Page 42 - HIV/AIDS Guidelines

Initiating Antiretroviral Therapy in Treatment-Naive Patients
(Last updated March 29, 2012; last reviewed March 27, 2012)

Panel’s Recommendations

• Antiretroviral therapy (ART) is recommended for all HIV-infected individuals. The strength of this recommendation varies
on the basis of pretreatment CD4 cell count:
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• CD4 count <350 cells/mm (AI)
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• CD4 count 350 to 500 cells/mm (AII)
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• CD4 count >500 cells/mm (BIII)
• Regardless of CD4 count, initiation of ART is strongly recommended for individuals with the following conditions:
• Pregnancy (AI) (see perinatal guidelines for more detailed discussion)
• History of an AIDS-defining illness (AI)
• HIV-associated nephropathy (HIVAN) (AII)
• HIV/hepatitis B virus (HBV) coinfection (AII)
• Effective ART also has been shown to prevent transmission of HIV from an infected individual to a sexual partner;
therefore, ART should be offered to patients who are at risk of transmitting HIV to sexual partners (AI [heterosexuals] or
AIII [other transmission risk groups]; see text for discussion).
• Patients starting ART should be willing and able to commit to treatment and should understand the benefits and risks of
therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-
case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors.

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

Introduction
The primary goal of antiretroviral therapy (ART) is to reduce HIV-associated morbidity and mortality. This
goal is best accomplished by using effective ART to maximally inhibit HIV replication, as defined by
achieving and maintaining plasma HIV RNA (viral load) below levels detectable by commercially available
assays. Durable viral suppression improves immune function and quality of life, lowers the risk of both
AIDS-defining and non-AIDS-defining complications, and prolongs life. Based on emerging evidence,
additional benefits of ART include a reduction in HIV-associated inflammation and possibly its associated
complications.

The results of a randomized controlled trial and several observational cohort studies demonstrated that ART
can reduce transmission of HIV. Therefore, a secondary goal of ART is to reduce an HIV-infected
individual’s risk of transmitting the virus to others. Although the Panel concurs that this public health benefit
of ART is significant, Panel recommendations on when to initiate ART are based primarily on the benefit of
treatment to the HIV-infected individual.
The strength of Panel recommendations depends on disease stage. Randomized controlled trials provide
definitive evidence supporting the benefit of ART in patients with CD4 counts <350 cells/mm . Results from
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multiple observational cohort studies demonstrate benefits of ART in reducing AIDS- and non-AIDS-
associated morbidity and mortality in patients with CD4 counts ranging from 350 to 500 cells/mm . The
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Panel therefore recommends ART for patients with CD4 counts ≤500 cells/mm (AI for CD4 count <350
Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents E-1

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