Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States
Recommendations for Use of Antiretroviral Drugs During Pregnancy
Pregnant Women Living with HIV Who Are Currently Receiving Antiretroviral Therapy
Last Updated: November 14, 2017; Last Reviewed: November 14, 2017
|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 generally continue their ART regimen during pregnancy, provided it is well-tolerated and effective in suppressing viral replication.
As newer, highly effective antiretroviral (ARV) drugs are approved, women living with HIV may present for prenatal care on ART regimens that include ARV drugs for which there is a lack of significant experience in pregnancy, with limited data on pharmacokinetics and safety. There are certain drugs which should not be continued in pregnant women because of toxicity risk (stavudine, didanosine, and treatment-dose ritonavir, which are also recommended for non-pregnant individuals). Additionally, consider replacing certain drugs that have low drug exposure in pregnant women associated with potential increase in virologic failure (i.e., elvitegravir/cobicistat). These drugs should be replaced with ARVs recommended in pregnancy (see Table 6). However, discontinuation or alteration 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.1 Maintenance of viral suppression is paramount for both maternal health and prevention of perinatal transmission. Thus, if questions arise about specific 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. In addition, more frequent virologic monitoring is warranted when an ARV regimen is altered during pregnancy. 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.
Women with HIV 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 Efavirenz section). 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% CI, 0.56–1.08). The Panel on Treatment of Pregnant Women Living with HIV and Prevention of Perinatal Transmission recommends that efavirenz be continued in pregnant women receiving efavirenz-based ART, provided that the ARV regimen is well tolerated and results 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.
- 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.
- AIDSinfo Drug Database
- AIDSinfo Patient Materials: Preventing Mother-to-Child Transmission of HIV
- AIDSinfo Patient Materials: HIV Medicines During Pregnancy and Childbirth
- AIDSinfo Patient Materials: Protecting Baby from HIV
- AETC National HIV Curriculum
- How to Cite These Guidelines
- Perinatal Guidelines Archive