Pregnancy and HIV

Treatment Scenarios

Pregnant Women / Women Who Wish to Conceive

1. Women planning to be pregnant or becoming pregnant while already on ART

• Maintain ART: The main goal of ART during pregnancy is maintaining treatment efficacy, both for the women’s benefit and HIV transmission risk.
• ART may be switched temporarily for the duration of pregnancy to the preferred combinations recommended for ART naïve pregnant women, see table 1 below
• The decision on switching ART should be individualized taking into account the person’s history of treatment, adherence and tolerability, and weighed against potential risk coming from ART exposure or suboptimal pharmacokinetics in pregnancy
• If the purpose for switching is insufficient data about safety and efficacy in pregnancy, it should be explained to the pregnant woman and her decision/ willingness to switch current regimen taken into account:
  • Lower serum concentration was observed in persons on therapies boosted with COBI, DRV/r qd and RPV
  • There is insufficient data in pregnancy for BIC, DOR, RAL qd, and dual regimens
• Pregnant women should be monitored monthly or bimonthly (depending on adherence and length of virological suppression) and as close as possible to the predicted delivery date. HIV-VL should be tested every two months of pregnancy and including 36 weeks of gestation

2. Women becoming pregnant while treatment-naïve

Starting ART as soon as possible is highly recommended, see table 1 below

3. Women whose follow-up starts late in the second or in the third trimester

Start ART immediately (see table 1 below) and consider RAL or DTG as the preferred choice to obtain rapid HIV-VL decline and to ensure the HIV-VL is undetectable by the time of delivery

4. Women whose HIV-VL is not undetectable at third trimester

Perform resistance testing and consider changing to or adding INSTI (RAL or DTG) if not on this class to obtain rapid HIV-VL decline

5. Women whose HIV-VL is > 50 copies/mL at week 34-36 of pregnancy

Elective cesarean section to be planned at week 38, see labour and breastfeeding

6. Women diagnosed with HIV in labour

See labour and breastfeeding, below

7. Labour

1) Women whose HIV-VL is > 50 copies/mL at week 34-36:

• Elective cesarean section to be planned at week 38
• iv ZDV: During labour and delivery: 2 mg/kg loading dose followed by continuous iv infusion of 1 mg/kg/hour until delivery
  • Scheduled cesarean delivery: start iv ZDV 3 hours before surgery
  • Unscheduled cesarean delivery: consider administering loading dose then proceed to delivery

2) Women diagnosed with HIV during labour:

• If possible, perform caesarean section
• iv ZDV: During labour and delivery: 2 mg/kg loading dose followed by continuous iv infusion of 1 mg/kg/hour until delivery. Consider administering loading dose then proceed to delivery

Postnatal prophylaxis (PNP) should be given to all newborns born to mothers living with HIV according to local guidelines. For antiretroviral therapy in children with HIV, See Paediatric HIV Treatment: ART Initiation and Initial Regimen

8. Breastfeeding

• Breastfeeding is not recommended routinely
• In situations where there is persistently undetectable maternal HIV viral load and very low risk of transmission, breastfeeding may be facilitated by joint decision making and with appropriate close monitoring of mother and infant. Please see the section on General Principles of Postnatal Prophylaxis and Infant Feeding for details

Table 1: Antiretroviral regimen for ART-naïve pregnant women

ART-naïve pregnant women should initiate treatment as soon as possible. The decision of ART regimen should be discussed with the person and individualized taking into account tolerability, possible adherence issues, as well weighed against potential risk coming from ART exposure or suboptimal pharmacokinetics in pregnancy.

Pregnant women starting ART should be monitored monthly or bimonthly (depending on adherence and length of virological suppression) and as close as possible to the predicted delivery date. HIV-VL should be tested every two months of pregnancy and including 36 weeks of gestation

Additional guidance

1. Some generic forms of TDF use phosphate, maleate, and succinate salts instead of fumarate. They may be used interchangeably. In certain countries, TDF is labelled as 245 mg rather than 300 mg to reflect the amount of the prodrug (tenofovir disoproxil) rather than the fumarate salt (tenofovir disoprox- il fumarate)
2. There were no reports of neural tube defects among 1991 prospective reports of RAL exposure in pregnancy, 456 of which were in the periconception period. No data on RAL 1200 mg qd: not recommended
3. DRV/r 800/100 mg qd not recommended as initial ART during pregnancy due to decreased levels, but could be continued if the woman has already undetectable VL. DRV/c is not recommended during pregnancy due to significant lower exposures of DRV and COBI in the second and third trimester of pregnancy
4. Boosting with COBI is not recommended after the second trimester of pregnancy (insufficient drug levels)
5. ABC contraindicated if HLA-B*57:01 positive. Even if HLA-B*57:01 negative, counselling on HSR risk still mandatory. If testing for HLA-B*57:01 results in delay of ART initiation, consider other recommended backbone
6. EFV not active against HIV-2 and HIV-1 group O strains
7. Lower RPV exposure during second and third trimesters; Consider monitoring VL more frequently. RPV is not active against HIV-2
8. Pregnant women are often prescribed anti-H2 or proton pump inhibitors for nausea. Careful review of concomitant medicines at each visit and providing pregnant women with information on potential interactions is recommended