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On July 31, 2012, the U.S. Department of Health and Human Services released an updated version of its guidelines for perinatal antiretroviral use. The most important changes in clinical recommendations are as follows:
Ritonavir-boosted atazanavir is now a “preferred” agent for initial treatment of HIV infection in pregnant women, reflecting cumulative safety data on this drug in pregnancy. Lopinavir/ritonavir (twice daily) also remains in the “preferred” protease inhibitor category, and ritonavir-boosted darunavir is now an “alternative” agent, having been elevated from the “insufficient data to recommend use” category.
Because ddI and d4T are more toxic than other available nucleoside reverse transcriptase inhibitors, they are no longer “alternative” agents and should be restricted to “use in special circumstances.”
Raltegravir is now considered an agent to “use in special circumstances,” having been moved from the “insufficient data to recommend use” category.
HIV-infected women who become pregnant while their virus is controlled on an efavirenz-containing regimen may now continue that regimen, rather than switching from efavirenz and risking virologic failure. This new recommendation is based on the fact that a switch from efavirenz during pregnancy probably occurs too late to counter the main risk of the drug — neural tube defects, which typically occur during the first 6 weeks of pregnancy, before most women are even aware they are pregnant.
Antiretroviral therapy (ART) is now recommended for the HIV-infected partner in serodiscordant couples who wish to conceive. Additionally, pre-exposure prophylaxis (PrEP) for the uninfected partner may be useful, with the caveat that studies have not been completed to assess the effect of PrEP in settings where the HIV-infected partner has achieved virologic suppression on ART.
Pregnant HIV-infected women should be screened not only for hepatitis B virus infection, as detailed in previous guidelines, but also for hepatitis C virus infection and tuberculosis.
Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Jul 31, 2012. (http://aidsinfo.nih.gov/guidelines/html/3/perinatal-guidelines/0)
Comment
The recommendations in this update increase the options both for treating pregnant HIV-infected women and for preventing HIV acquisition by uninfected partners in serodiscordant couples who wish to conceive. For pregnant women, the designation of ritonavir-boosted atazanavir as a preferred agent is particularly important, because it allows for the construction of a well-tolerated once-daily regimen. The recommendation to continue efavirenz in women who become pregnant while virologically suppressed on this drug is also important, because it should result in fewer virologic failures than the previous practice of switching virologically suppressed pregnant women off of efavirenz. Notably, pregnancy testing should always be performed before initiating efavirenz in women of childbearing potential, and antiretroviral agents other than efavirenz should be selected for women desiring pregnancy or not using effective contraceptive methods.
With the recent plethora of data on both pre-exposure prophylaxis (PrEP) and “treatment as prevention,” reproductive options for serodiscordant couples now exist and are more fully discussed in the updated guidelines. Although the guidelines continue to state that artificial insemination and sperm-preparation techniques remain the safest options, the panel is clearly rooted in the reality that these measures may be unacceptable or unaffordable to many couples. Other options being explored include ART for the HIV-infected partner, with maximal virologic suppression before attempted conception, and PrEP for the uninfected partner. However, concerns exist with both of these options; there have been reports of discordance between genital and plasma viral loads (AIDS 2010; 24:2489 and 2009; 23:2050), and the value of PrEP when the infected partner is virologically suppressed on ART is unknown. Clearly, more studies in this area are needed, but in the meantime, it is satisfying to see guideline panels recognize the need for and provide practical advice on a range of options for HIV-serodiscordant couples who wish to become parents.