Antiretroviral Therapy (ART) During Pregnancy

"Although considerations associated with pregnancy may affect decisions regarding timing and choice of therapy, pregnancy is not a reason to defer standard therapy." A recent recommendation of the United States Public Health Service.

There are two primary goals of ART during pregnancy. The first goal is to treat the HIV positive woman by suppressing viral load, sustaining her immune system and controlling opportunistic infection. The second goal is to reduce the risk of mother to child transfer (MTCT).

Pregnancy presents special issues, including:

These special consideration, viral resistance and pre-existing conditions may require modification of standard ART regimens. Some drugs may need to be excluded or decreased, others increased.

Beginning therapy:

Anti-HIV medications are recommended for all pregnant women regardless of CD4 count and viral load.

Current recommendations for beginning antiretroviral therapy are similar to those for a non-pregnant individual. In general, it is recommended that pregnant women who are starting therapy for their own health be treated as soon as possible, including in the first trimester. For women who are beginning therapy only to prevent mother-to-child transmission, delaying anti- HIV medication until after the first trimester can be considered. Regardless of the recommendations, a women's decision to use, refuse or delay ART must be respected.

ART will usually be offered for the following reasons:

Safety of antiretroviral drugs during pregnancy:

Almost all patients who undergo highly active antiretroviral therapy (ART) will experience some side effects. Recent studies indicate that there are differences in pharmacokenetics between men and women. Women appear to be at higher risk for ART associated lactic acidosis, nevirapine-associated rash and hepatotoxicity, and fat redistribution. Patients need to be able to recognize side effect and report them as early as possible.

Fetal effects associated with ART use.

Reducing Mother to Child Transmission (MTCT):

Ideally maternal HIV plasma levels will be suppressed to "undetectable" during pregnancy. Several studies indicate that Cesarean delivery prior to labor and rupture of membranes significantly reduces perinatal transmission of HIV. Finally, breast feeding is a known mode of transmission and should be avoided.

The U.S. Public Health Service Task Force Recommendations for Antiretroviral Drug Use by
Pregnant HIV-Infected Women and Prevention of Perinatal HIV-1 Transmission in
the United States.

April 29, 2009 Release

1

HIV-infected woman of childbearing potential but not pregnant, and who has indications for initiating antiretroviral theratherapy
  • Initiate ART as per adult treatment guidelines.
  • Avoid drugs with teratogenic potential (e.g., EFV) in women of childbearing age
    unless adequate contraception ensured. Exclude pregnancy before starting treatment with EFV.
2 HIV-infected woman who is receiving ART and becomes pregnant Woman:
• Continue current ART regimen if successfully suppressing viremia, except avoid use of EFV or other potentially teratogenic drugs in the first trimester and drugs with known adverse potential for mother (combination d4T/ddI).
• HIV antiretroviral drug resistance testing is recommended if the woman has detectable viremia on therapy.
• In general, if woman requires treatment, antiretroviral drugs should not be stopped during the 1st trimester.
• Continue ART regimen during intrapartum period (ZDV given as continuous infusion1 during labor while other antiretroviral agents are continued orally) and postpartum.
• Scheduled cesarean delivery at 38 weeks gestation if plasma HIV RNA remains >1,000 copies/mL near the time of delivery.

Infant:
• ZDV for 6 weeks started within 6 to 12 hours after birth.
3 HIV-infected pregnant woman who is antiretroviral naïve and
has indications for antiretroviral therapy

Woman:

  • HIV antiretroviral drug resistance testing is recommended prior to the initiation of therapy, and if suboptimal viral suppression after initiation of ART.
  • Initiate ART regimen.
  • Avoid use of EFV or other potentially teratogenic drugs in the first trimester and drugs with known adverse potential for mother (combination d4T/ddI).
  • Use of ZDV as a component of the antiretroviral regimen is recommended when feasible.
  • NVP can be used as a component of ART for women with CD4 count ≤250 cells/mm3, but should only be used as a component of therapy in women with CD4 counts >250 cells/mm3 if the benefit clearly outweighs the risk due to an increased risk of severe hepatic toxicity.
  • For women who require immediate initiation of therapy for their own health, treatment should be initiated as soon as possible, including in the first trimester.
  • Continue ART regimen during intrapartum period (ZDV given as continuous infusion1 during labor while other antiretroviral agents are continued orally) and postpartum.
  • Scheduled cesarean delivery at 38 weeks gestation if plasma HIV RNA remains >1,000 copies/mL near the time of delivery.

Infant:
• ZDV for 6 weeks started within 6 to 12 hours after birth.
4 IHIV-infected pregnant woman who is antiretroviral naïve and does not require treatment for her own health

Woman:

  • HIV antiretroviral drug resistance testing is recommended prior to the initiation of
    therapy, and if suboptimal viral suppression after initiation of ART.
  • ART is recommended for prophylaxis of perinatal transmission in women who do not require treatment for their own health.
  • Consider delaying ART initiation until after first trimester is completed.
  • Avoid use of EFV or other potentially teratogenic drugs in the first trimester and drugs with known adverse potential for mother (combination d4T/ddI).
  • Use of ZDV as a component of the antiretroviral regimen is recommended when feasible.
  • NVP should only be used as a component of therapy in women with CD4 counts >250 cells/mm3 if the benefit clearly outweighs the risk due to an increased risk of severe hepatic toxicity.
  • Use of ZDV prophylaxis alone is controversial, but may be considered for those women with plasma HIV RNA levels <1,000 copies/mL on no therapy.
  • Continue ART regimen during intrapartum period (ZDV given as continuous infusion1 during labor while other antiretroviral agents are continued orally).
  • Evaluate need for continued therapy postpartum; discontinue ART unless has indications for continued therapy. If regimen includes drug with long half-life like NNRTI, consider stopping NRTIs 7 days after stopping NNRTI. (Limited data exist on this.)
  • Scheduled cesarean delivery at 38 weeks gestation if plasma HIV RNA remains >1,000 copies/mL near the time of delivery.

Infant:

  • ZDV for 6 weeks started within 6 to 12 hours after birth.
5 HIV-infected woman who has received no antiretroviral therapy prior to labor

Woman: ZDV given as continuous infusion during labor.
Infant: ZDV for 6 weeks started within 6 to 12 hours after birth.

or

Combination ZDV + Single-Dose NVP:
Woman: ZDV given as continuous infusion during labor, plus single-dose NVP3 at onset of labor. Consideration should be given to adding 3TC during labor and maternal ZDV/3TC for 7 days postpartum, which may reduce development of NVP resistance.
Infant: Single-dose NVP3 plus ZDV for 6 weeks.

or


Woman: ZDV given as continuous infusion during labor.
Infant: Some clinicians may choose to use ZDV in combination with additional drugs in the infant, but appropriate dosing for neonates is incompletely defined and the additional efficacy of this approach in reducing transmission is not known. Consultation with a pediatric HIV specialist is recommended.

  • Evaluate need for initiation of maternal therapy postpartum.
  Infant born to HIV-infected woman who has received no antiretroviral therapy prior to or during labor
  • ZDV given for 6 weeks to the infant, started as soon as possible after birth.

or

  • Some clinicians may choose to use ZDV in combination with additional drugs, but appropriate dosing for neonates is incompletely defined and the additional efficacy of this approach in reducing transmission is not known. Consultation with a pediatric HIV specialist is recommended.
  • Evaluate need for initiation of maternal therapy postpartum.

 

Clinical Scenarios and Recommendations Regarding Mode of Delivery to Reduce
Perinatal HIV Transmission

1 HIV-infected women presenting in late pregnancy (after about 36 weeks gestation), known to be HIV-infected but not receiving antiretroviral therapy, and who have HIV RNA level and CD4 count pending but unlikely to be available before delivery.
  • The woman should be started on antiretroviral therapy.
  • The woman should be counseled that scheduled cesarean section is likely to reduce the risk of transmission to her infant. She should also be informed of the increased risks to her from cesarean section, including increased rates of postoperative infection, anesthesia risks, and other surgical risks.
  • If cesarean section is chosen, the procedure should be scheduled at 38 weeks gestation based on the best available clinical information.
  • When scheduled cesarean section is performed, the woman should receive continuous intravenous ZDV infusion beginning 3 hours before surgery and her infant should receive 6 weeks of ZDV therapy after birth.
  • Use of prophylactic antibiotics at the time of cesarean delivery is generally recommended.
  • Options for continuing or initiating combination antiretroviral therapy after delivery should be discussed with the woman as soon as her viral load and CD4 count results are available.
2 HIV-infected women who initiated prenatal care early in the third trimester, are receiving ART, and have an initial virologic response, but have HIV RNA levels that remain substantially more than 1,000 copies/mL at 36 weeks gestation. • The current combination antiretroviral regimen should be continued as the HIV RNA level is dropping appropriately.
• The woman should be counseled that although she is responding to the antiretroviral therapy, it is unlikely that her HIV RNA level will fall below 1,000 copies/mL before delivery. Therefore, scheduled cesarean section may provide additional benefit in preventing intrapartum transmission of HIV. She should also be informed of the increased risks to her of cesarean section, including increased rates of postoperative infection, anesthesia risks, and surgical risks.
• If she chooses scheduled cesarean section, it should be performed at 38 weeks gestation according to the best available dating parameters, and intravenous ZDV should be begun at least 3 hours before surgery and her infant should receive 6 weeks of ZDV therapy after birth.
• Other antiretroviral medications should be continued on schedule as much as possible before and after surgery.
• Use of prophylactic antibiotics at the time of cesarean delivery is generally recommended.
• The importance of adhering to therapy after delivery for the woman’s health should be emphasized.
• The infant should be treated with 6 weeks of ZDV therapy after birth.
3 HIV-infected women on ART with an
undetectable HIV RNA level at 36 weeks gestation.		 • The woman should be counseled that her risk of perinatal transmission of HIV with a persistently undetectable HIV RNA level is low, probably 2% or less, even with vaginal delivery. There is currently no information to evaluate whether performing a scheduled cesarean section will lower her risk further.
• Cesarean section has an increased risk of complications for the woman compared to vaginal delivery, and these risks must be balanced against the uncertain benefit of cesarean section in this case.
4 HIV-infected women who have elected scheduled cesarean section but present in early labor or shortly after rupture of membranes. • Intravenous ZDV should be started immediately since the woman is in labor or has ruptured membranes.
• If labor is progressing rapidly, the woman may deliver vaginally.
• If cervical dilatation is minimal and a long period of labor is anticipated, some clinicians may choose to administer the loading dose of intravenous ZDV and proceed with cesarean section to minimize the duration of membrane rupture and avoid vaginal delivery. Others might begin pitocin augmentation to enhance contractions and potentially expedite delivery.
• If the woman is allowed to labor, scalp electrodes and other invasive monitoring and operative delivery should be avoided if possible.
• The infant should be treated with 6 weeks of ZDV therapy after birth
     

 

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