Risk of vertical transmission | Prophylactic regimen | ||
Newborns at low risk | |||
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Newborns at high risk | |||
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Drug | Gestational age at birth | Dosing§ | |
Zidovudine (ZDV)¥ | ≥35 weeks |
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Weight band (kg) | Volume (mL) 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 |
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<30 weeks |
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Abacavir (ABC)† | ≥37 weeks |
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Lamivudine (3TC) | ≥32 weeks |
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Nevirapine (NVP)** | ≥37 weeks |
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≥34 to <37 weeks |
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≥32 to <34 weeksΔΔ |
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Raltegravir (RAL)◊◊ | ≥37 weeks and weighing ≥2 kg | Body weight (kg) | Volume (dose) of RAL 10 mg/mL suspension |
Birth to 1 week: Once-daily dosing, approximately 1.5 mg/kg/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/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/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 |
ART: antiretroviral therapy; NAAT: nucleic acid amplification test; IV: intravenous; BSA: body surface area; FDA: US Food and Drug Administration; UGT1A1: uridine diphosphate glucotransferase.
* The optimal duration of empiric HIV therapy in newborns at high risk of vertical HIV transmission is unknown. We favor a three-drug regimen for 6 weeks. An alternative approach to using a three-drug regimen for the full duration, particularly if there are side effects or complications, is to discontinue the 3TC and NVP or RAL components at 2 weeks if the HIV NAAT at birth was negative and continue ZDV alone for the full 6 weeks. In highly select cases, a two-drug regimen might be appropriate. Consultation with an expert in pediatric HIV for regimen selection is recommended.
¶ Raltegravir (instead of nevirapine) should be used in infants at risk of HIV-2 infection.
Δ Primary HIV infection refers to the first 6 months of infection.
◊ Breastfeeding is not recommended for mothers with HIV in resource-rich settings. This statement only applies to individuals who are diagnosed with HIV while breastfeeding.
§ These doses are only for the prophylaxis regimens in infants without confirmed HIV infection. Continuation of ART with potential regimen and/or dose adjustments is warranted for infants who are diagnosed with HIV infection.
¥ For newborns who are unable to tolerate oral agents, the IV dose is 75% of the oral dose while maintaining the same dosing interval.
‡ Previous recommendations were to increase the ZDV dose to 12 mg/kg after 4 weeks of age, but this is no longer recommended for infants without confirmed HIV infection.
† ABC is not approved by FDA for use in infants aged <3 months. Dosing recommendations have been modeled using pharmacokinetic simulation. Prior to using abacavir, negative testing for HLA-B5701 allele should be confirmed.
** Investigational NVP treatment dose recommended by the United States Department of Health and Human Services; the FDA has not approved a dose of NVP for infants <1 month of age.
¶¶ Previous recommendations were to increase the NVP dose to 200 mg/m2 BSA per dose orally twice daily after 4 weeks of age, but this is no longer recommended for infants without confirmed HIV infection.
ΔΔ These doses may underestimate potential toxicity in infants in this age group as the doses are based on modeling and lower doses were used to develop the model than what is now recommended.
◊◊ If the mother has taken RAL 2 to 24 hours prior to delivery, the neonate's first dose of RAL should be delayed until 24 to 48 hours after birth; ZDV and 3TC, however, should be started as soon as possible after birth. 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 to 6 weeks of life. No dosing information is available for preterm or infants weighing <2 kg at birth.