Treatment algorithm

Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups: see disclaimer

ACUTE

HIV-1-infected pregnant women: <38 weeks not in labor (regardless of HIV RNA level)

1st line – preferred 2-NRTI backbone

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ACUTE
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HIV-1-infected pregnant women: <38 weeks not in labor (regardless of HIV RNA level)
1st line – 

preferred 2-NRTI backbone

Women with HIV who are receiving antiretroviral therapy (ART) should continue their ART during pregnancy provided that it is safe, effective in suppressing viral replication, and well tolerated. Women who are not currently taking ART should be started on a regimen as soon as HIV is a feasible diagnosis, regardless of CD4 count or viral load; earlier viral suppression is associated with a lower risk of perinatal transmission.[7]

Antiretroviral regimens are complex and a specialist should be consulted for guidance on the best combination to use. The options listed here are based on current US guidance for pregnant women (and those trying to conceive).[7]​ Other regimens may be recommended in special circumstances and specific situations; local guidelines should be consulted.

Two nucleoside reverse transcriptase inhibitors are recommended as the backbone of combination regimens.[7]

Primary options

abacavir/lamivudine

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OR

emtricitabine/tenofovir disoproxil

OR

emtricitabine/tenofovir alafenamide

OR

lamivudine/tenofovir disoproxil

OR

lamivudine

and

tenofovir alafenamide

Secondary options

lamivudine/zidovudine

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Plus – INSTI or PI or NNRTI

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ACUTE
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HIV-1-infected pregnant women: <38 weeks not in labor (regardless of HIV RNA level)
Plus – 

INSTI or PI or NNRTI

Treatment recommended for ALL patients in selected patient group

Antiretroviral regimens are complex and a specialist should be consulted for guidance on the best combination to use. The options listed here are based on current US guidance for pregnant women.[7]​ Other regimens may be recommended in special circumstances and specific situations; local guidelines should be consulted.

An integrase strand transfer inhibitor (INSTI) is the preferred agent to add to the 2-NRTI backbone. Protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) may also be used; however, there are no preferred PIs or NNRTIs in treatment-naive pregnant women.[7]

Primary options

INSTI-based regimen

dolutegravir

Secondary options

INSTI-based regimen

raltegravir

OR

INSTI-based regimen

bictegravir/emtricitabine/tenofovir alafenamide

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OR

PI-based regimen

darunavir

and

ritonavir

OR

PI-based regimen

atazanavir

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and

ritonavir

OR

NNRTI-based regimen

efavirenz

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OR

NNRTI-based regimen

rilpivirine

HIV-1-infected pregnant women with HIV-1 RNA levels >1000 copies/mL: at 38 weeks or in labor

1st line – cesarean delivery

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ACUTE
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HIV-1-infected pregnant women with HIV-1 RNA levels >1000 copies/mL: at 38 weeks or in labor
1st line – 

cesarean delivery

A scheduled cesarean delivery at 38 weeks' gestation is recommended for pregnant women with HIV and who have HIV-1 RNA levels >1000 copies/mL or unknown viral load near the time of delivery (within 4 weeks of delivery), in order to reduce the risk of perinatal transmission.[7]

In nonvirally suppressed patients who present in labor prior to their scheduled cesarean delivery date, an emergency cesarean delivery should be performed. In patients who present with rupture of membranes, there are insufficient data to address the question of how long after the onset of labor or rupture of membranes the benefit of cesarean delivery to prevention of perinatal transmission is lost.

Urgent consideration with a perinatal HIV specialist is recommended.

Plus – zidovudine plus continue antiretroviral therapy

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ACUTE
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HIV-1-infected pregnant women with HIV-1 RNA levels >1000 copies/mL: at 38 weeks or in labor
Plus – 

zidovudine plus continue antiretroviral therapy

Treatment recommended for ALL patients in selected patient group

Intravenous zidovudine should be started at least 3 hours before scheduled delivery in women with HIV RNA >1000 copies/mL or unknown viral load near delivery (within 4 weeks of delivery).[7]

Women should also continue taking their antepartum antiretroviral therapy during labor delivery as prescribed.[7]

Primary options

zidovudine: 2 mg/kg intravenously as a loading dose, followed by 1 mg/kg/hour infusion until cord clamp

HIV-1-infected pregnant women with HIV-1 RNA levels ≤1000 copies/mL: at 38 weeks or in labor

1st line – await normal vaginal delivery plus continue antiretroviral therapy

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ACUTE
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HIV-1-infected pregnant women with HIV-1 RNA levels ≤1000 copies/mL: at 38 weeks or in labor
1st line – 

await normal vaginal delivery plus continue antiretroviral therapy

Scheduled cesarean delivery is not routinely recommended for women on antiretroviral therapy (ART) who have HIV RNA levels ≤1000 copies/mL because of the low rate of perinatal transmission in these patients, as well as limited or no known evidence of benefit and an increased risk of infection, surgical trauma, hospital deaths, and prolonged hospitalization associated with cesarean delivery.[7][14][94]​​

If scheduled cesarean delivery or induction is indicated in these patients, it should be performed at the standard time for obstetric indications.

Women should also continue taking their antepartum ART during labor and delivery as prescribed, regardless of route of delivery.

Consider – zidovudine

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ACUTE
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HIV-1-infected pregnant women with HIV-1 RNA levels ≤1000 copies/mL: at 38 weeks or in labor
Consider – 

zidovudine

Treatment recommended for SOME patients in selected patient group

Intravenous zidovudine may be considered in women with HIV RNA between 50 and ≤1000 copies/mL within 4 weeks of delivery; however, there are inadequate data to determine whether this provides additional protection against perinatal transmission in this group. It is not recommended in women receiving ART with HIV RNA ≤50 copies/mL during late pregnancy and near delivery, provided there are no concerns about adherence to ART.[7]

Primary options

zidovudine: 2 mg/kg intravenously as a loading dose, followed by 1 mg/kg/hour infusion until cord clamp

infants born to HIV-infected mothers

1st line – presumptive HIV therapy or two-drug prophylaxis

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ACUTE
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infants born to HIV-infected mothers
1st line – 

presumptive HIV therapy or two-drug prophylaxis

All infants who have been perinatally exposed to HIV should receive postpartum antiretroviral therapy (ART) to reduce the risk of perinatal transmission. ART should be started as close to the time of delivery as possible, preferably within 6 hours. The ART regimen depends on whether the infant is at low or high risk of perinatal transmission.[7]

Infants at low risk of perinatal transmission: a 2-week course of zidovudine is recommended, provided the newborn is ≥37 weeks’ gestation and is born to a mother who meets all of the following criteria: currently receiving ART and has received at least 10 consecutive weeks of treatment during pregnancy; achieved and/or maintained viral suppression for the duration of pregnancy (defined as at least 2 consecutive tests with <50 copies/mL obtained at least 4 weeks apart); viral load is <50 copies/mL at or after 36 weeks’ gestation; did not have acute HIV infection during pregnancy; has good ART adherence. Infants who do not meet these criteria, but who have a viral load <50 copies/mL at, or after, 36 weeks’ gestation should receive a 4- to 6-week course of zidovudine. All premature infants <37 weeks’ gestation should receive a 4- to 6-week course of zidovudine.[7]

Infants at high risk of perinatal transmission: presumptive HIV therapy with a 3-drug regimen (i.e., zidovudine plus lamivudine plus nevirapine [treatment dose], or zidovudine plus lamivudine plus raltegravir) administered from birth for 2-6 weeks is recommended in infants born to a mother who: has not received antepartum ART; or has received only intrapartum ART; or has received antepartum ART but who did not achieve viral suppression within 4 weeks of delivery; or had primary or acute HIV infection during pregnancy. If the duration of treatment is shorter than 6 weeks, zidovudine monotherapy should be continued to complete a 6-week treatment course. Infants born to mothers who have primary or acute HIV infection during breast-feeding should be managed as per infants at high risk of perinatal transmission.[7]

In some situations, a two-drug prophylaxis regimen (zidovudine for 6 weeks plus 3 prophylactic doses of nevirapine within 48 hours of birth, 48 hours after first dose, and 96 hours after second dose) may be considered in infants aged ≥32 weeks gestation at birth who weigh ≥1.5 kg. However, this decision depends on the likelihood of HIV transmission and should be made by a specialist.[7]

Antiretroviral regimens are complex and a pediatric HIV specialist should be consulted for guidance on the best combination to use. The options listed here are based on current US guidance.[7]

Primary options

zidovudine: consult specialist for guidance on dose

OR

zidovudine: consult specialist for guidance on dose

-- AND --

lamivudine: consult specialist for guidance on dose

-- AND --

nevirapine: consult specialist for guidance on dose

or

raltegravir: consult specialist for guidance on dose

Secondary options

zidovudine: consult specialist for guidance on dose

and

nevirapine: consult specialist for guidance on dose

Plus – infant feeding

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infants born to HIV-infected mothers
Plus – 

infant feeding

Treatment recommended for ALL patients in selected patient group

Several studies in low‐resource settings with exclusive breast-feeding in women with HIV demonstrated next to no perinatal HIV transmission with maternal viral suppression on antiretroviral therapy (ART).[37][95][96]​ However, while suppressive ART significantly reduces the risk of perinatal HIV transmission through breast-feeding, it does not completely eliminate the risk (estimated to be 3/1000).[7]

US guidelines recommend that patients should receive patient-centered, evidence-based counseling to support shared decision-making about infant feeding, including breast-feeding. Replacement feeding is recommended to eliminate the risk of HIV transmission via breast-feeding when people with HIV are not on ART, and/or do not have a suppressed viral load during pregnancy (at a minimum throughout the third trimester), and at delivery. However, patients who are on ART with a sustained undetectable viral load should be supported if they choose to breast-feed.[7]

Measures that minimize risk of HIV transmission (e.g., exclusive breast-feeding for the first 6 months, gradual weaning, immediate treatment of maternal mastitis and infant thrush, infant monitoring) are recommended in women who choose to breast-feed.[7]

The American Academy of Pediatrics (AAP) supports a harm reduction approach to support people on ART with sustained viral suppression <50 copies/mL, but recommends counseling people against breast-feeding if they are not on ART or are on ART without viral suppression.[97] 

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Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups. See disclaimer

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