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People should be given information about the benefits and risks of initiating an antiretroviral regimen or making changes to an existing regimen during pregnancy or when trying to conceive so that they can make informed decisions about their care (see Appendix C: Antiretroviral Counseling Guide for Health Care Providers). Patient autonomy and informed choice should be considered in all aspects of medical care, including HIV and obstetric care. These are primary guiding principles in all the recommendations of the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission.
| ART Regimen Component | Initiating ART in Pregnancy When ARV Drugs Have Never Previously Been Used | Continuing ART When Pregnancy Occurs on a Fully Suppressive, Well-Tolerated Regimen | Starting or restarting ART During Pregnancy When ARV Drugs Have Been Used in the Pasta | Switching to a New ART Regimen During Pregnancy When Current Regimen Is Not Well Tolerated and/or Is Not Fully Suppressive | Starting ART When Trying to Conceiveb |
|---|---|---|---|---|---|
| Integrase Strand Transfer Inhibitor (INSTI) Drugs Used in combination with a dual–nucleoside reverse transcriptase inhibitor (NRTI) backbonec,d | |||||
| DTGa | Preferreda | Continue | Preferreda | Preferreda | Preferreda |
| BICa,e | Preferreda,e | Continue | Preferreda,e | Preferrede | Preferreda,e |
| RAL | Alternative | Continue | Alternative | Alternative | Alternative |
| CABd Oral (lead-in) Long-acting (IM) | Not recommendedd | Continue with frequent viral load monitoring or consider switching due to insufficient data.d | Insufficient datad | Insufficient datad | Insufficient datad |
| EVG/cf | Not recommendedf | Continue with frequent viral load monitoring or consider switching.f | Not recommendedf | Not recommendedf | Not recommendedf |
| Protease Inhibitor (PI) Drugs Used in combination with a dual-NRTI backbonec | |||||
| ATV/rg | Alternativeg | Continue | Alternativeg | Alternativeg | Alternativeg |
| DRV/ra,g | Alternativea,g | Continue | Alternativea,g | Alternativeg | Alternativea,g |
| LPV/rg | Not recommended, except in special circumstancesg | Continue | Not recommended, except in special circumstancesg | Not recommended, except in special circumstancesg | Not recommended, except in special circumstancesg |
| ATV/cf | Not recommendedf | Continue with frequent viral load monitoring or consider switching.f | Not recommendedf | Not recommendedf | Not recommendedf |
| DRV/cf | Not recommendedf | Continue with frequent viral load monitoring or consider switching.f | Not recommendedf | Not recommendedf | Not recommendedf |
| Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Drugs Used in combination with a dual-NRTI backbonec,d | |||||
| EFV | Alternative | Continue | Alternative | Alternative | Alternative |
| RPVh Oral | Alternativeh | Continueh | Alternativeh | Alternativeh | Alternativeh |
| RPV Long-acting (IM)d | Not recommended | Continue with frequent viral load monitoring or consider switching due to insufficient datad | Insufficient data | Insufficient data | Insufficient data |
| DORi | Insufficient datai | Continue with frequent viral load monitoring or consider switching due to insufficient data.i | Insufficient datai | Insufficient datai | Insufficient datai |
| ETRj | Not recommendedj | Continuej | Not recommended, except in special circumstancesj | Not recommended, except in special circumstancesj | Not recommended, except in special circumstancesj |
| NVPj | Not recommendedj | Continuej | Not recommendedj | Not recommendedj | Not recommendedj |
| NRTI Drugsc,k | |||||
| FTC | Preferred | Continue | Preferred | Preferred | Preferred |
| 3TC | Preferred | Continue | Preferred | Preferred | Preferred |
| TDFc | Preferredc | Continue | Preferred | Preferred | Preferred |
| TAFc | Preferredc | Continue | Preferred | Preferred | Preferred |
| ABCc,k | Alternativec,k | Continue | Alternativec,k | Alternativec,k | Alternativec,k |
| ZDV | Alternative | Continue | Alternative | Alternative | Alternative |
| Entry, Attachment, Fusion, and Capsid Inhibitor Drugs | |||||
| FTRj | Not recommended | Continuej | Not recommended, except in special circumstancesj | Not recommended, except in special circumstances | Not recommended, except in special circumstances |
| IBAj | Not recommended | Continuej | Not recommended, except in special circumstances | Not recommended, except in special circumstances | Not recommended, except in special circumstances |
| LENj | Not recommended | Continuej | Not recommended, except in special circumstances | Not recommended, except in special circumstances | Not recommended, except in special circumstances |
| MVCj | Not recommended | Continuej | Not recommended, except in special circumstances | Not recommended, except in special circumstances | Not recommended, except in special circumstances |
| T-20j | Not recommended | Continuej | Not recommended, except in special circumstances | Not recommended, except in special circumstances | Not recommended, except in special circumstances |
| Fixed-Dose Combination (FDC) and Coadministered Regimense,l The individual drug component that is most responsible for the overall recommendation is indicated in parentheses. | |||||
| BIC/FTC/TAFe | Preferrede | Continue | Preferrede | Preferrede | Preferrede |
| DTG/ABC/3TCa,c,k | Alternative (ABC)a,c,k | Continue | Alternative (ABC)a,c,k | Alternative (ABC)a,c,k | Alternative (ABC)a,c,k |
| EFV/FTC/TDF | Alternative (EFV) | Continue | Alternative (EFV) | Alternative (EFV) | Alternative (EFV) |
| EFV/3TC/TDF | Alternative (EFV) | Continue | Alternative (EFV) | Alternative (EFV) | Alternative (EFV) |
| RPV/TDF/FTCh | Alternative (RPV)h | Continue (RPV)h | Alternative (RPV)h | Alternative (RPV)h | Alternative (RPV)h |
| RPV/TAF/FTCh | Alternativeh | Continue | Alternativeh | Alternativeh | Alternativeh |
| DOR/3TC/TDFi | Insufficient data (DOR)i | Continue with frequent viral load monitoring or consider switching due to insufficient data (DOR). | Insufficient data (DOR)i | Insufficient data (DOR)i | Insufficient data (DOR)i |
| IM CAB and RPVd As a complete regimen | Not recommendedd | Continue with frequent viral load monitoring or consider switching due to insufficient data.d | Insufficient datad | Insufficient datad | Insufficient datad |
| DRV/c/FTC/TAFf | Not recommended (DRV/c)f | Continue with frequent viral load monitoring or consider switching (DRV/c).f | Not recommended (DRV/c)f | Not recommended (DRV/c)f | Not recommended (DRV/c)f |
| EVG/c/FTC/TDFf | Not recommended (EVG/c)f | Continue with frequent viral load monitoring or consider switching (EVG/c).f | Not recommended (EVG/c)f | Not recommended (EVG/c)f | Not recommended (EVG/c)f |
| EVG/c/FTC/TAFf | Not recommended (EVG/c)f | Continue with frequent viral load monitoring or consider switching (EVG/c).f | Not recommended (EVG/c)f | Not recommended (EVG/c)f | Not recommended (EVG/c)f |
| DTG/3TC As a complete regimenm | Not recommendedm | Continue with frequent viral load monitoring.m | Not recommendedm | Not recommendedm | Not recommendedm |
| DTG/RPV As a complete regimenm | Not recommendedm | Continue with frequent viral load monitoringm | Not recommendedm | Not recommendedm | Not recommendedm |
| a Do not initiate ARV regimens with components that have documented resistance or suspected resistance based on prior ARV exposure. DTG and BIC are not recommended for initial treatment if CAB has been taken in the past for PrEP, due to concerns about INSTI resistance mutations in the absence of INSTI genotype information; DRV/r is Preferred in this situation. b This guidance is intended only when actively trying to conceive in the context of starting ART for the first time or currently receiving ART. For ART recommendations where the possibility exists for unintended pregnancy, please see Adult and Adolescent Antiretroviral Guidelines. c TDF plus FTC, TAF plus FTC, and TDF plus 3TC are Preferred dual-NRTI backbones; ZDV plus 3TC and ABC plus 3TC are Alternative dual-NRTI backbones for ARV regimens due to more frequent dosing and mild adverse events (ZDV) and the need for HLA-B*5701 testing and concerns over cardiac safety (ABC). d Long-acting injectable formulations of CAB and RPV are available only as a co-packaged product. Coadministration of CAB plus RPV is a complete two-drug ART regimen for nonpregnant adults with HIV RNA levels <50 copies/mL for at least 3 months, on a stable ARV regimen, with no history of treatment failure, and with no known or suspected resistance to CAB or RPV. Oral lead-in dosing with CAB and RPV for at least 28 days may be used to assess tolerability before starting monthly long-acting IM injections. CAB plus RPV (oral or injectable) should not be administered with NRTIs or other ARV drugs. Oral and injectable CAB and injectable RPV are not recommended for initiation in pregnancy due to lack of dosing, PK, and safety data for injectable RPV and for injectable or oral CAB. However, if conception occurs while suppressed on injectable CAB/RPV may have few other treatment options, and the Panel recommends a shared decision-making process to decide whether to continue this regimen with viral load monitoring every 1 to 2 months or to switch to a recommended oral regimen. If a switch is made, the timing of the switch must take into account the long half-life of the long-acting injectable formulations with persistence of the drug for up to 12 months. With the current dosing schedule of injections monthly or every 2 months, change to an oral regimen should occur within 1 month (+/- 7 days) after the last CAB IM injection or 2 months after the last RPV IM injection. Dosing recommendations, including guidance for switching to an oral regimen, can be found in the prescribing information. (See Cabotegravir in the Perinatal Guidelines and Optimizing Antiretroviral Therapy in the Setting of Viral Suppression in the Adult and Adolescent Antiretroviral Guidelines.) e Available data for BIC during pregnancy suggest sufficient PK, efficacy, and safety of this medication to support its use as a Preferred agent in those who are pregnant or trying to conceive. No safety concerns have been observed. Drug levels are lower in the second and third trimester of pregnancy than in nonpregnant or postpartum patients and are reduced in later pregnancy to a greater degree for BIC than for DTG. BIC levels remained above the protein-adjusted 95% effective concentration during pregnancy and thus are anticipated to suppress viral load. f DRV/c, EVG/c, and ATV/c are not recommended for use in pregnancy because of PK changes that pose a risk for low drug levels and viral rebound in the second and third trimesters. However, in cases where virologically suppression on regimens that include these drugs is present at the time of presentation to prenatal HIV care, these drug combinations can be continued with frequent (every 1–2 months) viral load monitoring or can be switched to a Recommended or Alternative agent. If concerns about switching exist, see Antiretroviral Therapy Use During Prepregnancy and Early Pregnancy. If the cobicistat pharmacologic booster is replaced with RTV for ATV and DRV, attention to dosing in pregnancy is critical; in the second and third trimesters, higher doses of ATV are required if coadministered with TDF or antacids, and twice-daily dosing is required for DRV. g DRV/r, rather than ATV/r, is recommended as an option for initial ART in nonpregnant adults. However, DRV/r requires twice-daily dosing in pregnancy, and dosing frequency affects ARV adherence. For these reasons, when use of a PI-based regimen is indicated during pregnancy, some Panel members would use ATV/r rather than DRV/r for initial ART. LPV/r is not recommended for use in pregnancy but may be needed in special circumstances because it is safe for use in pregnancy and provides an option if a liquid formulation is needed (e.g., G-tube administration). However, because LPV/r solution contains approximately 42% (v/v) ethanol and 15% (w/v) propylene glycol, it should be used with caution in pregnancy. h Although PK data indicate that RPV plasma concentration is reduced during the second and third trimesters, the reduction is less than that seen with use of EVG/c or DRV/c. Higher-than-standard doses of RPV have not been studied, so data are insufficient to recommend a dose change in pregnancy. With standard dosing, viral load should be monitored more frequently (every 1–2 months). i Data on the safety, PK, and dosing of DOR in pregnancy are limited. Viral load should be monitored more frequently (every 1–2 months). Because fewer than 200 first-trimester and periconception exposures have been reported in the Antiretroviral Pregnancy Registry, it is not yet possible to exclude a risk of birth defects greater than that in the general population. Please report all exposures to the Antiretroviral Pregnancy Registry. j Although these drugs are not recommended for initial treatment in pregnancy when ARV drugs have never previously been used, in special circumstances of substantial prior ART experience, it may be necessary to continue or initiate ETR, FTR, IBA, LEN, NVP, MVC, and T-20 to maintain or achieve viral suppression. Safety and efficacy data about the use of ETR, FTR, IBA, LEN, MVC, and T20 in pregnancy are limited. For highly treatment-experienced patients, consider switching to a regimen approved for use in pregnancy, or for patients without therapeutic alternatives, continue with frequent (every 1–2 months) viral load monitoring and counsel patients that safety data are not available during pregnancy. NVP is not recommended for ART-naive people 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 NVP-containing regimen is well tolerated and associated with effective viral suppression when pregnancy occurs, it is likely that NVP will be safe and effective during pregnancy. See Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy When Antiretroviral Therapy Has Never Been Received and Nevirapine for more information. k 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. l When using FDC tablets, refer to Table 14. Antiretroviral Drug Use in Pregnancy: Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy and the drug sections in Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy for information about the dosing and safety of individual components of the FDC tablet during pregnancy. m Two-drug oral ARV regimens are not recommended for initial use in pregnancy because of the lack of available data about use in pregnancy. However, if an oral two drug regimen with DTG/3TC or DTG/RPV is well tolerated and associated with effective viral suppression when pregnancy occurs, this regimen can be continued with more frequent viral load monitoring (every 1–2 months) throughout pregnancy because the component drugs are recommended for use in pregnancy. Note: The following drugs and drug combinations, which are not listed above, should not be used during pregnancy: 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). If pregnancy occurs while taking any of these medications, medications should be switched to a recommended regimen. See Archived Drugs in the Perinatal Guidelines for individual ARV drugs, ARV combinations, and ARV regimens that are not recommended or should not be used in adults. Refer to the table above and Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy When Antiretroviral Therapy Has Never Been Received for ARV regimens that are recommended for use in pregnancy. Key: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; ATV/r = atazanavir/ritonavir; BIC = bictegravir; CAB = cabotegravir; d4T = stavudine; ddI = didanosine; DOR = doravirine; DRV = darunavir; 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; FTR = fostemsavir; IBA = ibalizumab; IDV = indinavir; IDV/r = indinavir/ritonavir; IM = intramuscular; IM CAB and RPV = long-acting intramuscular formulations of cabotegravir and rilpivirine; INSTI = integrase strand transfer inhibitor; LEN = lenacapavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NFV = nelfinavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; the Panel = Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission; PI = protease inhibitor; PK = pharmacokinetic; 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 | |||||