Pregnancy and HIV

Treatment of Pregnant Women Living with HIV or Women Considering Pregnancy

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, EVG, 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

 

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

PEP 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

  • The topic of feeding intentions should be discussed with a pregnant woman as early as possible in pregnancy, together with providing education and support to the mother
  • We advise against breastfeeding, as in high-income settings the optimal way to prevent mother-to-child transmission is to feed infants born to mothers living with HIV with formula milk
    • To reduce the potential physical and emotional discomfort associated with breast engorgement, together with the risk of covert breastfeeding, women living with HIV should be given cabergoline to suppress lactation after delivery
  • In situations where a woman chooses to breastfeed, we recommend input from an interdisciplinary team including adult HIV specialist, paediatrician and obstetrician/gynecologist
    • We recommend monthly follow-up during the whole breastfeeding period with increased clinical and virological monitoring of both the mother and the infant. Measurement of drug concentrations in the milk could be done to inform clinical practice
    • Maternal HIV-VL > 50 copies/mL should result in cessation of breastfeeding, providing cabergoline and support from interdisciplinary team and a nursing specialist
    • Immediate consulting by the interdisciplinary team should be provided in case of signs and symptoms of mastitis, infant mouth or gut infections
    • Currently there is no evidence supporting PrEP recommendation for the infants who are breastfed
    • After stopping the breastfeeding, the child should undergo routine diagnostics as recommended in HIV-exposed children

 

Antiretroviral Drugs

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

 

 Regimen Main Requirements Additional guidance (see footnotes)
Recommended regimens
2 NRTIs + INSTI (PREFERRED)
ABC/3TC + DTG or
ABC/3TC/DTG

DTG to be discussed with women considering to become pregnant or if to be used in first 6 weeks of pregnancy

HLA-B*57:01 negative

HBsAg negative

I    (ABC: HLA-B*57:01, may delay starting ART)
II   (DTG: neural tube defects risk during periconception)

TDF/XTC or TAF/FTC
+ DTG

DTG to be discussed with women considering to become pregnant or if to be used in first 6 weeks of pregnancy.

TAF/FTC not recommended in first 14 weeks of pregnancy

II   (DTG: neural tube defects risk during periconception)
III  (Tenofovir salts)
IV   (TAF & pregnancy)

TDF/XTC or TAF/FTC
+ RAL 400 mg bid
 TAF/FTC not recommended in first 14 weeks of pregnancy III  (Tenofovir salts)
IV   (TAF & pregnancy)
V    (RAL in pregnancy, bid dosing)
2 NRTIs + PI/r
TDF/XTC or TAF/FTC
+ DRV/r 600 mg/100 mg bid
With food
TAF/FTC not recommended in first 14 weeks of pregnancy
III   (Tenofovir salts)
IV   (TAF & pregnancy)
VI   (DRV dosing)
VII  (COBI boosting)
Alternative regimens
2 NRTIs + INSTI
ABC/3TC + RAL 400 mg bid HBsAg negative
HLA-B*57:01 negative
I   (ABC: HLA-B*57:01, may delay starting ART)
V  (RAL in pregnancy, bid dosing)
2 NRTIs + NNRTI
ABC/3TC + EFV HLA-B*57:01 negative
HBsAg negative
HIV-VL < 100,000 copies/mL
At bedtime or 2 hours before dinner
I      (ABC: HLA-B*57:01, may delay starting ART)
VIII  (EFV HIV-2 & group O)
TDF/XTC or TAF/FTC + EFV or TDF/FTC/EFV At bedtime or 2 hours before dinner
TAF/FTC not recommended in first 14 weeks of pregnancy

III   (Tenofovir salts)
IV    (TAF & pregnancy)
VIII (EFV HIV-2 & group O)

TDF/XTC or TAF/FTC + RPV or TDF/FTC/RPV or
TAF/FTC/RPV

CD4 count > 200 cells/μL
HIV-VL < 100,000 copies/mL
Not on gastric pH increasing agents
With food
TAF/FTC not recommended in first 14 weeks of pregnancy
II    (Tenofovir salts)
IV   (TAF & pregnancy)
IX   (RPV exposure during 2nd and 3rd trimester, HIV-2)
X    (Interactions)
2 NRTIs + PI/r
ABC/3TC
+ DRV/r 600 mg/100 mg bid
HLA-B*57:01 negative
HBsAg negative
With food
     (ABC: HLA-B*57:01, may delay starting ART)
VI    (DRV dosing)
VII   (COBI boosting)

 

Additional guidance

  1. 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
  2. The last interim analysis from Tsepamo observational cohort showed that there was a small non-statistically significant increase in neural tube defects among women receiving DTG from conception compared with all other antiretroviral exposure
  3. 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 disoproxil fumarate)
  4. TAF/FTC not recommended in first 14 weeks of gestational age as IMPACT 2010/VESTED randomized study evaluating the safety and virologic efficacy of this combination recruited women only between 14-28 weeks of pregnancy
  5. 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
  6. DRV/r 800/100 mg qd not recommended during pregnancy due to decreased levels. DRV/c is not recommended during pregnancy due to significant lower exposures of DRV and COBI in the second and third trimester of pregnancy
  7. Boosting with COBI is not recommended after the second trimester of pregnancy (insufficient drug levels)
  8. EFV not active against HIV-2 and HIV-1 group O strains
  9. Lower RPV exposure during second and third trimesters; Consider monitoring VL more frequently. RPV is not active against HIV-2
  10. 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