ART Guidelines
References

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- South African National Department of Health 2019 Guideline for the Prevention of Mother to Child Transmission of Communicable Infections.
- South African National Department of Health 2019 ART Clinical Guidelines for the Management of HIV in Adults, Pregnancy, Adolescents, Children, Infants and Neonates.
- The prevention of mother-to-child transmission of HIV (PMTCT) programme includes peri-conception, pregnancy, delivery and breastfeeding, and encompasses the prevention of unplanned pregnancies.
- In low-resource settings, breastfeeding commonly continues for up to 24 months. Breastfeeding transmission is now the most common mode of mother-to-child transmission of HIV in many parts of sub-Saharan Africa; rendering post-natal retention-in-care vital to successful PMTCT intervention.
- Virological suppression on ART is essential for maternal health, and to prevent HIV transmission to the infant. An elevated VL > 50 copies/mL in a pregnant or breastfeeding woman requires urgent action.
- In well-functioning PMTCT programmes, a significant proportion of infections in infants result from undetected seroconversion during pregnancy and breastfeeding. Repeated HIV testing throughout these periods is essential for women initially testing HIV-negative.
- Interventions that support HIV-risk reduction in women include: male partner HIV testing and linkage to ART for ‘treatment as prevention’, encouraging consistent condom use throughout pregnancy and breastfeeding, and providing pre-exposure prophylaxis (PrEP) to women at substantial risk of HIV infection.
- Maternal health is central to healthy infants, and is an essential focus of PMTCT services: advanced HIV results in life-threatening OIs, leading to miscarriage, stillbirth, premature delivery and maternal death.
Overall, the risk of mother-to-child transmission of HIV is ~40% in the absence of any intervention. Timing of such transmission is as follows: in utero: 5%; during delivery: 15–20%; up to 24 months of breastfeeding: 20%.
The time of highest risk coincides with delivery, which spans a matter of hours; the risk during 24 months of breastfeeding is slightly higher, but over a significantly greater timespan. Breastfeeding should not be stopped because of a new diagnosis of HIV, or an elevated VL in women already on ART. Instead, initiation of ART and management of raised VL (together with infant prophylaxis) are interventions to ‘make breastfeeding safer’.
All HIV-positive pregnant and breastfeeding women should be initiated on lifelong ART, ideally the same day that pregnancy is confirmed. Standard first-, second- and third-line regimens should be used in pregnancy (refer to Module 11, Module 12, Module 13 and Module 14). Regarding DTG use in pregnancy, it is important to note that the absolute risk of neural-tube defects is low (< 0.5%) and this risk may be outweighed by the additional benefits of DTG over alternative therapies. We currently recommend that women of childbearing potential (WOCP) who wish to become pregnant or who have no reliable access to effective contraception should be counselled adequately about the potential risks and benefits of DTG- vs. EFV-based ART, and should be offered the choice of first-line regimens.
Other points regarding ART in pregnancy:
- EFV 600 mg is a safe and effective regimen for use by WOCP including during the time from conception to the end of the first trimester. There are insufficient data to recommend routine use of EFV 400 mg in pregnant women.
- These guidelines no longer recommend initiating NVP in any patients. Maternal deaths in pregnant women have been associated with NVP due to liver and skin hypersensitivity reactions.
- NRTIs: contraindications and adverse effects are as for general use. Note that commonly used CrCl calculations are not validated for pregnant women, therefore avoid TDF if sCr ≥ 85 μmol/L.
- Dose adjustment of ART during pregnancy is only indicated for women taking both TDF and ATV/r during the second/third trimester; the dose should be increased from ATV/r 300 mg/100 mg to 400 mg/100 mg.
- Women taking LPV/r 800 mg/200 mg daily should be advised to adjust this to 400 mg/100 mg 12-hourly (twice daily) during pregnancy due to altered pharmacokinetics. These women should also be informed about the association between LPV/r and premature labour and delivery.
- Particular importance should be placed on the drug-drug interactions between DTG and divalent cation-containing medication in pregnancy, since pregnant women frequently receive iron supplements and/or magnesium-/aluminium-containing antacids.
Patients returning to care in pregnancy after defaulting a first-line regimen or those exposed to previous PMTCT regimens should generally be put directly on a DTG-based regimen, rather than retrying an NNRTI-regimen (see also Module 16). As per current PMTCT guidelines, women not already on ART at the time of labour or delivery should commence TLD immediately and also receive an additional stat dose of NVP 200 mg. Women who are newly diagnosed with HIV during the breastfeeding period may continue breastfeeding as per maternal preference, provided that maternal ART and infant prophylaxis are initiated and adherence support is given.
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TABLE 22: Timing of viral load monitoring during pregnancy, delivery and breastfeeding. | ||||
Period | ART initiation in pregnancy | Already on ART at diagnosis of pregnancy | Previously taken ART, not currently on treatment (ART interruption, ART for PMTCT) | Newly diagnosed HIV infection during delivery or breastfeeding |
---|---|---|---|---|
Antenatal | VL at baseline and after 3 months of ART: if > 28 weeks’ gestation, then repeat VL at delivery | VL at first ANC visit | VL at initiation of DTG-based regimen; repeat VL 3 months later – change in VL determines management | - |
Delivery | All women need VL measurement at delivery; review result at day 3–6 postnatal visit | - | ||
Postnatal, up to the end of breastfeeding | VL measure at 6 months postpartum; repeat VL 6-monthly during breastfeeding | VL after 3 months of ART, then 6-monthly during breastfeeding | ||
ANC, antenatal care; ART, antiretroviral therapy; DTG, dolutegravir; PMTCT, prevention of mother-to-child transmission; VL, viral load. |
Other key recommendations:
- All pregnant women should be screened at every visit for sexually transmitted infections (STIs) and treated as needed.
- All pregnant and breastfeeding women should be screened for TB at every visit. If the TB screen is negative, then consider TB-preventive therapy during pregnancy only in women with a CD4+ count < 350 cells/μL (see Module 27).
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Common pitfall: Not performing VL monitoring at the appropriate time. See Table 22 for the appropriate monitoring intervals. |
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Common pitfall: An elevated VL is not acted upon urgently. VL results should be fast-tracked, and women failing their current regimen must be identified early and, if necessary, a regimen switch made without delay. |