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Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa
BACKGROUND: A subset of HIV-1 infected patients starting highly active antiretroviral treatment (HAART) experience suboptimal CD4 response (SCR) despite virologic suppression. We studied the rate of and risk factors for SCR among women starting HAART in the ACTG A5208 study conducted in 7 African co...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4083139/ https://www.ncbi.nlm.nih.gov/pubmed/24938526 http://dx.doi.org/10.1186/1471-2334-14-331 |
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author | Asmelash, Aida Zheng, Yu Kaloustian, Kara Wools Shaffer, Douglas Sawe, Fred Ogwu, Anthony Salata, Robert Currier, Judith Hughes, Michael D Lockman, Shahin |
author_facet | Asmelash, Aida Zheng, Yu Kaloustian, Kara Wools Shaffer, Douglas Sawe, Fred Ogwu, Anthony Salata, Robert Currier, Judith Hughes, Michael D Lockman, Shahin |
author_sort | Asmelash, Aida |
collection | PubMed |
description | BACKGROUND: A subset of HIV-1 infected patients starting highly active antiretroviral treatment (HAART) experience suboptimal CD4 response (SCR) despite virologic suppression. We studied the rate of and risk factors for SCR among women starting HAART in the ACTG A5208 study conducted in 7 African countries. 741 HAART-naive women with screening CD4 count <200 cells/μL were randomized to start HAART with Tenofovir/Emtricitabine plus either Nevirapine or Lopinavir/Ritonavir. METHODS: This analysis includes the 625 women who remained on-study through 48 weeks without experiencing protocol-defined virologic failure. We defined SCR as < 100 CD4 cells/μL increase from baseline and absolute CD4 cell count < 350 cells/μL, both at 48 weeks after HAART initiation. RESULTS: The baseline characteristics for the 625 women prior to HAART initiation were: median age 33 years, screening CD4 count 134 cells/μL, and HIV-1 RNA 5.1 log(10) copies/mL; 184 (29%) were WHO Stage 3 or 4. Seventy one (11%) of these 625 women experienced SCR. Baseline factors independently associated with increased odds of SCR included older age, lower HIV-1 RNA, positive Hepatitis B surface antigen, and site location. At 96 weeks, only 6% of the SCR group had CD4 ≥ 350 cells/μL compared with 67% in the non SCR group. CONCLUSION: After starting HAART, 11% of women with virologic suppression through 48 weeks experienced SCR. These patients were also less likely to achieve CD4 ≥ 350 cells/μL by 96 weeks. The underlying causes and long term clinical implications of SCR deserve further investigation. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00089505 |
format | Online Article Text |
id | pubmed-4083139 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-40831392014-07-08 Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa Asmelash, Aida Zheng, Yu Kaloustian, Kara Wools Shaffer, Douglas Sawe, Fred Ogwu, Anthony Salata, Robert Currier, Judith Hughes, Michael D Lockman, Shahin BMC Infect Dis Research Article BACKGROUND: A subset of HIV-1 infected patients starting highly active antiretroviral treatment (HAART) experience suboptimal CD4 response (SCR) despite virologic suppression. We studied the rate of and risk factors for SCR among women starting HAART in the ACTG A5208 study conducted in 7 African countries. 741 HAART-naive women with screening CD4 count <200 cells/μL were randomized to start HAART with Tenofovir/Emtricitabine plus either Nevirapine or Lopinavir/Ritonavir. METHODS: This analysis includes the 625 women who remained on-study through 48 weeks without experiencing protocol-defined virologic failure. We defined SCR as < 100 CD4 cells/μL increase from baseline and absolute CD4 cell count < 350 cells/μL, both at 48 weeks after HAART initiation. RESULTS: The baseline characteristics for the 625 women prior to HAART initiation were: median age 33 years, screening CD4 count 134 cells/μL, and HIV-1 RNA 5.1 log(10) copies/mL; 184 (29%) were WHO Stage 3 or 4. Seventy one (11%) of these 625 women experienced SCR. Baseline factors independently associated with increased odds of SCR included older age, lower HIV-1 RNA, positive Hepatitis B surface antigen, and site location. At 96 weeks, only 6% of the SCR group had CD4 ≥ 350 cells/μL compared with 67% in the non SCR group. CONCLUSION: After starting HAART, 11% of women with virologic suppression through 48 weeks experienced SCR. These patients were also less likely to achieve CD4 ≥ 350 cells/μL by 96 weeks. The underlying causes and long term clinical implications of SCR deserve further investigation. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT00089505 BioMed Central 2014-06-17 /pmc/articles/PMC4083139/ /pubmed/24938526 http://dx.doi.org/10.1186/1471-2334-14-331 Text en Copyright © 2014 Asmelash et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Asmelash, Aida Zheng, Yu Kaloustian, Kara Wools Shaffer, Douglas Sawe, Fred Ogwu, Anthony Salata, Robert Currier, Judith Hughes, Michael D Lockman, Shahin Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa |
title | Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa |
title_full | Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa |
title_fullStr | Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa |
title_full_unstemmed | Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa |
title_short | Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa |
title_sort | predictors of suboptimal cd4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, africa |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4083139/ https://www.ncbi.nlm.nih.gov/pubmed/24938526 http://dx.doi.org/10.1186/1471-2334-14-331 |
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