Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States
The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.
Preconception Counseling and Care for Women of Childbearing Age Living with HIV
Last Updated: December 7, 2018; Last Reviewed: December 7, 2018
|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
The Centers for Disease Control and Prevention (CDC), the American College of Obstetricians and Gynecologists (ACOG), and other national organizations recommend offering all women of childbearing age comprehensive family planning and the opportunity to receive preconception counseling and care as a component of routine primary medical care. The purpose of preconception care is to improve the health of each woman before conception by identifying risk factors for adverse maternal or fetal outcomes, providing education and counseling tailored to patients’ individual needs, and treating or stabilizing medical conditions to optimize maternal and fetal outcomes.1 Preconception care is not something that occurs in a single clinical visit; rather, it is a process of ongoing care and interventions integrated into primary care to address the needs of women during the different stages of reproductive life. It is important that comprehensive family planning and preconception care be integrated into routine health visits, because almost half of all pregnancies in the United States are unplanned.2-10 Providers should initiate and document a nonjudgmental conversation with all women of reproductive age concerning their reproductive desires, because women may be reluctant to bring this up themselves.11-14 Health care providers who routinely care for women of reproductive age who are living with HIV play an important role in promoting preconception health and informed reproductive decisions. However, even among providers who offer primary care to women living with HIV, the delivery of comprehensive reproductive counseling often falls short of the current guidelines.15
The fundamental principles of preconception counseling and care are outlined in the CDC Preconception Care Work Group’s Recommendations to Improve Preconception Health and Health Care. In addition to the general components of preconception counseling and care that are appropriate for all women of reproductive age, women living with HIV have specific needs that should be addressed.16-19 Health care providers should:
- Discuss reproductive options, actively assess women’s pregnancy intentions on an ongoing basis throughout the course of care, and, when appropriate, make referrals to experts in HIV and women’s health, including experts in reproductive endocrinology and infertility when necessary.11,20
- The primary treatment goal for women who are on ART and planning a pregnancy should be sustained suppression of plasma viral load (below the limit of) detection prior to conception. This is important for the health of the woman and to decrease the risk of both perinatal transmission and sexual transmission to a partner without HIV (see Reproductive Options).
- Counsel women on safer sex practices (including condoms and ART) that prevent HIV transmission to sexual partners, protect women from acquiring sexually transmitted infections, and reduce the risk of acquiring resistant strains of HIV (see Reproductive Options).
- Encourage sexual partners to receive HIV counseling and testing so that they can seek HIV care if they have HIV or seek advice about oral pre-exposure prophylaxis (PrEP) and other measures to prevent HIV acquisition if they do not have HIV.
- Counsel women on eliminating the use of alcohol, tobacco, and other drugs of abuse. Appropriately treat (e.g., with methadone or buprenorphine) and manage (e.g., provide access to syringe services program) the use of these drugs when elimination is not feasible.
- Counsel women contemplating pregnancy to take a daily multivitamin that contains 400 mcg of folic acid to help prevent certain birth defects. Women who are at higher risk of having a child with neural tube defects than the baseline population are candidates for higher (1 to 4 mg) dose folic acid supplementation.
- Educate and counsel women about risk factors for perinatal transmission of HIV, strategies to reduce those risks, potential effects of HIV or of antiretroviral (ARV) drugs given during pregnancy on pregnancy course and outcomes, and the recommendation that women living with HIV in the United States not breastfeed because of the risk of transmission of HIV to their infants and the availability of safe and sustainable infant feeding alternatives.
- When prescribing antiretroviral therapy (ART) to women of childbearing age, consider the regimen’s effectiveness, an individual’s hepatitis B virus (HBV) status, the potential for teratogenicity, and possible adverse outcomes for mother and fetus.21-23
- Provide counseling about the potential risk of neural tube defects when dolutegravir is taken during conception to patients who are currently receiving dolutegravir as part of their ARV regimen or who wish to be started on dolutegravir, see Interim Recommendations about the Use of Dolutegravir at the Time of Conception and During Pregnancy in Teratogenicity and Recommendations for the Use of Antiretroviral Drugs During Pregnancy.
- Use the preconception period to modify the ART regimen of women who are contemplating pregnancy to optimize virologic suppression and minimize potential adverse effects, see Recommendations for Use of Antiretroviral Drugs in Pregnancy and Table 7.
- Recognize that women with perinatally acquired HIV may have special needs24 (see Women with Perinatal HIV Infection).
- Evaluate and manage therapy-associated side effects (e.g., hyperglycemia, anemia, hepatotoxicity) that may adversely impact maternal-fetal health outcomes.
- Administer all vaccines as indicated, (see Guidance for Vaccine Recommendations for Pregnant and Breastfeeding Women and 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host) including vaccines for influenza, pneumococcus, HBV, and tetanus. All women, including those with HIV, should receive Tdap vaccination during each pregnancy.
- Offer all women who do not currently desire pregnancy effective and appropriate contraceptive methods to reduce the likelihood of unintended pregnancy. Women living with HIV can use all available contraceptive methods, including hormonal contraception (e.g., pill, patch, ring, injection, implant) and intrauterine devices (IUDs).25 Providers should be aware of potential interactions between ARV drugs and hormonal contraceptives that could lower contraceptive efficacy (see Table 3 below).
- Offer emergency contraception as appropriate, including emergency contraceptive pills and the copper IUD (see The ACOG Practice Bulletin on Emergency Contraception). Concerns about drug interactions between ARV drugs and emergency contraceptive pills containing estrogen and a progestin, or containing levonorgestrel only, may be similar to concerns when those formulations are used for regular contraception.26 There are no data on potential interactions between ARV drugs and ulipristal acetate, a progesterone receptor modulator; however, ulipristal acetate is predominantly metabolized by cytochrome P450 (CYP) 3A4, so interactions may be expected (see the HIV Drug Interaction Checker).
- Optimize the woman’s health prior to conception (e.g., ensure appropriate folate intake, test for all sexually transmitted infections and treat as indicated, consider the teratogenic potential of all prescribed medications, and consider switching to safer medications).
Drug-Drug Interactions Between Hormonal Contraceptives and Antiretroviral Therapy
Data on drug interactions between ARV agents and hormonal contraceptives primarily come from drug labels and limited studies.26-42 The contraceptive effectiveness of the levonorgestrel IUD (Mirena) is largely through local (i.e., intrauterine) release of levonorgestrel, not through systemic absorption. The CDC’s U.S. Medical Eligibility Criteria for Contraceptive Use list the levonorgestrel IUD (Mirena) as category 1 (no restrictions) in drug interactions with all ARVs in women who already have an IUD and category 1/2 (benefits outweigh risk) for those initiating use of an IUD.
Hormonal contraceptives can be used with ART in women without other contraindications. Additional or alternative methods of contraception may be recommended when drug interactions are known. For women using ritonavir-boosted protease inhibitors (PI/r) who are also on combination hormonal contraceptives (e.g., pills, patches, rings) or progestin-only pills, use of an alternative or additional method of contraception may be considered, since the AUC of hormones may be decreased in some PI/r (i.e., darunavir/ritonavir [DRV/r], fosamprenavir/ritonavir, and lopinavir/ritonavir [LPV/r]) but not in others (see Table 3). Depot medroxyprogesterone acetate (DMPA) can be used without restriction because of its relatively higher dose than other progesterone-based contraception, and limited studies have shown no significant interaction between DMPA and ARV drugs.28,30,40,43 Nucleoside reverse transcriptase inhibitors have no effect on hormonal contraceptive doses.
While contraceptive implants (e.g., etonogestrel/levonorgestrel) generally can be used in women on ART, both pharmacokinetic (PK) and clinical data suggest that these implants have decreased efficacy when used with efavirenz-based regimens.38,44-46 Scarsi et al. reported on three groups of Ugandan women living with HIV (those who were not on ART [17 women], those taking nevirapine-based ART [20 women], and those taking efavirenz-based ART [20 women]) who had levonorgestrel implants placed and had levonorgestrel PK levels assessed at 1, 4, 12, 24, 36, and 48 weeks post-insertion. The geometric mean ratio of levonorgestrel (patients taking efavirenz-based ART vs. ART-naive patients) was 0.53 at 24 weeks and 0.43 at 48 weeks. Three pregnancies (3/20, 15%) occurred in the efavirenz group between weeks 36 and 48, whereas no pregnancies occurred in the ART-naive or nevirapine groups.42
In a study of 570 women with HIV in Swaziland who had levonorgestrel implants (i.e., Jadelle), none of the women on nevirapine- or LPV/r-based regimens (n = 208 and n = 13, respectively) became pregnant, whereas 15 women on efavirenz (n = 121; 12.4%) became pregnant.38 Because of their overall efficacy, implants remain equally effective as or more effective than oral and injectable contraceptives among women with HIV who are using efavirenz, and all hormonal contraceptives remain more effective than no contraception among these women.45,47 A study collected data from 5,153 women with HIV who were followed prospectively for 1 to 3 years. During the follow-up period, 9% of the women used implants (mostly levonorgestrel), 40% used injectables, and 14% used oral contraceptives; 31% of these women took ART during the follow-up period, mostly nevirapine (75%) or efavirenz (15%). Among women not using contraception, pregnancy rates were 13.2 per 100 person-years for those who were on ART and 22.5 per 100 person-years for those who were not on ART. Implants greatly reduced the incidence of pregnancy among women on ART (adjusted hazard ratio [aHR] 0.06; 95% CI, 0.01–0.45) and not on ART (aHR 0.05; 95% CI, 0.02–0.11). Injectables and oral contraceptives also reduced pregnancy risk, though to lesser degrees. ART use did not significantly diminish contraceptive effectiveness, although all methods showed nonstatistically significant reduced contraceptive effectiveness when a woman was using efavirenz concurrently.47
Because data are limited on pregnancy rates among women on different hormonal contraceptives and ARV drugs, the dosing recommendations in Table 3 are based on consensus expert opinion. Whenever possible, the recommendations are based on available data regarding PK interactions between ARV drugs and combined hormonal methods, DMPA, and levonorgestrel and etonogestrel implants. The smallest decrease in PK for which an alternative method was recommended was a 14% decrease in norethindrone (with DRV/r). For women using atazanavir without ritonavir boosting (ethinyl estradiol increase 48%, norethindrone increase 110%), the Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission (the Panel) recommends use of oral contraceptives containing ≤30 µg ethinyl estradiol. The Panel does not recommend any change in ethinyl estradiol dose for etravirine (ethinyl estradiol increase 22%), rilpivirine (ethinyl estradiol increase 14%), or indinavir (ethinyl estradiol increase 25%, norethindrone increase 26%).
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- Johnson K, Posner SF, Biermann J, et al. Recommendations to improve preconception health and health care--United States. A report of the CDC/ATSDR Preconception Care Work Group and the Select Panel on Preconception Care. MMWR Recomm Rep. 2006;55(RR-6):1-23. Available at: https://www.ncbi.nlm.nih.gov/pubmed/16617292.
- Cohn SE, Umbleja T, Mrus J, Bardeguez AD, Andersen JW, Chesney MA. Prior illicit drug use and missed prenatal vitamins predict nonadherence to antiretroviral therapy in pregnancy: adherence analysis A5084. AIDS Patient Care STDS. 2008;22(1):29-40. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18442305.
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- Kost K, Finer LB, Singh S. Variation in state unintended pregnancy rates in the United States. Perspect Sex Reprod Health. 2012;44(1):57-64. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22405153.
- Sun M, Peipert JF, Zhao Q, et al. Trends in contraceptive use among women with human immunodeficiency virus. Obstet Gynecol. 2012;120(4):783-790. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22996095.
- Sutton MY, Patel R, Frazier EL. Unplanned pregnancies among HIV-infected women in care-United States. J Acquir Immune Defic Syndr. 2014;65(3):350-358. Available at: http://www.ncbi.nlm.nih.gov/pubmed/24189153.
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- Atazanavir [package insert]. Food and Drug Administration. 2015. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf.
- Indinavir sulfate [package insert]. Food and Drug Administration. 2015. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020685s077lbl.pdf.
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- AIDSinfo Drug Database
- AIDSinfo Patient Materials: Preventing Mother-to-Child Transmission of HIV
- AIDSinfo Patient Materials: HIV Medicines During Pregnancy and Childbirth
- AIDSinfo Patient Materials: Protecting Baby from HIV
- AETC National HIV Curriculum
- How to Cite These Guidelines
- Perinatal Guidelines Archive