Page 52 - HIV/AIDS Guidelines

personal circumstances. Deferring therapy for the reasons discussed below may be reasonable in patients
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with high CD4 counts (e.g., >500 cells/mm ) but deferring therapy in patients with much lower CD4 counts
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(e.g., <200 cells/mm ) should be considered only in rare situations and should be undertaken with close
clinical follow-up. A brief delay in initiating therapy to allow a patient more time to prepare for lifelong
treatment may be considered.
When there are significant barriers to adherence (also see Adherence to Antiretroviral Therapy)
In patients with higher CD4 counts who are at risk of poor adherence, it may be prudent to defer treatment
while addressing the barriers to adherence. However, in patients with conditions that require urgent initiation
of ART (see above), therapy should be started while simultaneously addressing the barriers to adherence.

Several methodologies exist to help providers assess adherence. When the most feasible measure of
adherence is self-report, this assessment should be completed at each clinic visit using one of the available
reliable and valid instruments. 140-141 If other objective measures (e.g., pharmacy refill data, pill count) are
available, these methods should be used to assess adherence at each follow-up visit. 142-144 Continuous
assessment and counseling make it possible for the clinician to intervene early to address barriers to
adherence occurring at any point during treatment (see Adherence to Antiretroviral Therapy).
Presence of comorbidities that complicate or prohibit antiretroviral therapy
Deferral of ART may be considered when either the treatment or manifestations of other medical conditions
could complicate the treatment of HIV infection or vice versa. Examples include:

• Surgery that may result in an extended interruption of ART.
• Treatment with medications that have clinically significant drug interactions with ART and for which
alternative medications are not available.

In each of these circumstances, the assumption is that the situation is temporary and that ART will be
initiated after the conflicting condition has resolved.

Some less common situations exist in which ART may not be indicated at any time while CD4 counts remain
high. In particular, such situations include that of patients with a poor prognosis due to a concomitant
medical condition who would not be expected to gain survival or quality-of-life benefits from ART.
Examples include patients with incurable non-HIV-related malignancies or end-stage liver disease who are
not being considered for liver transplantation. The decision to forego ART in such patients may be easier to
make in those with higher CD4 counts; they are likely asymptomatic for HIV, and their survival is unlikely to
be prolonged by ART. However, it should be noted that ART may improve outcomes, including survival, in
patients with some HIV-associated malignancies (e.g., lymphoma or Kaposi sarcoma) and in patients with
liver disease due to chronic HBV or HCV.

Long-term nonprogressors and elite HIV controllers
A small subset of ARV-untreated HIV-infected individuals (~3%−5%) can maintain normal CD4 cell counts
for many years (long-term nonprogressors), and an even smaller subset (~1%) can maintain suppressed viral
loads for years (elite controllers). 145-146 Although therapy theoretically may be beneficial for patients in either
group, clinical data supporting therapy for nonprogressors and elite controllers are lacking.

The Need for Early Diagnosis of HIV

Fundamental to the earlier initiation of ART recommended in these guidelines is the assumption that patients
will be diagnosed early in the course of HIV infection, making earlier initiation of therapy an option.
Unfortunately, most HIV-infected patients are not diagnosed until they are at much later stages of disease. 147-
150 Despite the 2006 Centers for Disease Control and Prevention (CDC) recommendations for routine,
opt-out HIV screening in the health care setting regardless of perceptions about a patient’s risk of

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents E-11

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