Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial).
<h4>Objective</h4>To assess efavirenz plasma concentrations and their association with treatment efficacy and tolerance of efavirenz 600 mg daily in HIV-tuberculosis co-infected patients.<h4>Methods</h4>HIV-infected adults with CD4+ T cell count ≤ 200/mm(3) received standard...
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2014
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oai:doaj.org-article:be9fc25d4ed04959999b95bd23d3eb022021-11-18T08:29:07ZPlasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial).1932-620310.1371/journal.pone.0090350https://doaj.org/article/be9fc25d4ed04959999b95bd23d3eb022014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24608960/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Objective</h4>To assess efavirenz plasma concentrations and their association with treatment efficacy and tolerance of efavirenz 600 mg daily in HIV-tuberculosis co-infected patients.<h4>Methods</h4>HIV-infected adults with CD4+ T cell count ≤ 200/mm(3) received standard 6-month tuberculosis treatment and antiretroviral therapy including a daily-dose of 600 mg of efavirenz, irrespective of their body weight. Mid-dose blood samples were drawn both on tuberculosis treatment (week +2 and week +6 after antiretroviral therapy initiation, and week 22 of follow-up) and off tuberculosis treatment (week 50 of follow-up). Considered therapeutic range was 1,000 to 4,000 ng/mL. Multivariate analysis was performed to evaluate the association between efavirenz concentration below 1,000 ng/mL and virological failure. Linear regression was used to test the association between efavirenz exposure and CD4+ T cell gain. Severe side effects potentially related to efavirenz were described and their association with efavirenz exposure was tested by multivariate analysis.<h4>Results</h4>Efavirenz plasma concentrations were available in 540 patients. Median [interquartile range] efavirenz concentrations were 2,674 ng/mL [1,690-4,533], 2,667 ng/mL [1,753-4,494] and 2,799 ng/mL [1,804-4,744] at week +2, week +6, week 22, respectively, and 2,766 ng/mL [1,941-3,976] at week 50. Efavirenz concentrations were lower at week 50 (off rifampicin) compared to week 22 (on rifampicin) (p<0.001). Late attendance to study visit and low hemoglobinemia were the only factors associated with an increased risk of efavirenz concentration below 1,000 ng/mL. Efavirenz concentration below 1,000 ng/mL was not associated with treatment failure. Efavirenz concentration above 4,000 ng/mL was associated with higher risk of central nervous system side effects (p<0.001) and of hepatotoxicity (p<0.001).<h4>Conclusion</h4>Body weight and tuberculosis treatment were not associated with low efavirenz concentrations or treatment failure, supporting the 600 mg daily-dose of efavirenz in HIV-tuberculosis co-infected patients. High efavirenz concentrations were related to a higher risk of central nervous system side effects and hepatotoxicity.<h4>Trial registration</h4>ClinicalTrials.gov NCT01300481.Laurence BorandYoann MadecDidier LaureillardMonidarin ChouOlivier MarcyPhearavin PhengNarom PrakChindamony KimKhemarin Kim LakChanroeun HakBunnet DimEric NerrienetArnaud FontanetThim SokAnne E GoldfeldFrançois-Xavier BlancAnne-Marie TaburetPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 3, p e90350 (2014) |
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| collection |
DOAJ |
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EN |
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Medicine R Science Q |
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Medicine R Science Q Laurence Borand Yoann Madec Didier Laureillard Monidarin Chou Olivier Marcy Phearavin Pheng Narom Prak Chindamony Kim Khemarin Kim Lak Chanroeun Hak Bunnet Dim Eric Nerrienet Arnaud Fontanet Thim Sok Anne E Goldfeld François-Xavier Blanc Anne-Marie Taburet Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial). |
| description |
<h4>Objective</h4>To assess efavirenz plasma concentrations and their association with treatment efficacy and tolerance of efavirenz 600 mg daily in HIV-tuberculosis co-infected patients.<h4>Methods</h4>HIV-infected adults with CD4+ T cell count ≤ 200/mm(3) received standard 6-month tuberculosis treatment and antiretroviral therapy including a daily-dose of 600 mg of efavirenz, irrespective of their body weight. Mid-dose blood samples were drawn both on tuberculosis treatment (week +2 and week +6 after antiretroviral therapy initiation, and week 22 of follow-up) and off tuberculosis treatment (week 50 of follow-up). Considered therapeutic range was 1,000 to 4,000 ng/mL. Multivariate analysis was performed to evaluate the association between efavirenz concentration below 1,000 ng/mL and virological failure. Linear regression was used to test the association between efavirenz exposure and CD4+ T cell gain. Severe side effects potentially related to efavirenz were described and their association with efavirenz exposure was tested by multivariate analysis.<h4>Results</h4>Efavirenz plasma concentrations were available in 540 patients. Median [interquartile range] efavirenz concentrations were 2,674 ng/mL [1,690-4,533], 2,667 ng/mL [1,753-4,494] and 2,799 ng/mL [1,804-4,744] at week +2, week +6, week 22, respectively, and 2,766 ng/mL [1,941-3,976] at week 50. Efavirenz concentrations were lower at week 50 (off rifampicin) compared to week 22 (on rifampicin) (p<0.001). Late attendance to study visit and low hemoglobinemia were the only factors associated with an increased risk of efavirenz concentration below 1,000 ng/mL. Efavirenz concentration below 1,000 ng/mL was not associated with treatment failure. Efavirenz concentration above 4,000 ng/mL was associated with higher risk of central nervous system side effects (p<0.001) and of hepatotoxicity (p<0.001).<h4>Conclusion</h4>Body weight and tuberculosis treatment were not associated with low efavirenz concentrations or treatment failure, supporting the 600 mg daily-dose of efavirenz in HIV-tuberculosis co-infected patients. High efavirenz concentrations were related to a higher risk of central nervous system side effects and hepatotoxicity.<h4>Trial registration</h4>ClinicalTrials.gov NCT01300481. |
| format |
article |
| author |
Laurence Borand Yoann Madec Didier Laureillard Monidarin Chou Olivier Marcy Phearavin Pheng Narom Prak Chindamony Kim Khemarin Kim Lak Chanroeun Hak Bunnet Dim Eric Nerrienet Arnaud Fontanet Thim Sok Anne E Goldfeld François-Xavier Blanc Anne-Marie Taburet |
| author_facet |
Laurence Borand Yoann Madec Didier Laureillard Monidarin Chou Olivier Marcy Phearavin Pheng Narom Prak Chindamony Kim Khemarin Kim Lak Chanroeun Hak Bunnet Dim Eric Nerrienet Arnaud Fontanet Thim Sok Anne E Goldfeld François-Xavier Blanc Anne-Marie Taburet |
| author_sort |
Laurence Borand |
| title |
Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial). |
| title_short |
Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial). |
| title_full |
Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial). |
| title_fullStr |
Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial). |
| title_full_unstemmed |
Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial). |
| title_sort |
plasma concentrations, efficacy and safety of efavirenz in hiv-infected adults treated for tuberculosis in cambodia (anrs 1295-cipra kh001 camelia trial). |
| publisher |
Public Library of Science (PLoS) |
| publishDate |
2014 |
| url |
https://doaj.org/article/be9fc25d4ed04959999b95bd23d3eb02 |
| work_keys_str_mv |
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