CARE OF THE HIV-EXPOSED INFANT WITH INDETERMINATE STATUS

______________________________________________________________________________

Important Notes:
The recommended routine postnatal prophylaxis for all HIV-exposed infants has changed.
The new recommended dosing is as follows:
• Zidovudine (ZDV) syrup, 4 mg/kg per dose PO given twice daily through 6 weeks of age,
started as soon as possible (within 6 hours, and no later than 12 hours of delivery). See
Table 1 for dosing for premature infants <35 weeks’ gestation.
---------------------------------------------------------------------------------------------------------------------
Clinical scenarios that warrant supplemental prophylaxis are as follows:
• Mother received no antepartum therapy and only intrapartum ZDV
• Mother received no antepartum and no intrapartum prophylaxis
• Mother received antepartum therapy with incomplete (HIV RNA >1,000 copies/mL) or unknown
degree of viral suppression
• Mother has known drug-resistant HIV

The recommended supplemental postnatal prophylaxis is as follows:

• ZDV as above
plus
• Nevirapine (NVP) – 3 doses given in the first week of life (see Table 1):
12 mg PO per dose if BW >2 kg
8 mg PO per dose if BW 1.5 – 2 kg
---------------------------------------------------------------------------------------------------------------------
When treating infants born to mothers with known or suspected drug resistance, clinicians
should consult with a pediatric provider who has experience with HIV treatment and
management. Whenever possible, consultation should occur before delivery.

01/14 New York State Department of Health AIDS Institute: www.hivguidelines.org 1

GENERAL RECOMMENDATION:

All HIV-exposed infants should receive care from, or in consultation with, a pediatrician
experienced with HIV treatment and management. (AI)

The pediatric HIV epidemic has changed dramatically in New York State since the late 1980s,
largely as a result of earlier diagnosis of HIV infection in pregnant women and antiretroviral
(ARV) prophylaxis to prevent mother-to-child transmission (MTCT) of HIV. In 2012, the rate of
MTCT in New York State was only 0.8% (3 cases). Although there has been a significant decline
in MTCT, New York State continues to have approximately 450 to 500 HIV-exposed infants
born annually. Pediatricians play an important role in ensuring the health of these HIV-exposed
infants by providing HIV-related follow-up care that includes neonatal ARV prophylaxis, serial
diagnostic testing to determine HIV status, and counseling to the mother regarding avoidance of
breastfeeding.

In New York State, if a woman’s HIV status is unknown when she presents for delivery (i.e., no
documentation of a negative HIV test during the current pregnancy and she is not known to be
HIV-infected), expedited HIV testing must be conducted. New York State requires that results of
expedited HIV testing in the obstetrical setting must be available as soon as possible, preferably
within 1 hour, and no longer than 12 hours after the mother’s consent or the infant’s birth if the
mother declines testing.

For purposes of this chapter, an exposed infant is any infant born to a mother with HIV infection.

I. NEWBORN ARV PROPHYLAXIS FOR HIV-EXPOSED INFANTS

RECOMMENDATIONS:
Clinicians should administer zidovudine (ZDV) for prevention of mother-to-child-
transmission of HIV to all HIV-exposed infants as soon as possible after birth (AI):
• ZDV (4mg/kg PO twice daily) should be administered as soon as possible after birth,
within 6 hours, and no later than 12 hours of delivery (AII)
• ZDV prophylaxis should be given for 6 weeks (AI); dose adjustments should be
made as the infant’s weight changes
• Dosing of ZDV prophylaxis should be adjusted for premature infants < 35 weeks’
gestational age (see Table 1) (AII)

Clinicians should administer supplemental ARV prophylaxis as close to the time of birth as
possible for the following infants:
• Infants born to HIV-infected women who received no antepartum antiretroviral
therapy (ART) and only intrapartum ZDV
• Infants born to HIV-infected women who received no antepartum ART and no
intrapartum ZDV
• Infants born to HIV-infected women with suboptimal viral load levels (>1,000
copies/mL) (consider)

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 • Infants born to HIV-infected women with known drug-resistant HIV
The preferred prophylactic regimen includes 6 weeks of daily ZDV plus 3 doses of
nevirapine administered during the first week of life (at birth, 48 hours after the first dose,
and 96 hours after the second dose). See Table 1 for dosing. (AI)
Clinicians should consult a pediatric provider who has experience with HIV treatment and
management when using combination regimens other than those shown in Table 1 and
should discuss potential risks and benefits with the mother. Whenever possible,
consultation should occur before delivery. Clinicians who do not have access to experienced
pediatric HIV clinicians should call the New York State Pediatric Warmline at 1-866-637-2342,
for free consultation Monday-Friday from 8:00am – 5:00pm (calls after 5:00pm or on
holidays/weekends will be returned the next business day). The National Perinatal HIV Hotline
also can be consulted and provides free clinical consultation 24 hours/day, at 1-888-448-8765.
At each visit, clinicians should:
• Educate and demonstrate to the caregiver how to measure and administer the
correct ZDV dosage to be given to the infant because the dosage will change as the
infant’s weight changes
• Recommend and provide infant oral syringes for administering accurate ZDV
dosages
• Use vocabulary that caregivers can understand, regardless of educational level, and
provide written information that is well organized and easy to understand
• Document in the medical record that administration of the accurate ZDV dosage
was discussed with the caregiver
The interval during which infant prophylaxis can be initiated and still be of benefit is undefined;
however, infant prophylaxis should be initiated as soon as possible after delivery. A study
conducted in New York State demonstrated loss of efficacy when prophylaxis was delayed
beyond 48 hours after birth.1,2
Dosage of infant ZDV is based on weight; therefore, dose adjustments are needed as the infant’s
weight changes. At each visit, the clinician should ensure the mother is administering the ZDV
dosage correctly. When a change in dosage is necessary based on infant’s weight change, the
clinician should ensure that the caregiver understands how to measure and administer the new
dosage. Comparisons of dosage delivery devices have demonstrated that accurate doses are more
likely to be delivered when oral syringes are used.3
Anemia has been associated with the use of ZDV; therefore, some experts recommend obtaining
a complete blood count (CBC) and differential prior to initiating ZDV. (BIII) If CBC and
differential is obtained, initiation of ZDV prophylaxis should not be delayed while awaiting the
results of the CBC. Hematologic abnormalities are most common in pre-term infants.4 Anemia
generally resolves by 12 weeks; a baseline CBC is most useful for identifying a child at risk for
developing severe anemia while receiving ZDV. Hematologic monitoring of the infant after birth
is an individualized decision based on several factors, such as gestational age at birth, maternal
antepartum regimen, and medications given to the infant. For infants who experience significant
ZDV toxicity, consideration should be given to decreasing the duration of ZDV from 6 weeks to
4 weeks.5 The 4-week regimen has been shown to allow earlier recovery from anemia.5

01/14 New York State Department of Health AIDS Institute: www.hivguidelines.org 3

Key Point:
Birth facilities should routinely stock liquid formulations of ZDV and NVP for immediate use in
infants born to HIV-infected mothers, as indicated in Table 1.

TABLE 1
ANTIRETROVIRAL PROPHYLAXIS REGIMENS TO REDUCE MOTHER-TO-CHILD
HIV TRANSMISSION IN HIV-EXPOSED INFANTS
Routine Postnatal Prophylaxis for All HIV-Exposed Infants
Full-Term Newborn Regimen (≥35 weeks’ gestation)
Start as soon as possible (within 6 hours, and no later than 12 hours of delivery)
• ZDV syrup, 4 mg/kg per dose PO given twice daily through 6 weeks of agea
Preterm Newborn Regimen
Start as soon as possible (within 6 hours, and no later than 12 hours of delivery)
• For ≥30 to <35 weeks’ gestation: ZDV 2 mg/kg per dose PO [or 1.5 mg/kg per dose IV] given
every 12 hours, then advance to 3 mg/kg/dose (2.3 mg/kg/dose IV) every 12 hours beginning at
age 15 days through 6 weeks of age
• For <30 weeks’ gestation: ZDV 2 mg/kg per dose PO [or 1.5 mg/kg per dose IV] given every
12 hours, then advance to 3 mg/kg/dose (2.3 mg/kg/dose IV) every 12 hours beginning at 4 weeks
of age through 6 weeks of age

Supplemental Postnatal Antiretroviral Prophylaxis

(see Table 2 for infants who should receive supplemental prophylaxis)
Drugs for Dosing Duration
Infant
2-drug regimen:
ZDV + NVPb ZDV: as above Birth through 6 weeks
(4 mg/kg per dose PO twice a day)

NVP: 12 mg PO per dose if BW>2 kg 3 doses in first week of life:

8 mg PO per dose if BW 1.5-2 kg • 1st dose within first 48 hr of birth
• 2nd dose 48 hr after 1st dose
• 3rd dose 96 hr after 2nd dose
NVP, nevirapine; ZDV, zidovudine.
a
If unable to tolerate orally, administer ZDV 3.0 mg/kg per dose IV every 12 hours, started as soon as possible after
birth (within 6 hours, and no later than 12 hours of delivery).
b
Consultation with a pediatric provider who has experience with HIV treatment and management is advised before
administering nevirapine to neonates who are <1.5 kg or <32 weeks estimated gestational age at birth.

Nevirapine is the only non-nucleoside reverse transcriptase inhibitor (NNRTI) with a pediatric
drug formulation and neonatal dosing information6; currently, no protease inhibitors are
recommended for neonatal use. Toxicities from nevirapine in the infant are rare but have

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included severe and potentially life-threatening rash and hepatic toxicity. Toxicities are much
more common with nevirapine dosing for chronic infection than with the three-dose prophylactic
regimen recommended for some neonates7-10; routine monitoring of serum liver enzyme levels is
not indicated with short-term nevirapine dosing. For infants who receive nevirapine as
prophylaxis but still become infected, resistance to nevirapine can occur.11
Duration of Antiretroviral Prophylaxis Regimen
In the United States, the current recommendation is 6 weeks of ZDV prophylaxis; however, this
Committee has begun to review the evidence to support the use of a 4-week ZDV regimen in
some infants who are at lower risk for MTCT.12 An update will be issued upon completion of the
review.

TABLE 2
CLINICAL SCENARIOS FOR WHICH SUPPLEMENTAL ANTIRETROVIRAL PROPHYLAXIS IS
INDICATED TO PREVENT MOTHER-TO-CHILD HIV TRANSMISSION
Clinical Scenario Drugs for Infanta
Mother received no antepartum therapy • 2-drug regimen: ZDV + NVP
and only intrapartum ZDV
Mother received no antepartum and no • 2-drug regimen: ZDV + NVP
intrapartum prophylaxis
Mother received antepartum therapy with • Scheduled elective cesarean section
incomplete (HIV RNA >1,000 copies/mL) • Consider the 2-drug regimen of ZDV + NVP in
or unknown degree of viral suppression consultation with a pediatric provider who has
experience with HIV treatment and management
Mother has known drug-resistant HIV • Consider a 2- or 3-drugb regimen in consultation with
a pediatric provider who has experience with HIV
treatment and management
NVP, nevirapine; ZDV, zidovudine.
a
See Table 1 for dosing.
b
See Section A.3. Infants Born to Mothers Who Did Not Receive Antepartum or Intrapartum Antiretroviral Drugs

A. Newborn Antiretroviral Prophylaxis: Specific Scenarios

1. Infants Born to Mothers Who Received Antepartum Antiretroviral Therapy with Undetectable
HIV Viral Load Levels at Delivery
RECOMMENDATION:
All infants whose mothers received antepartum ART with undetectable HIV viral load
levels at the time of delivery should be given ZDV for 6 weeks (see Table 1). (AI)
The risk of HIV acquisition is low in infants born to women who received standard ART
regimens during pregnancy with undetectable viral loads at delivery. These infants should
receive the 6-week regimen for ZDV infant prophylaxis.13,14 In this situation, adding additional
ARV drugs to the ZDV regimen to reduce transmission risk is not recommended because the
benefit would be very limited.

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2. Infants Born to Mothers Who Received Only Intrapartum Prophylaxis

RECOMMENDATION:
Infants born to mothers who received only intrapartum ARV drugs should be given ZDV
for 6 weeks plus 3 doses of nevirapine in the first week of life (see Table 1). (AI)

Infant prophylaxis is a critical component of prevention of HIV transmission when the mother
did not receive any ARV drugs antepartum. In the PETRA study, intrapartum prophylaxis alone,
without infant prophylaxis, was ineffective in reducing perinatal transmission.15 In the NICHD-
HPTN 040/PACTG 1043 randomized clinical trial of ARV prophylactic regimens for infants
born to mothers who had not received antepartum therapy, a majority of the mothers did not
receive intrapartum prophylaxis; however, multi-drug infant prophylaxis alone was effective in
preventing HIV transmission.7

3. Infants Born to Mothers Who Did Not Receive Antepartum or Intrapartum Antiretroviral
Drugs

RECOMMENDATION:
All infants whose mothers did not receive antepartum ART or intrapartum ZDV should be
given ZDV for 6 weeks plus 3 doses of nevirapine in the first week of life (see Table 1). (AI)

The two-drug regimen of 6 weeks of ZDV plus three doses of nevirapine in the first week of life
(see Table 1) is recommended for infants whose mothers did not receive antepartum or
intrapartum ARV drugs based on the results of the randomized controlled clinical trial NICHD-
HPTN 040/PACTG 1043. This trial demonstrated increased efficacy of either two- or three-drug
regimens (2.2% to 2.4% transmission) in reducing intrapartum transmission compared with use
of ZDV alone (4.9%) in infants born to mothers who did not receive antepartum or intrapartum
ARV drugs.7

In NICHD-HPTN 040/PACTG 1043, the 2-drug regimen used was ZDV + nevirapine (Table 1);
the three-drug regimen used was ZDV + lamivudine + nelfinavir.7 Nelfinavir is no longer
available in a pediatric formulation in the United States, and other protease inhibitors have
neonatal toxicities, poor pharmacokinetics, or both, which limits their use in infants. Thus,
nevirapine is currently the only recommended ARV agent to add to the ZDV prophylactic
regimen in the newborn period based on availability of a pediatric formulation and its low
toxicity profile. Use of regimens other than those shown in Table 1 should be considered only in
consultation with a pediatrician with experience in HIV treatment and management.

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In early 2013, a case of a “functional cure” of an HIV-infected infant was reported.16 The infant
was born at 35 weeks’ gestation by vaginal delivery to a woman who received no prenatal care
and was diagnosed with HIV infection by rapid testing during delivery. No intrapartum ARV
prophylaxis could be given. At 30 hours of age, the infant was given ZDV, lamivudine, and
nevirapine (NVP was given at higher therapeutic doses rather than standard prophylactic doses).
Lopinavir-ritonavir was substituted for nevirapine at 7 days of age; this decision preceded
warnings from the FDA against the use of lopinavir-ritonavir in infants younger than 14 days.
Numerous DNA and RNA assays confirmed HIV infection in the infant. Therapy was
discontinued by the mother at 18 months, but when the child returned for care at 2 years of age,
levels of plasma viral RNA and HIV antibodies remained undetectable. Further investigation is
ongoing, and clinical trials are planned to address whether early administration of therapeutic
ART regimens is safe and effective in infants.

This Committee continues to recommend that regimens other than those shown in Table 1 should
only be used in consultation with a pediatrician with experience in HIV treatment and
management. Key issues that warrant caution include 1) the absence of safety data related to the
high therapeutic dosing of nevirapine in infants under 2 weeks of age, and 2) the use of
lopinavir-ritonavir in infants under 2 weeks of age, which is contraindicated due to toxicity.

4. Infants Born to Mothers Who Have Received Antepartum/Intrapartum Antiretroviral Drugs

but Have Suboptimal Viral Suppression Near Delivery

RECOMMENDATION:
Providers should consult with a pediatric provider who has experience with HIV treatment
and management of HIV-exposed infants to determine whether to use the two-drug
regimen of ZDV + NVP (see Table 1) for infants of mothers with suboptimal viral
suppression. (BIII)

The risk of perinatal HIV transmission is higher in infants born to mothers with higher viral load
levels near delivery, particularly with vaginal deliveries.17-19 In the Women and Infants
Transmission Study (WITS), the risk of transmission of HIV was ≤1.8% in women who received
three-drug ART during pregnancy and had HIV RNA levels <30,000 copies/mL at delivery; risk
increased to 4.8% in women with HIV RNA levels ≥30,000 copies/mL.19

No specific data address whether adding an additional agent to the prophylactic regimen
provides additional protection against transmission when maternal antepartum/intrapartum
prophylaxis is received but viral replication near delivery is significant. A two-drug regimen of
ZDV + NVP should be considered in consultation with a pediatric provider who has experience
with HIV treatment and management (see Table 1).7 Initiation of ZDV should not be delayed
while awaiting consultation.

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5. Infants Born to Mothers with Antiretroviral Drug-Resistant Virus

RECOMMENDATION:
Before delivery, clinicians should consult a pediatric provider who has experience with
HIV treatment and management when treating infants born to mothers with known or
suspected drug resistance. (BIII)

The optimal prophylactic regimen for newborns delivered by women with ARV drug-resistant
virus is unknown, and few ARV agents are able to be safely administered to newborns and
infants. ARV prophylaxis for infants born to mothers with known or suspected drug resistance
should be determined before delivery in consultation with an experienced provider in pediatric
HIV infection.

B. Antiretroviral Drug Dosing for Premature Infants

Use of ARV drugs other than ZDV and nevirapine should be avoided in premature infants
(see Table 1). (BIII)

RECOMMENDATIONS:
Clinicians should consult a pediatric provider who has experience with HIV treatment and
management to determine the optimal regimen when the neonate is at high risk for HIV
infection. (BIII)

Clinicians should consult with a pediatric provider who has experience with HIV
treatment and management before administering nevirapine to neonates who are
<1.5 kg or <32 weeks’ estimated gestational age at birth.

Use of ARV agents other than ZDV and nevirapine is not recommended in premature infants
because data on dosing and safety are lacking. However, in situations where there is high risk of
infant HIV infection, consultation with a pediatric provider who has experience with ART is
recommended to determine whether the benefits of an ARV prophylactic regimen other than
ZDV + nevirapine outweigh the potential risks.
ZDV and nevirapine both have prolonged half-lives in premature infants.20-22 Dosing of ZDV for
premature infants is outlined in Table 1. Few data are available to guide dosing of nevirapine in
infants <1.5 kg or <32 weeks’ estimated gestational age at birth.

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II. DIAGNOSTIC TESTING

RECOMMENDATIONS:
New York State Department of Health (NYSDOH) recommends that all NYS birth
facilities and pediatricians caring for HIV-exposed infants use the Pediatric HIV Testing
Services at the Wadsworth Center.

In New York State, HIV qualitative RNA testing (nucleic acid test or NAT) is
recommended for early detection of HIV infection in infants. Testing should be performed
at the following ages: (AII)
• Within 48 hours of birth (BIII)
• At 2 weeks of age (AII)
• At 4 to 6 weeks of age (AII)
• At 4 to 6 months of age (AII)

Positive HIV NAT results at any age should be confirmed by repeat testing as soon as
possible on a new sample. (AII) Two independent positive test results definitively diagnose
pediatric HIV infection in HIV-exposed infants and subsequent testing is not necessary.

Once a positive HIV test result is confirmed, the clinician should:

• Consult a provider with experience in pediatric HIV care (AI)
• Discontinue perinatal prophylactic ZDV, if still being administered (AI)
• Evaluate for initiation of combination ART as soon as possible (AI)

Two negative HIV NAT results, one obtained ≥4 weeks of age and one obtained ≥4 months
of age, definitively exclude pediatric HIV infection in HIV-exposed infants. (AII)

Early diagnosis of HIV infection in infants is important so that treatment with ART may be
initiated as soon as possible. In NYS, HIV qualitative RNA diagnostic testing is recommended
within 48 hours of birth, at age 2 weeks, at age 4 to 6 weeks, and at age 4 to 6 months. The
NYSDOH has a free pediatric HIV diagnostic testing service, including overnight shipping, for
NYS providers caring for HIV-exposed infants. The Pediatric HIV Testing Service uses the only
FDA-approved qualitative RNA test (Aptima) for diagnosing HIV infection. Quantitative RNA
tests (viral load) are not FDA approved for diagnostic purposes.

Providers who have not previously used the Testing Service should contact the Testing Service
to obtain the specimen collection kits and shipping supplies. The provider should set up a
tracking system to ensure that results for all HIV diagnostic testing are obtained promptly. The
Pediatric HIV Testing Service is located within the Bloodborne Viruses Laboratory at
Wadsworth Center. To contact the Pediatric HIV Testing Service, call 518-474-2163 or visit
www.wadsworth.org/divisions/infdis/hiv/pedhivtest.html

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Two negative HIV NAT results, one at >4 weeks of age and a second at >4 months of age,
definitively excludes pediatric HIV infection. The infant may then be treated as a non-HIV-
infected infant.

For more information, see Diagnosis of Pediatric HIV Infection in HIV-Exposed Infants.

III. PNEUMOCYSTIS JIROVECII PNEUMONIA (PCP) PROPHYLAXIS

RECOMMENDATION:
Clinicians should initiate prophylaxis against PCP at 6 weeks of age for all HIV-exposed
infants unless HIV diagnostic testing definitively or presumptively excludes HIV infection
(see Table 3). Prophylaxis should be continued until the diagnosis of HIV infection is
presumptively or definitively excluded (see definitions of exclusion below). (AII)

Early diagnosis and treatment of HIV-infected infants with ART has substantially decreased the
risk of PCP in HIV-infected infants. Nevertheless, PCP continues to be the presenting HIV-
associated infection in many HIV-infected infants.

PCP prophylaxis is recommended at 6 weeks of age for all HIV-exposed infants until diagnostic
testing definitively or presumptively excludes HIV infection.

Definitions of Exclusion of HIV Infection for HIV-Exposed Infants

• Presumptive exclusion: Two negative HIV NAT results, one at ≥2 weeks of age and the
other at >4 weeks of age

• Definitive exclusion: Two negative HIV NAT results, one at >4 weeks of age and a
second at >4 months of age (see Section II. Diagnostic Testing)

PCP prophylaxis may be withheld when HIV infection is either definitively or presumptively
excluded. If the infant is found to be HIV-infected, PCP prophylaxis should be continued, and
the infant should be referred to a pediatric provider with experience in the care of HIV-infected
children.

For more information about PCP prophylaxis, see Guidelines for the Prevention and Treatment
of Opportunistic Infections Among HIV-Exposed and HIV-Infected Children.

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 TABLE 3
PNEUMOCYSTIS JIROVECII PNEUMONIA (PCP) PROPHYLAXIS FOR
HIV-EXPOSED INFANTS*
Preferred Regimen Alternative Regimens
Trimethoprim-sulfamethoxazole (TMP-SMX): If TMP-SMX is not tolerated:
TMP 5mg/kg/day (or 150 mg/m2/day), with
SMX 25 mg/kg/day (or 750 mg/m2/day) PO Dapsone
in 2 equally divided doses twice daily 3x/weekly on 2 mg/kg PO once daily
(Max daily dose: 100 mg)
consecutive days
or
4 mg/kg PO once weekly
(Max daily dose: 200 mg)
Acceptable alternative schedules for TMP-SMX
prophylaxis (using same dose as above): or
Single daily dose PO, 3x/weekly on consecutive days Atovaquone
or Age 6 wks to ≤3 mos:
Equally divided dose, given PO twice daily, 7 days/week 30 mg/kg PO once daily
or (Max daily dose: 1500 mg)
Equally divided dose, given PO twice daily, 3x/weekly on
alternate days Age 4 mos to 1 yr:
45 mg/kg PO once daily
(Max daily dose: 320 mg TMP/1600 mg SMX) (Max daily dose: 1500 mg)
*Age 6 weeks to 1 year without presumptive or definitive exclusion of HIV infection.
Derived from American Academy of Pediatrics. Red Book: 2012 Report of the Committee on Infectious Diseases.
Pickering LK, ed. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

IV. FEEDING HIV-EXPOSED INFANTS

RECOMMENDATIONS:
In New York State, breastfeeding by HIV-infected women is contraindicated, even when
the mother is receiving combination ART. (AI)

Clinicians should strongly advise breastfeeding mothers with newly suspected or diagnosed
HIV infection to discontinue breastfeeding immediately. Clinicians should consult with a
pediatric provider who has experience with HIV treatment and management to determine
whether prophylaxis should be given to the infant.

Clinicians should advise HIV-infected women to avoid premasticating food for infants.
(AII)

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HIV can be transmitted through breastfeeding. Infants whose mothers are HIV-infected, or
whose HIV status is undetermined, should not be breastfed.23 The risk of HIV transmission
depends on multiple infant and maternal factors, including maternal viral load and CD4 cell
count.24 In the United States, where adequate formula preparations are readily available, HIV-
exposed infants should not be breastfed.

When HIV infection has not been definitively excluded in the mother, pumping and discarding
breast milk may be considered while awaiting results from confirmatory diagnostic testing. If
HIV infection is definitively excluded, the mother may then initiate breastfeeding.

Studies have reported pediatric HIV transmission attributed to premasticating food for
children.25,26 HIV-infected mothers and mothers whose HIV infection status is not known should
be advised against premasticating food for infants.

V. IMMUNIZATIONS

RECOMMENDATION:
Clinicians should follow the Centers for Disease Control and Prevention (CDC)
recommended immunization schedules for HIV-exposed and HIV-infected infants.

During the first months of life, HIV-exposed infants should follow the same routine
immunization schedule recommended for infants who were not exposed to HIV. For infants who
test positive for HIV infection, modifications regarding live vaccines may be necessary.

VI. FREQUENCY OF VISITS AND LONG-TERM FOLLOW-UP

RECOMMENDATIONS:
All HIV-exposed infants should receive care from, or in consultation with, a pediatrician
experienced with HIV treatment and management by at least 2 weeks of age, and again at
1 month, 2 months, 4 months, and 6 months.

Clinicians should evaluate for potential mitochondrial dysfunction in ARV-exposed

children who develop significant organ system abnormalities. (BIII)

Clinicians should:
• Document in utero exposure to ARV drugs in the patient’s permanent medical
record (AIII)
• Report cases of prenatal exposure to ARV drugs to the Antiretroviral Pregnancy
Registry

HIV-exposed infants should receive care from, or in consultation with, a pediatrician

experienced with HIV treatment and management by at least 2 weeks of age, and again at
1 month, 2 months, 4 months, and 6 months. These visits will coincide with HIV diagnostic
testing recommendations.

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ARV drugs have not been determined to be carcinogenic or mutagenic in humans; however, that
possibility cannot be excluded until long-term studies of in utero ART-exposed children are
completed. Follow-up data from PACTG 076 showed no long-term changes in growth,
development, or risk of malignancies in children through 5.6 years of age who received the ZDV
regimen.27 In utero exposure to ARV drugs should be documented in the child’s permanent
medical record, and follow-up should continue into adulthood.

The Antiretroviral Pregnancy Registry is a voluntary reporting system that collects data about
infants exposed to ART medications in utero. The data are analyzed on a regular basis by an
advisory committee of pediatricians and obstetricians to look for an increased incidence of
congenital defects, malignancies, death, or other untoward effects in children exposed to ART
medications. For more information, see the Antiretroviral Pregnancy Registry.28

01/14 New York State Department of Health AIDS Institute: www.hivguidelines.org 13

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