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The recommended regimens in the DHHS and IAS-USA guidelines for first-line ART in adults and adolescents are very similar and have shifted in the last couple of years to focus on INSTI-based therapy.[1,2] The largest difference between the 2 major guidelines is that RAL remains one of the options recommended for “most people with HIV” in the DHHS guidelines, whereas the IAS-USA guidelines focus more on BIC- and DTG-based regimens based on clinical trials showing high efficacy, safety, tolerability, and convenience with these agents. For treatment-naive women of childbearing age, the DHHS guidelines recommend that a pregnancy test be performed prior to initiating ART, and the IAS-USA guidelines recommend documentation of a negative pregnancy test result before initiating DTG-based therapy.
Guidelines from the WHO also recommend a DTG-based regimen as the preferred regimen for first-line ART, with an efavirenz (EFV)‑based regimen listed as the alternative. These recommendations are based on an updated systematic review conducted in 2019 that reaffirmed higher rates of virologic suppression, lower risk of discontinuing treatment, and lower risk of developing HIV drug resistance with DTG plus 2 NRTIs vs EFV-based regimens in treatment‑naive adults. Of importance, the WHO recommends that effective contraception be offered to women and adolescent girls of childbearing potential but emphasizes that DTG can be prescribed in this patient population if the woman wishes to become pregnant or is not using consistent or effective contraception, provided that she has been fully informed of the potential increased risk of neural tube defects (NTDs) with DTG use at conception and early in the first trimester.
It is important to discuss ART in women of childbearing age because the recommendations vary slightly from those of other adolescents and adults based on clinical experience and pharmacokinetic (PK) data in pregnancy. Often, the changes in ART regimen recommendations for women of childbearing age and in those who are pregnant mirror changes in the general adult guidelines, but tend to occur later, once additional data on use during pregnancy have accrued.
The first key consideration regarding ART in women of childbearing age is safety. Because pregnant women are generally excluded from clinical trials of investigational ARV drugs, there is often a dearth or delay in information about the safety of new regimens in pregnancy. Therefore, our experience of ARVs in pregnant women usually comes when women of become pregnant—either intentionally or unintentionally—while receiving different ART regimens. It is also important to remember that pregnancy is often not recognized until during or after the greatest risk of teratogenic potential, which is generally early in the first trimester.
Another key consideration regarding ART in women of childbearing age, particularly during pregnancy, is efficacy. Indeed, some ARV agents have lower drug levels in late pregnancy, which may increase the risk of loss of viral suppression with standard dosing.
Drug–drug interactions between ARVs and contraceptive agents must also be considered for those who are trying to prevent pregnancy. Of note, the combination of some ARV agents and hormonal contraceptive methods may potentially reduce contraceptive or ARV efficacy and/or increase the risk of adverse events.
For women wishing to become pregnant, the goal of either the initial choice of an ART regimen or modification of an existing regimen should be sustained viral suppression prior to conception. The regimen should also be tolerable, which may pose a greater challenge during early pregnancy when many women experience gastrointestinal distress. Achieving stable viral suppression optimizes maternal health, minimizes the risk of perinatal HIV transmission when pregnancy occurs, and prevents sexual transmission to a partner who is not infected with HIV.
It is important that ethical issues are considered when prescribing ART to women who are pregnant or who might become pregnant. The DHHS perinatal guidelines distinguish between women who might become pregnant and women who are trying to conceive but, regardless, emphasize that counseling and informed decision-making are critical with all ART regimens. Furthermore, this counseling should be given using a woman‑centered approach, whereby medical guidance is given in a noncoercive manner that respects autonomy in decision-making.
In addition, caution should be used in unilaterally restricting the choice of ART regimens in women of childbearing age or in switching away from fully suppressive ART regimens in women who present during pregnancy. Doing so may affect the likelihood of achieving or maintaining sustained viral suppression. When considering the appropriateness of an ART regimen during pregnancy, it is important to remember that the absence of data on use during pregnancy is not equivalent to evidence of harm.
If you are treating a woman who becomes pregnant or is considering pregnancy while receiving ART and you are unsure about how to manage her regimen, the recommendation of this author is to consult the DHHS perinatal guidelines or discuss options with a provider who has expertise in both HIV and pregnancy.