Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa.

TitlePredictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa.
Publication TypeJournal Article
Year of Publication2014
AuthorsAsmelash A, Zheng Y, Kaloustian KWools, Shaffer D, Sawe F, Ogwu A, Salata R, Currier J, Hughes MD, Lockman S
JournalBMC Infect Dis
Volume14
Pagination331
Date Published2014
ISSN1471-2334
KeywordsAdenine, Adult, Africa, Anti-HIV Agents, CD4 Lymphocyte Count, CD4-Positive T-Lymphocytes, Deoxycytidine, Emtricitabine, Female, HIV Infections, HIV-1, Humans, Lopinavir, Nevirapine, Organophosphonates, Ritonavir, Tenofovir, Treatment Outcome
Abstract

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 log10 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.

DOI10.1186/1471-2334-14-331
Alternate JournalBMC Infect. Dis.
PubMed ID24938526
PubMed Central IDPMC4083139
Grant ListAI38838 / AI / NIAID NIH HHS / United States
AI68634 / AI / NIAID NIH HHS / United States
U01AI068636 / AI / NIAID NIH HHS / United States
UM1 AI068634 / AI / NIAID NIH HHS / United States
UM1 AI068636 / AI / NIAID NIH HHS / United States
UM1 AI069424 / AI / NIAID NIH HHS / United States
UM1 AI069456 / AI / NIAID NIH HHS / United States
UM1 AI106701 / AI / NIAID NIH HHS / United States
UM1 AI108568 / AI / NIAID NIH HHS / United States