Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study
BACKGROUND: In addition to demonstrated public health benefits on reducing transmission, it remains unclear how early antiretroviral therapy (ART) must be started after acquisition of human immunodeficiency virus (HIV) to maximize individual benefits. METHODS: We conducted an open-label randomized c...
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2020
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| author | Javier R. Lama Rachel Bender Ignacio Ricardo Alfaro Jessica Ríos Jorge A. Gallardo-Cartagena Rogelio Valdez Carolyn Bain Karin Sosa Barbarán Manuel Villarán Christopher D. Pilcher Pedro Gonzáles Jorge Sánchez Ann Duerr |
| author_browse | Ann Duerr Carolyn Bain Christopher D. Pilcher Javier R. Lama Jessica Ríos Jorge A. Gallardo-Cartagena Jorge Sánchez Karin Sosa Barbarán Manuel Villarán Pedro Gonzáles Rachel Bender Ignacio Ricardo Alfaro Rogelio Valdez |
| author_facet | Javier R. Lama Rachel Bender Ignacio Ricardo Alfaro Jessica Ríos Jorge A. Gallardo-Cartagena Rogelio Valdez Carolyn Bain Karin Sosa Barbarán Manuel Villarán Christopher D. Pilcher Pedro Gonzáles Jorge Sánchez Ann Duerr |
| author_sort | Javier R. Lama |
| collection | Producción científica |
| description | BACKGROUND: In addition to demonstrated public health benefits on reducing transmission, it remains unclear how early antiretroviral therapy (ART) must be started after acquisition of human immunodeficiency virus (HIV) to maximize individual benefits. METHODS: We conducted an open-label randomized clinical study in Lima, Peru among adult men who have sex with men and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent (confirmed negative HIV-antibody or RNA test within 3 months) HIV infection, who were randomized to start ART immediately versus defer by 24 weeks. We evaluated outcomes by treatment arm and immunologic markers by days since estimated date of detectible infection (EDDI). RESULTS: Of 216 participants, 105 were assigned to immediate arm and 111 to deferred arm (median age 26.8 years, 37% with acute HIV). The incidence of non-ART-related adverse events was lower in immediate versus deferred arm (83 vs 123/100 person-years, IRR 0.67 (95% confidence interval [CI] .47, .95; P = .02), the difference dominated by fewer infections in those treated immediately. After 24 weeks of ART, between-group differences in CD4/CD8 cell ratio lessened (P = .09 overall), but differences between those initiating ART ≤ 30 days from EDDI (median 1.03, interquartile range [IQR] 0.84, 1.37), and those initiating > 90 days (0.88, IQR 0.61, 1.11) remained, P = .02. Principal components analysis of 20 immune biomarkers demonstrated distinct patterns between those starting ART > 90 days from EDDI versus those starting within 30 or 90 days (both P < .001). CONCLUSIONS: To our knowledge, this is the only evaluation of randomized ART initiation during primary HIV and provides evidence to explicitly consider acute HIV in World Health Organization recommendations for universal ART. CLINICAL TRIALS REGISTRATION: NCT01815580. |
| format | Article |
| id | oai:cris.upeu.edu.pe:20.500.15037/1764 |
| institution | UPeU |
| language | English |
| publishDate | 2020 |
| publishDateRange | 2020 |
| publishDateSort | 2020 |
| record_format | dspace |
| spelling | oai:cris.upeu.edu.pe:20.500.15037/17642026-10-30T16:16:43ZClinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical StudyJavier R. LamaRachel Bender IgnacioRicardo AlfaroJessica RíosJorge A. Gallardo-CartagenaRogelio ValdezCarolyn BainKarin Sosa BarbaránManuel VillaránChristopher D. PilcherPedro GonzálesJorge SánchezAnn DuerrMedicineHuman immunodeficiency virus (HIV)Antiretroviral therapySidaRandomized controlled trialImmunologyClinical trialVirologyIntensive care medicineViral diseaseViral loadInternal medicineMedicineHuman immunodeficiency virus (HIV)Antiretroviral therapySidaRandomized controlled trialImmunologyClinical trialVirologyIntensive care medicineViral diseaseViral loadInternal medicineSexual and Gender MinoritiesSexual and Gender MinoritiesSexual and Gender MinoritiesSexual and Gender MinoritiesAdultAdultAdultAdultFemaleFemaleFemaleFemaleHumansHumansHumansHumansMaleMaleMaleMalePeru epidemiologyPeru epidemiologyPeru epidemiologyPeru epidemiologyHIV Infections drug therapyHIV Infections drug therapyHIV Infections drug therapyHIV Infections drug therapyHomosexuality, MaleHomosexuality, MaleHomosexuality, MaleHomosexuality, MaleCD4 Lymphocyte CountCD4 Lymphocyte CountCD4 Lymphocyte CountCD4 Lymphocyte CountAnti-HIV Agents therapeutic useAnti-HIV Agents therapeutic useAnti-HIV Agents therapeutic useAnti-HIV Agents therapeutic useHealth Sciences Medicine Infectious Diseases HIV/AIDS Research and InterventionsLife Sciences Immunology and Microbiology Virology HIV Research and TreatmentLife Sciences Biochemistry, Genetics and Molecular Biology Molecular Biology Biological Research and Disease StudiesBACKGROUND: In addition to demonstrated public health benefits on reducing transmission, it remains unclear how early antiretroviral therapy (ART) must be started after acquisition of human immunodeficiency virus (HIV) to maximize individual benefits. METHODS: We conducted an open-label randomized clinical study in Lima, Peru among adult men who have sex with men and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent (confirmed negative HIV-antibody or RNA test within 3 months) HIV infection, who were randomized to start ART immediately versus defer by 24 weeks. We evaluated outcomes by treatment arm and immunologic markers by days since estimated date of detectible infection (EDDI). RESULTS: Of 216 participants, 105 were assigned to immediate arm and 111 to deferred arm (median age 26.8 years, 37% with acute HIV). The incidence of non-ART-related adverse events was lower in immediate versus deferred arm (83 vs 123/100 person-years, IRR 0.67 (95% confidence interval [CI] .47, .95; P = .02), the difference dominated by fewer infections in those treated immediately. After 24 weeks of ART, between-group differences in CD4/CD8 cell ratio lessened (P = .09 overall), but differences between those initiating ART ≤ 30 days from EDDI (median 1.03, interquartile range [IQR] 0.84, 1.37), and those initiating > 90 days (0.88, IQR 0.61, 1.11) remained, P = .02. Principal components analysis of 20 immune biomarkers demonstrated distinct patterns between those starting ART > 90 days from EDDI versus those starting within 30 or 90 days (both P < .001). CONCLUSIONS: To our knowledge, this is the only evaluation of randomized ART initiation during primary HIV and provides evidence to explicitly consider acute HIV in World Health Organization recommendations for universal ART. CLINICAL TRIALS REGISTRATION: NCT01815580.Articlehttps://pubmed.ncbi.nlm.nih.gov/32107526https://www.ncbi.nlm.nih.gov/pmc/articles/795877410.1093/cid/ciaa167https://hdl.handle.net/20.500.15037/1764W3006762782enClinical Infectious Diseases1058-48381537-65912020-02-262026-06-13T14:21:48Z2026-06-13T14:21:48Z |
| spellingShingle | Medicine Human immunodeficiency virus (HIV) Antiretroviral therapy Sida Randomized controlled trial Immunology Clinical trial Virology Intensive care medicine Viral disease Viral load Internal medicine Medicine Human immunodeficiency virus (HIV) Antiretroviral therapy Sida Randomized controlled trial Immunology Clinical trial Virology Intensive care medicine Viral disease Viral load Internal medicine Sexual and Gender Minorities Sexual and Gender Minorities Sexual and Gender Minorities Sexual and Gender Minorities Adult Adult Adult Adult Female Female Female Female Humans Humans Humans Humans Male Male Male Male Peru epidemiology Peru epidemiology Peru epidemiology Peru epidemiology HIV Infections drug therapy HIV Infections drug therapy HIV Infections drug therapy HIV Infections drug therapy Homosexuality, Male Homosexuality, Male Homosexuality, Male Homosexuality, Male CD4 Lymphocyte Count CD4 Lymphocyte Count CD4 Lymphocyte Count CD4 Lymphocyte Count Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Health Sciences Medicine Infectious Diseases HIV/AIDS Research and Interventions Life Sciences Immunology and Microbiology Virology HIV Research and Treatment Life Sciences Biochemistry, Genetics and Molecular Biology Molecular Biology Biological Research and Disease Studies Javier R. Lama Rachel Bender Ignacio Ricardo Alfaro Jessica Ríos Jorge A. Gallardo-Cartagena Rogelio Valdez Carolyn Bain Karin Sosa Barbarán Manuel Villarán Christopher D. Pilcher Pedro Gonzáles Jorge Sánchez Ann Duerr Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study |
| title | Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study |
| title_full | Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study |
| title_fullStr | Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study |
| title_full_unstemmed | Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study |
| title_short | Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study |
| title_sort | clinical and immunologic outcomes after immediate or deferred antiretroviral therapy initiation during primary human immunodeficiency virus infection the sabes randomized clinical study |
| topic | Medicine Human immunodeficiency virus (HIV) Antiretroviral therapy Sida Randomized controlled trial Immunology Clinical trial Virology Intensive care medicine Viral disease Viral load Internal medicine Medicine Human immunodeficiency virus (HIV) Antiretroviral therapy Sida Randomized controlled trial Immunology Clinical trial Virology Intensive care medicine Viral disease Viral load Internal medicine Sexual and Gender Minorities Sexual and Gender Minorities Sexual and Gender Minorities Sexual and Gender Minorities Adult Adult Adult Adult Female Female Female Female Humans Humans Humans Humans Male Male Male Male Peru epidemiology Peru epidemiology Peru epidemiology Peru epidemiology HIV Infections drug therapy HIV Infections drug therapy HIV Infections drug therapy HIV Infections drug therapy Homosexuality, Male Homosexuality, Male Homosexuality, Male Homosexuality, Male CD4 Lymphocyte Count CD4 Lymphocyte Count CD4 Lymphocyte Count CD4 Lymphocyte Count Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Health Sciences Medicine Infectious Diseases HIV/AIDS Research and Interventions Life Sciences Immunology and Microbiology Virology HIV Research and Treatment Life Sciences Biochemistry, Genetics and Molecular Biology Molecular Biology Biological Research and Disease Studies |
| topic_facet | Medicine Human immunodeficiency virus (HIV) Antiretroviral therapy Sida Randomized controlled trial Immunology Clinical trial Virology Intensive care medicine Viral disease Viral load Internal medicine Medicine Human immunodeficiency virus (HIV) Antiretroviral therapy Sida Randomized controlled trial Immunology Clinical trial Virology Intensive care medicine Viral disease Viral load Internal medicine Sexual and Gender Minorities Sexual and Gender Minorities Sexual and Gender Minorities Sexual and Gender Minorities Adult Adult Adult Adult Female Female Female Female Humans Humans Humans Humans Male Male Male Male Peru epidemiology Peru epidemiology Peru epidemiology Peru epidemiology HIV Infections drug therapy HIV Infections drug therapy HIV Infections drug therapy HIV Infections drug therapy Homosexuality, Male Homosexuality, Male Homosexuality, Male Homosexuality, Male CD4 Lymphocyte Count CD4 Lymphocyte Count CD4 Lymphocyte Count CD4 Lymphocyte Count Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Anti-HIV Agents therapeutic use Health Sciences Medicine Infectious Diseases HIV/AIDS Research and Interventions Life Sciences Immunology and Microbiology Virology HIV Research and Treatment Life Sciences Biochemistry, Genetics and Molecular Biology Molecular Biology Biological Research and Disease Studies |
| url | https://pubmed.ncbi.nlm.nih.gov/32107526 https://www.ncbi.nlm.nih.gov/pmc/articles/7958774 https://hdl.handle.net/20.500.15037/1764 |
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