Timing of Antiretroviral Therapy for HIV-1 Infection and Tuberculosis
In this international study involving 809 patients with HIV and TB coinfection, earlier therapy for both infections, versus waiting 8 to 12 weeks to initiate antiretrovirals after anti-TB therapy, was beneficial in patients with a low CD4+ T-cell count (<50 per cubic millimeter). The treatment of...
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| Published in: | The New England journal of medicine Vol. 365; no. 16; pp. 1482 - 1491 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Waltham, MA
Massachusetts Medical Society
20.10.2011
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| Subjects: | |
| ISSN: | 0028-4793, 1533-4406, 1533-4406 |
| Online Access: | Get full text |
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| Abstract | In this international study involving 809 patients with HIV and TB coinfection, earlier therapy for both infections, versus waiting 8 to 12 weeks to initiate antiretrovirals after anti-TB therapy, was beneficial in patients with a low CD4+ T-cell count (<50 per cubic millimeter).
The treatment of patients with tuberculosis and newly identified infection with human immunodeficiency virus type 1 (HIV-1) is one of the most challenging aspects of HIV medicine. Antiretroviral therapy (ART) must be started during treatment for tuberculosis,
1
,
2
yet starting ART very early in the course of tuberculosis therapy increases the pill burden, the potential drug toxicity, and the risk of tuberculosis-associated immune reconstitution inflammatory syndrome (IRIS).
3
,
4
For these reasons, programs, providers, and patients are reluctant to initiate ART during the intensive 8-week induction phase of tuberculosis therapy, when the pill burden and toxicity of tuberculosis medications are greatest. . . . |
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| AbstractList | BackgroundAntiretroviral therapy (ART) is indicated during tuberculosis treatment in patients infected with human immunodeficiency virus type 1 (HIV-1), but the timing for the initiation of ART when tuberculosis is diagnosed in patients with various levels of immune compromise is not known.MethodsWe conducted an open-label, randomized study comparing earlier ART (within 2 weeks after the initiation of treatment for tuberculosis) with later ART (between 8 and 12 weeks after the initiation of treatment for tuberculosis) in HIV-1 infected patients with CD4+ T-cell counts of less than 250 per cubic millimeter and suspected tuberculosis. The primary end point was the proportion of patients who survived and did not have a new (previously undiagnosed) acquired immunodeficiency syndrome (AIDS)–defining illness at 48 weeks.ResultsA total of 809 patients with a median baseline CD4+ T-cell count of 77 per cubic millimeter and an HIV-1 RNA level of 5.43 log10 copies per milliliter were enrolled. In the earlier-ART group, 12.9% of patients had a new AIDS-defining illness or died by 48 weeks, as compared with 16.1% in the later-ART group (95% confidence interval [CI], −1.8 to 8.1; P=0.45). Among patients with screening CD4+ T-cell counts of less than 50 per cubic millimeter, 15.5% of patients in the earlier-ART group versus 26.6% in the later-ART group had a new AIDS-defining illness or died (95% CI, 1.5 to 20.5; P=0.02). Tuberculosis-associated immune reconstitution inflammatory syndrome was more common with earlier ART than with later ART (11% vs. 5%, P=0.002). The rate of viral suppression at 48 weeks was 74% and did not differ between the groups (P=0.38).ConclusionsOverall, earlier ART did not reduce the rate of new AIDS-defining illness and death, as compared with later ART. In persons with CD4+ T-cell counts of less than 50 per cubic millimeter, earlier ART was associated with a lower rate of new AIDS-defining illnesses and death. (Funded by the National Institutes of Health and others; ACTG A5221 ClinicalTrials.gov number, NCT00108862.) In this international study involving 809 patients with HIV and TB coinfection, earlier therapy for both infections, versus waiting 8 to 12 weeks to initiate antiretrovirals after anti-TB therapy, was beneficial in patients with a low CD4+ T-cell count (<50 per cubic millimeter). The treatment of patients with tuberculosis and newly identified infection with human immunodeficiency virus type 1 (HIV-1) is one of the most challenging aspects of HIV medicine. Antiretroviral therapy (ART) must be started during treatment for tuberculosis, 1 , 2 yet starting ART very early in the course of tuberculosis therapy increases the pill burden, the potential drug toxicity, and the risk of tuberculosis-associated immune reconstitution inflammatory syndrome (IRIS). 3 , 4 For these reasons, programs, providers, and patients are reluctant to initiate ART during the intensive 8-week induction phase of tuberculosis therapy, when the pill burden and toxicity of tuberculosis medications are greatest. . . . Antiretroviral therapy (ART) is indicated during tuberculosis treatment in patients infected with human immunodeficiency virus type 1 (HIV-1), but the timing for the initiation of ART when tuberculosis is diagnosed in patients with various levels of immune compromise is not known. We conducted an open-label, randomized study comparing earlier ART (within 2 weeks after the initiation of treatment for tuberculosis) with later ART (between 8 and 12 weeks after the initiation of treatment for tuberculosis) in HIV-1 infected patients with CD4+ T-cell counts of less than 250 per cubic millimeter and suspected tuberculosis. The primary end point was the proportion of patients who survived and did not have a new (previously undiagnosed) acquired immunodeficiency syndrome (AIDS)-defining illness at 48 weeks. A total of 809 patients with a median baseline CD4+ T-cell count of 77 per cubic millimeter and an HIV-1 RNA level of 5.43 log(10) copies per milliliter were enrolled. In the earlier-ART group, 12.9% of patients had a new AIDS-defining illness or died by 48 weeks, as compared with 16.1% in the later-ART group (95% confidence interval [CI], -1.8 to 8.1; P=0.45). Among patients with screening CD4+ T-cell counts of less than 50 per cubic millimeter, 15.5% of patients in the earlier-ART group versus 26.6% in the later-ART group had a new AIDS-defining illness or died (95% CI, 1.5 to 20.5; P=0.02). Tuberculosis-associated immune reconstitution inflammatory syndrome was more common with earlier ART than with later ART (11% vs. 5%, P=0.002). The rate of viral suppression at 48 weeks was 74% and did not differ between the groups (P=0.38). Overall, earlier ART did not reduce the rate of new AIDS-defining illness and death, as compared with later ART. In persons with CD4+ T-cell counts of less than 50 per cubic millimeter, earlier ART was associated with a lower rate of new AIDS-defining illnesses and death. (Funded by the National Institutes of Health and others; ACTG A5221 ClinicalTrials.gov number, NCT00108862.). Antiretroviral therapy (ART) is indicated during tuberculosis treatment in patients infected with human immunodeficiency virus type 1 (HIV-1), but the timing for the initiation of ART when tuberculosis is diagnosed in patients with various levels of immune compromise is not known.BACKGROUNDAntiretroviral therapy (ART) is indicated during tuberculosis treatment in patients infected with human immunodeficiency virus type 1 (HIV-1), but the timing for the initiation of ART when tuberculosis is diagnosed in patients with various levels of immune compromise is not known.We conducted an open-label, randomized study comparing earlier ART (within 2 weeks after the initiation of treatment for tuberculosis) with later ART (between 8 and 12 weeks after the initiation of treatment for tuberculosis) in HIV-1 infected patients with CD4+ T-cell counts of less than 250 per cubic millimeter and suspected tuberculosis. The primary end point was the proportion of patients who survived and did not have a new (previously undiagnosed) acquired immunodeficiency syndrome (AIDS)-defining illness at 48 weeks.METHODSWe conducted an open-label, randomized study comparing earlier ART (within 2 weeks after the initiation of treatment for tuberculosis) with later ART (between 8 and 12 weeks after the initiation of treatment for tuberculosis) in HIV-1 infected patients with CD4+ T-cell counts of less than 250 per cubic millimeter and suspected tuberculosis. The primary end point was the proportion of patients who survived and did not have a new (previously undiagnosed) acquired immunodeficiency syndrome (AIDS)-defining illness at 48 weeks.A total of 809 patients with a median baseline CD4+ T-cell count of 77 per cubic millimeter and an HIV-1 RNA level of 5.43 log(10) copies per milliliter were enrolled. In the earlier-ART group, 12.9% of patients had a new AIDS-defining illness or died by 48 weeks, as compared with 16.1% in the later-ART group (95% confidence interval [CI], -1.8 to 8.1; P=0.45). Among patients with screening CD4+ T-cell counts of less than 50 per cubic millimeter, 15.5% of patients in the earlier-ART group versus 26.6% in the later-ART group had a new AIDS-defining illness or died (95% CI, 1.5 to 20.5; P=0.02). Tuberculosis-associated immune reconstitution inflammatory syndrome was more common with earlier ART than with later ART (11% vs. 5%, P=0.002). The rate of viral suppression at 48 weeks was 74% and did not differ between the groups (P=0.38).RESULTSA total of 809 patients with a median baseline CD4+ T-cell count of 77 per cubic millimeter and an HIV-1 RNA level of 5.43 log(10) copies per milliliter were enrolled. In the earlier-ART group, 12.9% of patients had a new AIDS-defining illness or died by 48 weeks, as compared with 16.1% in the later-ART group (95% confidence interval [CI], -1.8 to 8.1; P=0.45). Among patients with screening CD4+ T-cell counts of less than 50 per cubic millimeter, 15.5% of patients in the earlier-ART group versus 26.6% in the later-ART group had a new AIDS-defining illness or died (95% CI, 1.5 to 20.5; P=0.02). Tuberculosis-associated immune reconstitution inflammatory syndrome was more common with earlier ART than with later ART (11% vs. 5%, P=0.002). The rate of viral suppression at 48 weeks was 74% and did not differ between the groups (P=0.38).Overall, earlier ART did not reduce the rate of new AIDS-defining illness and death, as compared with later ART. In persons with CD4+ T-cell counts of less than 50 per cubic millimeter, earlier ART was associated with a lower rate of new AIDS-defining illnesses and death. (Funded by the National Institutes of Health and others; ACTG A5221 ClinicalTrials.gov number, NCT00108862.).CONCLUSIONSOverall, earlier ART did not reduce the rate of new AIDS-defining illness and death, as compared with later ART. In persons with CD4+ T-cell counts of less than 50 per cubic millimeter, earlier ART was associated with a lower rate of new AIDS-defining illnesses and death. (Funded by the National Institutes of Health and others; ACTG A5221 ClinicalTrials.gov number, NCT00108862.). |
| Author | Havlir, Diane V Sawe, Fred Kendall, Michelle A Ive, Prudence Kumarasamy, N Kumwenda, Johnstone Hosseinipour, Mina C Mohapi, Lerato Sanchez, Jorge Veloso, Valdilea G Wu, Xingye Sanchez, Alejandro Moko, Evans Hogg, Evelyn Rooney, James F Padayatchi, Nesri Lama, Javier R Luetkemeyer, Anne F Swindells, Susan Mugyenyi, Peter Sanne, Ian Lalloo, Umesh Andersen, Janet Pape, Jean W Santos, Breno R Hakim, James Some, Fatuma F Asmelash, Aida Qasba, Sarojini S Reid, Stewart |
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| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24623407$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22010914$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1086/651497 10.2307/2281868 10.1056/NEJMoa1014181 10.1097/QAD.0b013e32833dfc68 10.1371/journal.pone.0005575 10.1056/NEJMoa0905848 10.1086/651492 10.2307/2336502 10.1093/cid/cir230 10.2307/2530245 10.1086/651495 10.1016/j.ccm.2009.08.016 10.1056/NEJMoa1013911 10.1016/S1473-3099(08)70184-1 10.1001/jama.300.4.423 10.1016/S0140-6736(10)60492-8 10.1136/thx.2003.019224 |
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| Copyright | Copyright © 2011 Massachusetts Medical Society. All rights reserved. 2015 INIST-CNRS |
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| Keywords | Immunopathology Antiretroviral agent HIV-1 virus Retroviridae AIDS Mycobacterial infection Immune deficiency Lentivirus Infection Virus Medicine Chemotherapy Treatment Tuberculosis Viral disease Bacteriosis Temporal study Antiviral Human immunodeficiency virus Timing |
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| Snippet | In this international study involving 809 patients with HIV and TB coinfection, earlier therapy for both infections, versus waiting 8 to 12 weeks to initiate... Antiretroviral therapy (ART) is indicated during tuberculosis treatment in patients infected with human immunodeficiency virus type 1 (HIV-1), but the timing... BackgroundAntiretroviral therapy (ART) is indicated during tuberculosis treatment in patients infected with human immunodeficiency virus type 1 (HIV-1), but... |
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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 drugs Antiretroviral therapy Antitubercular Agents - therapeutic use Antiviral agents Biological and medical sciences CD4 antigen CD4 Lymphocyte Count Drug Administration Schedule Female General aspects HIV HIV Infections - complications HIV Infections - drug therapy HIV Infections - mortality HIV-1 Human immunodeficiency virus Human viral diseases Humans Immune reconstitution Infectious diseases Inflammation Kaplan-Meier Estimate Laboratories Lymphocytes T Male Medical sciences Mortality Patients Pharmacology. Drug treatments Ribonucleic acid RNA Tuberculosis Tuberculosis - complications Tuberculosis - drug therapy Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
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| Title | Timing of Antiretroviral Therapy for HIV-1 Infection and Tuberculosis |
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