Treatment algorithm

Your Organisational Guidance

ebpracticenet urges you to prioritise the following organisational guidance:

Richtlijn zorg voor patiënten met hiv in de eerste lijnPublished by: Werkgroep Ontwikkeling Richtlijnen Eerste Lijn (Worel)Last published: 2023GPC sur la prise en charge des patients vivant avec le VIHPublished by: Groupe de Travail Développement de recommmandations de première ligneLast published: 2023

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

pregnant women: <38 weeks not in labour (regardless of HIV RNA level)

1st line – antiretroviral therapy (ART): preferred 2-NRTI backbone

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

antiretroviral therapy (ART): preferred 2-NRTI backbone

Women with HIV who are receiving 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 examples only and 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; consult local guidelines for options in other countries.

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

Primary options

emtricitabine/tenofovir disoproxil

OR

emtricitabine/tenofovir alafenamide

OR

lamivudine/tenofovir disoproxil

OR

lamivudine

and

tenofovir alafenamide

Secondary options

abacavir/lamivudine

More

OR

lamivudine/zidovudine

More

Plus – antiretroviral therapy (ART): INSTI or PI or NNRTI

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ACUTE
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pregnant women: <38 weeks not in labour (regardless of HIV RNA level)
Plus – 

antiretroviral therapy (ART): 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 examples only and are based on current US guidance for pregnant women.[7] Other regimens may be recommended in special circumstances and specific situations; consult local guidelines for options in other countries.

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

bictegravir/emtricitabine/tenofovir alafenamide

More

OR

INSTI-based regimen

dolutegravir

Secondary options

INSTI-based regimen

raltegravir

OR

PI-based regimen

darunavir

and

ritonavir

OR

PI-based regimen

atazanavir

More

and

ritonavir

OR

NNRTI-based regimen

efavirenz

More

OR

NNRTI-based regimen

rilpivirine

pregnant women with HIV RNA levels >1000 copies/mL: at 38 weeks or in labour

1st line – caesarean delivery

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

caesarean delivery

A scheduled caesarean 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]​ Individualised birth plans to extend pregnancies beyond 38 weeks and to avoid the need for caesarean delivery may be considered in women with HIV RNA >1000 copies/mL or unknown viral load who have started intrapartum antiretroviral therapy (ART).[7]

In non-virally suppressed patients who present in labour prior to their scheduled caesarean delivery date, an emergency caesarean 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 labour or rupture of membranes the benefit of caesarean delivery to prevention of perinatal transmission is lost.

Urgent consideration with a perinatal HIV specialist is recommended.

Plus – zidovudine plus continue antiretroviral therapy (ART)

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

zidovudine plus continue antiretroviral therapy (ART)

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). It is also recommended if there is a known or suspected lack of adherence to ART since the last HIV RNA result, or the patient tests positive during labour.[7]

Women should also continue taking their antepartum ART on schedule during labour and and before scheduled delivery.[7]

Primary options

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

pregnant women with HIV RNA levels ≤1000 copies/mL: at 38 weeks or in labour

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

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

await normal vaginal delivery plus continue antiretroviral therapy (ART)

Scheduled caesarean delivery is not routinely recommended for women on 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 hospitalisation associated with caesarean delivery.[7][15][91]​​

If scheduled caesarean 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 on schedule during labour and before delivery, regardless of route of delivery.

Consider – zidovudine

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

zidovudine

Additional 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 also recommended if there is a known or suspected lack of adherence to antiretroviral therapy (ART) since the last HIV RNA result, or the patient tests positive during labour. 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

infant with in utero or intrapartum HIV exposure

1st line – initial postnatal antiretroviral prophylaxis

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ACUTE
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infant with in utero or intrapartum HIV exposure
1st line – 

initial postnatal antiretroviral prophylaxis

All infants who have been perinatally exposed to HIV should receive postnatal antiretroviral prophylaxis in the immediate neonatal period to reduce the risk of perinatal transmission. Antiretroviral prophylaxis should be started as close to the time of delivery as possible, and preferably within 6 hours of birth.[7]

Choice of antiretroviral regimen for infants with in utero or intrapartum exposure to HIV is based on the predicted risk for transmission as determined by the mother’s HIV RNA levels.[7]

Infants at high risk of HIV acquisition (i.e., born to a pregnant woman with HIV RNA ≥50 copies/mL in the 4 weeks prior to delivery): a three-drug regimen consisting of zidovudine plus lamivudine plus either nevirapine (treatment dose) or raltegravir is recommended, administered from birth for 2-6 weeks. This serves as presumptive HIV therapy or enhanced prophylaxis. If the HIV test at birth is negative and the duration of prophylaxis is <6 weeks, zidovudine monotherapy should be continued to complete a 6-week course.[7]

Infants at low risk of HIV acquisition (i.e., born to a pregnant woman with HIV RNA <50 copies/mL from 20 weeks’ gestation through to delivery, ideally documented by at least 2 consecutive tests at least 4 weeks apart but can be based on clinical judgement): zidovudine monotherapy for 2 weeks is recommended.[7]

Infants who do not meet the criteria above should receive antiretroviral regimens and durations based on case-specific factors related to the level and timing of viraemia during pregnancy.[7]​ Consult your local guidance for more information.

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

Primary options

Infants at high risk of HIV acquisition

zidovudine

More

-- AND --

lamivudine

-- AND --

nevirapine

or

raltegravir

OR

Infants at low risk of HIV acquisition

zidovudine

Plus – counselling on infant feeding options

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ACUTE
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infant with in utero or intrapartum HIV exposure
Plus – 

counselling on infant feeding options

Treatment recommended for ALL patients in selected patient group

US guidelines recommend that patients should receive patient-centred, evidence-based counselling to support shared decision-making about infant feeding, including breastfeeding. Counselling should include information about available feeding options, including formula feeding, use of banked donor milk, or breastfeeding.[7]

Several studies in low‐resource settings with exclusive breastfeeding in women with HIV demonstrated next to no perinatal HIV transmission with maternal viral suppression on antiretroviral therapy (ART).[38][92][93]​ However, while suppressive ART significantly reduces the risk of perinatal HIV transmission through breastfeeding, it does not completely eliminate the risk (estimated to be 3/1000).[7]

Replacement feeding is recommended to eliminate the risk of HIV transmission via breastfeeding 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 breastfeed. If the breastfeeding parent has a detectable viral load, replacement feeding should be initiated and breastfeeding temporarily stopped or discontinued while viral load is rechecked and causes for the viraemia are investigated. If the repeat viral load is undetectable, breastfeeding may resume. If the repeat viral load is detectable, options may include initiating or modifying infant antiretroviral prophylaxis, permanently discontinuing breastfeeding, and considering the need for infant HIV testing. Most experts recommend permanently discontinuing breastfeeding if HIV RNA is ≥200 copies/mL.[7]

Measures that minimise risk of HIV transmission (e.g., exclusive breastfeeding for the first 6 months, gradual weaning, immediate treatment of maternal mastitis and infant thrush, infant monitoring) are recommended in women who choose to breastfeed.[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 counselling people against breastfeeding if they are not on ART or are on ART without viral suppression.[94] 

Consider – extended antiretroviral prophylaxis

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ACUTE
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infant with in utero or intrapartum HIV exposure
|
exposure to HIV during breastfeeding: maternal HIV RNA <50 copies/mL
Consider – 

extended antiretroviral prophylaxis

Additional treatment recommended for SOME patients in selected patient group

Extended antiretroviral prophylaxis during breastfeeding should ensure continuous prophylaxis through the entire postnatal period. Infants should be transitioned to extended prophylaxis only after completion of initial postnatal prophylaxis with zidovudine.[7]

HIV RNA levels of the breastfeeding parent should be monitored periodically during breastfeeding.[7]

Choice of antiretroviral regimen in infants with exposure to HIV during the breastfeeding period is based on the current or anticipated virological status of the breastfeeding parent.[7]

Infants at low risk of HIV acquisition during breastfeeding (i.e., breastfeeding parent is receiving ART with HIV RNA <50 copies/mL for at least 3 months prior to delivery and there are no concerns about ART adherence): there is no consensus about management in these patients. Nevirapine or lamivudine are the recommended options. However, some experts do not recommend extended prophylaxis in these patients.[7]

Infants currently at low risk of HIV acquisition during breastfeeding but with concerns for future risk (i.e., concerns about lack of ART adherence or loss of virological suppression for other reasons during breastfeeding): nevirapine or lamivudine should be considered.[7]

Extended prophylaxis should continue until either 6 weeks after the last exposure to breast milk, or 6 weeks after concerns about the breastfeeding parent’s virological suppression have resolved, whichever comes first. It may be reasonable to discontinue prophylaxis earlier if the concerns for viraemia in the breastfeeding parent have resolved.[7]

Nevirapine or lamivudine can be given from birth (replacing zidovudine) to provide initial postnatal prophylaxis and extended prophylaxis during breastfeeding.[7]​ Consult your local guidelines for more information.

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

Primary options

nevirapine

OR

lamivudine

Consider – stop breastfeeding and start presumptive antiretroviral therapy (ART)

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ACUTE
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infant with in utero or intrapartum HIV exposure
|
exposure to HIV during breastfeeding: new maternal viraemia during breastfeeding
Consider – 

stop breastfeeding and start presumptive antiretroviral therapy (ART)

Additional treatment recommended for SOME patients in selected patient group

HIV RNA levels of the breastfeeding parent should be monitored periodically during breastfeeding. If the breastfeeding parent experiences new vireamia during breastfeeding, breastfeeding should be temporarily stopped or discontinued, replacement feeding initiated, and an HIV test performed in the infant. Permanent discontinuation is recommended by most experts when HIV RNA is ≥200 copies/mL, but some support resuming breastfeeding once virological suppression is achieved again.[7]

The choice of antiretroviral regimen depends on the level of maternal viraemia.[7]

HIV RNA ≥200 copies/mL: in infants aged <4 weeks, zidovudine plus lamivudine plus nevirapine (treatment dose) or raltegravir for 2-6 weeks is recommended. In infants aged ≥4 weeks, a three-drug regimen consisting of zidovudine plus lamivudine plus dolutegravir for 2-6 weeks is recommended. This serves as presumptive HIV therapy or enhanced prophylaxis. If the HIV test is negative and the duration of prophylaxis is <6 weeks, zidovudine monotherapy can be continued to complete a 6-week course.[7]

HIV RNA <200 copies/mL: there is no consensus about management in these patients. Some experts recommend a three-drug regimen (as for those with HIV RNA ≥200 copies/mL), while others recommend a single-drug regimen with either nevirapine or lamivudine. Others recommend management based on repeat HIV RNA testing of the breastfeeding parent. Consultation with an expert is recommended.[7]

Infants of mothers with a new diagnosis of HIV during breastfeeding should be managed as per the recommendations for infants at high risk of in utero or intrapartum HIV acquisition, along with replacement feeding.[7]

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

Primary options

Maternal HIV RNA ≥200 copies/mL: infant <4 weeks of age

zidovudine

-- AND --

lamivudine

-- AND --

nevirapine

or

raltegravir

OR

Maternal HIV RNA ≥200 copies/mL: infant ≥4 weeks of age

zidovudine

and

lamivudine

and

dolutegravir

OR

Maternal HIV RNA <200 copies/mL

nevirapine

OR

Maternal HIV RNA <200 copies/mL

lamivudine

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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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