Raltegravir pharmacokinetics in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C)
To describe raltegravir pharmacokinetics at steady-state in HIV/hepatitis C virus (HCV)-coinfected patients under antiretroviral (ARV) treatment with (n = 5) and without (n = 5) advanced liver cirrhosis (Child-Pugh C). This was a non-randomized, Phase I, parallel-assignment, open-label pharmacokinet...
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| Veröffentlicht in: | Journal of antimicrobial chemotherapy 2014-02, Vol.69 (2), p.471-475 |
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| container_title | Journal of antimicrobial chemotherapy |
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| creator | Hernández-Novoa, Beatriz Moreno, Ana Pérez-Elías, María J Quereda, Carmen Dronda, Fernando Casado, José L Madrid-Elena, Nadia Aguilar, Mónica Fumero, Emilio Moltó, José Moreno, Santiago |
| description | To describe raltegravir pharmacokinetics at steady-state in HIV/hepatitis C virus (HCV)-coinfected patients under antiretroviral (ARV) treatment with (n = 5) and without (n = 5) advanced liver cirrhosis (Child-Pugh C).
This was a non-randomized, Phase I, parallel-assignment, open-label pharmacokinetic study in HIV/HCV-coinfected patients with Child-Pugh grade C hepatic cirrhosis. We recruited clinically stable HIV/HCV-coinfected adult patients with controlled HIV viraemia ( |
| doi_str_mv | 10.1093/jac/dkt386 |
| format | Article |
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This was a non-randomized, Phase I, parallel-assignment, open-label pharmacokinetic study in HIV/HCV-coinfected patients with Child-Pugh grade C hepatic cirrhosis. We recruited clinically stable HIV/HCV-coinfected adult patients with controlled HIV viraemia (<50 copies/mL) for at least 6 months. Raltegravir (400 mg twice daily) was added under fasting conditions for 5 days to the successful ritonavir-boosted protease inhibitor-based ARV regimen. The trial was registered in the ClinicalTrials.gov database (NCT01289951) (LIVERAL).
Raltegravir AUC0-12 and C12 were increased 1.72-fold (90% CI, 1.02 to 2.92) and 6.58-fold (90% CI, 2.92 to14.85), respectively, in patients with advanced liver cirrhosis. No safety issues were identified and raltegravir was well tolerated by all patients.
Raltegravir plasma levels are increased in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C). Despite the higher exposure, raltegravir was safe and well tolerated.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkt386</identifier><identifier>PMID: 24097843</identifier><language>eng</language><publisher>England: Oxford Publishing Limited (England)</publisher><subject>Adult ; Antiretroviral drugs ; Female ; Hepatitis ; Hepatitis C - blood ; Hepatitis C - drug therapy ; Hepatitis C - epidemiology ; Hepatitis C virus ; HIV ; HIV Infections - blood ; HIV Infections - drug therapy ; HIV Infections - epidemiology ; HIV Integrase Inhibitors - blood ; HIV Integrase Inhibitors - pharmacokinetics ; HIV Integrase Inhibitors - therapeutic use ; Human immunodeficiency virus ; Humans ; Liver cirrhosis ; Liver Cirrhosis - blood ; Liver Cirrhosis - drug therapy ; Liver Cirrhosis - epidemiology ; Male ; Middle Aged ; Protease inhibitors ; Pyrrolidinones - blood ; Pyrrolidinones - pharmacokinetics ; Pyrrolidinones - therapeutic use ; Raltegravir Potassium</subject><ispartof>Journal of antimicrobial chemotherapy, 2014-02, Vol.69 (2), p.471-475</ispartof><rights>Copyright Oxford Publishing Limited(England) Feb 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-bd35f58c444f7b1428589dc604e0e421e71dc2e164870673f53742fa690a1f023</citedby><cites>FETCH-LOGICAL-c384t-bd35f58c444f7b1428589dc604e0e421e71dc2e164870673f53742fa690a1f023</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24097843$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hernández-Novoa, Beatriz</creatorcontrib><creatorcontrib>Moreno, Ana</creatorcontrib><creatorcontrib>Pérez-Elías, María J</creatorcontrib><creatorcontrib>Quereda, Carmen</creatorcontrib><creatorcontrib>Dronda, Fernando</creatorcontrib><creatorcontrib>Casado, José L</creatorcontrib><creatorcontrib>Madrid-Elena, Nadia</creatorcontrib><creatorcontrib>Aguilar, Mónica</creatorcontrib><creatorcontrib>Fumero, Emilio</creatorcontrib><creatorcontrib>Moltó, José</creatorcontrib><creatorcontrib>Moreno, Santiago</creatorcontrib><title>Raltegravir pharmacokinetics in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C)</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>To describe raltegravir pharmacokinetics at steady-state in HIV/hepatitis C virus (HCV)-coinfected patients under antiretroviral (ARV) treatment with (n = 5) and without (n = 5) advanced liver cirrhosis (Child-Pugh C).
This was a non-randomized, Phase I, parallel-assignment, open-label pharmacokinetic study in HIV/HCV-coinfected patients with Child-Pugh grade C hepatic cirrhosis. We recruited clinically stable HIV/HCV-coinfected adult patients with controlled HIV viraemia (<50 copies/mL) for at least 6 months. Raltegravir (400 mg twice daily) was added under fasting conditions for 5 days to the successful ritonavir-boosted protease inhibitor-based ARV regimen. The trial was registered in the ClinicalTrials.gov database (NCT01289951) (LIVERAL).
Raltegravir AUC0-12 and C12 were increased 1.72-fold (90% CI, 1.02 to 2.92) and 6.58-fold (90% CI, 2.92 to14.85), respectively, in patients with advanced liver cirrhosis. No safety issues were identified and raltegravir was well tolerated by all patients.
Raltegravir plasma levels are increased in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C). Despite the higher exposure, raltegravir was safe and well tolerated.</description><subject>Adult</subject><subject>Antiretroviral drugs</subject><subject>Female</subject><subject>Hepatitis</subject><subject>Hepatitis C - blood</subject><subject>Hepatitis C - drug therapy</subject><subject>Hepatitis C - epidemiology</subject><subject>Hepatitis C virus</subject><subject>HIV</subject><subject>HIV Infections - blood</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - epidemiology</subject><subject>HIV Integrase Inhibitors - blood</subject><subject>HIV Integrase Inhibitors - pharmacokinetics</subject><subject>HIV Integrase Inhibitors - therapeutic use</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Liver cirrhosis</subject><subject>Liver Cirrhosis - blood</subject><subject>Liver Cirrhosis - drug therapy</subject><subject>Liver Cirrhosis - epidemiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Protease inhibitors</subject><subject>Pyrrolidinones - blood</subject><subject>Pyrrolidinones - pharmacokinetics</subject><subject>Pyrrolidinones - therapeutic use</subject><subject>Raltegravir Potassium</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqN0U1LxDAQgOEgiq4fF3-ABLyoUHfy0SQ9SlF3QVBE91qyaWqzdts1SVf891ZWPXjyNDA8DAwvQscELglkbLzQZly-RqbEFhoRLiChkJFtNAIGaSJ5yvbQfggLABCpULtoj3LIpOJshOpH3UT74vXaebyqtV9q07261kZnAnYtnkxn40k-S0zn2sqaaEu80tHZNgb87mKNdbnWrRnWjVtbj43zvu6CC_gsr11TJg_9S43z80O0U-km2KPveYCeb66f8klyd387za_uEsMUj8m8ZGmVKsM5r-SccKpSlZVGALdgOSVWktJQSwRXEoRkVcokp5UWGWhSAWUH6Gxzd-W7t96GWCxdMLZpdGu7PhSEZ0JlihL5HwqSZJJ-0dM_dNH1vh0eGZRUlAkGZFAXG2V8F4K3VbHybqn9R0Gg-EpVDKmKTaoBn3yf7OdLW_7SnzbsE_qijck</recordid><startdate>201402</startdate><enddate>201402</enddate><creator>Hernández-Novoa, Beatriz</creator><creator>Moreno, Ana</creator><creator>Pérez-Elías, María J</creator><creator>Quereda, Carmen</creator><creator>Dronda, Fernando</creator><creator>Casado, José L</creator><creator>Madrid-Elena, Nadia</creator><creator>Aguilar, Mónica</creator><creator>Fumero, Emilio</creator><creator>Moltó, José</creator><creator>Moreno, Santiago</creator><general>Oxford Publishing Limited (England)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QO</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>201402</creationdate><title>Raltegravir pharmacokinetics in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C)</title><author>Hernández-Novoa, Beatriz ; Moreno, Ana ; Pérez-Elías, María J ; Quereda, Carmen ; Dronda, Fernando ; Casado, José L ; Madrid-Elena, Nadia ; Aguilar, Mónica ; Fumero, Emilio ; Moltó, José ; Moreno, Santiago</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-bd35f58c444f7b1428589dc604e0e421e71dc2e164870673f53742fa690a1f023</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Antiretroviral drugs</topic><topic>Female</topic><topic>Hepatitis</topic><topic>Hepatitis C - blood</topic><topic>Hepatitis C - drug therapy</topic><topic>Hepatitis C - epidemiology</topic><topic>Hepatitis C virus</topic><topic>HIV</topic><topic>HIV Infections - blood</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - epidemiology</topic><topic>HIV Integrase Inhibitors - blood</topic><topic>HIV Integrase Inhibitors - pharmacokinetics</topic><topic>HIV Integrase Inhibitors - therapeutic use</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Liver cirrhosis</topic><topic>Liver Cirrhosis - blood</topic><topic>Liver Cirrhosis - drug therapy</topic><topic>Liver Cirrhosis - epidemiology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Protease inhibitors</topic><topic>Pyrrolidinones - blood</topic><topic>Pyrrolidinones - pharmacokinetics</topic><topic>Pyrrolidinones - therapeutic use</topic><topic>Raltegravir Potassium</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hernández-Novoa, Beatriz</creatorcontrib><creatorcontrib>Moreno, Ana</creatorcontrib><creatorcontrib>Pérez-Elías, María J</creatorcontrib><creatorcontrib>Quereda, Carmen</creatorcontrib><creatorcontrib>Dronda, Fernando</creatorcontrib><creatorcontrib>Casado, José L</creatorcontrib><creatorcontrib>Madrid-Elena, Nadia</creatorcontrib><creatorcontrib>Aguilar, Mónica</creatorcontrib><creatorcontrib>Fumero, Emilio</creatorcontrib><creatorcontrib>Moltó, José</creatorcontrib><creatorcontrib>Moreno, Santiago</creatorcontrib><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 & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hernández-Novoa, Beatriz</au><au>Moreno, Ana</au><au>Pérez-Elías, María J</au><au>Quereda, Carmen</au><au>Dronda, Fernando</au><au>Casado, José L</au><au>Madrid-Elena, Nadia</au><au>Aguilar, Mónica</au><au>Fumero, Emilio</au><au>Moltó, José</au><au>Moreno, Santiago</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Raltegravir pharmacokinetics in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C)</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2014-02</date><risdate>2014</risdate><volume>69</volume><issue>2</issue><spage>471</spage><epage>475</epage><pages>471-475</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><abstract>To describe raltegravir pharmacokinetics at steady-state in HIV/hepatitis C virus (HCV)-coinfected patients under antiretroviral (ARV) treatment with (n = 5) and without (n = 5) advanced liver cirrhosis (Child-Pugh C).
This was a non-randomized, Phase I, parallel-assignment, open-label pharmacokinetic study in HIV/HCV-coinfected patients with Child-Pugh grade C hepatic cirrhosis. We recruited clinically stable HIV/HCV-coinfected adult patients with controlled HIV viraemia (<50 copies/mL) for at least 6 months. Raltegravir (400 mg twice daily) was added under fasting conditions for 5 days to the successful ritonavir-boosted protease inhibitor-based ARV regimen. The trial was registered in the ClinicalTrials.gov database (NCT01289951) (LIVERAL).
Raltegravir AUC0-12 and C12 were increased 1.72-fold (90% CI, 1.02 to 2.92) and 6.58-fold (90% CI, 2.92 to14.85), respectively, in patients with advanced liver cirrhosis. No safety issues were identified and raltegravir was well tolerated by all patients.
Raltegravir plasma levels are increased in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C). Despite the higher exposure, raltegravir was safe and well tolerated.</abstract><cop>England</cop><pub>Oxford Publishing Limited (England)</pub><pmid>24097843</pmid><doi>10.1093/jac/dkt386</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of antimicrobial chemotherapy, 2014-02, Vol.69 (2), p.471-475 |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection; Free Full-Text Journals in Chemistry |
| subjects | Adult Antiretroviral drugs Female Hepatitis Hepatitis C - blood Hepatitis C - drug therapy Hepatitis C - epidemiology Hepatitis C virus HIV HIV Infections - blood HIV Infections - drug therapy HIV Infections - epidemiology HIV Integrase Inhibitors - blood HIV Integrase Inhibitors - pharmacokinetics HIV Integrase Inhibitors - therapeutic use Human immunodeficiency virus Humans Liver cirrhosis Liver Cirrhosis - blood Liver Cirrhosis - drug therapy Liver Cirrhosis - epidemiology Male Middle Aged Protease inhibitors Pyrrolidinones - blood Pyrrolidinones - pharmacokinetics Pyrrolidinones - therapeutic use Raltegravir Potassium |
| title | Raltegravir pharmacokinetics in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C) |
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