What antiretroviral prophylaxis regimen should be given to a newborn born to an HIV (Human Immunodeficiency Virus) positive mother?

Antiretroviral Prophylaxis for Newborns Born to HIV-Positive Mothers

All newborns born to HIV-positive mothers should receive antiretroviral prophylaxis initiated as soon as possible after birth, ideally within 6-12 hours of delivery, with a full 6-week course of zidovudine (ZDV) as the standard regimen. 1

Timing of Prophylaxis Initiation

• Start ARV prophylaxis immediately after birth, preferably within 6 hours but certainly by 12 hours after delivery. 1, 2, 3
• The effectiveness of prophylaxis decreases significantly with delayed initiation—after 48 hours, efficacy is substantially reduced. 1
• By 14 days of age, HIV infection is already established in most infected infants, making later prophylaxis ineffective. 1

Standard Prophylaxis Regimen

The cornerstone of neonatal prophylaxis is a 6-week course of zidovudine (ZDV). 1, 4

• This 6-week regimen should be provided to the family with careful administration instructions before hospital discharge. 1
• The full course must be completed even if the infant appears healthy. 1

Risk-Stratified Approach

For Infants Born to Mothers Who Received Adequate Prenatal ARV Therapy

• Standard 6-week ZDV prophylaxis is appropriate when the mother achieved virologic suppression (HIV RNA <50 copies/mL). 3
• The mother should have received combination antiretroviral therapy during pregnancy and intravenous ZDV during labor. 1

For Infants Born to Mothers Who Received No or Inadequate ARV Therapy

These high-risk infants require more aggressive prophylaxis. 1, 4

• At minimum, provide the standard 6-week ZDV regimen initiated as soon as possible after delivery. 1
• Some experts recommend combination antiretroviral prophylaxis (similar to post-exposure prophylaxis protocols) for these high-risk infants, though definitive efficacy data are limited. 1, 4
• Combination regimens may include ZDV plus lamivudine (3TC), or ZDV plus nevirapine, particularly if maternal ZDV-resistant virus is suspected. 1, 5
• For children ≤10 years requiring combination therapy, the preferred backbone is ZDV + lamivudine with lopinavir/ritonavir as the third drug. 4

For Mothers with Unknown HIV Status at Delivery

Rapid HIV antibody testing should be performed immediately on the mother or newborn. 1

• Results must be available within 12 hours of birth to guide prophylaxis decisions. 1
• If the rapid test is positive, initiate ARV prophylaxis immediately without waiting for confirmatory testing. 1
• If confirmatory testing is negative, stop prophylaxis and allow breastfeeding. 1

Critical Implementation Points

Breastfeeding Prohibition

Infants born to HIV-positive mothers should not breastfeed under any circumstances in resource-rich settings. 1

• Breastfeeding accounts for approximately 10% of mother-to-child HIV transmission. 6
• Formula feeding is the only proven method to eliminate transmission during the breastfeeding period. 6

Consultation and Follow-Up

• All care of HIV-exposed newborns should be performed in consultation with specialists experienced in pediatric HIV infection. 1
• Early diagnostic testing should be performed to identify infected infants so treatment can be initiated promptly. 1
• Infants whose HIV status is undetermined should receive trimethoprim-sulfamethoxazole prophylaxis for Pneumocystis jiroveci pneumonia. 1

Common Pitfalls to Avoid

• Never delay prophylaxis while awaiting confirmatory HIV testing results—the window for effective prophylaxis is narrow. 1
• Do not assume oral ZDV during labor provides equivalent protection to intravenous ZDV—intravenous administration ensures rapid, stable drug levels in both mother and infant during delivery. 1
• Do not discontinue prophylaxis prematurely—the full 6-week course is essential even if early infant HIV testing is negative, as infection may not be detectable immediately after birth. 1
• Ensure adequate dosing for premature or low birth weight infants—pharmacokinetics differ in these populations and may require dose adjustments. 7

Documentation Requirements

• Maternal HIV status must be documented in both the maternal and infant medical records. 1
• This documentation should be a standard quality measure for hospital care. 1