August 2025
INTRODUCTION —
Advances in the potency and tolerability of antiretroviral (ARV) drugs have resulted in high rates of viral suppression in pregnant women living with human immunodeficiency virus (HIV) and considerable progress towards the elimination of new infections in infants. In addition to maternal antiretroviral therapy (ART), the use of ARVs as prophylaxis in infants with exposure to HIV continues to play a key role in preventing new infections.
We recognize that not all pregnant, postpartum, and lactating individuals identify as women or mothers. The topics discussed here are based on risks driven by pregnancy and transmission of infection to the fetus/infant and apply regardless of the pregnant person's gender identity. We use the term "woman" to signify the pregnant person or someone who may become pregnant and the term "mother" to signify the birthing biological parent of a child (regardless of gender identity and/or parental rights).
This topic will review the management of infants born to women with HIV, including the use of ARV drugs as prophylaxis and additional screening. Management of this patient population in resource-limited settings is discussed separately. (See "Prevention of vertical HIV transmission in resource-limited settings", section on 'Infant postnatal prophylaxis' and "Prevention of HIV transmission during breastfeeding in resource-limited settings", section on 'Infant antiretroviral use'.)
Approach to the diagnosis of HIV in infants and children younger than 18 months is discussed separately as well. (See "Pediatric HIV infection: Diagnostic testing in children younger than 18 months".)
Management of the mother during pregnancy, labor, and postpartum is discussed in the following topics:
●Resource-abundant settings:
•(See "Prenatal evaluation of women with HIV in resource-abundant settings".)
•(See "Intrapartum and postpartum management of pregnant women with HIV in resource-abundant settings".)
●Resource-limited settings:
•(See "Prevention of vertical HIV transmission in resource-limited settings".)
•(See "Prevention of HIV transmission during breastfeeding in resource-limited settings".)
GENERAL PRINCIPLES
Risk of perinatal HIV acquisition — Infants can acquire HIV from exposure in utero, during delivery, or during breastfeeding [1]. The risk of HIV acquisition from exposure is driven by whether or not the mother is receiving antiretroviral therapy (ART) and the level of maternal viremia [2-4]. (See "Prevention of vertical HIV transmission in resource-limited settings", section on 'Epidemiology' and "Prevention of HIV transmission during breastfeeding in resource-limited settings", section on 'Epidemiology of HIV transmission through breastfeeding'.)
Prompt initiation of prophylaxis for HIV-exposed infants — We administer antiretroviral (ARV) prophylaxis to all infants born to women with HIV to decrease the risk of HIV acquisition. Infant ARV prophylaxis should be initiated as soon as possible after birth, ideally within the first 6 to 12 hours of delivery [5,6]. Blood for HIV testing should be drawn before or immediately after initiating ARV drugs. An exception is infants at very low risk of acquiring HIV who are not being breastfed, for whom initial testing can be delayed until two weeks of life. (See "Pediatric HIV infection: Diagnostic testing in children younger than 18 months", section on 'Approach to perinatal HIV diagnosis'.)
APPROACH TO ARV DRUG MANAGEMENT —
The choice and duration of antiretroviral (ARV) prophylaxis in HIV-exposed infants are based on the timing and level of HIV viremia in the mother and choice of infant feeding modality (table 1 and algorithm 1).
Clinicians managing these patients should also consider consulting a pediatric HIV expert, the United States National Institutes of Health (NIH) Department of Health and Human Services (DHHS) guidelines, or the Perinatal HIV/acquired immunodeficiency syndrome (AIDS) consultation line (1-888-448-8765) at the University of California, San Francisco National Clinician Consultation Center for additional guidance.
Infant prophylaxis regimens in resource-limited settings are discussed separately. (See "Prevention of vertical HIV transmission in resource-limited settings", section on 'Infant postnatal prophylaxis' and "Prevention of HIV transmission during breastfeeding in resource-limited settings", section on 'Infant antiretroviral use'.)
Initial ARV prophylaxis for all HIV-exposed infants
Infants born to mothers with sustained viral suppression since 20 weeks gestation — Infants born to mothers with sustained viral suppression since 20 weeks gestation are at very low risk of acquiring HIV during birth.
●Clinical approach – For infants born to women who have maintained a viral load <50 copies/mL on antiretroviral therapy (ART) from 20 weeks gestation through delivery, we suggest two weeks of infant prophylaxis with zidovudine (ZDV; twice daily) (table 1 and algorithm 1 and table 2) [5]. Ideally, the assessment of viral control during pregnancy should be based on documented HIV ribonucleic acid (RNA) levels; however, when HIV RNA results are unavailable, the risk of undocumented viremia can be assessed clinically, using reported ART adherence and HIV RNA levels from prior to the pregnancy. This suggestion is in line with the recommendations outlined in the United States DHHS perinatal HIV guidelines. There is some variability in guidance from other countries; most recommend two to four weeks of ZDV, although a small number of national guidelines support giving no prophylaxis in low-risk scenarios [7].
Use of ZDV prophylaxis in the first weeks of life in neonates is generally considered safe and does not require laboratory monitoring [5].
With highly sensitive HIV RNA assays, some women may have detectable and/or quantifiable viral loads of <50 copies/mL during pregnancy. While these low levels could prompt more frequent monitoring, most experts do not believe these levels confer increased HIV transmission risk that would merit additional prophylaxis for the infant.
●Rationale
•Risk of vertical transmission in this patient group – The risk of perinatal HIV transmission in the setting of sustained maternal viral suppression during pregnancy is very low [8,9]. In a nationwide, prospective, multicenter French cohort that included over 6000 women with HIV who were on ART at conception, the perinatal transmission rate was 0.03 percent from 2011 to 2017; there were no infections among 5482 infants born to women on ART at conception who had undetectable viral load (<50 copies/mL) near delivery, whereas transmission was 1.1 percent for women on ART at conception but who had a detectable viral load near delivery [8].
The United States DHHS guidelines panel decided that viremia before 20 weeks gestation does not need to be considered in determining the choice of antiretroviral (ARV) given to neonates. The vast majority of transmissions are believed to occur from in utero exposure in the late second and third trimester, or from exposure during delivery. If a mother has maintained viral suppression from 20 weeks gestation and onward, the risk of transmission is extremely low. In particular, in utero transmission due to exposure to maternal viremia at gestational ages <20 weeks is believed to be very uncommon; therefore, the panel reached consensus that presumptive treatment for exposure to viremia at gestational ages <20 weeks is not indicated [1].
•Duration of prophylaxis – The duration of ZDV prophylaxis is largely based on expert opinion since there are limited data available about the optimal duration of ZDV prophylaxis in this low-risk infant group. At the beginning of the HIV pandemic, six weeks of ZDV were the standard practice [10]. However, since the risk of transmission to infants born to mothers who have been receiving ART and maintaining virologic suppression throughout their pregnancy has decreased to near zero [8], there has been a desire to utilize shorter durations of ZDV to avert unnecessary toxicity, such as anemia [11,12]. So far, there has been no evidence of increased transmission risk with the use of shorter durations.
•Preferred antiviral drugs – ZDV (twice daily) has been the drug of choice for infant HIV prophylaxis since 1994 when the seminal 076 trial demonstrated the efficacy of combining maternal ZDV during pregnancy and intrapartum with a six-week course of infant ZDV prophylaxis in preventing perinatal HIV transmission [10]. ZDV also has the largest body of evidence on efficacy and safety in infants compared with other ARVs.
Infants born to mothers without sustained viral suppression after 20 weeks gestation — For infants born to mothers who had detectable viral loads after 20 weeks of gestation, the approach to prophylaxis depends on the mother's viral load in the month prior to delivery.
Detectable viral load within four weeks prior to delivery — For infants born to women who have viremia (HIV RNA level ≥50 copies/mL, either documented or presumed if mother was not on treatment or nonadherent to ART) at the time of or in the four weeks prior to delivery, we recommend a three-drug ARV infant regimen. This regimen serves as enhanced prophylaxis for intrapartum transmission and as "presumptive therapy" if infection has already been established in utero. Duration of presumptive therapy ranges from two to six weeks. If the duration of the three-drug regimen is shorter than six weeks, ZDV should be continued alone, to complete a total of six weeks of prophylaxis.
●Preferred three-drug regimens – We administer infant ARV prophylaxis with a three-drug regimen (ZDV, lamivudine [3TC], plus either raltegravir or treatment-dose nevirapine (table 1 and table 2 and algorithm 1)). We generally prefer treatment with nevirapine-based regimens, supported by evidence from randomized clinical trials of nevirapine infant prophylaxis during breastfeeding and years of clinical experience with nevirapine as both prophylaxis and treatment [13]. Raltegravir is more complicated than nevirapine to administer, requiring dose and frequency changes over the first few weeks of life, and there is concern that if an infected infant fails treatment with raltegravir, integrase inhibitor resistance could develop that would compromise the potential future use of dolutegravir. However, raltegravir should be used when there is concern for infant exposure to HIV-2 virus or to nevirapine-resistant virus (based on maternal viral genotype testing results or history of clinical failure while taking non-nucleoside reverse transcriptase inhibitor [NNRTI]-based ART in the mother).
Decisions about infant prophylaxis regimens for high-risk infants should generally be made in consultation with a pediatric HIV specialist, preferably before delivery, and should consider the balance between the transmission risk and potential neonatal drug toxicities for the individual infant, with parental counseling on these issues.
●Duration – We suggest a duration of two weeks of the three-drug regimen, followed by four weeks of ZDV alone to minimize adverse drug effects in the infant [5]. However, some experts prefer to continue with the three-drug regimen for the full six weeks if the infant is tolerating the regimen. The choice of a longer duration of the three-drug regimen (ie, three to six weeks) could be utilized for infants exposed to high levels of virus, weighing potential benefit against unknown but presumably greater risk of adverse effects. If a transition from three drugs to prophylaxis with ZDV alone is chosen to complete the six-week prophylaxis period, at least one HIV nucleic acid test (ideally obtained at birth) should be negative before the switch, to exclude the possibility of established infection in the infant. (See "Pediatric HIV infection: Diagnostic testing in children younger than 18 months", section on 'Mother with HIV'.)
●Rationale – Apart from breastfeeding, most perinatal infections are related to HIV exposure in the four weeks prior to and during delivery, so viremia in that period confers the highest risk of HIV acquisition.
•Rationale for a three-drug regimen – The rationale for using a three-drug regimen is twofold: (1) it serves as "presumptive treatment" for infants who may be born having already been infected in utero; and (2) it serves as enhanced prophylaxis for infants with high-risk HIV exposure.
-Nevirapine-based three-drug regimens – The HIV Prevention Trials Network (HPTN) 040/Pediatric AIDS Clinical Trial Group 1043 study is the only randomized trial evaluating the efficacy of a three-drug combination prophylaxis regimen in preventing intrapartum vertical HIV transmission among infants born to women who presented late to care and received either intrapartum ZDV only or no ARV agents at all [14]. The rate of intrapartum transmission of HIV was higher when infants received six weeks of ZDV alone (4.8 percent) compared with six weeks of zidovudine plus three prophylaxis-level doses of nevirapine (the first within 48 hours of birth, the second 48 hours after the first dose, and the third 96 hours after the second dose; 2.2 percent) or six weeks of ZDV plus two weeks of nelfinavir and 3TC (2.4 percent). However, neutropenia was more common with the triple-drug regimen than the other two regimens. Thus, the two-drug ZDV plus nevirapine regimen offered the most favorable balance between efficacy and side effects. However, it is hypothesized that replacing nelfinavir in the three-drug regimen with raltegravir or treatment-dose nevirapine (which have greater potency against HIV) and giving the regimen for a full six weeks would result in even greater preventive efficacy that would offset the potential toxicity of a three-drug regimen. Observational data suggest that the three-drug regimen of ZDV, 3TC, and nevirapine is associated with slightly lower hemoglobin levels and higher premature discontinuation rates but no major toxicity compared with ZDV alone [15].
Clinical trials evaluating the impact of very early treatment on viral reservoirs in infants with HIV by treating high-risk HIV-exposed infants with the three-drug regimen of ZDV, 3TC, and nevirapine at treatment doses inform the pharmacokinetics and safety of this regimen in infants. The IMPAACT P1115 study found that nevirapine dosed at 6 mg/kg twice daily for term infants, or 4 mg/kg twice daily for the first week of life followed by 6 mg/kg twice daily afterward for preterm infants (34 to <37 weeks gestational age), was safe and provided therapeutic exposure nevirapine concentrations [13]. Preliminary findings from P1115 have also shown that early ART for infants with in utero HIV-1 infection achieved sustained virological suppression in most infants as well as restricted HIV-1 reservoirs by two years of age [16].
-Raltegravir-based three-drug regimens – Raltegravir is an alternative to nevirapine and may be a more potent option than nevirapine for "presumptive therapy" in a triple-drug regimen. In trials performed in adults with HIV, raltegravir was associated with greater and more durable viral suppression and less toxicity than efavirenz, another NNRTI similar to nevirapine [17]. Dosing for raltegravir is available for infants of gestational age ≥37 weeks and weighing ≥2 kg. A raltegravir formulation of granules that are made into suspension supports neonatal dosing but can be difficult for some families to prepare. Raltegravir-based triple-drug regimens should be used when there is maternal viral resistance to nevirapine. The three-drug regimen of ZDV, 3TC, and raltegravir is under study in some clinical trials as presumptive and early treatment of infants [18,19]. Data from these studies will guide future recommendations.
•Duration – The rationale for a two-week duration of the three-drug regimen followed by four weeks of ZDV comes from the HPTN 040/Pediatric AIDS Clinical Trial Group 1043 trial that is discussed above [14]. Although some experts would give the three-drug regimen for the full six weeks, we prefer a two-week duration of the three-drug regimen followed by four weeks of ZDV alone because the results of HIV nucleic acid birth testing should generally be available by two weeks, excluding the possibility that the infant was born already having been infected in utero, which is the main reason for initially administering a three-drug "presumptive treatment" regimen.
Detectable viral load after 20 weeks gestation, but undetectable viral load in the four weeks prior to delivery — For infants whose mothers experienced viremia beyond 20 weeks gestation but maintained an undetectable viral load during the four weeks prior to delivery, there is no consensus on infant ARV management (table 1 and algorithm 1). Some pediatric HIV experts favor administering the three-drug regimen for six weeks that serves as presumptive treatment regimen in case the infant was infected in utero, while others prefer to administer two to six weeks of ZDV alone. We thus favor a process of shared decision-making between providers and parents, weighing the concerns about risk of infection against the desire to avoid side effects from ARVs.
The higher the maternal viral load (and the closer in timing it is to delivery), the higher the risk of in utero HIV infection [2,20,21]. For example, in a woman newly diagnosed with HIV late in the second trimester of pregnancy who achieved undetectable viral load in the four weeks prior to delivery, the risk of peripartum transmission would be low, but the risk of in utero transmission moderately high; for this situation, a three-drug regimen (as presumptive treatment) would be reasonable until in utero infection had been excluded by birth testing. In contrast, in a woman who experienced only transient low-level viremia (eg, <400 copies) after 20 weeks gestation but more than four weeks before delivery, in utero infection is unlikely and intrapartum transmission risk is very low; for this situation, most experts would not administer presumptive treatment and instead administer ZDV prophylaxis alone, avoiding the potential additional side effects from three drugs.
Details on infant prophylaxis with ZDV alone are discussed separately. (See 'Infants born to mothers with sustained viral suppression since 20 weeks gestation' above.)
Details on three-drug presumptive treatment regimens are also discussed separately. (See 'Detectable viral load within four weeks prior to delivery' above.)
Continuation of ARV prophylaxis for breastfed infants — The initial antiretroviral (ARV) prophylaxis regimen in breastfed infants mirrors that in formula-fed infants. (See 'Initial ARV prophylaxis for all HIV-exposed infants' above.)
However, breastfed infants have ongoing potential exposure to HIV through breastmilk beyond delivery. Continuation of ARV prophylaxis following the initial infant prophylaxis regimen in breastfed infants is based on assessment of current and anticipated virologic status of the breastfeeding mother. Given that risk can change over time, plans for infant prophylaxis during breastfeeding are ideally made during the antepartum period and reassessed at the time of delivery and regularly during the breastfeeding period.
Clinicians in the United States may consult the National Perinatal HIV Hotline (1-888-448-8765) if they have questions regarding patients with HIV who desire to breastfeed [5]. Additional information can be found in the United States NIH DHHS guidelines.
We continue to monitor breastfed infants for HIV acquisition with HIV testing every three months during breastfeeding as well as four to six weeks, three months, and six months after cessation of breastfeeding (see "Pediatric HIV infection: Diagnostic testing in children younger than 18 months", section on 'Breastfed infants'). If an infant is diagnosed with HIV, the infant should be promptly transitioned to a full ARV regimen and HIV drug resistance testing should be sent.
Clinical decisions about maternal ART, viral load monitoring, and counseling of the mother in relation to breastfeeding are discussed separately. (See "Intrapartum and postpartum management of pregnant women with HIV in resource-abundant settings", section on 'Breastfeeding'.)
●Infants of breastfeeding mothers who have sustained viral suppression on ART
•Clinical approach – For decisions about prophylaxis for infants of women who have demonstrated sustained viral suppression on ART, we recommended engaging in shared decision-making with the mother.
If a mother has a long history of virologic suppression and is confident about adherence postpartum, we support providing no additional prophylaxis to infants beyond what is being used in the peripartum period (eg, two weeks of ZDV in most cases). (See 'Infants born to mothers with sustained viral suppression since 20 weeks gestation' above.)
However, new barriers to adherence often arise for postpartum women, and some mothers with current virologic suppression may have concerns about the maintenance of virologic suppression throughout the breastfeeding period. In that scenario, a breastfeeding mother may prefer to give her infant once-daily nevirapine or twice-daily 3TC (table 3) after completing the initial prophylaxis regimen, as a "safety net" in case viremia were to occur.
Guidance on the use of ARV prophylaxis for low-risk infants during breastfeeding varies. The United States DHHS guidelines panel did not reach a consensus on a recommendation; most panel members do not recommend extending prophylaxis beyond the initial two weeks of ZDV recommended for all infants of mothers with viral suppression while others recommend extending the initial prophylaxis regimen to complete four or six weeks of ZDV prophylaxis (table 2) or to extend prophylaxis with once-daily nevirapine or twice-daily 3TC for the duration of breastfeeding after completing the initial ZDV regimen (table 3) [5]. The American Academy of Pediatrics (AAP) has a similar assessment of risk and benefit and recommends consultation with a pediatric HIV expert for guidance [22]. The World Health Organization recommends six weeks of nevirapine from birth for low-risk infants [23], while the British HIV Association recommends no extension of prophylaxis past the two weeks of ZDV recommended for low-risk infants [5,24].
If infant prophylaxis is continued during breastfeeding, there is no consensus about how long to continue infant ARV prophylaxis after breastfeeding is stopped. The most conservative approach is to continue the prophylaxis for six weeks after the last breast milk exposure. However, if transmission risk has remained low throughout breastfeeding, it is reasonable to stop after two to four weeks or even at the same time as breastfeeding cessation. A mother with long-standing virologic control should also be supported if she wants to stop prophylaxis at any point during breastfeeding.
For infants who receive extended prophylaxis during breastfeeding, we suggest assessing blood counts and liver function testing once at age four to eight weeks and thereafter only if clinically indicated.
•Rationale – The potential benefit of continuing infant ART prophylaxis for the duration of breastfeeding when the mother is receiving ART depends on anticipated risk of viremia. The rationale for providing infant ART prophylaxis to infants of women on ART is to provide protection in the case that she develops unexpected and possibly unknown (eg, not documented by lab testing) viremia. Reports from clinical trials and observational data from clinical programs have demonstrated that the risk of transmission from women with HIV on ART to breastfeeding infants is very low, but not zero, with several cases of transmission documented [25-32]. One meta-analysis of published studies from 2005 to 2015 estimated that the overall postnatal transmission rates in breastfeeding infants of women with HIV on ART were 1.08 percent (95% CI 0.32-1.85) at six months and 2.93 percent (95% CI 0.68-5.18) at 12 months [33]. No randomized trials have demonstrated a benefit of ART prophylaxis when a mother has maintained virologic suppression throughout breastfeeding (and none likely ever will because the risk of transmission is probably close to zero).
Our recommendation for assessing blood counts and liver function in the infants once at baseline is to assess whether there is any early toxicity of the ARV and to provide a baseline with which to compare subsequent testing results, if indicated. There is no consensus about how to approach monitoring for toxicity during extended prophylaxis for breastfed infants. Neither the United States NIH DHHS guidelines nor the AAP guidelines provide specific guidance [34], but both groups endorse the safety of once-daily nevirapine and twice-daily 3TC. There have been no studies examining the optimal way to monitor for toxicity. The safety of once-daily nevirapine was evaluated in IMPAACT 1077BF, the breastfeeding component of the PROMISE trial [35]. Among 1204 infants who started once-daily nevirapine in the infant prophylaxis arm, there were no cases of hypersensitivity reported and no differences in grade 3 or 4 adverse events rates or liver or skin toxicity between the two study arms (infant nevirapine without maternal ART compared to maternal ART only); 20 infants (2 percent) stopped prophylaxis because of concerns for toxicity. In the randomized PROMISE-EPI trial, four severe adverse events occurred while infants were taking 3TC, with only one considered possibly related to the study drug (anemia) [22]. The safety of 3TC given throughout breastfeeding was also demonstrated in the "Mitra" study, an open-label single-arm prospective cohort trial in which 398 infants were treated with ZDV plus 3TC from birth to one week of age, and then with 3TC alone for the duration of breastfeeding (maximum of six months) plus two weeks after stopping breastfeeding; no serious adverse events were attributed to the 3TC [36].
●Harm reduction for infants of breastfeeding mothers who are not virally suppressed on ART
•Clinical approach – For infants of mothers who are not virally suppressed on ART, we strongly advise against breastfeeding given the high risk of HIV transmission. For those who still choose to breastfeed, we administer antiviral prophylaxis for the infant, while continued discussions with the mother occur about the elevated risks. We favor six weeks of a three-drug ART regimen from birth (table 1 and table 2) followed by once-daily nevirapine prophylaxis for the infant until six weeks after weaning (table 3). If the mother has nevirapine-resistant virus or the infant does not tolerate nevirapine, twice-daily 3TC is an alternative. ZDV should not be used as it is not effective prophylaxis for preventing infection during breastfeeding.
•Rationale – ARV drug prophylaxis in infants breastfed by mothers who are not on ART has been shown to reduce, but not eliminate, the risk of postnatal transmission in resource-limited settings [4,25-32,35,37-43]. In the open-label IMPAACT PROMISE trial that randomized 2431 mother-infant pairs to either infant prophylaxis (without maternal ART) or maternal ART only (without infant prophylaxis), 10 of 1211 (0.8 percent) infants receiving once-daily nevirapine in the infant-prophylaxis arm acquired HIV infection, compared to 8 of 1218 (0.7 percent) in the maternal treatment arm [35]. The PROMISE study showed that daily nevirapine was very effective, and safe, in preventing infection among infants of mothers who were not on ART and thus viremic. In another double-blinded, randomized trial in sub-Saharan Africa in 982 infants breastfed by mothers not on ART, the rate of HIV infection at six months was lower in infants who continued daily nevirapine prophylaxis for six months compared with those who stopped prophylaxis at six weeks (1.3 versus 3.4 percent) [43].
There is also evidence suggesting that infant ART prophylaxis is effective when given to breastfeeding infants of women on ART but viremic [4,25-32,35,37-43]. In the PROMISE-EPI trial, 1506 mother-infant pairs were randomized to viral load testing at six to eight weeks and six months post-partum, with initiation of twice-daily 3TC for the infant if the maternal viral load was >1000 copies/mL, or the standard of care per national guidelines (which included administration of infant HIV prophylaxis for 6 to 12 weeks in breastfed infants in both arms) [22]. At 12 months of age, only one infant in the experimental group acquired HIV compared to six in the control group (transmission incidence of 0.19 versus 1.16 per 100 person-years). Although the difference did not reach statistical significance, the results suggest that infant ART prophylaxis with twice-daily 3TC may be beneficial for preventing HIV transmission and underscore the value of monitoring maternal viral load during breastfeeding. (See "Intrapartum and postpartum management of pregnant women with HIV in resource-abundant settings", section on 'Breastfeeding'.)
Infants born to mothers with unknown HIV status — For the infant whose mother's HIV status is unknown postpartum (including individuals at risk for HIV infection who were not retested in the third trimester), rapid HIV testing of the mother (or the infant if the mother refuses or is unavailable for testing) with a combination antigen-antibody assay is recommended as soon as possible. The results of serologic testing (mother or infant) reflect the HIV status of the mother, not the infant, since it is maternal antibodies to HIV that will be detected.
If the initial antibody (or antigen-antibody) test of the mother is positive, confirmatory testing should be performed, repeating a serology test and ideally also with an HIV RNA level. The infant should also have HIV nucleic acid testing (RNA or deoxyribonucleic acid [DNA]) performed, and be given three-drug ARV prophylaxis. While awaiting confirmatory maternal HIV testing, infants in the situation should be managed as having high-risk exposure based on the presumption of the undiagnosed and untreated mother being viremic (table 1 and table 2) [5]. (See 'Detectable viral load within four weeks prior to delivery' above.)
For mothers who were planning to breastfeed, breastmilk should be expressed and stored appropriately until all maternal HIV test results are reviewed. If testing confirms that the mother does not have HIV, the banked milk can be used, breastfeeding should be supported without any additional precautions, and the infant's prophylaxis regimen can be discontinued. (See "Screening and diagnostic testing for HIV infection in adults".)
NEONATAL DRUG SAFETY AND PHARMACOLOGY —
It is important to note that pharmacokinetic data to allow appropriate dosing recommendations in neonates are only available for zidovudine (ZDV), lamivudine (3TC), abacavir, nevirapine, and raltegravir, and in preterm infants, only for ZDV, 3TC, and nevirapine.
Observational data on the use of three-drug prophylaxis regimens among 143 neonates (21 percent of whom were <37 weeks gestation and 40 percent of whom received ZDV, 3TC, and treatment-dose nevirapine as their regimen) demonstrated higher rates of nonspecific adverse signs and symptoms (10 percent) as well as premature drug discontinuation (10 percent) with three drugs compared with ZDV alone (0 and 2 percent, respectively), but have not suggested major toxicity [15].
A multicenter trial of full-term neonates exposed to HIV found daily raltegravir safe and well tolerated during the first six weeks of life [44]. There were no clinical adverse reactions. There were hypothetical mechanistic concerns that raltegravir could displace bilirubin off of albumin and place infants at increased risk of kernicterus; however, one study showed that raltegravir has minimal effect on bilirubin-albumin binding at the typical peak concentrations reached with usual dosing [45].
OTHER POSTNATAL MANAGEMENT CONSIDERATIONS —
Infants born to mothers with HIV require other management considerations besides initiation of antiretroviral therapy (ART) in addition to the typical newborn screening that is performed in the general population. (See "Overview of newborn screening".)
Congenital CMV testing — We test for congenital cytomegalovirus (CMV) in all infants born to mothers with HIV. We conduct testing within the first 21 days of an infant's life with a urine and/or saliva polymerase chain reaction (PCR) assay [5]. Among CMV-seropositive women, the rate of CMV shedding from the cervix is higher in women with HIV compared with women without HIV and neonates born to mothers with HIV are more likely to have congenital CMV infection, especially if the neonate is infected with HIV [46-49]. We test all infants for congenital CMV since congenital CMV is best diagnosed before the 21st day of life, when the HIV status of the neonate may not yet be known. Management of congenital CMV is discussed elsewhere. (See "Congenital cytomegalovirus (cCMV) infection: Clinical features and diagnosis", section on 'Newborn screening for congenital cytomegalovirus' and "Congenital cytomegalovirus (cCMV) infection: Management and outcome", section on 'Antiviral treatment'.)
Testing in infants born to mothers coinfected with HBV and/or HCV — Women with HIV should also be tested for hepatitis B virus (HBV) and hepatitis C virus (HCV) during pregnancy, if not already known to be positive. Infants born to mothers with HBV or HCV may need additional testing and/or management. (See "Hepatitis B virus immunization in infants, children, and adolescents", section on 'Routine infant immunization' and "Vertical transmission of hepatitis C virus", section on 'Diagnosis' and "Hepatitis viruses and the newborn: Clinical manifestations and treatment", section on 'Hepatitis B' and "Hepatitis viruses and the newborn: Clinical manifestations and treatment", section on 'Hepatitis C'.)
Limited role for pneumocystis prophylaxis — Although the United States Department of Health and Human Services (DHHS) guidelines suggest Pneumocystis jirovecii pneumonia (PJP) prophylaxis in select infants starting at the age of two months, in reality, most infants exposed to HIV in resource-abundant settings do not meet the indications criteria for PJP prophylaxis [5]. Most HIV-exposed infants do not require prophylaxis because they are either at low risk for HIV acquisition or HIV infection can be presumptively excluded by two months of age. Despite P. jirovecii being ubiquitous in the environment, acquisition of PJP within the first four weeks of life is rare. Most breastfed infants are also very low risk for acquiring HIV (as breastfeeding is only recommended for mothers with suppressed viral loads) and we thus do not administer PJP prophylaxis.
SOCIETY GUIDELINE LINKS —
Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: HIV infection in infants and children".)
SUMMARY AND RECOMMENDATIONS
●Risk of perinatal HIV acquisition – Infants can acquire HIV in utero, during delivery, or during breastfeeding. The risk from exposure is driven by whether the mother is receiving antiretroviral therapy (ART) and the level of maternal viremia. (See 'Risk of perinatal HIV acquisition' above and "Prevention of vertical HIV transmission in resource-limited settings", section on 'Mechanisms of transmission'.)
●Prompt initiation of antiretroviral drugs for exposed infants – Infant antiretroviral (ARV) prophylaxis should be initiated as soon as possible after birth, ideally within the first 6 to 12 hours of delivery. (See 'Prompt initiation of prophylaxis for HIV-exposed infants' above.)
●Initial ARV prophylaxis for all HIV-exposed infants
•Infants born to mothers with sustained viral suppression after 20 weeks gestation – For infants born to women who have maintained a viral load <50 copies/mL on ART from 20 weeks gestation through delivery (based on clinical judgement but ideally via documented HIV RNA levels), we suggest two weeks of prophylaxis with zidovudine (ZDV) (table 1 and table 2 and algorithm 1) (Grade 2C). Other experts choose to administer four weeks of ZDV, and a small number support giving no prophylaxis in very low-risk scenarios. (See 'Infants born to mothers with sustained viral suppression since 20 weeks gestation' above.)
•Infants born to mothers with viremia (≥50 copies/mL) after 20 weeks gestation
-For infants born to mothers who have viremia (HIV RNA level ≥50 copies/mL) either documented or presumed (if mother was not on treatment or nonadherent to ART) at the time of, or in the four weeks prior to delivery, we recommend presumptive therapy with a three-drug ARV regimen (table 1 and table 2 and algorithm 1) (Grade 1B). We suggest a two week duration of the three-drug regimen, followed by four weeks of ZDV alone to minimize adverse drug effects in the infant (Grade 2C). However, longer durations of the three-drug regimen (eg, for three to six weeks) may be utilized for infants exposed to high levels of virus or those in whom HIV nucleic acid testing at birth was not performed, weighing potential benefit of presumptive therapy against unknown but presumably greater risk of adverse effects with three-drug regimens. (See 'Detectable viral load within four weeks prior to delivery' above.)
-For infants whose mothers experienced viremia during gestation but maintained an undetectable viral load during the four weeks prior to delivery, we engage in shared decision making with the parents regarding whether to administer presumptive ART with a three-drug regimen or to administer ZDV alone for two to six weeks (table 1 and table 2 and algorithm 1).
The concerns about risk of infection in the infant must be weighed against the desire to avoid side effects from ARVs. The higher the maternal viral load (and the closer in timing it is to delivery), the higher the risk of transmitting HIV in utero to the infant. (See 'Detectable viral load after 20 weeks gestation, but undetectable viral load in the four weeks prior to delivery' above.)
●Continuation of ARV prophylaxis for breastfed infants
•Infants of breastfeeding mothers who have sustained viral suppression – For these infants, we engage in shared decision-making with the breastfeeding mother. If the mother is confident in her adherence to ART in the post-partum period, we prefer not to extend prophylaxis beyond the two-week ZDV prophylaxis that is recommended for low-risk infants. However, some experts would extend the initial single-drug ZDV prophylaxis regimen to four or six weeks. If the mother has concern for maintaining adherence to ART while breastfeeding, prophylaxis with once-daily nevirapine prophylaxis or twice-daily lamivudine (3TC) for the duration of breastfeeding is preferred (table 3). (See 'Continuation of ARV prophylaxis for breastfed infants' above.)
•Infants of breastfeeding mothers without sustained viral suppression – For these infants, we advise strongly against breastfeeding as the risk of transmission of HIV to the infant through breastmilk is high. (See 'Continuation of ARV prophylaxis for breastfed infants' above.)
●Newborn CMV testing in all HIV-exposed infants – We test all infants born to mothers with HIV for congenital cytomegalovirus (CMV) with a urine and/or saliva polymerase chain reaction (PCR) assay within the first 21 days of life. (See "Congenital cytomegalovirus (cCMV) infection: Clinical features and diagnosis", section on 'Newborn screening for congenital cytomegalovirus'.)
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