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Related Experiment Video

Updated: Mar 26, 2026

Humanized NOD/SCID/IL2rγnull (hu-NSG) Mouse Model for HIV Replication and Latency Studies
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CD4 Cell Count: Declining Value for Antiretroviral Therapy Eligibility.

Roger Ying1, Reuben M Granich2, Somya Gupta2

  • 1Weill Cornell Medical College, Cornell University, New York, New York.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|January 31, 2016
PubMed
Summary

Antiretroviral therapy (ART) initiation for people with HIV should no longer require CD4 counts. Current evidence shows CD4 counts do not predict health outcomes and are imprecise for guiding treatment decisions.

Keywords:
ARTCD4 cell countHIVcare continuumuniversal test and treat

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Area of Science:

  • Immunology
  • Public Health
  • Virology

Background:

  • Historically, antiretroviral therapy (ART) for human immunodeficiency virus (HIV) was initiated based on clinical indicators like CD4 cell counts.
  • CD4 counts have limitations, including intra-individual variability and lack of predictive value for key public health outcomes such as disease progression, mortality, and HIV transmission.

Purpose of the Study:

  • To evaluate the continued necessity of CD4 counts for initiating ART in people living with HIV.
  • To advocate for policy changes aligning with current evidence on HIV treatment and prevention.

Main Methods:

  • Review of existing studies and evidence regarding the role of CD4 counts in HIV management.
  • Analysis of the impact of CD4 count variability on ART initiation decisions.

Main Results:

  • CD4 counts early in HIV infection do not reliably predict disease progression, mortality, or HIV transmission.
  • Variability in CD4 counts leads to imprecise measurements and potentially arbitrary decisions regarding ART initiation.

Conclusions:

  • CD4 counts should no longer be a mandatory requirement for initiating ART in people living with HIV.
  • While CD4 counts may inform prophylaxis for opportunistic infections, they are not essential for determining the start of ART, supporting a focus on increased HIV diagnosis and ART coverage.