When to Start Therapy: Chronic HIV Infection

Maunank Shah, M.D., PhD, Joel E. Gallant, M.D., M.P.H.


  • Initiation of ART in a previously naive-patient.

DHHS Guidelines (section last updated in DHHS 12/18/2019)

  • ART recommended for all HIV+ individuals, regardless of CD4 count, to reduce HIV-related morbidity and mortality (AI)
  • ART initiation is recommended immediately (or as soon as possible) after HIV diagnosis in order to increase the uptake of ART and linkage to care, and decrease the time to viral suppression, and improve rate of virologic suppression (AII).
  • ART is also recommended for HIV-infected individuals to prevent HIV transmission (AI).
  • When initiating ART, it is important to educated patients on benefits and considerations regarding ART, and to address strategies to optimize adherence. On case-by-case basis, ART may be deferred because of clinical and/or psychosocial factors, but should be initiated as soon as possible.
  • Guidelines rating criteria:
    • Strength of recommendation:
      • A: strong recommendation
      • B: moderate recommendation
      • C: optional recommendation
    • Quality of evidence for recommendation:
      • I: Data from randomized controlled trials
      • II: Data from well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes
      • III: Expert opinion

IAS-USA Guidelines (2018)

  • ART should be initiated as soon as possible after diagnosis, including immediately after diagnosis, unless patient is not ready to commit to starting (AIa).
    • Focus of discussion is now on immediate ART (same day to 14 days after diagnosis), which requires improved linkage to care and addressing structural barriers and ART distribution systems.
    • Randomized trials of rapid ART start have shown improvements at 10 or 12 months in retention and suppression.
  • Opportunistic infections:
    • As soon as possible, preferably within the first 2 weeks for most opportrunistic infections (AIa)
    • Cryptococcal meningitis: in consultation with experts (BIII)
    • TB:
      • CD4 < 50: within 2 weeks of starting TB treatment (AIa)
      • CD4 >50: by 8-12 weeks (AIa)
      • TB meningitis: within first 2-8 weeks of diagnosis, in consultation with experts (BIII)

WHO Guidelines (Use of ARV drugs for treating and preventing HIV infection)

  • Treat all patients, regardless of WHO clinical stage and at any CD4 cell count (strong recommendation)
  • Effort should be taken to reduce the time between diagnosis and ART initiation based on person’s readiness

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Last updated: March 7, 2020