Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive

^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 in people with a history of CAB exposure 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 for people who are pregnant or trying to conceive. These recommendations are not intended for all people with HIV who might become pregnant.

^c ABC plus 3TC, TDF plus FTC, TAF plus FTC, and TDF plus 3TC are Preferred dual-NRTI backbones, and ZDV plus 3TC is an Alternative dual-NRTI backbone for ARV regimens. ABC is not recommended as part of regimens for initial treatment of early (acute or recent) HIV infection because it requires HLA-B*5701 testing before use. When results of HLA-B*5701 testing are not available, use of TDF or TAF rather than ABC will avoid delays in initiating ART.

^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, people who conceive 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 monthly injections, change to an oral regimen should occur within 4 weeks of the last CAB and RPV IM doses. 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 Data about BIC in nonpregnant adults show efficacy. PK and safety data in pregnancy remain limited to small studies. No safety concerns have been observed. Drug levels are lower in pregnant people who are in the third trimester 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 95% maximal 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 suppressed pregnant people present to care on regimens that include these drugs, 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 People With HIV Who Are Taking Antiretroviral Therapy When They Become Pregnant. If the cobicistat pharmacologic booster is replaced with RTV for ATV and DRV, attention to dosing in pregnancy is critical; higher doses of ATV are required if coadministered with TDF or antacids, and twice-daily dosing is required for DRV, in the second and third trimesters.

^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 ART-naive pregnant people, in special circumstances, ART-experienced people may need 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 T‑20 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 pregnant person presents to care on a well-tolerated, NVP-containing regimen, it is likely that NVP will be safe and effective during pregnancy. See Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy for People Who Are Antiretroviral-Naive 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 Pregnant People With HIV: Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy and the drug sections in Appendix B: Supplement: 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 use in pregnancy due to lack of available data about use in pregnancy. However, pregnant people who present to care on an oral DTG/3TC or DTG/RPV regimen with successfully maintained virologic suppression can continue it 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 a person becomes pregnant while taking any of these medications, they should switch to a recommended regimen. See Archived Drugs in the Perinatal Guidelines for individual ARV drugs, ARV combinations, and AR.V 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 for People Who Are Antiretroviral-Naive 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