Updated Reviewed

Recommendations for Use of Antiretroviral Drugs During Pregnancy

People with HIV Who Are Taking Antiretroviral Therapy When They Become Pregnant

Panel's Recommendations
  • In most cases, people with HIV who are receiving antiretroviral therapy (ART) and who present for pregnancy care should continue their ART during pregnancy, provided that the regimen is tolerated, safe, and effective in suppressing viral replication (defined as a regimen that maintains an HIV viral load less than lower limits of detection of the assay) (AII).
  • When considering changes in ART during pregnancy, the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission recommends patient counseling to support informed decision-making (AIII). See Appendix C: Antiretroviral Counseling Guide for Health Care Providers.
  • Clinicians need to consider whether pharmacokinetic changes in pregnancy, especially in the second and third trimester, may lead to a lower plasma level of some antiretroviral (ARV) drugs and necessitate increased doses, more frequent dosing, boosting, more frequent viral load monitoring, or a change in the ARV regimen (AII). See Appendix B: Supplement: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy.
  • Although there are no data on the use of two-drug oral regimens during pregnancy (e.g., dolutegravir [DTG] plus lamivudine [3TC], DTG plus rilpivirine [RPV]), the component drugs are recommended as Preferred or Alternative for use in pregnancy. Pregnant persons who present to care on DTG/3TC or DTG/RPV and have successfully maintained viral suppression can continue the two-drug regimen (BIII) with more frequent viral load monitoring every 1 to 2 months throughout pregnancy (CIII).
  • Data about the use of long-acting injectable cabotegravir and RPV during pregnancy are extremely limited and insufficient to make a recommendation for or against use in pregnancy. Pregnant people who present to care on this regimen should be counseled about limited data. Clinicians and pregnant people should reach a shared decision about continuing this regimen with frequent viral load monitoring (every 1–2 months) or switching to one of the Preferred or Alternative three-drug ARV regimens in conjunction with an HIV expert (CIII).
  • The use of cobicistat (COBI)-containing regimens during pregnancy is associated with lower plasma drug exposures due to physiologic changes associated with pregnancy. These lower drug exposures pose an increased risk of virologic failure during the second and third trimesters of pregnancy. When pregnant people present to care on one of these regimens, clinicians and pregnant people should reach a shared decision about whether to continue the regimen with frequent viral load monitoring or to switch to a different regimen that is recommended for use during pregnancy (BIII) (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). If a COBI-containing regimen is continued, absorption should be optimized by taking the drugs with food and following instructions for administration (e.g., spacing administration of vitamins containing iron and calcium) (AII). Viral load should be monitored more frequently (i.e., every 1–‍2 months) (CIII).
  • People who present during pregnancy on drugs that are not recommended for use because of toxicity (e.g., stavudine, didanosine) should stop taking these drugs and be switched to other ARV drugs that are recommended for use during pregnancy (AIII). See Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs for more information.
  • People who present in pregnancy on a regimen that is not fully suppressive should be evaluated carefully for adherence barriers, drug–drug and drug–food interactions, and HIV drug resistance to determine whether a change in ART regimen is indicated. See Pregnant People Who Have Not Achieved Viral Suppression for additional guidance.
  • For pregnant people on ART, ARV drug-resistance testing should be performed prior to changing an ARV regimen for people with HIV RNA levels >200 copies/mL (AI for >1,000 copies/mL, AIII for 501–‍1,000 copies/mL, CIII for 201–500 copies/mL). For people with confirmed HIV RNA levels >200 copies/mL but <500 copies/mL, drug-resistance testing may be unsuccessful but should still be considered. See Antiretroviral Drug Resistance and Resistance Testing in Pregnancy.
  • If an ARV regimen is altered during pregnancy, drugs in the new regimen should include ARV drugs that are recommended for use in pregnancy (BIII) (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 ARVs), and more frequent virologic monitoring is warranted until viral suppression is stably observed (CIII).

Please see Intrapartum Care for People with HIV for guidance about use of intrapartum intravenous zidovudine prophylaxis and scheduled cesarean delivery for pregnant people who have not achieved viral suppression on ART at delivery.

Rating of Recommendations: A = Strong; B = Moderate; C = Optional

Rating of Evidence: I = One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II = One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion 

People on Fully Suppressive Antiretroviral Therapy

In general, people who are already on a fully suppressive antiretroviral regimen when pregnancy occurs should continue their antiretroviral therapy (ART) regimens. The Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission (the Panel) recommends that effective ART regimens should not be changed just because the regimen includes antiretroviral (ARV) drugs that are not Preferred or Alternative for use in pregnancy. Discontinuing or altering therapy could cause an increase in viral load, leading to disease progression, a decline in immune status, and an increased risk of perinatal HIV transmission.1 In a study from the French Perinatal cohort among 1,797 women with HIV RNA levels <50 copies/mL before 14 weeks gestation, change in ARV regimen in 411 women due to safety concerns based on existing guidelines at the time of pregnancy did not result in loss of virologic control.2 However, among 662 pregnancies that were followed in Italy between 2001 and 2008, treatment modification during pregnancy was independently associated with HIV RNA level >400 copies/mL in late pregnancy (adjusted odds ratio [aOR] 1.66; 95% CI, 1.07–2.57; P = 0.024).1 This highlights the importance of establishing potent and well-tolerated regimens prior to pregnancy, using Preferred and Alternative ARVs for use in pregnancy whenever possible, to maximize effectiveness and minimize the need for modifying treatment in pregnancy.

Regimens that involve medications that are not recommended for use in adults because of high risk for toxicity (e.g., stavudine, indinavir, didanosine, and treatment-dose ritonavir) or inferior virologic efficacy (nelfinavir) should not be continued when pregnancy occurs; fortunately, these drugs are rarely used now. In this case, these drugs should be stopped and people switched to other ARV drugs 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).

Physiologic changes that occur during pregnancy may result in lower levels of certain ARVs, resulting in loss of virologic control with the potential for perinatal transmission. For patients who have achieved viral suppression and become pregnant while receiving regimens with a potential increased risk of virologic failure during pregnancy due to pharmacokinetic (PK) concerns (e.g., cobicistat [COBI]-boosted regimens, oral rilpivirine) or regimens with insufficient data about dosing and/or safety in pregnancy (e.g., doravirine [DOR], oral two-drug regimens, and long-acting injectable cabotegravir/rilpivirine), clinicians need to consider whether to continue the regimen or switch to a different regimen that is recommended for use during pregnancy3-5 (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).

For regimens with PK concerns or those with insufficient data about dosing in pregnancy, pregnant people and clinicians may elect to continue the suppressive regimen with frequent viral load monitoring (every 1–2 months, understanding that switching may be needed later in pregnancy and that potential viral rebound may increase vertical transmission risk and lead to cesarean delivery), or they may elect to switch to a recommended oral regimen as soon as pregnancy is recognized. In these cases, the Panel emphasizes the importance of patient counseling and informed decision-making, including consideration of individual factors (such as ARV resistance or intolerance, or difficulty with adherence to other regimens) that may increase the risk of virologic failure with a switch to a new regimen. When choosing to switch any ART regimen in pregnancy in people who are already virologically suppressed, clinicians should closely monitor tolerability of the new regimen, evaluate for adverse effects, and consider more frequent viral load monitoring (i.e., every 1–2 months). For additional information, see Appendix C: Antiretroviral Counseling Guide for Health Care Providers

Bictegravir

PK data on bictegravir (BIC) in human pregnancy are now available from two clinical studies and a case series.6,7 Drug levels are lower in the second and third trimesters than in nonpregnant or postpartum individuals and are reduced in later pregnancy to a greater degree for BIC than dolutegravir (DTG). However, viral suppression was generally maintained. BIC levels remained above the 95% maximal effective concentration and thus are anticipated to suppress viral load (see Bictegravir for additional information). As a result, BIC is now recommended as an Alternative ARV for use in pregnancy (see Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive).W 

Cobicistat-Boosted Regimens

Clinicians and pregnant people should be aware that the use of atazanavir/COBI, darunavir/COBI, or elvitegravir/cobicistat (EVG/c) is associated with lower plasma drug exposures (both of COBI and of the drug being boosted) during the second and third trimesters of pregnancy due to the physiologic changes associated with pregnancy. These low drug exposures pose an increased risk of virologic failure in the second and third trimesters and potential perinatal HIV transmission. When a pregnant person presents to care on one of these regimens, providers should consider continuing the regimen with more frequent viral load monitoring (i.e., every 1–2 months) or switching to a different regimen that is recommended for use during pregnancy (see Table 6. What to Start: Initial Combination Regimens for Antiretroviral-Naive Pregnant People and Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive).3-5 A multicenter, retrospective study of 134 pregnant women with HIV who received elvitegravir (EVG)-containing ART at any time during pregnancy reported that 81.3% of study participants had viral suppression at delivery (HIV RNA <40 copies/mL); among 68 women who initiated EVG before pregnancy and continued receiving EVG through delivery, the rate of viral suppression at delivery was 88.2%. The perinatal HIV transmission rate was 0.8% in this study.8 If one of these regimens is continued, absorption should be optimized by taking the drugs with food. Pregnant people who are taking regimens that include EVG/c should take ARV drugs and prenatal vitamins ≥2 hours apart.

Doravirine

PK data on DOR in human pregnancy are available only from PK modeling data based on ex vivo studies of placental transfer.9,10 Patients who become pregnant with viral suppression while receiving regimens with DOR should be counseled about limited available data, see Doravirine. Clinicians and patients should reach a shared decision about continuing DOR with frequent viral load monitoring (i.e., every 1–2 months) or switching to one of the Preferred or Alternative regimens.

Oral Two-Drug Regimens

Currently, no data exist on the use of oral two-drug regimens in pregnancy (e.g., DTG plus lamivudine [3TC] and DTG plus rilpivirine [RPV]). However, for both DTG/3TC and DTG/RPV, there are data in nonpregnant persons showing noninferiority when compared to a standard three-drug regimen.11,12 The component drugs in each of the oral two-drug regimens (DTG, 3TC, RPV) have well described PK that are adequate in pregnancy, and the individual drug components are recommended as Preferred or Alternative ARV drugs by the Panel. Note that although PK data indicate that RPV plasma concentration is reduced during the second and third trimesters of pregnancy, the reduction is less than the reductions seen with the COBI-containing regimens described above, and most pregnant people will have adequate exposure. A recent observational study of 188 pregnant people on oral RPV as part of a three-drug regimen at delivery found that 182 (96.8%) had viral load <200 copies/mL.13 Standard RPV dosing is recommended when used as part of a three-drug regimen, and viral load should be monitored frequently (e.g., every 1–2 months; see Rilpivirine, 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.

Long-Acting Injectable Cabotegravir and Rilpivirine

Data on long-acting injectable cabotegravir (CAB) and RPV are currently limited to a small number of patients without HIV who became pregnant while enrolled in trials of long-acting injectable CAB for pre-exposure prophylaxis and stopped the medication once pregnancy was recognized, usually in the first trimester.14-16 In these patients, the pharmacologic washout was similar in pregnant and nonpregnant adults.14,17 No data are available about the pharmacokinetics of CAB in the second and third trimesters, with either oral or injectable formulations. While data in nonpregnant adults suggest slower washout (and thus potentially higher CAB levels) with intramuscular CAB among people with obesity,18 this may not be applicable to the weight gain that is due to pregnancy, as the volume of distribution in pregnancy differs from that in obesity. No data exist on the PK of injectable RPV in pregnancy. Prior data have shown concern for lower concentrations of oral RPV in the third trimester,19 as above. Some patients who have achieved virologic suppression on injectable CAB and RPV experienced previous challenges with oral ART, such that switching back to oral ART could increase the risk of virologic rebound. Clinicians and pregnant people should reach a shared decision about continuing this regimen with frequent viral load monitoring (every 1–2 months) or switching to one of the Preferred or Alternative three-drug ARV regimens in conjunction with an HIV expert.

When switching from long-acting injectable CAB and RPV to an oral regimen in pregnancy, the timing of the switch must take into account the long half-life of the long-acting injectable formulation (median 5.6–11.5 weeks) with persistence of the drug for up to 12 months.20 When the dosing schedule is monthly, the change to an oral regimen should occur within 1 month of the last CAB and RPV injections.21 When the dosing schedule is every 2 months, the change to an oral regimen should occur within 2 months of the last CAB and RPV injections.22,23 Dosing recommendations, including guidance for switching to an oral regimen, can be found in the prescribing information.20,23 For additional information, see Optimizing Antiretroviral Therapy in the Setting of Viral Suppression and Discontinuation or Interruption of Antiretroviral Therapy in the Adult and Adolescent Antiretroviral Guidelines.

People Not on Fully Suppressive ART When Becoming Pregnant

People who are not fully suppressed and who are currently taking ART should be evaluated carefully for adherence barriers, drug–drug interactions, drug–food requirements, and HIV drug resistance, with every effort made to achieve rapid and full viral suppression through adherence interventions or medication changes (see Pregnant People Who Have Not Achieved Viral Suppression on Antiretroviral Therapy).

For pregnant people on ART, ARV drug-resistance testing should be performed prior to changing an ARV regimen if HIV RNA levels are >200 copies/mL. For people with HIV RNA levels >200 copies/mL but <500 copies/mL, drug-resistance testing may be unsuccessful but should still be considered (see Antiretroviral Drug Resistance and Resistance Testing in Pregnancy).

References

  1. Floridia M, Ravizza M, Pinnetti C, et al. Treatment change in pregnancy is a significant risk factor for detectable HIV-1 RNA in plasma at end of pregnancy. HIV Clin Trials. 2010;11(6):303-311. Available at: https://pubmed.ncbi.nlm.nih.gov/21239358.
  2. Peyronnet V, Warszawski J, Sibiude J, et al. Does changing antiretroviral therapy in the first trimester of pregnancy for safety concerns have an impact on viral suppression? J Acquir Immune Defic Syndr. 2019;80(5):574-584. Available at: https://pubmed.ncbi.nlm.nih.gov/30649033.
  3. Crauwels HM, Osiyemi O, Zorrilla C, et al. Reduced exposure to darunavir and cobicistat in HIV-1-infected pregnant women receiving a darunavir/cobicistat-based regimen. HIV Med. 2019;20(5):337-343. Available at: https://pubmed.ncbi.nlm.nih.gov/30873741.
  4. Momper J, Best BM, Wang J, et al. Elvitegravir/cobicistat pharmacokinetics in pregnant and postpartum women with HIV. AIDS. 2018;32(17):2507-2516. Available at: https://pubmed.ncbi.nlm.nih.gov/30134297.
  5. van der Galien R, Ter Heine R, Greupink R, et al. Pharmacokinetics of HIV-integrase inhibitors during pregnancy: mechanisms, clinical implications and knowledge gaps. Clin Pharmacokinet. 2018;58(3):309-323. Available at: https://pubmed.ncbi.nlm.nih.gov/29915921.
  6. Powis KM, Pinilla M, Bergam L, et al. Pharmacokinetics and virologic outcomes of bictegravir in pregnancy and postpartum. Type Presented at Conference on Retroviruses and Opportunistic Infections; Year; Seattle, WA. Available at: https://www.croiconference.org/wp-content/uploads/sites/2/posters/2023/IMPAACT_PHARMACOKINETICS_AND_VIROLOGIC_15Feb23-133209845782009090.pdf.
  7. Zhang H, Hindman JT, Lin L, et al. A study of the pharmacokinetics, safety, and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed pregnant women with HIV. AIDS. 2023. Available at: https://pubmed.ncbi.nlm.nih.gov/37939141.
  8. Badell ML, Sheth AN, Momplaisir F, et al. A multicenter analysis of elvitegravir use during pregnancy on HIV viral suppression and perinatal outcomes. Open Forum Infect Dis. 2019;6(4):ofz129. Available at: https://pubmed.ncbi.nlm.nih.gov/31037241.
  9. Le MP, Pencole L, Peytavin G, et al. Placental transfer of doravirine, a recent HIV-1 NNRTI in the ex vivo human cotyledon perfusion model. J Antimicrob Chemother. 2021;76(9):2364-2367. Available at: https://pubmed.ncbi.nlm.nih.gov/34151361.
  10. Bukkems VE, van Hove H, Roelofsen D, et al. Prediction of maternal and fetal doravirine exposure by Integrating physiologically based pharmacokinetic modeling and human placenta perfusion experiments. Clin Pharmacokinet. 2022;61(8):1129-1141. Available at: https://pubmed.ncbi.nlm.nih.gov/35579825.
  11. Cahn P, Madero JS, Arribas JR, et al. Durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-naive adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trials. J Acquir Immune Defic Syndr. 2020;83(3):310-318. Available at: https://pubmed.ncbi.nlm.nih.gov/31834000.
  12. van Wyk J, Ajana F, Bisshop F, et al. Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose 2-drug regimen vs continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with human Immunodeficiency virus Type 1: phase 3, randomized, noninferiority TANGO study. Clin Infect Dis. 2020;71(8):1920-1929. Available at: https://pubmed.ncbi.nlm.nih.gov/31905383.
  13. Patel K, Huo Y, Jao J, et al. Dolutegravir in pregnancy as compared with current HIV regimens in the United States. N Engl J Med. 2022;387(9):799-809. Available at: https://pubmed.ncbi.nlm.nih.gov/36053505.
  14. Patel P, Thiagarajah S, Ford S, et al. Cabotegravir pharmacokinetic tail in pregnancy and neonatal outcomes. Abstract 775. Presented at: Conference on Retroviruses and Opportunistic Infections 2020. Boston, MA. Available at: https://www.croiconference.org/abstract/cabotegravir-pharmacokinetic-tail-in-pregnancy-and-neonatal-outcomes.
  15. Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022;399(10337):1779-1789. Available at: https://pubmed.ncbi.nlm.nih.gov/35378077.
  16. Patel P, Ford SL, Baker M, et al. Pregnancy outcomes and pharmacokinetics in pregnant women living with HIV exposed to long-acting cabotegravir and rilpivirine in clinical trials. HIV Med. 2023;24(5):568-579. Available at: https://pubmed.ncbi.nlm.nih.gov/36411596.
  17. Delany-Moretlwe S, Hughes JP, Dadabhai S, et al. Long acting injectable cabotegravir: updated efficacy and safety results from HPTN 084. Type Presented at AIDS July 29 - August 2, 2022, Year; Montreal, Canada. Available at: https://www.hptn.org/sites/default/files/inline-files/HPTN%20084%20evaluation%20of%20CAB%20LA%20safety%20and%20pk%20CROI%202022%20FINAL.pdf.
  18. Yu Y, Bigos KL, Marzinke MA, et al. A population pharmacokinetic model based on HPTN 077 of long-acting injectable cabotegravir for HIV PrEP. Br J Clin Pharmacol. 2022;88(10):4623-4632. Available at: https://pubmed.ncbi.nlm.nih.gov/35949044.
  19. Osiyemi O, Yasin S, Zorrilla C, et al. Pharmacokinetics, antiviral activity, and safety of rilpivirine in pregnant women with HIV-1 infection: results of a phase 3b, multicenter, open-label study. Infect Dis Ther. 2018;7(1):147-159. Available at: https://pubmed.ncbi.nlm.nih.gov/29335895.
  20. Cabenuva (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular use [package insert]. Food and Drug Administration. 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s002lbl.pdf.
  21. Panel on Antiretroviral Guidelines for Adults and Adolescents. Optimizing antiretroviral therapy in the setting of viral suppression. 2022. Available at: https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/optimizing-antiretroviral-therapy
  22. McGowan JP, Fine SM, Vail RM, et al. Use of Injectable CAB/RPV LA as Replacement ART in Virally Suppressed Adults. New York State Department of Health AIDS Institute Clinical Guidelines [Type of Medium]. 2022; Available at: https://pubmed.ncbi.nlm.nih.gov/34379373. Accessed, Access 2022.
  23. Vocabria (cabotegravir) [package insert]. Food and Drug Administration. 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s005s006lbl.pdf.

Recommendations for Use of Antiretroviral Drugs During Pregnancy

People with HIV Who Are Taking Antiretroviral Therapy When They Become Pregnant

Panel's Recommendations
  • In most cases, people with HIV who are receiving antiretroviral therapy (ART) and who present for pregnancy care should continue their ART during pregnancy, provided that the regimen is tolerated, safe, and effective in suppressing viral replication (defined as a regimen that maintains an HIV viral load less than lower limits of detection of the assay) (AII).
  • When considering changes in ART during pregnancy, the Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission recommends patient counseling to support informed decision-making (AIII). See Appendix C: Antiretroviral Counseling Guide for Health Care Providers.
  • Clinicians need to consider whether pharmacokinetic changes in pregnancy, especially in the second and third trimester, may lead to a lower plasma level of some antiretroviral (ARV) drugs and necessitate increased doses, more frequent dosing, boosting, more frequent viral load monitoring, or a change in the ARV regimen (AII). See Appendix B: Supplement: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy.
  • Although there are no data on the use of two-drug oral regimens during pregnancy (e.g., dolutegravir [DTG] plus lamivudine [3TC], DTG plus rilpivirine [RPV]), the component drugs are recommended as Preferred or Alternative for use in pregnancy. Pregnant persons who present to care on DTG/3TC or DTG/RPV and have successfully maintained viral suppression can continue the two-drug regimen (BIII) with more frequent viral load monitoring every 1 to 2 months throughout pregnancy (CIII).
  • Data about the use of long-acting injectable cabotegravir and RPV during pregnancy are extremely limited and insufficient to make a recommendation for or against use in pregnancy. Pregnant people who present to care on this regimen should be counseled about limited data. Clinicians and pregnant people should reach a shared decision about continuing this regimen with frequent viral load monitoring (every 1–2 months) or switching to one of the Preferred or Alternative three-drug ARV regimens in conjunction with an HIV expert (CIII).
  • The use of cobicistat (COBI)-containing regimens during pregnancy is associated with lower plasma drug exposures due to physiologic changes associated with pregnancy. These lower drug exposures pose an increased risk of virologic failure during the second and third trimesters of pregnancy. When pregnant people present to care on one of these regimens, clinicians and pregnant people should reach a shared decision about whether to continue the regimen with frequent viral load monitoring or to switch to a different regimen that is recommended for use during pregnancy (BIII) (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). If a COBI-containing regimen is continued, absorption should be optimized by taking the drugs with food and following instructions for administration (e.g., spacing administration of vitamins containing iron and calcium) (AII). Viral load should be monitored more frequently (i.e., every 1–‍2 months) (CIII).
  • People who present during pregnancy on drugs that are not recommended for use because of toxicity (e.g., stavudine, didanosine) should stop taking these drugs and be switched to other ARV drugs that are recommended for use during pregnancy (AIII). See Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs for more information.
  • People who present in pregnancy on a regimen that is not fully suppressive should be evaluated carefully for adherence barriers, drug–drug and drug–food interactions, and HIV drug resistance to determine whether a change in ART regimen is indicated. See Pregnant People Who Have Not Achieved Viral Suppression for additional guidance.
  • For pregnant people on ART, ARV drug-resistance testing should be performed prior to changing an ARV regimen for people with HIV RNA levels >200 copies/mL (AI for >1,000 copies/mL, AIII for 501–‍1,000 copies/mL, CIII for 201–500 copies/mL). For people with confirmed HIV RNA levels >200 copies/mL but <500 copies/mL, drug-resistance testing may be unsuccessful but should still be considered. See Antiretroviral Drug Resistance and Resistance Testing in Pregnancy.
  • If an ARV regimen is altered during pregnancy, drugs in the new regimen should include ARV drugs that are recommended for use in pregnancy (BIII) (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 ARVs), and more frequent virologic monitoring is warranted until viral suppression is stably observed (CIII).

Please see Intrapartum Care for People with HIV for guidance about use of intrapartum intravenous zidovudine prophylaxis and scheduled cesarean delivery for pregnant people who have not achieved viral suppression on ART at delivery.

Rating of Recommendations: A = Strong; B = Moderate; C = Optional

Rating of Evidence: I = One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II = One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion 

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