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Updated Perinatal ART Guidelines for Pregnant Women with HIV

The U.S. Department of Health and Human Services has updated its guidelines for use of antiretroviral drugs by pregnant women with HIV, intended both to improve the health of women and to prevent transmission of the virus to their infants during gestation or delivery.

The full 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 are available online. Comments on the revision are being accepted until April 11, 2014.

The major changes in the latest version are outlined in the "What's New in the Guidelines" section. These include:

• All women with HIV who are contemplating pregnancy should be on maximally suppressive antiretroviral therapy (ART).
• HIV positive women who do not wish to become pregnant can use all available contraceptive methods, including hormonal contraception and emergency contraception.
• The HIV positive partner in a serodiscordant couple, or both partners if both have HIV, should achieve maximum viral suppression before attempting conception.
• Pre-exposure prophylaxis (PrEP) for uninfected partners may offer an additional tool to reduce the risk of sexual transmission while trying to become pregnant, and pregnancy is not a contraindication to PrEP. 
• A stronger warning that people with pre-existing liver disease should consider using antiretrovirals other than nevirapine (Viramune).
• Preferred NRTI options for treatment-naive pregnant women have been expanded to include abacavir (Ziagen) plus lamivudine (3TC, Epivir), and tenofovir (Viread) plus either emtricitabine (Emtriva) or lamivudine, in addition to zidovudine (AZT, Retrovir) plus lamivudine.
• Preferred protease inhibitors for treatment-naive pregnant women remain ritonavir-boosted atazanavir (Reyataz) or lopinavir/ritonavir (Kaletra), with ritonavir-boosted darunavir (Prezista) or saquinavir (Invirase) as alternatives.
• The preferred non-nucleoside reverse transcriptase inhibitor (NNRTI) is now efavirenz (Sustiva or Stocrin), started after the first 8 weeks of pregnancy, with nevirapine as an alternative.
• Raltegravir (Isentress) has been moved to the alternative category for treatment-naive pregnant women, for consideration particularly when drug interactions with protease inhibitors are a concern.
• There is not enough data to recommend routine use of the new integrase inhibitors dolutegravir (Tivicay) or elvitegravir (in the Stribild coformulation), boosted fosamprenavir (Lexiva), maraviroc (Selzentry), or rilpivirine (Edurant). 
• For HIV/HCV coinfected women, there is not enough information about use of new hepatitis C drugs during pregnancy, interferon is not recommended, and ribavirin should not be used because it may cause birth defects.
• CD4 T-cell monitoring can be done every 6 months (rather than every 3 months) if pregnant women are on ART with consistent viral load suppression and are above the CD4 cell threshold for opportunistic illnesses.
• The viral load threshold for requiring intravenous (IV) zidovudine during labor has been modified, now matching the threshold for scheduled cesarean delivery.
• IV zidovudine should be administered to women with HIV RNA >1000 copies/mL (or unknown) near delivery, but is not required for women receiving combination ART who have HIV RNA <1000 copies/mL consistently during late pregnancy and near delivery.
• Decisions about continuing ART after delivery should be made by a woman and her HIV provider, ideally before delivery, and ART is now recommended for all HIV positive individuals regardless of CD4 count. 
• A 4-week course of zidovudine prophylaxis can be considered for babies born to women on ART with consistent viral suppression.
• The NICHD/HPTN 040/P1043 infant prophylaxis regimen of 6 weeks of zidovudine plus 3 doses of nevirapine, started as soon as possible after birth, continues to be the general recommendation for babies born to mothers who did not receive ART during pregnancy or only during delivery.
• The Mississippi baby functional cure case is discussed, which suggests that immediate combination ART for infants may enable viral control off treatment. However, investigation is ongoing and clinical trials are planned, but changes in routine practice are not yet advised.

4/2/14

Sources

DHHS 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. Updated March 28, 2014.

U.S. Department of Health and Human Services. Updated HHS Perinatal Antiretroviral Treatment Guidelines Released. AIDSinfo At-A-Glance 10(7). March 28, 2014.