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.

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Preconception Counseling and Care for Women of Childbearing Age Living with HIV

Overview

Last Updated: December 24, 2019; Last Reviewed: December 24, 2019

Panel's Recommendations Regarding Preconception Counseling and Care for Women of Childbearing Age Living with HIV
Panel's Recommendations
  • Discuss reproductive desires with all women of childbearing age on an ongoing basis throughout the course of their care (AIII).
  • Provide information about effective and appropriate contraceptive methods to reduce the likelihood of unplanned pregnancy (AI).
  • During preconception counseling, provide information on safe sex and encourage the elimination of alcohol, tobacco, and other drugs of abuse; if elimination is not feasible, clinicians should provide appropriate treatment (e.g., methadone or buprenorphine) or counsel patients on how to manage health risks (e.g., use of a syringe services program) (AII).
  • Women with HIV should attain maximum viral suppression before attempting conception for their own health, to prevent sexual HIV transmission to partners without HIV (AI), and to minimize the risk of perinatal HIV transmission to the infant (AI).
  • When selecting or evaluating an antiretroviral (ARV) regimen for women of childbearing age with HIV, consider a regimen’s effectiveness, a woman’s hepatitis B status, the teratogenic potential of the drugs in the ARV regimen, and the possible adverse outcomes for the mother and fetus (AII). See Teratogenicity and Recommendations for Use of Antiretroviral Drugs During Pregnancy for more information. The Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission emphasizes the importance of counseling and informed decision-making regarding all ARV regimens for people with HIV (AIII).
  • HIV infection does not preclude the use of any contraceptive method; however, drug-drug interactions between hormonal contraceptives and antiretrovirals should be considered (AII).
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

Overview

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, tailoring education and counseling 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 requires integrating ongoing care and interventions 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 care visits, because almost half of all pregnancies in the United States are unplanned.2-12 Providers should initiate and document a nonjudgmental conversation with all women of reproductive age about their reproductive desires, because women may be reluctant to bring this up themselves.13-17 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 with HIV, the delivery of comprehensive reproductive counseling often falls short of the current guidelines.18,19

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 with HIV have specific needs that should be addressed.20-23 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.13,24
  • The primary treatment goal for women who are on antiretroviral therapy (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 it minimizes the risk of perinatal HIV transmission and prevents sexual HIV transmission to a partner without HIV (see Reproductive Options for Couples When One or Both Partners are Living with HIV).
  • People with HIV who take ART as prescribed and who achieve and maintain an undetectable viral load have effectively no risk of transmitting HIV through sex. This is commonly known as Undetectable = Untransmittable or U=U. For more information, see the Prevention IS Care Resources from CDC.
  • 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), if appropriate, 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. The use of these drugs should be appropriately treated (e.g., with methadone or buprenorphine) and managed (e.g., provide access to syringe services program) when elimination is not feasible.
  • Counsel women who are 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 (NTDs) than the baseline population are candidates for receiving a higher dose (1 to 4 mg) of folic acid.
  • Educate and counsel women about the risk factors for perinatal HIV transmission, the strategies to reduce those risks, and the potential effects of HIV or of taking antiretroviral (ARV) drugs during pregnancy on pregnancy course and outcomes. Education and counseling should also be directed at helping women to understand 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.
  • To support women’s informed decision-making about ART, clinicians should educate and counsel them about the factors that affect the selection of ARV drugs for women who are trying to conceive, pregnant women, or postpartum women. This includes discussing the small but significant increase in the risk of infant NTDs when dolutegravir (DTG) is taken around the time of conception with women who are currently receiving DTG as part of their ART regimen or women who wish to be started on DTG. For more information, see Teratogenicity, Updated Guidance about the Use of Dolutegravir in Pregnancy in Recommendations for Use of Antiretroviral Drugs During Pregnancy, Dolutegravir, and Appendix D: Dolutegravir Counseling Guide for Health Care Providers.
  • When prescribing ART to women of childbearing age, consider the regimen’s effectiveness, an individual’s hepatitis B virus (HBV) status, the potential for teratogenicity, the likelihood of developing drug resistance, and the possible adverse outcomes for mother and fetus.25-27
  • Use the preconception period to modify the ARV regimen of women who are contemplating pregnancy to optimize virologic suppression and minimize potential adverse effects (see Recommendations for Use of Antiretroviral Drugs During Pregnancy and Table 5).
  • Recognize that women with perinatally acquired HIV may have special needs28 (see Prenatal Care, Antiretroviral Therapy, and HIV Management in 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). This includes 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 with HIV can use all available contraceptive methods, including hormonal contraception (e.g., pill, patch, ring, injection, implant) and intrauterine devices (IUDs).29 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). Emergency contraceptive pills that contain estrogen and a progestin and those that only contain levonorgestrel may have interactions with ARV drugs that are similar to the ones observed with combined oral contraceptives.30 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 occur (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 drugs and hormonal contraceptives primarily come from drug labels and limited studies.30-47 The contraceptive effectiveness of the levonorgestrel IUD 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 lists the levonorgestrel IUD as category 1 (no restrictions) in drug interactions with all ARV drugs in women who already have an IUD and category 1/2 (benefits outweigh risk) for those who are initiating use of an IUD.

Hormonal contraceptives can be used with ARV drugs in women without other contraindications. Additional or alternative methods of contraception may be recommended when drug interactions are known. For women who are using ritonavir (RTV)-boosted protease inhibitors (PIs) and 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 area under the curve of hormones may be decreased with the use of some RTV-boosted PIs (i.e., darunavir/ritonavir [DRV/r], fosamprenavir/ritonavir, and lopinavir/ritonavir [LPV/r]) but not 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.32,34,44,48 Doses of hormonal contraceptives do not need to be adjusted in patients who are receiving nucleoside reverse transcriptase inhibitors.

While contraceptive implants (e.g., etonogestrel/levonorgestrel) generally can be used in women who are receiving ARV drugs, both pharmacokinetic (PK) and clinical data suggest that these implants have decreased efficacy when used with efavirenz (EFV)-based regimens.42,49-51 Scarsi et al. reported on three groups of Ugandan women with HIV: those who were not on ART (17 women), those taking nevirapine (NVP)-based ART (20 women), and those taking EFV-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 concentrations (patients taking EFV-based ART vs. ART-naive patients) was 0.53 at 24 weeks and 0.43 at 48 weeks. Three pregnancies occurred in the EFV group (15%) between weeks 36 and 48, whereas no pregnancies occurred in the ART-naive or NVP groups.46

In a study of 570 women with HIV in Swaziland who had levonorgestrel implants (i.e., Jadelle), none of the women on NVP- or LPV/r-based regimens (n = 208 and n = 13, respectively) became pregnant, whereas 15 women on EFV (n = 121; 12.4%) became pregnant.42 Because of their overall efficacy, implants remain as effective as or more effective than oral and injectable contraceptives among women with HIV who are using EFV, and all hormonal contraceptives remain more effective than no contraception among these women.50,52 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 NVP-containing (75%) or EFV-containing (15%) regimens. Among women who were 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% confidence interval [CI], 0.01–0.45) and women who were 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 EFV concurrently.52

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 who are using atazanavir without RTV 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 the use of oral contraceptives that contain ≤30 µg ethinyl estradiol. The Panel does not recommend any change in ethinyl estradiol dose in women who are receiving etravirine (ethinyl estradiol increase 22%), rilpivirine (ethinyl estradiol increase 14%), or indinavir (ethinyl estradiol increase 25%, norethindrone increase 26%).

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