Page 133 - HIV/AIDS Guidelines

HIV-Infected Women (Last updated March 27, 2012; last reviewed March 27, 2012)

Panel’s Recommendations

• The indications for initiation of antiretroviral therapy (ART) and the goals of treatment are the same for HIV-infected
women as for other HIV-infected adults and adolescents (AI).
• Women taking antiretroviral (ARV) drugs that have significant pharmacokinetic interactions with oral contraceptives
should use an additional or alternative contraceptive method to prevent unintended pregnancy (AIII).
• In pregnant women, an additional goal of therapy is prevention of perinatal transmission of HIV, with a goal of
maximal viral suppression to reduce the risk of transmission of HIV to the fetus and newborn (AI).
• When selecting an ARV combination regimen for a pregnant woman, clinicians should consider the known safety,
efficacy, and pharmacokinetic data on use during pregnancy for each agent (AIII).
• Use of efavirenz (EFV) should be avoided in a pregnant woman during the first trimester or in a woman who desires
to become pregnant or who does not or cannot use effective and consistent contraception (AIII).

• Clinicians should consult the most current Health and Human Services (HHS) Perinatal Guidelines when designing a
regimen for a pregnant woman (AIII).

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

This section provides discussion of some basic principles and unique considerations to follow when caring
for HIV-infected women, including during pregnancy. Clinicians who provide care for pregnant women
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should consult the current Perinatal Guidelines for in-depth discussion and management assistance.
Additional guidance on the management of HIV-infected women can be found at:
http://hab.hrsa.gov/deliverhivaidscare/clinicalguide11/.

Gender Considerations in Antiretroviral Therapy
In general, studies to date have not shown gender differences in virologic responses to ART, 2-4 although a
number of studies have suggested that gender may influence the frequency, presentation, and severity of
selected ARV-related adverse events. Although data are limited, there is also evidence that pharmacokinetics
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for some ARV drugs may differ between men and women, possibly due to variations between men and
women in factors such as body weight, plasma volume, gastric emptying time, plasma protein levels,
cytochrome P (CYP) 450 activity, drug transporter function, and excretion activity. 6-8

Adverse Effects:

• Nevirapine (NVP)-associated hepatotoxicity: NVP has been associated with an increased risk of
symptomatic, potentially fatal, and often rash-associated liver toxicity in ARV-naive individuals; women
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with higher CD4 counts (>250 cells/mm ) or elevated baseline transaminase levels appear to be at
greatest risk. 9-12 It is generally recommended that NVP not be prescribed to ARV-naive women who have
CD4 counts >250 cells/mm unless there is no other alternative and the benefit from NVP outweighs the
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risk of hepatotoxicity (AI).
• Lactic acidosis: There is a female predominance in the increased incidence of symptomatic and even
fatal lactic acidosis associated with prolonged exposure to nucleoside reverse transcriptase inhibitors
(NRTIs). Lactic acidosis is most common with stavudine (d4T), didanosine (ddI), and zidovudine (ZDV)
but it can occur with other NRTIs. 13

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents I-17

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