ART Guidelines

ART Guidelines

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    /r ritonavir-boosted
    3TC lamivudine
    ABC abacavir
    ADR adverse drug reaction
    AKI acute kidney injury
    ALT alanine transaminase
    ANC antenatal care
    ART antiretroviral therapy
    ARV antiretroviral
    AST aspartate transaminase
    ATV atazanavir
    ATV/r ritonavir-boosted atazanavir
    AZT zidovudine
    bd twice daily
    CD4+ cluster of differentiation 4
    CM cryptococcal meningitis
    CNS central nervous system
    CrAg cryptococcal antigen
    CrCl creatinine clearance rate
    CSF cerebrospinal fluid
    CTX cotrimoxazole
    d4T stavudine
    ddI didanosine
    DILI drug-induced liver injury
    DNA deoxyribonucleic acid
    DRV darunavir
    DRV/r ritonavir-boosted darunavir
    DTG dolutegravir
    eGFR estimated glomerular filtration rate
    ELISA enzyme-linked immunosorbent assay
    ETR etravirine
    FBC full blood count
    FTC emtricitabine
    GI gastrointestinal
    Hb haemoglobin
    HBsAg hepatitis B surface antigen
    HBV hepatitis B virus
    HIV human immunodeficiency virus
    ICU intensive care unit
    INH isoniazid
    INR international normalised ratio
    InSTI integrase strand transfer inhibitor
    IPT isoniazid preventive therapy
    IRIS immune reconstitution inflammatory syndrome
    LAM lipoarabinomannan
    LDL-C low-density lipoprotein cholesterol
    LFT liver function test
    LP lumbar puncture
    LPV lopinavir
    LPV/r ritonavir-boosted lopinavir
    MDRD modification of diet in renal disease
    MTCT mother-to-child transmission of HIV
    MVC maraviroc
    NGT nasogastric tube
    NNRTI non-nucleoside reverse transcriptase inhibitor
    NRTI nucleoside reverse transcriptase inhibitor
    NTDs neural-tube defects
    NtRTI nucleotide reverse transcriptase inhibitor
    NVP nevirapine
    OI opportunistic infection
    PAS p-aminosalicylic acid
    PCR polymerase chain reaction
    PI protease inhibitor
    PI/r ritonavir-boosted protease inhibitor
    PMTCT prevention of mother-to-child transmission of HIV
    PPIs proton pump inhibitors
    PrEP pre-exposure prophylaxis
    QTc corrected QT interval
    RAL raltegravir
    RCTs randomised controlled trials
    RIF rifampicin
    RFB rifabutin
    RNA ribonucleic acid
    RPV rilpivirine
    RTV or /r ritonavir
    sCr serum creatinine
    sCrAg serum cryptococcal antigen
    TAF tenofovir alafenamide
    TAM thymidine analogue mutation
    TB tuberculosis
    TB-IRIS tuberculosis immune reconstitution inflammatory syndrome
    TBM tuberculosis meningitis
    TC total cholesterol
    TDF tenofovir disoproxil fumarate
    TG triglycerides
    TST tuberculin skin test
    UDP uridine 5’-diphospho
    ULN upper limit of normal
    VL viral load
    WHO World Health Organization
    WOCP women of childbearing potential

    Pregnancy and breastfeeding
    It is beyond the scope of these guidelines to provide comprehensive guidance for the management of pregnant women. Key recommendations relating to the mother are included, but providers are encouraged to refer to national guidelines. All women should be linked to routine antenatal care when pregnancy is confirmed.

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    • 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.
    Mother-to-child transmission of HIV

    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’.

    Antiretroviral therapy for women of childbearing potential and during pregnancy and breastfeeding

    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).
    Common pitfall: Not performing VL monitoring at the appropriate time. See Table 22 for the appropriate monitoring intervals.
    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.