Management of Infants Born to Women with HIV Infection

Antiretroviral Management of Newborns with Perinatal HIV Exposure or HIV Infection

Panel's Recommendations for Antiretroviral Management of Newborns with Perinatal HIV Exposure or HIV Infection
Panel's Recommendations
  • All newborns who were perinatally exposed to HIV should receive postpartum antiretroviral (ARV) drugs to reduce the risk of perinatal transmission of HIV (AI).
  • Newborn ARV regimens administered at doses that are appropriate for the infant’s gestational age should be initiated as close to the time of birth as possible, preferably within 6 to 12 hours of delivery (AII).
  • A newborn’s ARV regimen should be determined based on maternal and infant factors that influence the risk of perinatal transmission of HIV (AII). The uses of ARV regimens in newborns include:
    • ARV Prophylaxis: The administration of one or more ARV drugs to a newborn without documented HIV infection to reduce the risk of perinatal acquisition of HIV.
    • Presumptive HIV Therapy: The administration of a three-drug ARV regimen to newborns who are at highest risk of perinatal acquisition of HIV. Presumptive HIV therapy is intended to be preliminary treatment for a newborn who is later documented to have HIV, but it also serves as prophylaxis against HIV acquisition for those newborns who are exposed to HIV in utero, during the birthing process, or during breastfeeding and who do not acquire HIV.
    • HIV Therapy: The administration of a three-drug ARV regimen at treatment doses (called antiretroviral therapy [ART]) to newborns with documented HIV infection (see Diagnosis of HIV Infection in Infants and Children).
  • A 4-week zidovudine (ZDV) ARV prophylaxis regimen can be used in newborns whose mothers received ART during pregnancy and had sustained viral suppression near delivery (defined as a confirmed HIV RNA level <50 copies/mL) and for whom there are no concerns related to maternal adherence (BII).
  • Newborns at higher risk of perinatal acquisition of HIV should initiate presumptive HIV therapy (see Table 7 for recommended regimens). Newborns at higher risk of HIV acquisition include those born to women with HIV who:
    • Have not received antepartum or intrapartum ARV drugs (AI), or
    • Have received only intrapartum ARV drugs (AI), or
    • Have received antepartum ARV drugs but who did not achieve viral suppression near delivery (AII), or
    • Have primary or acute HIV infection during pregnancy (AII), or
    • Have primary or acute HIV infection while breastfeeding (AII).
  • Newborns of women with unknown HIV statuses who test HIV positive on expedited testing during labor or shortly after birth should initiate an ARV regimen (either presumptive HIV therapy or two-drug ARV prophylaxis, based on clinician assessment of risk) (AII). If supplemental testing is negative, the ARV regimen should be discontinued (AII).
  • For newborns with HIV infection, ART should be initiated (AI).
  • The use of ARV drugs other than ZDV, lamivudine, and nevirapine cannot be recommended for any indication in premature newborns (<37 weeks gestational age) because of lack of dosing and safety data (BII).
  • Providers with questions about ARV management of perinatal HIV exposure should consult the National Perinatal HIV Hotline (1-888-448-8765), which provides free clinical consultation on all aspects of perinatal HIV, including newborn care (AIII).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II = One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion

Table 6. Neonatal Antiretroviral Management According to Risk of HIV Infection in the Newborn

Drug selection and dosing considerations are related to the age and gestational age of the newborn. Consultation is available through the National Perinatal HIV Hotline (1-888-448-8765).

Table 6. Neonatal Antiretroviral Management According to Risk of HIV Infection in the Newborn
Level of Perinatal HIV Transmission Risk Description Neonatal ARV Management
Low Risk of Perinatal HIV Transmission

Mothers who received ART during pregnancy with sustained viral suppression (defined as a confirmed HIV RNA level <50 copies/mL) near delivery and no concerns related to adherence

ZDV for 4 weeks
Higher Risk of Perinatal HIV Transmissiona,b

Mothers who received neither antepartum nor intrapartum ARV drugs

Mothers who received only intrapartum ARV drugs

Mothers who received antepartum and intrapartum ARV drugs but who have detectable viral loads near delivery, particularly when delivery was vaginal

Mothers with acute or primary HIV infection during pregnancy or breastfeeding (in which case, the mother should discontinue breastfeeding).c

Presumptive HIV therapy using either ZDV, 3TC, and NVP (treatment dose) or ZDV, 3TC, and RAL administered from birth up to 6 weeks.d
 
Presumed Newborn HIV Exposure

Mothers with unconfirmed HIV status who have at least one positive HIV test at delivery or postpartum

or

Whose newborns have a positive HIV antibody test

ARV management as described above for newborns with a higher risk of perinatal HIV transmission

Infant ARV drugs should be discontinued immediately if supplemental testing confirms that the mother does not have HIV
Newborn with HIVe

Positive newborn HIV virologic test/NAT

Three-drug ARV regimen using treatment doses
a See text for evidence that supports the use of presumptive HIV therapy and a two-drug ARV prophylaxis regimen.
b See Intrapartum Care for guidance on indications for scheduled cesarean delivery and intrapartum IV ZDV to reduce the risk of perinatal HIV transmission for mothers with an elevated viral load at delivery.
c Most Panel members would opt to administer empiric HIV therapy to infants whose mothers had acute HIV during pregnancy because of the higher risk for in utero transmission. If acute HIV is diagnosed during breastfeeding, the mother should stop breastfeeding.
d The optimal duration of presumptive HIV therapy in newborns who are at a higher risk of perinatal HIV transmission is unknown. If possible, newborns who are at a higher risk of HIV acquisition should receive ZDV for 6 weeks. Additional medications, such as 3TC, RAL, or NVP, may need to administered for 2 to 6 weeks; the recommended durations for these drugs vary based on HIV NAT results, maternal viral load at the time of delivery, and additional risk factors for HIV transmission. Consultation with an expert in pediatric HIV is recommended when selecting a therapy duration, as this decision should be based on case-specific risk factors and interim HIV NAT results. The two-drug regimen used in NICHD-HPTN 040/PACTG 1043 for infants who were at a higher risk of HIV acquisition is described in the text (see the Two-Drug Antiretroviral Prophylaxis section).
e Most Panel members do not recommend delaying the initiation of ART pending results of the confirmatory HIV NAT, given the low likelihood of a false-positive HIV NAT.

Note: ARV drugs should be initiated as close to the time of birth as possible, preferably within 6 to 12 hours of delivery. See Table 7 for dosing specifics.

Key: 3TC = lamivudine; ART = antiretroviral therapy; ARV = antiretroviral; IV = intravenous; NAT = nucleic acid test; NVP = nevirapine; the Panel = the Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV; RAL = raltegravir; ZDV = zidovudine

 

Table 7. Antiretroviral Dosing Recommendations for Newborns
Newborns at Low Risk of Perinatal HIV Transmission
Recommended Regimen Recommended Duration

ZDV

ZDV administered for 4 weeks at the doses listed below

Newborns at Higher Risk of Perinatal HIV Transmission
Recommended Regimen Recommended Duration

Three-drug HIV therapy: ZDV plus 3TC plus (NVP or RAL)

ZDV administered for 6 weeks, with no increase to the 12 mg/kg dose unless the infant has confirmed HIV infection. Dosing for 3TC, NVP, and RAL is described below. Duration for these three drugs may vary; see the guidance in footnote.a

Newborns with HIV Infection
Recommended Regimen Lifelong Duration Recommendedb

Three-drug HIV therapy: ZDV plus 3TC plus (NVP or RAL)

Lifelong therapy in accordance with current treatment guidelines. The ARV regimen should be individualized based on the infant’s age and clinical determinants. NVP can be replaced with LPV/r when the infant reaches a postmenstrual age of ≥42 weeks (defined as the time from the first day of the mother’s last menstrual period to birth plus the time elapsed after birth) and a postnatal age ≥14 days. NVP can be replaced with RAL at any age in infants who were born at a postmenstrual age of ≥37 weeks and who weigh ≥2 kg.

 

Drug Drug Doses by Gestational Age at Birth
ZDV

Note: For newborns who are unable to tolerate oral agents, the IV dose is 75% of the oral dose while maintaining the same dosing interval.
≥35 Weeks Gestation at Birth
Birth to Age 4 Weeks:
  • ZDV 4 mg/kg per dose orally twice daily
Age >4 Weeks:
  • ZDV 12 mg/kg per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
Simplified Weight-Band Dosing for Newborns Aged ≥35 Weeks Gestation from Birth to 4 Weeks
Weight Band Volume of ZDV 10 mg/mL Oral Syrup Twice Daily
2 to <3 kg 1 mL
3 to <4 kg 1.5 mL
4 to <5 kg 2 mL
≥30 to <35 Weeks Gestation at Birth
Birth to Age 2 Weeks:
  • ZDV 2 mg/kg per dose orally twice daily
Age 2 Weeks to 6–8 Weeks:
  • ZDV 3 mg/kg per dose orally twice daily
Age >6 to 8 Weeks:
  • ZDV 12 mg/kg per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
<30 Weeks Gestation at Birth
Birth to Age 4 Weeks:
  • ZDV 2 mg/kg per dose orally twice daily
Age 4 to 8–10 Weeks:
  • ZDV 3 mg/kg per dose orally twice daily
Aged >8 to 10 Weeks:
  • ZDV 12 mg/kg per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
3TC ≥32 Weeks Gestation at Birth
Birth to Age 4 Weeks:
  • 3TC 2 mg/kg per dose orally twice daily
Age >4 Weeks:
  • 3TC 4 mg/kg per dose orally twice daily
 NVP  ≥37 Weeks Gestation at Birth 
Birth to Age 4 Weeks:
  • NVP 6 mg/kg per dose orally twice dailyc
Age >4 Weeks:
  • NVP 200 mg/m2 of BSA per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
34 to <37 Weeks Gestation at Birth
Birth to Age 1 Week:
  • NVP 4 mg/kg per dose orally twice daily
Age 1 to 4 Weeks:
  • NVP 6 mg/kg per dose orally twice daily
Age >4 Weeks:
  • NVP 200 mg/m2 of BSA per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
RAL

Note: If the mother has taken RAL 2–24 hours prior to delivery, the neonate’s first dose of RAL should be delayed until 24–48 hours after birth; additional ARV drugs should be started as soon as possible.7
≥37 Weeks Gestation at Birth and Weighing ≥2 kgd
Birth to Age 6 Weeks:
Body Weight  Volume (Dose) of RAL 10 mg/mL Suspension
Birth to 1 Week: Once Daily Dosing Approximately 1.5 mg/kg per dose
2 to <3 kg 0.4 mL (4 mg) once daily
3 to <4 kg 0.5 mL (5 mg) once daily
4 to <5 kg 0.7 mL (7 mg) once daily
1 to 4 Weeks: Twice Daily Dosing Approximately 3 mg/kg per dose
2 to <3 kg 0.8 mL (8 mg) twice daily
3 to <4 kg 1 mL (10 mg) twice daily
4 to <5 kg 1.5 mL (15 mg) twice daily
4 to 6 Weeks: Twice Daily Dosing Approximately 6 mg/kg per dose
3 to <4 kg 2.5 mL (25 mg) twice daily
4 to <6 kg 3 mL (30 mg) twice daily
6 to <8 kg 4 mL (40 mg) twice daily
a The optimal duration of presumptive HIV therapy in newborns who are at a higher risk of perinatal HIV transmission is unknown. If possible, newborns who are at a higher risk of HIV acquisition should receive ZDV for 6 weeks. Additional medications, such as 3TC, RAL, or NVP, may need to administered for 2 to 6 weeks; the recommended durations for these drugs vary based on HIV NAT results, maternal viral load at the time of delivery, and additional risk factors for HIV transmission. Consultation with an expert in pediatric HIV is recommended when selecting a therapy duration, as this decision should be based on case-specific risk factors and interim HIV NAT results. The two-drug regimen used in NICHD-HPTN 040/PACTG 1043 for infants who were at a higher risk of HIV acquisition is described in the text (see the Two-Drug Antiretroviral Prophylaxis section).
b For ARV management after the newborn period, see the Pediatric Antiretroviral Guidelines.
c This dose is an investigational NVP treatment dose recommended by the Panel; the FDA has not approved a dose of NVP for infants aged <1 month. See the Two-Drug Antiretroviral Prophylaxis section for prophylactic NVP dosing if using the NICHD-HPTN 040/PACTG 1043 prophylaxis regimen.
d RAL dosing is increased at 1 and 4 weeks of age because metabolism by UGT1A1 is low at birth and increases rapidly during the next 4–6 weeks of life. No dosing information is available for preterm infants or infants weighing <2 kg at birth.

Key: 3TC = lamivudine; ARV =antiretroviral; BSA = body surface area; FDA = Food and Drug Administration; IV = intravenous; LPV/r = lopinavir/ritonavir; NAT = nucleic acid test; NVP = nevirapine; the Panel = the Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission; RAL = raltegravir; UGT = uridine diphosphate glucotransferase; ZDV = zidovudine

Management of Infants Born to Women with HIV Infection

Antiretroviral Management of Newborns with Perinatal HIV Exposure or HIV Infection

Panel's Recommendations for Antiretroviral Management of Newborns with Perinatal HIV Exposure or HIV Infection
Panel's Recommendations
  • All newborns who were perinatally exposed to HIV should receive postpartum antiretroviral (ARV) drugs to reduce the risk of perinatal transmission of HIV (AI).
  • Newborn ARV regimens administered at doses that are appropriate for the infant’s gestational age should be initiated as close to the time of birth as possible, preferably within 6 to 12 hours of delivery (AII).
  • A newborn’s ARV regimen should be determined based on maternal and infant factors that influence the risk of perinatal transmission of HIV (AII). The uses of ARV regimens in newborns include:
    • ARV Prophylaxis: The administration of one or more ARV drugs to a newborn without documented HIV infection to reduce the risk of perinatal acquisition of HIV.
    • Presumptive HIV Therapy: The administration of a three-drug ARV regimen to newborns who are at highest risk of perinatal acquisition of HIV. Presumptive HIV therapy is intended to be preliminary treatment for a newborn who is later documented to have HIV, but it also serves as prophylaxis against HIV acquisition for those newborns who are exposed to HIV in utero, during the birthing process, or during breastfeeding and who do not acquire HIV.
    • HIV Therapy: The administration of a three-drug ARV regimen at treatment doses (called antiretroviral therapy [ART]) to newborns with documented HIV infection (see Diagnosis of HIV Infection in Infants and Children).
  • A 4-week zidovudine (ZDV) ARV prophylaxis regimen can be used in newborns whose mothers received ART during pregnancy and had sustained viral suppression near delivery (defined as a confirmed HIV RNA level <50 copies/mL) and for whom there are no concerns related to maternal adherence (BII).
  • Newborns at higher risk of perinatal acquisition of HIV should initiate presumptive HIV therapy (see Table 7 for recommended regimens). Newborns at higher risk of HIV acquisition include those born to women with HIV who:
    • Have not received antepartum or intrapartum ARV drugs (AI), or
    • Have received only intrapartum ARV drugs (AI), or
    • Have received antepartum ARV drugs but who did not achieve viral suppression near delivery (AII), or
    • Have primary or acute HIV infection during pregnancy (AII), or
    • Have primary or acute HIV infection while breastfeeding (AII).
  • Newborns of women with unknown HIV statuses who test HIV positive on expedited testing during labor or shortly after birth should initiate an ARV regimen (either presumptive HIV therapy or two-drug ARV prophylaxis, based on clinician assessment of risk) (AII). If supplemental testing is negative, the ARV regimen should be discontinued (AII).
  • For newborns with HIV infection, ART should be initiated (AI).
  • The use of ARV drugs other than ZDV, lamivudine, and nevirapine cannot be recommended for any indication in premature newborns (<37 weeks gestational age) because of lack of dosing and safety data (BII).
  • Providers with questions about ARV management of perinatal HIV exposure should consult the National Perinatal HIV Hotline (1-888-448-8765), which provides free clinical consultation on all aspects of perinatal HIV, including newborn care (AIII).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II = One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion

Table 6. Neonatal Antiretroviral Management According to Risk of HIV Infection in the Newborn

Drug selection and dosing considerations are related to the age and gestational age of the newborn. Consultation is available through the National Perinatal HIV Hotline (1-888-448-8765).

Table 6. Neonatal Antiretroviral Management According to Risk of HIV Infection in the Newborn
Level of Perinatal HIV Transmission Risk Description Neonatal ARV Management
Low Risk of Perinatal HIV Transmission

Mothers who received ART during pregnancy with sustained viral suppression (defined as a confirmed HIV RNA level <50 copies/mL) near delivery and no concerns related to adherence

ZDV for 4 weeks
Higher Risk of Perinatal HIV Transmissiona,b

Mothers who received neither antepartum nor intrapartum ARV drugs

Mothers who received only intrapartum ARV drugs

Mothers who received antepartum and intrapartum ARV drugs but who have detectable viral loads near delivery, particularly when delivery was vaginal

Mothers with acute or primary HIV infection during pregnancy or breastfeeding (in which case, the mother should discontinue breastfeeding).c

Presumptive HIV therapy using either ZDV, 3TC, and NVP (treatment dose) or ZDV, 3TC, and RAL administered from birth up to 6 weeks.d
 
Presumed Newborn HIV Exposure

Mothers with unconfirmed HIV status who have at least one positive HIV test at delivery or postpartum

or

Whose newborns have a positive HIV antibody test

ARV management as described above for newborns with a higher risk of perinatal HIV transmission

Infant ARV drugs should be discontinued immediately if supplemental testing confirms that the mother does not have HIV
Newborn with HIVe

Positive newborn HIV virologic test/NAT

Three-drug ARV regimen using treatment doses
a See text for evidence that supports the use of presumptive HIV therapy and a two-drug ARV prophylaxis regimen.
b See Intrapartum Care for guidance on indications for scheduled cesarean delivery and intrapartum IV ZDV to reduce the risk of perinatal HIV transmission for mothers with an elevated viral load at delivery.
c Most Panel members would opt to administer empiric HIV therapy to infants whose mothers had acute HIV during pregnancy because of the higher risk for in utero transmission. If acute HIV is diagnosed during breastfeeding, the mother should stop breastfeeding.
d The optimal duration of presumptive HIV therapy in newborns who are at a higher risk of perinatal HIV transmission is unknown. If possible, newborns who are at a higher risk of HIV acquisition should receive ZDV for 6 weeks. Additional medications, such as 3TC, RAL, or NVP, may need to administered for 2 to 6 weeks; the recommended durations for these drugs vary based on HIV NAT results, maternal viral load at the time of delivery, and additional risk factors for HIV transmission. Consultation with an expert in pediatric HIV is recommended when selecting a therapy duration, as this decision should be based on case-specific risk factors and interim HIV NAT results. The two-drug regimen used in NICHD-HPTN 040/PACTG 1043 for infants who were at a higher risk of HIV acquisition is described in the text (see the Two-Drug Antiretroviral Prophylaxis section).
e Most Panel members do not recommend delaying the initiation of ART pending results of the confirmatory HIV NAT, given the low likelihood of a false-positive HIV NAT.

Note: ARV drugs should be initiated as close to the time of birth as possible, preferably within 6 to 12 hours of delivery. See Table 7 for dosing specifics.

Key: 3TC = lamivudine; ART = antiretroviral therapy; ARV = antiretroviral; IV = intravenous; NAT = nucleic acid test; NVP = nevirapine; the Panel = the Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV; RAL = raltegravir; ZDV = zidovudine

 

Table 7. Antiretroviral Dosing Recommendations for Newborns
Newborns at Low Risk of Perinatal HIV Transmission
Recommended Regimen Recommended Duration

ZDV

ZDV administered for 4 weeks at the doses listed below

Newborns at Higher Risk of Perinatal HIV Transmission
Recommended Regimen Recommended Duration

Three-drug HIV therapy: ZDV plus 3TC plus (NVP or RAL)

ZDV administered for 6 weeks, with no increase to the 12 mg/kg dose unless the infant has confirmed HIV infection. Dosing for 3TC, NVP, and RAL is described below. Duration for these three drugs may vary; see the guidance in footnote.a

Newborns with HIV Infection
Recommended Regimen Lifelong Duration Recommendedb

Three-drug HIV therapy: ZDV plus 3TC plus (NVP or RAL)

Lifelong therapy in accordance with current treatment guidelines. The ARV regimen should be individualized based on the infant’s age and clinical determinants. NVP can be replaced with LPV/r when the infant reaches a postmenstrual age of ≥42 weeks (defined as the time from the first day of the mother’s last menstrual period to birth plus the time elapsed after birth) and a postnatal age ≥14 days. NVP can be replaced with RAL at any age in infants who were born at a postmenstrual age of ≥37 weeks and who weigh ≥2 kg.

 

Drug Drug Doses by Gestational Age at Birth
ZDV

Note: For newborns who are unable to tolerate oral agents, the IV dose is 75% of the oral dose while maintaining the same dosing interval.
≥35 Weeks Gestation at Birth
Birth to Age 4 Weeks:
  • ZDV 4 mg/kg per dose orally twice daily
Age >4 Weeks:
  • ZDV 12 mg/kg per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
Simplified Weight-Band Dosing for Newborns Aged ≥35 Weeks Gestation from Birth to 4 Weeks
Weight Band Volume of ZDV 10 mg/mL Oral Syrup Twice Daily
2 to <3 kg 1 mL
3 to <4 kg 1.5 mL
4 to <5 kg 2 mL
≥30 to <35 Weeks Gestation at Birth
Birth to Age 2 Weeks:
  • ZDV 2 mg/kg per dose orally twice daily
Age 2 Weeks to 6–8 Weeks:
  • ZDV 3 mg/kg per dose orally twice daily
Age >6 to 8 Weeks:
  • ZDV 12 mg/kg per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
<30 Weeks Gestation at Birth
Birth to Age 4 Weeks:
  • ZDV 2 mg/kg per dose orally twice daily
Age 4 to 8–10 Weeks:
  • ZDV 3 mg/kg per dose orally twice daily
Aged >8 to 10 Weeks:
  • ZDV 12 mg/kg per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
3TC ≥32 Weeks Gestation at Birth
Birth to Age 4 Weeks:
  • 3TC 2 mg/kg per dose orally twice daily
Age >4 Weeks:
  • 3TC 4 mg/kg per dose orally twice daily
 NVP  ≥37 Weeks Gestation at Birth 
Birth to Age 4 Weeks:
  • NVP 6 mg/kg per dose orally twice dailyc
Age >4 Weeks:
  • NVP 200 mg/m2 of BSA per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
34 to <37 Weeks Gestation at Birth
Birth to Age 1 Week:
  • NVP 4 mg/kg per dose orally twice daily
Age 1 to 4 Weeks:
  • NVP 6 mg/kg per dose orally twice daily
Age >4 Weeks:
  • NVP 200 mg/m2 of BSA per dose orally twice daily; only make this dose increase for infants with confirmed HIV infection.
RAL

Note: If the mother has taken RAL 2–24 hours prior to delivery, the neonate’s first dose of RAL should be delayed until 24–48 hours after birth; additional ARV drugs should be started as soon as possible.7
≥37 Weeks Gestation at Birth and Weighing ≥2 kgd
Birth to Age 6 Weeks:
Body Weight  Volume (Dose) of RAL 10 mg/mL Suspension
Birth to 1 Week: Once Daily Dosing Approximately 1.5 mg/kg per dose
2 to <3 kg 0.4 mL (4 mg) once daily
3 to <4 kg 0.5 mL (5 mg) once daily
4 to <5 kg 0.7 mL (7 mg) once daily
1 to 4 Weeks: Twice Daily Dosing Approximately 3 mg/kg per dose
2 to <3 kg 0.8 mL (8 mg) twice daily
3 to <4 kg 1 mL (10 mg) twice daily
4 to <5 kg 1.5 mL (15 mg) twice daily
4 to 6 Weeks: Twice Daily Dosing Approximately 6 mg/kg per dose
3 to <4 kg 2.5 mL (25 mg) twice daily
4 to <6 kg 3 mL (30 mg) twice daily
6 to <8 kg 4 mL (40 mg) twice daily
a The optimal duration of presumptive HIV therapy in newborns who are at a higher risk of perinatal HIV transmission is unknown. If possible, newborns who are at a higher risk of HIV acquisition should receive ZDV for 6 weeks. Additional medications, such as 3TC, RAL, or NVP, may need to administered for 2 to 6 weeks; the recommended durations for these drugs vary based on HIV NAT results, maternal viral load at the time of delivery, and additional risk factors for HIV transmission. Consultation with an expert in pediatric HIV is recommended when selecting a therapy duration, as this decision should be based on case-specific risk factors and interim HIV NAT results. The two-drug regimen used in NICHD-HPTN 040/PACTG 1043 for infants who were at a higher risk of HIV acquisition is described in the text (see the Two-Drug Antiretroviral Prophylaxis section).
b For ARV management after the newborn period, see the Pediatric Antiretroviral Guidelines.
c This dose is an investigational NVP treatment dose recommended by the Panel; the FDA has not approved a dose of NVP for infants aged <1 month. See the Two-Drug Antiretroviral Prophylaxis section for prophylactic NVP dosing if using the NICHD-HPTN 040/PACTG 1043 prophylaxis regimen.
d RAL dosing is increased at 1 and 4 weeks of age because metabolism by UGT1A1 is low at birth and increases rapidly during the next 4–6 weeks of life. No dosing information is available for preterm infants or infants weighing <2 kg at birth.

Key: 3TC = lamivudine; ARV =antiretroviral; BSA = body surface area; FDA = Food and Drug Administration; IV = intravenous; LPV/r = lopinavir/ritonavir; NAT = nucleic acid test; NVP = nevirapine; the Panel = the Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission; RAL = raltegravir; UGT = uridine diphosphate glucotransferase; ZDV = zidovudine
Updated
Reviewed
Apr. 14, 2020

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