Appendix C: Antiretroviral Counseling Guide for Health Care Providers
Decision-Making About Antiretroviral Drugs for People Who Are Pregnant or Are Trying to Conceive
This guide summarizes current information about recommendations of the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission (the Panel), to support counseling about the use of antiretroviral (ARV) drugs and ARV therapy (ART) options during pregnancy for people who are pregnant or trying to conceive.
For people who are pregnant or trying to conceive, effective ART with sustained viral suppression maximizes their health and the prevention of perinatal HIV transmission. The risk of perinatal HIV transmission is reduced to the lowest levels (1% or less) in people with HIV who initiate ART prior to conception and have sustained viral suppression to undetectable levels throughout pregnancy. See Use of Antiretroviral Drugs to Prevent Perinatal HIV Transmission and Improve Health for Pregnant People.
Before, during, and after pregnancy, it is important to discuss future childbearing desires and plans, the potential benefits and risks of conceiving while taking specific ARV medications, and contraceptive options to prevent unintended pregnancy.
General Antiretroviral Counseling for People Who Are Pregnant or Are Trying to Conceive
- As part of shared decision-making, information should be provided to individuals who are pregnant or trying to conceive to help them understand and consider the benefits, advantages, disadvantages, and potential risks associated with the use of each individual ARV drug they are currently receiving or will be initiating. These factors include dosing frequency, side effects or tolerability issues, and adverse pregnancy outcomes (e.g., preterm delivery, birth defects). For additional information, refer to Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy for People Who Are Antiretroviral-Naive, Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive, Teratogenicity, and Antiretroviral Drug Regimens and Maternal and Neonatal Outcomes.
- People who are trying to conceive should receive information about the use of specific ARV regimens during pregnancy to enable them to make informed decisions before they become pregnant.
- It should be explained that not enough is known about the safety of using certain ARV drugs around the time of conception or during pregnancy or about the need for dosing changes during pregnancy, when relevant, because studies in pregnancy are limited. It is important to emphasize that a lack of data does not indicate the absence or presence of risk; rather, it means that we do not have all the information about the possible effects when using these drugs during pregnancy.
- The Antiretroviral Pregnancy Registry prospectively collects and reviews data about birth defects in order to detect any major teratogenic effect(s) involving the ARV drugs to which pregnant people are exposed. Clinicians are encouraged to report all cases of ARV drug exposure during pregnancy or in people who conceived while receiving ARV drugs to the Antiretroviral Pregnancy Registry.
- When discussing the risks of birth defects with ARV medication exposure, it is important to point out the overall risk of defects in the general population and explain during which weeks of gestation the fetus is at risk for developing that defect. For example, a background risk of neural tube defects (NTDs) exists, regardless of the ARV regimen used or a person’s HIV status during pregnancy. Most NTDs occur before the neural tube closes at 4 weeks postconception (approximately 6 weeks after the last menstrual period), often before a person is known to be pregnant. After 6 weeks’ gestation, the additional risk of NTDs developing is thought to be much less likely. Folic acid supplementation should be encouraged for all people trying to conceive and in early pregnancy (see Prepregnancy Counseling and Care for Persons of Childbearing Age with HIV.
- Early data from the Tsepamo study in Botswana raised concerns about a possible higher rate of NTDs among infants born to mothers who received dolutegravir (DTG) at the time of conception. Sufficient data now exist to indicate that DTG is not associated with an increased risk of NTDs. See Dolutegravir for additional information.
- Based on the June 2023 Antiretroviral Pregnancy Registry report, sufficient numbers of first-trimester exposures to bictegravir (BIC) have been reported to detect at least a twofold increase in the risk of overall birth defects. No such increase in birth defects has been detected with BIC. Previously, not enough reported data had existed to assess the risk of birth defects with BIC.
- Clinicians are encouraged to report all cases of ARV drug exposure during pregnancy or in people who conceived while receiving ARV drugs to the Antiretroviral Pregnancy Registry.
- The risk of other adverse pregnancy outcomes, many of which are more common than birth defects, also should be discussed. ARV regimens that contain ritonavir-boosted protease inhibitors may increase the risk of preterm delivery. See Antiretroviral Drug Regimens and Pregnancy Outcomes.
- In most cases, the Panel recommends that pregnant people with HIV continue their current regimen during pregnancy, provided that the regimen is tolerated and effective in suppressing viral replication (defined as a regimen that maintains an HIV viral load less than the lower limits of detection of the assay).
- Explain that changes in ART during pregnancy can lead to an increase in viral load, which increases the risk of perinatal HIV transmission; and may affect choices for future ARV regimens because of the possible development of drug resistance.
- Counsel individuals who are receiving ARVs that are not Preferred or Alternative options for use during pregnancy about the benefits and risks of continuing their current ART or switching to another ARV regimen.
- When individuals are receiving ARVs for which data about use in pregnancy are insufficient (e.g., long-acting cabotegravir, doravirine) or ARVs with pharmacokinetic (PK) changes that could lead to lower drug levels and loss of viral suppression (e.g., cobicistat-boosted regimens), discuss whether to continue the current regimen with frequent viral load monitoring (i.e., every 1 to 2 months) or consider switching to another ARV drug or drug regimen. In making this decision, consider the tolerability of each drug, the ability to maintain viral suppression, the risk of perinatal HIV transmission, and the risk of potential adverse outcomes.
- The Panel recognizes that to reach or maintain viral suppression, some people who are ART experienced may need to take ARV drugs that have insufficient data regarding use in pregnancy or are not recommended for use in pregnancy except in special circumstances.
- For additional information, see Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive and People with HIV Who Are Taking Antiretroviral Therapy When They Become Pregnant.
Antiretroviral Drugs That Are Recommended for Use in Pregnancy
- When making recommendations about the use of ARV drugs in pregnancy, the Panel considers available data from multiple sources about efficacy; PKs; and dosing, safety, and toxicity in pregnant and nonpregnant adults. The Panel requires adequate PK, dosing, and teratogenicity data from pregnant people to categorize a drug as Preferred or Alternative for use in people who are pregnant or trying to conceive. ARV drugs are assigned to one of the five categories (see Recommendations for Use of Antiretroviral Drugs During Pregnancy: Overview).
- Moderate amounts of data about pregnancy outcomes and birth defects exist for each of the drugs and drug combinations that are Preferred. Although these data are reassuring, it is important to note that among the Preferred drugs, a rigorous, systematic birth surveillance program that includes large numbers of women with periconception exposure is available only for DTG.
- Preferred ARV drug options include DTG used in combination with two nucleoside reverse transcriptase inhibitors (NRTIs): abacavir plus lamivudine (3TC) or emtricitabine (FTC), tenofovir disoproxil fumarate (TDF) plus 3TC or FTC, or tenofovir alafenamide (TAF) plus 3TC or FTC.
- DTG-based regimens are Preferred for people with early (acute or recent) HIV infection during pregnancy unless there is a history of prior exposure to long-acting cabotegravir, for pre-exposure prophylaxis. After long-acting cabotegravir exposure, a regimen of darunavir/ritonavir (DRV/r) with TDF or TAF plus FTC or 3TC is the Preferred ART regimen pending results of genotype testing. For additional information, see Early (Acute and Recent) HIV Infection.
- BIC, raltegravir, atazanavir/ritonavir, DRV/r, EFV, and rilpivirine (RPV) are recommended as Alternative ARV drug options in pregnancy. Alternative drugs may have more limited data on use in pregnancy than Preferred drugs or may be associated with more concerns about PK, dosing, tolerability, drug interaction, efficacy, or resistance than those in the Preferred category, but they are acceptable for use in pregnancy.
- To maximize ARV absorption and effectiveness, it is important to reinforce the need to check and follow the instructions for taking the regimen (e.g., taking DRV and RPV with food, spacing administration of integrase strand transfer inhibitors with antacids or divalent cation–containing vitamins, avoiding proton pump inhibitors and spacing administration of H2 blockers with atazanavir/cobicistat). See Appendix B: Supplement: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy for instructions about dosing and administration.
- Cobicistat-boosted regimens (atazanavir/cobicistat, darunavir/cobicistat, or elvitegravir/cobicistat) are not recommended for use during pregnancy. PK studies suggest increased drug metabolism and lower therapeutic drug levels of cobicistat-boosted ARV drugs during pregnancy. Individuals who choose to continue one of these regimens should have more frequent viral load monitoring (i.e., every 1 to 2 months).
- If an ARV regimen is changed during pregnancy, drugs in the new regimen should include those that are recommended for use in pregnancy whenever possible (see Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy for People Who Are Antiretroviral-Naive and Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive), and viral load should be monitored more frequently (i.e., every 1 to 2 months).
- If an ARV regimen is changed during pregnancy, drugs in the new regimen should include those that are recommended for use in pregnancy (see Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy for People Who Are Antiretroviral-Naive and Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive ), and viral load should be monitored more frequently (i.e., every 1 to 2 months).
- Recommendations regarding the use of specific ARV agents or ARV regimens change as more information on the safety, tolerability, and PK changes of these drugs in pregnancy becomes available. For additional information, see Recommendations for Use of Antiretroviral Drugs During Pregnancy: Overview, Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy for People Who Are Antiretroviral-Naive, Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive, and Appendix B: Supplement: Safety and Toxicity of Individual Antiretroviral Drugs in Pregnancy.