Page 118 - HIV/AIDS Guidelines

generally very high (>100,000 copies/mL). 5-6 A qualitative HIV RNA test can also be used in this setting.
Interest in routine screening for antibody-negative acute infection has led to select centers performing
virologic testing on all antibody-negative specimens, including the use of pooled HIV RNA testing on all
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seronegative serum samples. In addition, a combination HIV antigen/antibody test (ARCHITECT), recently
licensed by the Food and Drug Administration (FDA), could be used for this purpose. Patients diagnosed
with acute HIV infection by a virologic test while still antibody negative or indeterminate should have
confirmatory serologic testing performed over the next 3 months (AI). (See Table 10.)

Performance of Resistance Testing
Data from the United States and Europe demonstrate that transmitted virus may be resistant to at least one
ARV drug in 6%–16% of patients. 9-11 If the decision is made to initiate therapy in a person with acute HIV
infection, genotypic resistance testing at baseline to guide the selection of an ARV regimen will likely
optimize virologic response; this strategy is therefore recommended (AIII). (See Drug-Resistance Testing.)
If therapy is deferred, resistance testing should still be performed because the result may be useful in
optimizing the virologic response when therapy is ultimately initiated (AIII).

Treatment for Acute HIV Infection
Clinical trials information regarding treatment of acute HIV infection is limited. Ongoing trials are
addressing the question of the long-term benefit of potent treatment regimens initiated during acute infection.
Potential benefits and risks of treating acute infection are as follows:

• Potential Benefits of Treating Acute Infection. Preliminary data indicate that treatment of acute HIV
infection with combination ART has a beneficial effect on laboratory markers of disease progression. 12-16
Theoretically, early intervention could decrease the severity of acute disease; alter the initial viral
setpoint, which can affect disease progression rates; reduce the rate of viral mutation as a result of
suppression of viral replication; preserve immune function; and reduce the risk of viral transmission
during this highly infectious stage of disease. Additionally, although data are limited and the clinical
relevance is unclear, the profound loss of gastrointestinal lymphoid tissue that occurs during the first
weeks of infection may be mitigated by the early initiation of ART. 17-18

• Potential Risks of Treating Acute HIV Infection. The potential disadvantages of initiating therapy
include exposure to ART without a known clinical benefit, which could result in drug toxicities,
development of drug resistance, continuous need for therapy with strict adherence, and adverse effect on
quality of life.
Some of the potential benefits associated with treatment during acute infection remain uncertain and of
unknown clinical relevance, while the risks are largely consistent with those for initiating therapy in
chronically infected asymptomatic patients with high CD4 counts. The health care provider and the patient
should be fully aware that the rationale for therapy for acute HIV infection is based on theoretical
considerations, and the potential benefits should be weighed against the potential risks. For these reasons,
treatment of acute HIV infection should be considered optional at this time (CIII). Because acute or recent
HIV infection is associated with a high risk of MTCT of HIV, all HIV-infected pregnant women should start
a combination ARV regimen as soon as possible to prevent perinatal transmission of HIV (AI). Following
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delivery, considerations regarding continuation of the ARV regimen as therapy for the mother are the same as
for treatment of other nonpregnant individuals. Providers should consider enrolling patients with acute HIV
infection in a clinical trial to evaluate the natural history of acute HIV and to determine the role of ART in
this setting. Information regarding such trials can be obtained at www.clinicaltrials.gov or from local HIV
treatment experts.

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents I-2

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