The US Department of Health and Human Services publishes the guidelines for clinical care and prevention for HIV surrounding conception, pregnancy, and childbirth. Below is a summary of the recent updates to the guidelines as of August 6, 2015. The full guidelines can be found here.
What’s New in the Guidelines
(Last updated: August 6, 2015; last reviewed: August 6, 2015)
Key changes to the Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women and Interventions to Reduce Perinatal HIV Transmission in the United States are summarized below. Text, appendices, and references have been updated to include new data and publications where relevant. Throughout the guidelines, content has been revised to refer to expedited HIV testing, preferably using fourth-generation antigen/antibody expedited HIV tests, in accordance with current Centers for Disease Control and Prevention (CDC) recommendations. All changes are highlighted throughout the guidelines.
Pregnant Women with Perinatal HIV Infection
- The Panel has added a new section about pregnant women with perinatal HIV infection. Although the components of prenatal care and general principles of combination antiretroviral therapy (cART) and HIV management do not differ between pregnant women who were perinatally infected and those who acquired HIV infection in other ways, this section discusses some of the unique challenges in meeting these young women’s reproductive health care needs and optimizing prevention of perinatal HIV transmission.
Preconception Counseling and Care for HIV-Infected Women of Childbearing Age
- HIV infection does not preclude use of any contraceptive method (AII). However, the Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission (the Panel) recommends that drug-drug interactions between hormonal contraceptives and cART should be taken into account (seeTable 3: Drug Interactions between Antiretroviral Agents and Hormonal Contraceptives).
- The Panel noted that a World Health Organization expert group reviewed all available evidence regarding hormonal contraception and HIV transmission to an uninfected partner and recommended that women living with HIV can continue to use all existing hormonal contraceptive methods without restriction. Women should be strongly advised to also always use condoms and other HIV preventive measures.
Reproductive Options for HIV-discordant Couples
- For HIV-discordant couples, the Panel recommends that the HIV-infected partner receive cART and demonstrate sustained suppression of plasma viral load below the limits of detection (AI).
- Periconception administration of antiretroviral (ARV) pre-exposure prophylaxis for the HIV-uninfected partner may offer an additional tool to reduce the risk of sexual transmission (CIII).
General Principles Regarding Use of Antiretroviral Drugs during Pregnancy
- The Panel clarified that the goal of cART is to maintain a viral load below the limit of detection throughout pregnancy for all women.
- The Panel has added a link to the 2013 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for Vaccination of the Immunocompromised Host.
- Data from recently-reported cohort studies and updated Antiretroviral Pregnancy Registry data have been included, reaffirming the lack of clear association between first-trimester exposure to any ARV drug and increased risk of birth defects.
- The Panel reviewed an updated meta-analysis of studies of defects after efavirenz exposure; this analysis found no association between first-trimester exposure and increased risk of birth defects.
- The Panel noted that a recent study found significantly lower bone mineral content in newborns exposed to tenofovir disoproxil fumarate (tenofovir) in utero compared with infants without tenofovir exposure. The clinical significance and long-term outcome of these findings is not clear.
Combination Antiretroviral Drug Regimens and Pregnancy Outcome
- Content has been reorganized into two sections: earlier studies describing data prior to 2005 and recent studies describing data beginning in 2005.
Recommendations for Use of Antiretroviral Drugs during Pregnancy
- Content about mitochondrial toxicity associated with nucleoside reverse transcriptase inhibitors (NRTIs) has been moved into this section.
- Table 6: What to Start: Initial Combination Regimens for Antiretroviral Naive-Pregnant Women has been updated with new recommendations for initial therapy.
- Preferred protease inhibitor (PI): darunavir/ritonavir has been promoted to a preferred protease inhibitor for ARV-naive pregnant women; atazanavir/ritonavir remains a Preferred PI.
- Alternative PI: lopinavir/ritonavir has been changed from Preferred to Alternative PI.
- Preferred non-nucleoside reverse transcriptase inhibitor (NNRTI): efavirenz remains a Preferred NNRTI when initiated after the first 8 weeks of pregnancy.
- Alternative NNRTI: rilpivirine has been added as an Alternative NNRTI.
- Preferred integrase inhibitor: Raltegravir has been promoted to the Preferred category, providing a Preferred integrase inhibitor option for initial therapy in pregnancy.
- Not Recommended for ARV therapy: saquinavir/ritonavir and nevirapine are no longer recommended for initial ARV therapy in ARV naive women.
- Insufficient Data in Pregnancy to Recommend Routine Use in ARV Therapy-Naive Women: There are insufficient data to recommend cobicistat, which is now available to be prescribed as a boosting agent with PIs.
- Table 7: Antiretroviral Drug Use in Pregnant HIV-Infected Women: Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy and Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy have been updated with new data, and newly licensed drugs have been added.
HIV-Infected Pregnant Women Who Have Never Received Antiretroviral Drugs (Antiretroviral Naive)
- The Panel now recommends that consideration should be given to initiating cART as soon as HIV is diagnosed during pregnancy in light of data demonstrating an association between earlier viral suppression and lower risk of transmission.
- The section has been updated in accordance with changes in the recommendations for use of ARV drugs in pregnancy (see Table 6: What to Start: Initial Combination Regimens for Antiretroviral Naive-Pregnant Women).
Monitoring of the Woman and Fetus during Pregnancy
- The Panel pointed out that maternal HIV RNA levels assessed at approximately 34 to 36 weeks’ gestation to inform decisions about mode of delivery are also used to inform decisions about optimal treatment of the newborn.
Antiretroviral Drug Resistance and Resistance Testing in Pregnancy, HIV-Infected Women Pregnant Women Who Have Never Received Antiretroviral Drugs, and HIV-Infected Pregnant Women Who Have Previously Received Antiretroviral Treatment
- Individual sections have been updated to reflect the Panel’s recommendations that cART can be initiated prior to receiving results of ARV drug-resistance studies in light of data demonstrating an association between earlier viral suppression and lower risk of perinatal HIV transmission. The ARV regimen should be modified, if necessary, based on the results of the resistance assay (BIII).
Lack of Viral Suppression
- Because maternal antenatal viral load correlates with risk of perinatal transmission of HIV, the Panel has added a recommendation that suppression of HIV RNA to undetectable levels should be achieved as rapidly as possible (AII).
Special Populations: HIV/Hepatitis C Virus Coinfection
- The Panel has added a link to the recently updated hepatitis C virus (HCV) treatment guidelines of the American Association for the Study of Liver Diseases, IDSA, and International Antiviral Society-USA with a brief discussion about the importance of HCV testing although currently available anti-HCV treatments lack sufficient safety data to be recommended during pregnancy.
HIV-2 Infection and Pregnancy
- The Panel updated this section to incorporate the new 2014 CDC HIV testing algorithm, which may enhance the diagnosis of HIV-2 (CDC Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations 2014).
Other Intrapartum Management Considerations
- Recent data suggest that epidural anesthesia can be used safely regardless of ARV regimen.
- In discussing the avoidance of breastfeeding as the strong, standard recommendation for HIV-infected women in the United States, the Panel notes that women may face social, familial, and personal pressures to breastfeed despite this recommendation and that it is important to begin addressing possible barriers to formula feeding during the antenatal period.
Long-term Follow-Up of Antiretroviral Drug-Exposed Infants
- Content about the potential mitochondrial toxicity of NRTIs has been moved into this section.