Page 94 - HIV/AIDS Guidelines

Management of the Treatment-Experienced Patient

Virologic and Immunologic Failure (Last updated January 10, 2011; last reviewed January 10,
2011)

Panel’s Recommendations

• Assessing and managing an antiretroviral (ARV)-experienced patient experiencing failure of antiretroviral therapy (ART) is
complex. Expert advice is critical and should be sought.
• Evaluation of virologic failure should include an assessment of the severity of the patient’s HIV disease, ART history, use
of concomitant medications with consideration of adverse drug interactions with ARV agents, HIV RNA and CD4 T-cell
count trends over time, and prior drug-resistance testing results.
• Drug-resistance testing should be obtained while the patient is taking the failing ARV regimen or within 4 weeks of
treatment discontinuation (AII).
• The goal of treatment for ARV-experienced patients with drug resistance who are experiencing virologic failure is to re-
establish virologic suppression (e.g., HIV RNA <48 copies/mL) (AI).

• To design a new regimen, the patient’s treatment history and past and current resistance test results should be used to
identify at least two (preferably three) fully active agents to combine with an optimized background ARV regimen (AI). A
fully active agent is one that is likely to have ARV activity on the basis of the patient’s treatment history, drug-resistance
testing, and/or a novel mechanism of action.

• In general, adding a single, fully active ARV in a new regimen is not recommended because of the risk of rapid
development of resistance (BII).
3
• In patients with a high likelihood of clinical progression (e.g., CD4 count <100 cells/mm ) and limited drug options, adding
a single drug may reduce the risk of immediate clinical progression, because even transient decreases in HIV RNA and/or
transient increases in CD4 cell counts have been associated with clinical benefits (CI).

• For some highly ART-experienced patients, maximal virologic suppression is not possible. In this case, ART should be
continued (AI) with regimens designed to minimize toxicity, preserve CD4 cell counts, and avoid clinical progression.
• Discontinuing or briefly interrupting therapy in a patient with viremia may lead to a rapid increase in HIV RNA and a
decrease in CD4 cell count and increases the risk of clinical progression. Therefore, this strategy is not recommended
(AI).
• In the setting of virologic suppression, there is no consensus on how to define or treat immunologic failure.

Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: 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

Virologic Definitions
Virologic suppression: A confirmed HIV RNA level below the limit of assay detection (e.g., <48
copies/mL).

Virologic failure: The inability to achieve or maintain suppression of viral replication (to an HIV RNA level
<200 copies/mL).

Incomplete virologic response: Two consecutive plasma HIV RNA levels >200 copies/mL after 24 weeks
on an ARV regimen. Baseline HIV RNA may affect the time course of response, and some regimens will take
longer than others to suppress HIV RNA levels.

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents H-1

Downloaded from http://aidsinfo.nih.gov/guidelines on 12/8/2012 EST.