug therapy
Tuberculosis - metabolism
Tuberculosis and atypical mycobacterial infections
tuberculosis therapy
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
title Pharmacokinetic interaction between rifampicin and the once-daily combination of saquinavir and low-dose ritonavir in HIV-infected patients with tuberculosis
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