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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

Recommendations for Women

HIV-Infected Pregnant Women Who Are Currently Receiving Antiretroviral Therapy

(Last updated: August 6, 2015; last reviewed: August 6, 2015)

Panel's Recommendations

Panel's Recommendations

  • In general, HIV-infected pregnant women receiving combination antiretroviral therapy (cART) who present for care during the first trimester should continue treatment during pregnancy, assuming the regimen is tolerated and effective in suppressing viral replication (HIV-1 viral load less than lower limits of detection of the assay) (AII).
  • The Panel recommends that efavirenz be continued in pregnant women receiving efavirenz-based cART who present for antenatal care in the first trimester, provided the regimen is achieving virologic suppression (CIII).
  • HIV antiretroviral drug-resistance testing should be performed to assist in the selection of active drugs when changing antiretroviral regimens in pregnant women on therapy with virologic failure and HIV RNA levels >1,000 copies/mL (AI). In individuals with HIV RNA levels >500 but <1,000 copies/mL, testing may be unsuccessful but should still be considered (BII) (see Lack of Viral Suppression).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II = One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion

Women who have been receiving combination antiretroviral therapy (cART) for their HIV infection should continue treatment during pregnancy, assuming it is effective in suppressing viral replication and well-tolerated. Discontinuation of therapy could lead to an increase in viral load with possible decline in immune status and disease progression as well as adverse consequences for the fetus, including increased risk of HIV transmission. Continuation of cART is recommended when pregnancy is identified in HIV-infected women receiving cART.

HIV-infected women receiving cART who present for care during the first trimester should be counseled regarding the benefits and potential risks of administration of antiretroviral (ARV) drugs during this period. Providers should emphasize that continuation of cART is recommended. There are concerns regarding efavirenz use in the first trimester and potential for neural tube defects, based on non-human primate data and retrospective case reports (for more details see Teratogenicity). However, a recent meta-analysis including data on 2,026 women with first-trimester efavirenz exposure from 21 prospective studies did not find an increased relative risk (RR) of overall birth defects in infants born to women receiving efavirenz-based versus non-efavirenz-based regimens (RR 0.78, 95% confidence interval [CI], 0.56–1.08). One neural tube defect was identified, resulting in an incidence of 0.05% (95% CI, <0.01 to 0.28) similar to the incidence of neural tube defects in the general population.1 Although a 2- to 3-fold increased incidence of a rare outcome (e.g., neural tube defects [0.02% to 0.2% incidence in the United States]) cannot be ruled out given the limited data on first-trimester efavirenz exposure, the available data suggest that first-trimester exposure is not associated with a large (i.e., 10-fold or more) increase in risk of neural tube defects. 

The risk of neural tube defects is restricted to the first 5 to 6 weeks of pregnancy. Pregnancy is rarely recognized before 5 to 6 weeks, and changes in ARV drugs during pregnancy may be associated with lack of virologic suppression at the end of pregnancy and increased risk of perinatal transmission.2 The Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission recommends that efavirenz be continued in pregnant women receiving efavirenz-based cART who present for antenatal care in the first trimester, provided that the ARV regimen is resulting in virologic suppression. 
 
Resistance testing should be performed in pregnant women on cART when a change in active drugs is being considered because of virologic failure with HIV RNA levels >1,000 copies/mL. In individuals with HIV RNA levels >500 but <1,000 copies/mL, testing may be unsuccessful but it still should be considered. The results can be used to select a new regimen with a greater likelihood of suppressing viral replication to undetectable levels. 

Pregnant women for whom nevirapine-containing regimens result in virologic suppression and who are tolerating therapy may be continued on that regimen, regardless of current CD4 T lymphocyte (CD4) cell count. Although hepatic toxicity is a concern in women starting a nevirapine-containing regimen who have CD4 cell counts >250 cells/mm3, an increased risk of hepatic toxicity has not been seen in women continuing nevirapine-based therapy that has resulted in CD4 counts >250 cell/mm3.

References

  1. Ford N, Shubber Z, Jao J, Abrams EJ, Frigati L, Mofenson L. Safety of cotrimoxazole in pregnancy: a systematic review and meta-analysis. J Acquir Immune Defic Syndr. 2014. Available at http://www.ncbi.nlm.nih.gov/pubmed/24853309.
  2. Floridia M, Ravizza M, Pinnetti C, et al. Treatment change in pregnancy is a significant risk factor for detectable HIV-1 RNA in plasma at end of pregnancy. HIV Clin Trials. 2010;11(6):303-311. Available at http://www.ncbi.nlm.nih.gov/pubmed/21239358.

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