Recommendations for Use of Antiretroviral Drugs During Pregnancy

Table 5. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant Women and Nonpregnant Women Who Are Trying to Conceive

Women should be given information about the benefits and risks of initiating an ARV regimen or making changes to an existing regimen so they can make informed decisions about their care. Patient autonomy and informed choice should be considered in all aspects of medical care, including HIV and obstetric care. This is the primary guiding principle in all the Panel’s recommendations.

ART Regimen Component ART for Pregnant Women Who Have Never Received ARV Drugs and Who Are Initiating ART for the First Time Continuing ART for Women Who Become Pregnant on a Fully Suppressive, Well-Tolerated Regimen ART for Pregnant Women Who Have Received ARV Drugs in the Past and Who Are Restarting ARTa New ARV Regimen for Pregnant Women Whose Current Regimen is Not Well Tolerated and/or is Not Fully Suppressivea ART for Nonpregnant Women Who Are Trying to Conceivea,b
INSTIs
Used in combination with a dual-NRTI backbonec
DTGd
 
Preferred Continue Preferred Preferred Alternative
RAL Preferred Continue Preferred Preferred Preferred
BIC Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data
EVG/ce Not recommended Consider switching, or continuing the same regimen with frequent viral load monitoring Not recommended Not recommended Not recommended
PIs
Used in combination with a dual-NRTI backbonec
ATV/r Preferred Continue Preferred Preferred Preferred
DRV/r Preferred Continue Preferred Preferred Preferred
LPV/r Alternative Continue Alternative Alternative Alternative
ATV/ce Not recommended Consider altering the regimen, or continuing the same regimen with frequent viral load monitoring Not recommended Not recommended Not recommended
DRV/ce Not recommended Consider altering the regimen, or continuing the same regimen with frequent viral load monitoring Not recommended Not recommended Not recommended
NNRTIs
Used in combination with a dual-NRTI backbonec
EFV Alternative Continue Alternative Alternative Alternative
RPVf Alternative Continue Alternative Alternative Alternative
DOR Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data
ETRg Not recommended Continue Not recommended, except in special circumstances Not recommended, except in special circumstances Not recommended, except in special circumstances
NVPg Not recommended Continue Not recommended, except in special circumstances Not recommended, except in special circumstances Not recommended, except in special circumstances
NRTIsc,h
ABCi Preferred Continue Preferred Preferred Preferred
FTC Preferred Continue Preferred Preferred Preferred
3TC Preferred Continue Preferred Preferred Preferred
TDF Preferred Continue Preferred Preferred Preferred
ZDV Alternative Continue Alternative Alternative Alternative
TAFj Insufficient data Continue Insufficient data Insufficient data Insufficient data
Entry and Fusion Inhibitors
IBA Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data
MVCg Not recommended Continue Not recommended, except in special circumstances Not recommended, except in special circumstances Not recommended, except in special circumstances
T-20g Not recommended Continue Not recommended, except in special circumstances Not recommended, except in special circumstances Not recommended, except in special circumstances
FDC Regimense,h
The individual drug component that is most responsible for the overall recommendation is indicated in parentheses.
ABC/DTG/3TCd,i Preferred Continue Preferred Preferred Alternative (DTG)
EFV/FTC/TDF Alternative (EFV) Continue Alternative (EFV) Alternative (EFV) Alternative (EFV)
EFV/3TC/TDF Alternative (EFV) Continue Alternative (EFV) Alternative (EFV) Alternative (EFV)
FTC/RPV/TDFf Alternative (RPV) Continue (RPV) Alternative (RPV) Alternative (RPV) Alternative (RPV)
BIC/FTC/TAF Insufficient data (BIC, TAF) Insufficient data (BIC) Insufficient data (BIC, TAF) Insufficient data (BIC, TAF) Insufficient data (BIC, TAF)
DOR/3TC/TDF Insufficient data (DOR) Insufficient data (DOR) Insufficient data (DOR) Insufficient data (DOR) Insufficient data (DOR)
FTC/RPV/TAF Insufficient data (TAFj) Continue (RPVf, TAFj) or consider switching to FTC/RPV/TDF Insufficient data (TAFj) Insufficient data (TAFj) Insufficient data (TAFj)
EVG/c/FTC/TDFe Not recommended (EVG/c) Consider switching, or continuing the same regimen with frequent viral load monitoring (EVG/c) Not recommended (EVG/c) Not recommended (EVG/c) Not recommended (EVG/c)
EVG/c/FTC/TAFe Not recommended (EVG/c) Consider switching, or continuing the same regimen with frequent viral load monitoring (EVG/c) Not recommended (EVG/c) Not recommended (EVG/c) Not recommended (EVG/c)
DRV/c/FTC/TAFe Not recommended (DRV/c) Consider switching, or continuing the same regimen with frequent viral load monitoring (DRV/c) Not recommended (DRV/c) Not recommended (DRV/c) Not recommended (DRV/c)
DTG/3TC
As a complete regimenk
Not recommended Not recommended; switch, or add additional agents Not recommended Not recommended Not recommended
DTG/RPV
As a complete regimenk
Not recommended Not recommended; switch, or add additional agentsf Not recommended Not recommended Not recommended
a Do not initiate ARV regimens with components that have documented resistance or suspected resistance based on prior ARV exposure.

b This guidance is intended for women who are trying to conceive. These recommendations are not intended for all women with HIV who might become pregnant.

c ABC plus 3TC, TDF plus FTC, and TDF plus 3TC are Preferred dual-NRTI backbones, and ZDV plus 3TC is an Alternative dual-NRTI backbone for ARV regimens.

d The decision to designate DTG as a Preferred ARV drug for therapy in pregnant women, irrespective of trimester, was based on several factors. First, DTG is associated with higher rates of virologic suppression, faster rates of viral load decline, and a higher genetic barrier to drug resistance than other Preferred and Alternative agents. Second, a recent study that evaluated a large number of pregnancies has shown that the risk of NTDs is lower than previously reported in preliminary data. This risk is also largely limited to a short period of time (before 6 weeks post-last menstrual period). A very small minority of women with HIV initiate their first ARV regimen during this period of time. Some Panel members would avoid using DTG in women who are initiating ART before 6 weeks of gestation. After this time, any additional risk of NTDs due to DTG is minimal. Third, data are extremely limited on the risks that are associated with using other Preferred and Alternative ARV drugs preconception or in very early pregnancy; this lack of data does not indicate either the presence or absence of risk when using alternatives to DTG. DTG is recommended as an Alternative agent for people trying to conceive, as these patients have more time to achieve virologic suppression on regimens that do not contain DTG. For additional information see Teratogenicity, Updated Guidance About the Use of Dolutegravir in Pregnancy in Recommendations for the Use of Antiretroviral Drugs in Pregnancy, and Appendix D: Dolutegravir Counseling Guide for Health Care Providers.

e DRV/c, EVG/c, and ATV/c are not recommended for use in pregnancy due to PK changes that pose a risk for low drug levels and viral rebound in the second and third trimesters. However, in cases where virologically suppressed pregnant women present to care on regimens that include these drugs, clinicians can consider continuing the use of these drug combinations with frequent viral load monitoring. If there are concerns about switching, see Pregnant Women Living with HIV Who Are Currently Receiving Antiretroviral Therapy.

f Although PK data indicate that RPV plasma concentration is reduced during the second and third trimester, the reduction is less than the reductions seen with use of EVG/c or DRV/c. Higher-than-standard doses of RPV have not been studied, so there are insufficient data to recommend a dose change in pregnancy. With standard dosing, viral load should be monitored more frequently.

g Although these drugs are not recommended for initial treatment in ART-naive pregnant women, there may be special circumstances in which ART-experienced women may need to continue or initiate ETR, NVP, MVC, and T-20 in order to maintain or achieve viral suppression. There are limited safety and efficacy data about the use of ETR, MVC, and T-20 in pregnancy. NVP is not recommended for ART-naive women because it has a greater potential for adverse events than other NNRTIs, complex lead-in dosing, and a low barrier to resistance; however, if a pregnant woman presents to care on a well-tolerated, NVP-containing regimen, it is likely that NVP will be safe and effective during pregnancy. See Table 4 and Nevirapine for more information.

h When using FDC tablets, refer to Table 8 and the drug sections in Appendix B for information about the dosing and safety of individual components of the FDC tablet during pregnancy.

i Testing for HLA-B*5701 identifies patients who are at risk of developing hypersensitivity reactions while taking ABC; testing should be performed and a patient should be documented as negative before initiating ABC.

j Available data about the use of TAF in pregnancy support continuing it in pregnant women who are virally suppressed, although data are insufficient to recommend it when initiating ART in pregnancy.

k Two-drug ARV regimens are not recommended for use in pregnancy.

The following drugs and drug combinations (that are not listed above) should not be used during pregnancy; if a woman becomes pregnant while taking any of these medications, she should switch to a recommended regimen: d4T, ddI, FPV, FPV/r, IDV, IDV/r, NFV, RTV (as the sole PI), SQV, SQV/r, TPV, TPV/r, or a three-NRTI ARV regimen (e.g., ABC/ZDV/3TC). See Archived Drugs in the Perinatal Guidelines and What Not to Use in 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. Refer to the table above and Table 4 for ARV regimens that are recommended for use in pregnancy.

Key: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; d4T = stavudine; ddI = didanosine; DOR = doravirine; DRV/c = darunavir/cobicistat; DRV/r = darunavir/ritonavir; DTG = dolutegravir; EFV = efavirenz; ETR = etravirine; EVG/c = elvitegravir/cobicistat; FDC = fixed-dose combination; FPV = fosamprenavir; FPV/r = fosamprenavir/ritonavir; FTC = emtricitabine; IBA =ibalizumab; IDV = indinavir; IDV/r = indinavir/ritonavir; INSTI = integrase strand transfer inhibitor; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NFV = nelfinavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; PI = protease inhibitor; PK = pharmacokinetic; 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 5. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant Women and Nonpregnant Women Who Are Trying to Conceive

Women should be given information about the benefits and risks of initiating an ARV regimen or making changes to an existing regimen so they can make informed decisions about their care. Patient autonomy and informed choice should be considered in all aspects of medical care, including HIV and obstetric care. This is the primary guiding principle in all the Panel’s recommendations.

ART Regimen Component ART for Pregnant Women Who Have Never Received ARV Drugs and Who Are Initiating ART for the First Time Continuing ART for Women Who Become Pregnant on a Fully Suppressive, Well-Tolerated Regimen ART for Pregnant Women Who Have Received ARV Drugs in the Past and Who Are Restarting ARTa New ARV Regimen for Pregnant Women Whose Current Regimen is Not Well Tolerated and/or is Not Fully Suppressivea ART for Nonpregnant Women Who Are Trying to Conceivea,b
INSTIs
Used in combination with a dual-NRTI backbonec
DTGd
 
Preferred Continue Preferred Preferred Alternative
RAL Preferred Continue Preferred Preferred Preferred
BIC Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data
EVG/ce Not recommended Consider switching, or continuing the same regimen with frequent viral load monitoring Not recommended Not recommended Not recommended
PIs
Used in combination with a dual-NRTI backbonec
ATV/r Preferred Continue Preferred Preferred Preferred
DRV/r Preferred Continue Preferred Preferred Preferred
LPV/r Alternative Continue Alternative Alternative Alternative
ATV/ce Not recommended Consider altering the regimen, or continuing the same regimen with frequent viral load monitoring Not recommended Not recommended Not recommended
DRV/ce Not recommended Consider altering the regimen, or continuing the same regimen with frequent viral load monitoring Not recommended Not recommended Not recommended
NNRTIs
Used in combination with a dual-NRTI backbonec
EFV Alternative Continue Alternative Alternative Alternative
RPVf Alternative Continue Alternative Alternative Alternative
DOR Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data
ETRg Not recommended Continue Not recommended, except in special circumstances Not recommended, except in special circumstances Not recommended, except in special circumstances
NVPg Not recommended Continue Not recommended, except in special circumstances Not recommended, except in special circumstances Not recommended, except in special circumstances
NRTIsc,h
ABCi Preferred Continue Preferred Preferred Preferred
FTC Preferred Continue Preferred Preferred Preferred
3TC Preferred Continue Preferred Preferred Preferred
TDF Preferred Continue Preferred Preferred Preferred
ZDV Alternative Continue Alternative Alternative Alternative
TAFj Insufficient data Continue Insufficient data Insufficient data Insufficient data
Entry and Fusion Inhibitors
IBA Insufficient data Insufficient data Insufficient data Insufficient data Insufficient data
MVCg Not recommended Continue Not recommended, except in special circumstances Not recommended, except in special circumstances Not recommended, except in special circumstances
T-20g Not recommended Continue Not recommended, except in special circumstances Not recommended, except in special circumstances Not recommended, except in special circumstances
FDC Regimense,h
The individual drug component that is most responsible for the overall recommendation is indicated in parentheses.
ABC/DTG/3TCd,i Preferred Continue Preferred Preferred Alternative (DTG)
EFV/FTC/TDF Alternative (EFV) Continue Alternative (EFV) Alternative (EFV) Alternative (EFV)
EFV/3TC/TDF Alternative (EFV) Continue Alternative (EFV) Alternative (EFV) Alternative (EFV)
FTC/RPV/TDFf Alternative (RPV) Continue (RPV) Alternative (RPV) Alternative (RPV) Alternative (RPV)
BIC/FTC/TAF Insufficient data (BIC, TAF) Insufficient data (BIC) Insufficient data (BIC, TAF) Insufficient data (BIC, TAF) Insufficient data (BIC, TAF)
DOR/3TC/TDF Insufficient data (DOR) Insufficient data (DOR) Insufficient data (DOR) Insufficient data (DOR) Insufficient data (DOR)
FTC/RPV/TAF Insufficient data (TAFj) Continue (RPVf, TAFj) or consider switching to FTC/RPV/TDF Insufficient data (TAFj) Insufficient data (TAFj) Insufficient data (TAFj)
EVG/c/FTC/TDFe Not recommended (EVG/c) Consider switching, or continuing the same regimen with frequent viral load monitoring (EVG/c) Not recommended (EVG/c) Not recommended (EVG/c) Not recommended (EVG/c)
EVG/c/FTC/TAFe Not recommended (EVG/c) Consider switching, or continuing the same regimen with frequent viral load monitoring (EVG/c) Not recommended (EVG/c) Not recommended (EVG/c) Not recommended (EVG/c)
DRV/c/FTC/TAFe Not recommended (DRV/c) Consider switching, or continuing the same regimen with frequent viral load monitoring (DRV/c) Not recommended (DRV/c) Not recommended (DRV/c) Not recommended (DRV/c)
DTG/3TC
As a complete regimenk
Not recommended Not recommended; switch, or add additional agents Not recommended Not recommended Not recommended
DTG/RPV
As a complete regimenk
Not recommended Not recommended; switch, or add additional agentsf Not recommended Not recommended Not recommended
a Do not initiate ARV regimens with components that have documented resistance or suspected resistance based on prior ARV exposure.

b This guidance is intended for women who are trying to conceive. These recommendations are not intended for all women with HIV who might become pregnant.

c ABC plus 3TC, TDF plus FTC, and TDF plus 3TC are Preferred dual-NRTI backbones, and ZDV plus 3TC is an Alternative dual-NRTI backbone for ARV regimens.

d The decision to designate DTG as a Preferred ARV drug for therapy in pregnant women, irrespective of trimester, was based on several factors. First, DTG is associated with higher rates of virologic suppression, faster rates of viral load decline, and a higher genetic barrier to drug resistance than other Preferred and Alternative agents. Second, a recent study that evaluated a large number of pregnancies has shown that the risk of NTDs is lower than previously reported in preliminary data. This risk is also largely limited to a short period of time (before 6 weeks post-last menstrual period). A very small minority of women with HIV initiate their first ARV regimen during this period of time. Some Panel members would avoid using DTG in women who are initiating ART before 6 weeks of gestation. After this time, any additional risk of NTDs due to DTG is minimal. Third, data are extremely limited on the risks that are associated with using other Preferred and Alternative ARV drugs preconception or in very early pregnancy; this lack of data does not indicate either the presence or absence of risk when using alternatives to DTG. DTG is recommended as an Alternative agent for people trying to conceive, as these patients have more time to achieve virologic suppression on regimens that do not contain DTG. For additional information see Teratogenicity, Updated Guidance About the Use of Dolutegravir in Pregnancy in Recommendations for the Use of Antiretroviral Drugs in Pregnancy, and Appendix D: Dolutegravir Counseling Guide for Health Care Providers.

e DRV/c, EVG/c, and ATV/c are not recommended for use in pregnancy due to PK changes that pose a risk for low drug levels and viral rebound in the second and third trimesters. However, in cases where virologically suppressed pregnant women present to care on regimens that include these drugs, clinicians can consider continuing the use of these drug combinations with frequent viral load monitoring. If there are concerns about switching, see Pregnant Women Living with HIV Who Are Currently Receiving Antiretroviral Therapy.

f Although PK data indicate that RPV plasma concentration is reduced during the second and third trimester, the reduction is less than the reductions seen with use of EVG/c or DRV/c. Higher-than-standard doses of RPV have not been studied, so there are insufficient data to recommend a dose change in pregnancy. With standard dosing, viral load should be monitored more frequently.

g Although these drugs are not recommended for initial treatment in ART-naive pregnant women, there may be special circumstances in which ART-experienced women may need to continue or initiate ETR, NVP, MVC, and T-20 in order to maintain or achieve viral suppression. There are limited safety and efficacy data about the use of ETR, MVC, and T-20 in pregnancy. NVP is not recommended for ART-naive women because it has a greater potential for adverse events than other NNRTIs, complex lead-in dosing, and a low barrier to resistance; however, if a pregnant woman presents to care on a well-tolerated, NVP-containing regimen, it is likely that NVP will be safe and effective during pregnancy. See Table 4 and Nevirapine for more information.

h When using FDC tablets, refer to Table 8 and the drug sections in Appendix B for information about the dosing and safety of individual components of the FDC tablet during pregnancy.

i Testing for HLA-B*5701 identifies patients who are at risk of developing hypersensitivity reactions while taking ABC; testing should be performed and a patient should be documented as negative before initiating ABC.

j Available data about the use of TAF in pregnancy support continuing it in pregnant women who are virally suppressed, although data are insufficient to recommend it when initiating ART in pregnancy.

k Two-drug ARV regimens are not recommended for use in pregnancy.

The following drugs and drug combinations (that are not listed above) should not be used during pregnancy; if a woman becomes pregnant while taking any of these medications, she should switch to a recommended regimen: d4T, ddI, FPV, FPV/r, IDV, IDV/r, NFV, RTV (as the sole PI), SQV, SQV/r, TPV, TPV/r, or a three-NRTI ARV regimen (e.g., ABC/ZDV/3TC). See Archived Drugs in the Perinatal Guidelines and What Not to Use in 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. Refer to the table above and Table 4 for ARV regimens that are recommended for use in pregnancy.

Key: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; d4T = stavudine; ddI = didanosine; DOR = doravirine; DRV/c = darunavir/cobicistat; DRV/r = darunavir/ritonavir; DTG = dolutegravir; EFV = efavirenz; ETR = etravirine; EVG/c = elvitegravir/cobicistat; FDC = fixed-dose combination; FPV = fosamprenavir; FPV/r = fosamprenavir/ritonavir; FTC = emtricitabine; IBA =ibalizumab; IDV = indinavir; IDV/r = indinavir/ritonavir; INSTI = integrase strand transfer inhibitor; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NFV = nelfinavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; PI = protease inhibitor; PK = pharmacokinetic; 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
Updated
Dec. 12, 2019
Reviewed
Dec. 12, 2019

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