Antiretroviral Therapy in Pregnancy   TOP

Continually updated recommendations:

US Department of Health and Human Services. Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the U.S. November 17, 2005.

Recommendation for antiretroviral drugs in pregnancy:

All pregnant women with HIV infection should be treated.

Goal of therapy:

VL < 1000 c/mL

Regimen:

See Pregnancy Table 1

Pregnancy Table 1.   TOP

Preferred Antiretroviral Agents

NRTI Class

• Preferred: AZT/3TC
• Alternates: ddI, FTC, d4T, ABC
• Insufficient data: TDF
• Not recommended: ddC

NNRTI Class

• Preferred: NVP (if baseline CD4 is < 250/mm³)
• Not recommended: EFV and DLV

PI Class

• Recommended: NFV (1250 mg bid), SQV/r (1000/100 mg bid)
• Alternatives: IDV, LPV/r, RTV
• Insufficient data: APV, FPV, ATV, TPV

Entry Inhibitor Class

• Insufficient data: ENF

Pregnancy Table 2.   TOP

* June 23, 2005
** Pregnancy categories:

A = Controlled studies show no risk
B = No evidence of risk in humans
C = Risk cannot be excluded
D = Positive evidence of risk

Pregnancy Table 3.   TOP

Antiretroviral Drugs for Delivery

A. ACTG 076 Protocol
(Should be used as part of ART regimen in all pregnant women, if possible)

• Antepartum: AZT 300 bid or 200 tid po, wk 14 until delivery
• Intrapartum: AZT IV 2 mg/kg over first hr then 1 mg/kg/hr until delivery
• Postpartum: (Infant): AZT syrup 2 mg/kg po q 6h (or 1.5 mg/kg q 6h IV) x 6 wks

B. Regimen for 2nd & 3rd Trimesters

Standard ART, but:

• Include AZT * according to 076 protocol
• Treat based upon maternal clinical/immunologic status but avoid: EFV, HU, AZT & d4T, d4T & ddI, APV solution
• Previously untreated pregnant women with VL <1000 c/mL and CD4 >350 cells/mm³ may be treated with AZT monotherapy, AZT + 3TC, or HAART

C. Choices for Untreated Women Presenting In Labor and Their Infants

• NVP: 200 mg po onset labor; Infant: single 2 mg/kg po at 48-72 hrs
• AZT: 600 mg po onset labor and 300 mg po q3h until delivery PLUS 3TC 150 mg po onset labor and 150 mg po q12h until delivery; Infant: AZT 4mg/kg po q12h PLUS 3TC 2mg/kg po q12h for 7 days
• AZT: 2mg/kg IV bolus then 1mg/kg/hr IV infusion until delivery; Infant: AZT 2mg/kg po q6h for 6 wk (ACTG 076 Protocol)
• NVP + AZT: NVP:200 mg po onset labor PLUS AZT 2mg/kg IV bolus then 1 mg/kg/hr IV infusion until delivery; Infant: NVP single 2 mg/kg po at 48-72 hrs PLUS AZT 2mg/kg po q6h for 6 wk

* Unless unacceptable side effects or toxicity or requires d4T-containing regimen
** AZT & d4T: pharmacologic antagonism; do not use together. APV oral solution (only) is contraindicated in pregnancy because it contains large quantities of propylene glycol, which cannot be metabolized in pregnancy. d4T & ddI: concerns about lactic acidosis; use only when other NRTIs have failed or caused unacceptable side effects/toxicity (New Engl J Med 1999; 340:1723). EFV, HU: concerns about teratogenicity or birth defects; EFV: avoid in pregnancy.

Drug Information
A listing of antiretroviral drugs with information pertinent to their use in pregnancy may be found in Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States, Table 3.

Pregnancy Table 4.   TOP

Pregnancy Issues

Adverse Drug Reactions (ADR)

Generally, pregnant women are at the same risk of ADRs as non-pregnant individuals, but some ADRs may be more common because of pregnancy-related physiologic changes: anemia (iron & folate deficiency), nausea & vomiting (esp in 1st trimester), amniotransferase elevation. PIs may exacerbate pregnancy-related risk of hyperglycemia and NRTIs (especially d4T/ddI) increase risk of lactic acidosis.

Risk for Perinatal HIV Transmission

Viral load in plasma & genital tract (most significant), primary infection or late stage HIV, low CD4 count, STDs/other co-infections, pre-term delivery, increasing duration of membrane rupture, placental disruption, invasive fetal monitoring or assessment, vaginal delivery, and lack of AZT prophylaxis.

Post-Partum Risk

Breast feeding: not recommended in U.S.

Pregnancy Table 5.   TOP

Clinical Scenarios and Management of
Untreated Pregnant Patients Including C-Section

Scenario 1: No prior ART

• Standard lab and clinical care
• HAART for VL > 1000 c/mL
• Include the 3–part 076 protocol (see Pregnancy Table 3.A.)
• Consider delay initial therapy until after 1st trimester

Scenario 2: Currently receiving ART

• Continue therapy, but include AZT according to 076 protocol (see Pregnancy Table 3.A.)
• Option to stop in 1st trimester

Scenario 3: Woman in labor no prior therapy—options are:

• Intrapartum AZT and 6–week course for neonate
• AZT/3TC during labor and 3 weeks for neonate
• Single dose NVP intrapartum and single dose for infant
• Two–dose NVP and intrapartum AZT and 6 weeks AZT for newborn

Scenario 4: Woman has delivered

• Discuss HIV detection and implications
• Offer AZT to infant
• The mother should be evaluated for HIV management

Pregnancy Table 6.   TOP

Pregnancy Table 7.   TOP

Antiretroviral Pregnancy Registry
1011 Ashes Dr., Wilmington NC 28405
Telephone: 800-258-4263
Fax: 800-800-1052