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 Use of Antiretroviral Drugs During Pregnancy
HIV-Infected Pregnant Women Who Are Currently Receiving Antiretroviral Therapy
Last Updated: October 26, 2016; Last Reviewed: October 26, 2016
|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 antiretroviral therapy (ART) 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. Furthermore, changes in the pharmacokinetics (PK) of antiretroviral (ARV) drugs during pregnancy may be associated with lack of virologic suppression at the end of pregnancy and increased risk of perinatal transmission.1
As newer, highly effective ARV drugs are approved, HIV-infected women may present for prenatal care on ART regimens that include ARV drugs for which there is a lack ofsignificant experience in pregnancy, with limited data on PK and safety. Maintenance of viral suppression is paramount for both maternal health and prevention of perinatal transmission. Thus, if questions arise about particular drugs in an ART regimen, providers are encouraged to consult with an HIV perinatal specialist before considering altering a regimen that is achieving full viral suppression and is well tolerated. Because little is known about the use of newly approved drugs in pregnancy, providers should make every effort to report all ART exposures in pregnant women to the Antiretroviral Pregnancy Registry.
HIV-infected women receiving ART who present for care during the first trimester should be counseled regarding the benefits and potential risks of administration of ARV drugs during this period. Providers should emphasize that continuation of effective ART is recommended. There have been 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.2 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 and that the risk is not greater than that seen in the general population. 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 ART 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 ART 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.
- 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.
- Ford N, Mofenson L, Shubber Z, et al. Safety of efavirenz in the first trimester of pregnancy: an updated systematic review and meta-analysis. AIDS. 2014;28 Suppl 2:S123-131. Available at http://www.ncbi.nlm.nih.gov/pubmed/24849471.