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The DHHS perinatal guidelines recommend ARV agents and combinations for use in women who are trying to conceive and during pregnancy based on 4 categories. The preferred category includes agents with high efficacy, durability, tolerability, and ease of use, as demonstrated in clinical trials in adults. Additional features of the options included in this category are the availability of PK data to guide dosing during pregnancy, a favorable risk–benefit profile vs other agents, and acceptable safety outcomes for pregnancy, fetuses, and newborn infants.
Alternative agents include those for which clinical trial data in adults show efficacy, and the data in pregnancy are reassuring but more limited.
The category “insufficient data to recommend” includes agents that are approved for use in adults but for which specific PK or safety data in pregnancy are limited.
Some agents are only recommended in special circumstances. These include agents for which there may be more limited data on safety and efficacy, but their initiation or continuation may be necessary in some ART-experienced women in order to reach and/or maintain viral suppression.
Finally, some agents are not recommended under any circumstances. This category includes agents for which there is inferior virologic efficacy, potentially serious maternal or fetal safety concerns, or PK data demonstrating lower drug levels and an increased risk of viral rebound during pregnancy.
It should be noted that the first 3 categories—preferred, alternative, and insufficient data to recommend—change fairly frequently because drugs that are in the alternative or insufficient data categories may move up a category as additional data accumulate.
This table shows the DHHS recommendations for initial ART among antiretroviral-naive women during pregnancy. Three NRTI combinations are listed in the preferred category: 3TC/ABC, FTC/TDF, and 3TC plus TDF, although ABC should only be used if the patient is HLA-B*5701 negative. 3TC/zidovudine (ZDV) is listed as an alternative NRTI combination, and there are currently insufficient data to recommend TAF for initial therapy in pregnancy.
Regarding INSTIs, DTG is a preferred agent throughout pregnancy, although, as will be discussed later, there is a potential slight increased risk of NTDs with use at conception and in very early pregnancy, which should be discussed with patients. RAL is also listed as a preferred INSTI during pregnancy.
Finally, ATV/RTV and DRV/RTV are in the preferred category for PIs, but it should be noted that DRV/RTV should be given twice daily during pregnancy rather than once daily based on PK data. Boosting of these PIs with COBI is not currently recommended in antiretroviral-naive women in pregnancy based on PK results showing risk for low blood levels and potential viral rebound.
This table shows situation-specific recommendations regarding the use of INSTIs and PIs during pregnancy and in women who are trying to conceive. The first column lists the ARV and each additional column represents different situations that may be encountered when providing care for women who are pregnant or trying to conceive. The recommendations for women who become pregnant while ART naive were reviewed on the preceding slide, but women are increasingly becoming pregnant while already receiving ART, or have past ART experience, and the middle 3 columns in the table address these situations. The final column shows recommendations for women who are not pregnant but are actively trying to conceive.
A few points are worth highlighting in this table. First, as noted previously, DTG is now a preferred regimen for ART-naive women who become pregnant. It is also preferred for women who are restarting ART and those who are receiving a regimen that is not well tolerated or fully suppressive when they become pregnant. For women who are not pregnant and are trying to conceive, however, it is listed as an alternative agent, and we will discuss the data that led to its placement in this category later in this module.
BIC, which is now listed as a preferred agent for most people with HIV in both the DHHS and IAS-USA guidelines, still has insufficient data for recommendation in the setting of pregnancy or for women who are trying to conceive.
Finally, COBI-boosted elvitegravir (EVG) and COBI-boosted PIs are not recommended during pregnancy because of PK data demonstrating decreased blood levels during pregnancy.[16-18]
This table shows situation-specific recommendations regarding the use of NNRTIs and NRTIs during pregnancy and in women who are trying to conceive. Of particular note is that there are insufficient data to recommend TAF for most women who become pregnant or those trying to conceive. However, if a woman becomes pregnant and is on a suppressive and well-tolerated ART regimen that includes TAF, the recommendation is to continue, based on reassuring data to date regarding safety.
Also of note is that ZDV, which was preferred in pregnancy for some time based on a dramatic reduction in perinatal transmission as shown in the landmark 076 study, is no longer in the preferred category, but rather is listed as an alternative agent due to tolerability issues. However, if a woman becomes pregnant and is on a well-tolerated ZDV-containing regimen, the recommendation is to continue.