Recommendations for Use of Antiretroviral Drugs During Pregnancy
Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy When Antiretroviral Therapy Has Never Been Received
Recommendations for initial antiretroviral therapy (ART) during pregnancy are intended when there has never been prior receipt of ART or antiretroviral (ARV) drugs for prophylaxis (i.e., ARV-naive) and there is no evidence of significant resistance to regimen components (see Lack of Experience With Antiretroviral Drugs During Pregnancy and Prior to Pregnancy [Antiretroviral-Naïve]). Recommendations about the use of ARVs in other scenarios are detailed in Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs During Pregnancy and When Trying to Conceive.
In general, the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission (the Panel) recommends that pre-pregnancy regimens should be continued when pregnancy occurs on fully suppressive ARV regimens, unless these regimens include an ARV drug or ARV regimen that is not recommended for use in nonpregnant adults or concerns exist about safety and inferior efficacy during pregnancy (see Table 7 and Antiretroviral Therapy Use During Prepregnancy and Early Pregnancy). Clinicians may need to consider additional factors when initiating ART in patients who previously received ART or ARV drugs for prophylaxis (see Previous Experience With Antiretroviral Medications but Not on Antiretroviral Therapy During Current Pregnancy and Table 7).
Whenever possible, changes in ARV regimens should be timed so that viral suppression can be achieved before attempts at becoming pregnant begin (see Table 7).
Regimens are listed alphabetically within each drug class and recommendation category for initial therapy when there has never been prior ART or ARV exposure (ARV-naïve), so the order does not indicate a ranking of preference. In addition, except where noted below, the Panel makes no recommendation for one agent or regimen over another within each category (e.g., among Preferred or Alternative medications). The table also indicates ARV drugs or regimens that are available in fixed-dose combination tablets. Patients and providers should make shared decisions about which ARV drugs to use during pregnancy after discussing the benefits of ART and the known and potential health risks during pregnancy and risks to fetuses and infants (see Appendix C: Antiretroviral Counseling Guide for Health Care Providers and Recommendations for Use of Antiretroviral Drugs During Pregnancy: Overview).
Note: For more information about the use of specific drugs and dosing in pregnancy, see Table 7, the individual drug sections in Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy, and Table 14. Antiretroviral Drug Use in Pregnancy: Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy.
Preferred Initial Regimens in Pregnancy | ||
---|---|---|
Drugs or drug combinations are designated as Preferred for therapy during pregnancy when clinical trial data in adults have demonstrated efficacy and durability with acceptable toxicity and ease of use, and pregnancy-specific PK data are available to guide dosing. In addition, the available data must suggest a favorable risk-benefit balance for the drug or drug combination compared with other ARV drug options; the assessment of risks and benefits should incorporate outcomes for health during pregnancy as well as the health of the fetus and infant. Some Preferred drugs or regimens may have minimal toxicity or teratogenicity risks that are offset by other advantages during pregnancy or when trying to conceive. Therefore, it is important to read all the information on each drug in the Perinatal Guidelines before administering any of these medications to patients (see Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy). | ||
Preferred Dual-NRTI Backbones | Advantages | Disadvantages |
TAF/FTC or TAF Plus 3TC |
|
|
TDF/FTC or TDF/3TC |
|
|
Preferred INSTI Regimens | Advantages | Disadvantages |
BIC/TAF/FTC (FDC) |
|
|
DTG Plus a Preferred Dual-NRTI Backbone |
|
|
Preferred PI Regimens | Advantages | Disadvantages |
DRV/r Plus a Preferred Dual-NRTI Backbone |
|
|
Alternative Initial Regimens in Pregnancy | ||
Drugs or drug combinations are designated as Alternative options for therapy during pregnancy when clinical trial data in adults show efficacy and the data in pregnancy are generally favorable but limited. Most Alternative drugs or regimens are associated with more PK, dosing, tolerability, formulation, administration, or interaction concerns than those in the Preferred category, but they are acceptable for use in pregnancy. Some Alternative drugs or regimens may have known toxicity or teratogenicity risks that are offset by other advantages for during pregnancy or when trying to conceive. Therefore, it is important to read all the information on each drug in the Perinatal Guidelines before administering any of these medications to patients (see Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy). | ||
Alternative INSTI Regimens | Advantages | Disadvantages |
DTG/ABC/3TC (FDC) |
|
|
RAL Plus a Preferred Dual-NRTI Backbone |
|
|
Alternative PI Regimens | Advantages | Disadvantages |
ATV/r Plus a Preferred Dual-NRTI Backbone |
|
|
DRV/r Plus a Preferred Dual-NRTI Backbone |
|
|
Alternative Dual-NRTI Backbone | Advantages | Disadvantages |
ABC/3TC |
|
|
ZDV/3TC |
|
|
Alternative NNRTI Regimens | Advantages | Disadvantages |
EFV/TDF/FTC (FDC) or EFV/TDF/3TC (FDC) or EFV Plus a Preferred Dual-NRTI Backbone |
|
|
RPV/TDF/FTC (FDC) or RPV/TAF/FTC (FDC) or RPV (oral) Plus a Preferred Dual-NRTI Backbone |
|
|
Insufficient Data for Use as Initial Regimens in Pregnancy | ||
These drugs and drug combinations are approved for use in adults, but pregnancy-specific PK or safety data are too limited to make recommendations for use in pregnancy. When virologic suppression on one of these drugs or drug combinations is present when pregnancy occurs, providers and patients should consider whether to continue the current regimen or switch to a Preferred ARV regimen (see Antiretroviral Therapy Use During Prepregnancy and Early Pregnancy and Table 7). It is critical that providers report exposures to these medications in pregnancy to the Antiretroviral Pregnancy Registry. | ||
Insufficient Data | Advantages | Disadvantages |
DOR or DOR/TDF/FTC |
|
|
Not Recommended for Use as Initial Regimens in Pregnancy | ||
Drugs and drug combinations listed in this category are Not Recommended for initial use in pregnancy because of inferior virologic efficacy or potentially serious safety concerns for during pregnancy or for the fetus or because they are not recommended for initial therapy in nonpregnant adults. This category includes drugs or drug combinations for which PK data demonstrate low drug levels and risk of viral rebound during pregnancy. Levels of these drugs are often low in late pregnancy (during the second and third trimesters), when risk for perinatal transmission is high if viremia occurs (see Table 7 and Table 14). Note: When virologic suppression on one of these drugs or drug combinations is present when pregnancy occurs, providers and patients should consider whether to continue the current regimen or switch to a Preferred ARV regimen (see Antiretroviral Therapy Use During Prepregnancy and Early Pregnancy and Table 7). | ||
Not Recommended | Advantages | Disadvantages |
ATV/c |
| |
Long-Acting Injectable CAB Plus RPV (Co-packaged Formulation) |
|
|
DRV/c (FDC) or DRV/c/FTC/TAF (FDC) |
|
|
EVG/c/FTC/TAF (FDC) or EVG/c/FTC/TDF (FDC) |
|
|
Not Recommended for Initial Use in Pregnancy, but May Be Used in Special Circumstances of Substantial Prior ART Experience | ||
These drugs are Not Recommended for initial use in pregnancy when there has never been prior receipt of ART or antiretroviral (ARV) drugs for prophylaxis (i.e., ARV-naive). Except for NVP and LPV/r, data on the PK, safety, and efficacy of these drugs during pregnancy are limited. These drugs also are categorized as Not Recommended during pregnancy, except in special circumstances, because the Panel recognizes that circumstances may exist in which patients who are ART-experienced may need to initiate or continue these drugs during pregnancy to reach or maintain viral suppression (see Table 7). | ||
Not Recommended Except in Special Circumstances of Substantial Prior ART Experience | Advantages | Disadvantages |
ETR |
|
|
FTR |
| |
IBA |
| |
LEN |
| |
LPV/r Plus a Preferred Dual-NRTI Backbone |
|
|
MVC |
|
|
NVP |
|
|
T-20 |
| |
The following drugs and drug combinations (not listed above) should not be used during pregnancy; if pregnancy occurs while taking any of these medications, medications should be switched to a recommended regimen: d4T, ddI, FPV, FPV/r, IDV, IDV/r, NFV, RTV (as the sole PI), SQV, SQV/r, TPV, TPV/r, two-drug ARV regimens, or a three-NRTI ARV regimen (e.g., ABC/ZDV/3TC). See Archived Drugs in the Perinatal Guidelines and the Adult and Adolescent Antiretroviral Guidelines for individual ARV drugs, ARV combinations, and ARV regimens that are not recommended or that should not be used in adults. Key: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CD4 = CD4 T lymphocyte; CAB = cabotegravir; CAB-LA = long-acting cabotegravir; COBI = cobicistat; d4T = stavudine; ddI = didanosine; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DRV/r = darunavir/ritonavir; DTG = dolutegravir; EC95 = 95% maximal effective concentration; EFV = efavirenz; ETR = etravirine; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDC = fixed-dose combination; FPV = fosamprenavir; FPV/r = fosamprenavir/ritonavir; FTC = emtricitabine; FTR = fostemsavir; H2 blocker = histamine H2-receptor antagonist; HBV = hepatitis B virus; HD = high dose; IBA = ibalizumab; IDV = indinavir; IDV/r = indinavir/ritonavir; IMPAACT = International Maternal Pediatric Adolescent AIDS Clinical Trials; INSTI = integrase strand transfer inhibitor; IV = intravenous; LEN = lenacapavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NFV = nelfinavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NTD = neural tube defect; NVP = nevirapine; the Panel = the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission; PI = protease inhibitor; PK = pharmacokinetic; PPI = proton pump inhibitor; PrEP = pre-exposure prophylaxis; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SQV = saquinavir; SQV/r = saquinavir/ritonavir; T‑20 = enfuvirtide; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV = tipranavir; TPV/r = tipranavir/ritonavir; ZDV = zidovudine |
Recommendations for Use of Antiretroviral Drugs During Pregnancy
Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy for People Who Are Antiretroviral-Naive
Preferred Initial Regimens in Pregnancy | ||
---|---|---|
Drugs or drug combinations are designated as Preferred for therapy during pregnancy when clinical trial data in adults have demonstrated efficacy and durability with acceptable toxicity and ease of use, and pregnancy-specific PK data are available to guide dosing. In addition, the available data must suggest a favorable risk-benefit balance for the drug or drug combination compared with other ARV drug options; the assessment of risks and benefits should incorporate outcomes for health during pregnancy as well as the health of the fetus and infant. Some Preferred drugs or regimens may have minimal toxicity or teratogenicity risks that are offset by other advantages during pregnancy or when trying to conceive. Therefore, it is important to read all the information on each drug in the Perinatal Guidelines before administering any of these medications to patients (see Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy). | ||
Preferred Dual-NRTI Backbones | Advantages | Disadvantages |
TAF/FTC or TAF Plus 3TC |
|
|
TDF/FTC or TDF/3TC |
|
|
Preferred INSTI Regimens | Advantages | Disadvantages |
BIC/TAF/FTC (FDC) |
|
|
DTG Plus a Preferred Dual-NRTI Backbone |
|
|
Preferred PI Regimens | Advantages | Disadvantages |
DRV/r Plus a Preferred Dual-NRTI Backbone |
|
|
Alternative Initial Regimens in Pregnancy | ||
Drugs or drug combinations are designated as Alternative options for therapy during pregnancy when clinical trial data in adults show efficacy and the data in pregnancy are generally favorable but limited. Most Alternative drugs or regimens are associated with more PK, dosing, tolerability, formulation, administration, or interaction concerns than those in the Preferred category, but they are acceptable for use in pregnancy. Some Alternative drugs or regimens may have known toxicity or teratogenicity risks that are offset by other advantages for during pregnancy or when trying to conceive. Therefore, it is important to read all the information on each drug in the Perinatal Guidelines before administering any of these medications to patients (see Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy). | ||
Alternative INSTI Regimens | Advantages | Disadvantages |
DTG/ABC/3TC (FDC) |
|
|
RAL Plus a Preferred Dual-NRTI Backbone |
|
|
Alternative PI Regimens | Advantages | Disadvantages |
ATV/r Plus a Preferred Dual-NRTI Backbone |
|
|
DRV/r Plus a Preferred Dual-NRTI Backbone |
|
|
Alternative Dual-NRTI Backbone | Advantages | Disadvantages |
ABC/3TC |
|
|
ZDV/3TC |
|
|
Alternative NNRTI Regimens | Advantages | Disadvantages |
EFV/TDF/FTC (FDC) or EFV/TDF/3TC (FDC) or EFV Plus a Preferred Dual-NRTI Backbone |
|
|
RPV/TDF/FTC (FDC) or RPV/TAF/FTC (FDC) or RPV (oral) Plus a Preferred Dual-NRTI Backbone |
|
|
Insufficient Data for Use as Initial Regimens in Pregnancy | ||
These drugs and drug combinations are approved for use in adults, but pregnancy-specific PK or safety data are too limited to make recommendations for use in pregnancy. When virologic suppression on one of these drugs or drug combinations is present when pregnancy occurs, providers and patients should consider whether to continue the current regimen or switch to a Preferred ARV regimen (see Antiretroviral Therapy Use During Prepregnancy and Early Pregnancy and Table 7). It is critical that providers report exposures to these medications in pregnancy to the Antiretroviral Pregnancy Registry. | ||
Insufficient Data | Advantages | Disadvantages |
DOR or DOR/TDF/FTC |
|
|
Not Recommended for Use as Initial Regimens in Pregnancy | ||
Drugs and drug combinations listed in this category are Not Recommended for initial use in pregnancy because of inferior virologic efficacy or potentially serious safety concerns for during pregnancy or for the fetus or because they are not recommended for initial therapy in nonpregnant adults. This category includes drugs or drug combinations for which PK data demonstrate low drug levels and risk of viral rebound during pregnancy. Levels of these drugs are often low in late pregnancy (during the second and third trimesters), when risk for perinatal transmission is high if viremia occurs (see Table 7 and Table 14). Note: When virologic suppression on one of these drugs or drug combinations is present when pregnancy occurs, providers and patients should consider whether to continue the current regimen or switch to a Preferred ARV regimen (see Antiretroviral Therapy Use During Prepregnancy and Early Pregnancy and Table 7). | ||
Not Recommended | Advantages | Disadvantages |
ATV/c |
| |
Long-Acting Injectable CAB Plus RPV (Co-packaged Formulation) |
|
|
DRV/c (FDC) or DRV/c/FTC/TAF (FDC) |
|
|
EVG/c/FTC/TAF (FDC) or EVG/c/FTC/TDF (FDC) |
|
|
Not Recommended for Initial Use in Pregnancy, but May Be Used in Special Circumstances of Substantial Prior ART Experience | ||
These drugs are Not Recommended for initial use in pregnancy when there has never been prior receipt of ART or antiretroviral (ARV) drugs for prophylaxis (i.e., ARV-naive). Except for NVP and LPV/r, data on the PK, safety, and efficacy of these drugs during pregnancy are limited. These drugs also are categorized as Not Recommended during pregnancy, except in special circumstances, because the Panel recognizes that circumstances may exist in which patients who are ART-experienced may need to initiate or continue these drugs during pregnancy to reach or maintain viral suppression (see Table 7). | ||
Not Recommended Except in Special Circumstances of Substantial Prior ART Experience | Advantages | Disadvantages |
ETR |
|
|
FTR |
| |
IBA |
| |
LEN |
| |
LPV/r Plus a Preferred Dual-NRTI Backbone |
|
|
MVC |
|
|
NVP |
|
|
T-20 |
| |
The following drugs and drug combinations (not listed above) should not be used during pregnancy; if pregnancy occurs while taking any of these medications, medications should be switched to a recommended regimen: d4T, ddI, FPV, FPV/r, IDV, IDV/r, NFV, RTV (as the sole PI), SQV, SQV/r, TPV, TPV/r, two-drug ARV regimens, or a three-NRTI ARV regimen (e.g., ABC/ZDV/3TC). See Archived Drugs in the Perinatal Guidelines and the Adult and Adolescent Antiretroviral Guidelines for individual ARV drugs, ARV combinations, and ARV regimens that are not recommended or that should not be used in adults. Key: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CD4 = CD4 T lymphocyte; CAB = cabotegravir; CAB-LA = long-acting cabotegravir; COBI = cobicistat; d4T = stavudine; ddI = didanosine; DOR = doravirine; DRV = darunavir; DRV/c = darunavir/cobicistat; DRV/r = darunavir/ritonavir; DTG = dolutegravir; EC95 = 95% maximal effective concentration; EFV = efavirenz; ETR = etravirine; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDC = fixed-dose combination; FPV = fosamprenavir; FPV/r = fosamprenavir/ritonavir; FTC = emtricitabine; FTR = fostemsavir; H2 blocker = histamine H2-receptor antagonist; HBV = hepatitis B virus; HD = high dose; IBA = ibalizumab; IDV = indinavir; IDV/r = indinavir/ritonavir; IMPAACT = International Maternal Pediatric Adolescent AIDS Clinical Trials; INSTI = integrase strand transfer inhibitor; IV = intravenous; LEN = lenacapavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NFV = nelfinavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NTD = neural tube defect; NVP = nevirapine; the Panel = the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission; PI = protease inhibitor; PK = pharmacokinetic; PPI = proton pump inhibitor; PrEP = pre-exposure prophylaxis; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SQV = saquinavir; SQV/r = saquinavir/ritonavir; T‑20 = enfuvirtide; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV = tipranavir; TPV/r = tipranavir/ritonavir; ZDV = zidovudine |
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