Earlier versus Later Start of Antiretroviral Therapy in HIV-Infected Adults with Tuberculosis
When to initiate antiretroviral therapy in patients with newly diagnosed HIV infection and TB has been debated. In this study from Cambodia, giving antiretrovirals 2 weeks after the start of TB therapy was superior to therapy begun at 8 weeks, with a decrease in mortality. Tuberculosis is a major ca...
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| Vydáno v: | The New England journal of medicine Ročník 365; číslo 16; s. 1471 - 1481 |
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| Hlavní autoři: | , , , , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
Waltham, MA
Massachusetts Medical Society
20.10.2011
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| Témata: | |
| ISSN: | 0028-4793, 1533-4406, 1533-4406 |
| On-line přístup: | Získat plný text |
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| Abstract | When to initiate antiretroviral therapy in patients with newly diagnosed HIV infection and TB has been debated. In this study from Cambodia, giving antiretrovirals 2 weeks after the start of TB therapy was superior to therapy begun at 8 weeks, with a decrease in mortality.
Tuberculosis is a major cause of death in persons infected with the human immunodeficiency virus (HIV), especially in resource-limited settings.
1
,
2
Despite effective tuberculosis therapy, mortality is particularly high among patients with severe immunosuppression.
3
,
4
Although mortality among HIV-infected patients has been reported to be approximately 30% within the first 2 months of tuberculosis treatment if antiretroviral therapy (ART) is withheld,
5
the timing for starting ART in patients with tuberculosis has remained unclear.
Arguments that support delayed initiation of ART include concern about the combined toxic effects of drugs, an increased risk of the immune reconstitution inflammatory syndrome (IRIS), and . . . |
|---|---|
| AbstractList | When to initiate antiretroviral therapy in patients with newly diagnosed HIV infection and TB has been debated. In this study from Cambodia, giving antiretrovirals 2 weeks after the start of TB therapy was superior to therapy begun at 8 weeks, with a decrease in mortality.
Tuberculosis is a major cause of death in persons infected with the human immunodeficiency virus (HIV), especially in resource-limited settings.
1
,
2
Despite effective tuberculosis therapy, mortality is particularly high among patients with severe immunosuppression.
3
,
4
Although mortality among HIV-infected patients has been reported to be approximately 30% within the first 2 months of tuberculosis treatment if antiretroviral therapy (ART) is withheld,
5
the timing for starting ART in patients with tuberculosis has remained unclear.
Arguments that support delayed initiation of ART include concern about the combined toxic effects of drugs, an increased risk of the immune reconstitution inflammatory syndrome (IRIS), and . . . BackgroundTuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with regard to the timing for the initiation of antiretroviral therapy (ART) in relation to the start of antituberculosis therapy.MethodsWe tested the hypothesis that the timing of ART initiation would significantly affect mortality among adults not previously exposed to antiretroviral drugs who had newly diagnosed tuberculosis and CD4+ T-cell counts of 200 per cubic millimeter or lower. After beginning the standard, 6-month treatment for tuberculosis, patients were randomly assigned to either earlier treatment (2 weeks after beginning tuberculosis treatment) or later treatment (8 weeks after) with stavudine, lamivudine, and efavirenz. The primary end point was survival.ResultsA total of 661 patients were enrolled and were followed for a median of 25 months. The median CD4+ T-cell count was 25 per cubic millimeter, and the median viral load was 5.64 log10 copies per milliliter. The risk of death was significantly reduced in the group that received ART earlier, with 59 deaths among 332 patients (18%), as compared with 90 deaths among 329 patients (27%) in the later-ART group (hazard ratio, 0.62; 95% confidence interval [CI]; 0.44 to 0.86; P=0.006). The risk of tuberculosis-associated immune reconstitution inflammatory syndrome was significantly increased in the earlier-ART group (hazard ratio, 2.51; 95% CI, 1.78 to 3.59; P<0.001). Irrespective of the study group, the median gain in the CD4+ T-cell count was 114 per cubic millimeter, and the viral load was undetectable at week 50 in 96.5% of the patients.ConclusionsInitiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower. (Funded by the French National Agency for Research on AIDS and Viral Hepatitis and the National Institutes of Health; CAMELIA ClinicalTrials.gov number, NCT01300481.) Tuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with regard to the timing for the initiation of antiretroviral therapy (ART) in relation to the start of antituberculosis therapy.BACKGROUNDTuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with regard to the timing for the initiation of antiretroviral therapy (ART) in relation to the start of antituberculosis therapy.We tested the hypothesis that the timing of ART initiation would significantly affect mortality among adults not previously exposed to antiretroviral drugs who had newly diagnosed tuberculosis and CD4+ T-cell counts of 200 per cubic millimeter or lower. After beginning the standard, 6-month treatment for tuberculosis, patients were randomly assigned to either earlier treatment (2 weeks after beginning tuberculosis treatment) or later treatment (8 weeks after) with stavudine, lamivudine, and efavirenz. The primary end point was survival.METHODSWe tested the hypothesis that the timing of ART initiation would significantly affect mortality among adults not previously exposed to antiretroviral drugs who had newly diagnosed tuberculosis and CD4+ T-cell counts of 200 per cubic millimeter or lower. After beginning the standard, 6-month treatment for tuberculosis, patients were randomly assigned to either earlier treatment (2 weeks after beginning tuberculosis treatment) or later treatment (8 weeks after) with stavudine, lamivudine, and efavirenz. The primary end point was survival.A total of 661 patients were enrolled and were followed for a median of 25 months. The median CD4+ T-cell count was 25 per cubic millimeter, and the median viral load was 5.64 log(10) copies per milliliter. The risk of death was significantly reduced in the group that received ART earlier, with 59 deaths among 332 patients (18%), as compared with 90 deaths among 329 patients (27%) in the later-ART group (hazard ratio, 0.62; 95% confidence interval [CI]; 0.44 to 0.86; P=0.006). The risk of tuberculosis-associated immune reconstitution inflammatory syndrome was significantly increased in the earlier-ART group (hazard ratio, 2.51; 95% CI, 1.78 to 3.59; P<0.001). Irrespective of the study group, the median gain in the CD4+ T-cell count was 114 per cubic millimeter, and the viral load was undetectable at week 50 in 96.5% of the patients.RESULTSA total of 661 patients were enrolled and were followed for a median of 25 months. The median CD4+ T-cell count was 25 per cubic millimeter, and the median viral load was 5.64 log(10) copies per milliliter. The risk of death was significantly reduced in the group that received ART earlier, with 59 deaths among 332 patients (18%), as compared with 90 deaths among 329 patients (27%) in the later-ART group (hazard ratio, 0.62; 95% confidence interval [CI]; 0.44 to 0.86; P=0.006). The risk of tuberculosis-associated immune reconstitution inflammatory syndrome was significantly increased in the earlier-ART group (hazard ratio, 2.51; 95% CI, 1.78 to 3.59; P<0.001). Irrespective of the study group, the median gain in the CD4+ T-cell count was 114 per cubic millimeter, and the viral load was undetectable at week 50 in 96.5% of the patients.Initiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower. (Funded by the French National Agency for Research on AIDS and Viral Hepatitis and the National Institutes of Health; CAMELIA ClinicalTrials.gov number, NCT01300481.).CONCLUSIONSInitiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower. (Funded by the French National Agency for Research on AIDS and Viral Hepatitis and the National Institutes of Health; CAMELIA ClinicalTrials.gov number, NCT01300481.). Tuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with regard to the timing for the initiation of antiretroviral therapy (ART) in relation to the start of antituberculosis therapy. We tested the hypothesis that the timing of ART initiation would significantly affect mortality among adults not previously exposed to antiretroviral drugs who had newly diagnosed tuberculosis and CD4+ T-cell counts of 200 per cubic millimeter or lower. After beginning the standard, 6-month treatment for tuberculosis, patients were randomly assigned to either earlier treatment (2 weeks after beginning tuberculosis treatment) or later treatment (8 weeks after) with stavudine, lamivudine, and efavirenz. The primary end point was survival. A total of 661 patients were enrolled and were followed for a median of 25 months. The median CD4+ T-cell count was 25 per cubic millimeter, and the median viral load was 5.64 log(10) copies per milliliter. The risk of death was significantly reduced in the group that received ART earlier, with 59 deaths among 332 patients (18%), as compared with 90 deaths among 329 patients (27%) in the later-ART group (hazard ratio, 0.62; 95% confidence interval [CI]; 0.44 to 0.86; P=0.006). The risk of tuberculosis-associated immune reconstitution inflammatory syndrome was significantly increased in the earlier-ART group (hazard ratio, 2.51; 95% CI, 1.78 to 3.59; P<0.001). Irrespective of the study group, the median gain in the CD4+ T-cell count was 114 per cubic millimeter, and the viral load was undetectable at week 50 in 96.5% of the patients. Initiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower. (Funded by the French National Agency for Research on AIDS and Viral Hepatitis and the National Institutes of Health; CAMELIA ClinicalTrials.gov number, NCT01300481.). BACKGROUND: Tuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with regard to the timing for the initiation of antiretroviral therapy (ART) in relation to the start of antituberculosis therapy.METHODS: We tested the hypothesis that the timing of ART initiation would significantly affect mortality among adults not previously exposed to antiretroviral drugs who had newly diagnosed tuberculosis and CD4+ T-cell counts of 200 per cubic millimeter or lower. After beginning the standard, 6-month treatment for tuberculosis, patients were randomly assigned to either earlier treatment (2 weeks after beginning tuberculosis treatment) or later treatment (8 weeks after) with stavudine, lamivudine, and efavirenz. The primary end point was survival.RESULTS: A total of 661 patients were enrolled and were followed for a median of 25 months. The median CD4+ T-cell count was 25 per cubic millimeter, and the median viral load was 5.64 log10 copies per milliliter. The risk of death was significantly reduced in the group that received ART earlier, with 59 deaths among 332 patients (18%), as compared with 90 deaths among 329 patients (27%) in the later-ART group (hazard ratio, 0.62; 95% confidence interval [CI]; 0.44 to 0.86; P=0.006). The risk of tuberculosis-associated immune reconstitution inflammatory syndrome was significantly increased in the earlier-ART group (hazard ratio, 2.51; 95% CI, 1.78 to 3.59; P<0.001). Irrespective of the study group, the median gain in the CD4+ T-cell count was 114 per cubic millimeter, and the viral load was undetectable at week 50 in 96.5% of the patients.CONCLUSIONS: Initiating ART 2 weeks after the start of tuberculosis treatment significantly improved survival among HIV-infected adults with CD4+ T-cell counts of 200 per cubic millimeter or lower. |
| Author | Prak, Narom Guillard, Bertrand Fernandez, Marcelo Sun, Sath Nerrienet, Eric Fox, Lawrence Rekacewicz, Claire Sin, Chhun Im Madec, Yoann Sar, Borann Goldfeld, Anne E Laureillard, Didier Chan, Sarin Lak, Khemarin Kim Vong, Sirenda Borand, Laurence Kim, Chindamony Blanc, François-Xavier Sok, Thim Marcy, Olivier Hak, Chanroeurn Delfraissy, Jean-François Dim, Bunnet |
| Author_xml | – sequence: 1 givenname: François-Xavier surname: Blanc fullname: Blanc, François-Xavier – sequence: 2 givenname: Thim surname: Sok fullname: Sok, Thim – sequence: 3 givenname: Didier surname: Laureillard fullname: Laureillard, Didier – sequence: 4 givenname: Laurence surname: Borand fullname: Borand, Laurence – sequence: 5 givenname: Claire surname: Rekacewicz fullname: Rekacewicz, Claire – sequence: 6 givenname: Eric surname: Nerrienet fullname: Nerrienet, Eric – sequence: 7 givenname: Yoann surname: Madec fullname: Madec, Yoann – sequence: 8 givenname: Olivier surname: Marcy fullname: Marcy, Olivier – sequence: 9 givenname: Sarin surname: Chan fullname: Chan, Sarin – sequence: 10 givenname: Narom surname: Prak fullname: Prak, Narom – sequence: 11 givenname: Chindamony surname: Kim fullname: Kim, Chindamony – sequence: 12 givenname: Khemarin Kim surname: Lak fullname: Lak, Khemarin Kim – sequence: 13 givenname: Chanroeurn surname: Hak fullname: Hak, Chanroeurn – sequence: 14 givenname: Bunnet surname: Dim fullname: Dim, Bunnet – sequence: 15 givenname: Chhun Im surname: Sin fullname: Sin, Chhun Im – sequence: 16 givenname: Sath surname: Sun fullname: Sun, Sath – sequence: 17 givenname: Bertrand surname: Guillard fullname: Guillard, Bertrand – sequence: 18 givenname: Borann surname: Sar fullname: Sar, Borann – sequence: 19 givenname: Sirenda surname: Vong fullname: Vong, Sirenda – sequence: 20 givenname: Marcelo surname: Fernandez fullname: Fernandez, Marcelo – sequence: 21 givenname: Lawrence surname: Fox fullname: Fox, Lawrence – sequence: 22 givenname: Jean-François surname: Delfraissy fullname: Delfraissy, Jean-François – sequence: 23 givenname: Anne E surname: Goldfeld fullname: Goldfeld, Anne E |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24623406$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22010913$$D View this record in MEDLINE/PubMed https://hal.science/hal-02868136$$DView record in HAL |
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| CODEN | NEJMAG |
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| ContentType | Journal Article |
| Contributor | Tong, Ratanak Sok, Cheung Heng, Tay Kry Chea, Sotheary Cheung, Sok Toeung, Pichda Yim, Chanthon Sean, Soeun Tun, Sophy Teang, Sophary Chheang, Ra Chhay, Sinan Pao, Sam Aun Kong, Kunthea Chhoeun, Sokim Kry, Pheakun Khin, Vannath Tith, Saorin Kao, Chheng Lang Kam, Sokhoeun Van, Thieng Be, Phally Am, Bora Yim, Sean Chan, Sithan Sok, Sina Tan, Posson Sok, Kim Eng Monidarin, Chou Phon, Kerya Chan Ear, Nimul Ouk, Vara Meas, Sina Chea, Kimlay Lao, Phea Te, Nai Sim Nget, Chan Chhaya Samret, Tol Keo, Chantary Nouhin, Janin Y, Tuon Seang Chan, Lay Heng Sieng, Hort Ing, Phany Kuoch, Sokhon Lim, Hok Kean Chea, Phalla Neak, Vibol Soum, Sophea Ngin, Sopheak San, Soeun Ear, Chan Nimul Chea, Sokeo Koh, Chuop Chum Yoeun, Yong Men, Nimul Roat Keo, Kimthan Koy, Thoeun Ung, Chanthan Me, Yimtheavy Hem, Sareth Ken, Sreymom Say, Leakhena Kaing, Sor Say, Vanny Chy, Say Men, Thoeurn Tes, Kunthea Kun, Sopheap Chhun, Seam Yim, Chanthan Voeung, Sokbophang Sum, Sarann Dy, Keo Kunthea Uorng, Saroeun Ban, Boroath Ken, Nyn Meardey, Keolinelyanneth Song, Sovannara Ay, Sao Sarady Prak, Vanda Chan, |
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surname: Tan fullname: Tan, Posson |
| Copyright | Copyright © 2011 Massachusetts Medical Society. All rights reserved. 2015 INIST-CNRS Distributed under a Creative Commons Attribution 4.0 International License |
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| DOI | 10.1056/NEJMoa1013911 |
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| Keywords | Human Immunopathology Antiretroviral agent AIDS Mycobacterial infection Immune deficiency Infection Medicine Chemotherapy Treatment Tuberculosis Viral disease Bacteriosis Adult Antiviral Comparative study |
| Language | English |
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| Snippet | When to initiate antiretroviral therapy in patients with newly diagnosed HIV infection and TB has been debated. In this study from Cambodia, giving... Tuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with regard to... BackgroundTuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with... BACKGROUND: Tuberculosis remains an important cause of death among patients infected with the human immunodeficiency virus (HIV). Robust data are lacking with... |
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| SubjectTerms | Acquired immune deficiency syndrome Adult AIDS AIDS-Related Opportunistic Infections - drug therapy Anti-Retroviral Agents - administration & dosage Anti-Retroviral Agents - adverse effects Antibiotics. Antiinfectious agents. Antiparasitic agents Antiretroviral agents Antiretroviral drugs Antiretroviral therapy Antitubercular Agents - therapeutic use Antiviral agents Biological and medical sciences CD4 antigen CD4 Lymphocyte Count Drug Administration Schedule Drug therapy Efavirenz Female Follow-Up Studies General aspects Hepatitis HIV HIV Infections - complications HIV Infections - drug therapy HIV Infections - mortality Human health and pathology Human immunodeficiency virus Human viral diseases Humans Immune reconstitution Immunosuppressive agents Infectious diseases Inflammation Kaplan-Meier Estimate Lamivudine Life Sciences Lymphocytes T Male Medical sciences Mortality Patients Pharmaceutical sciences Pharmacology Pharmacology. Drug treatments Santé publique et épidémiologie Stavudine Tuberculosis Tuberculosis - complications Tuberculosis - drug therapy Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral Load |
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| Title | Earlier versus Later Start of Antiretroviral Therapy in HIV-Infected Adults with Tuberculosis |
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