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

    Patients who return after stopping antiretroviral therapy
            Key points
    • Many patients return to care after treatment interruption when they experience clinical deterioration – screening for opportunistic infections (OIs) should be performed.
    • VL measurement should be performed before re-initiation, and repeated 3–6-monthly.
    • Choosing the appropriate regimen in patients who return to therapy depends on their previous regimen, their level of treatment adherence prior to disengaging from care, and their current CD4+ count and hospitalisation status.

    It is common for patients receiving ART to interrupt their treatment for a variety of reasons (e.g. treatment fatigue, denial, life event, depression, new job, relocation). Many patients return to care after an interruption, often precipitated by clinical deterioration. Patients who have clinical symptoms of an OI when returning to care should be investigated and, if appropriate, started on treatment for the infection before restarting ART. In particular, patients should be screened for headache and for TB symptoms when returning to care. Reasons for delaying ART re-initiation are the same as for delaying initiation in ART-naïve patients (see Module 6). Patients who are asymptomatic when they return to care could be re-initiated on ART the same day with appropriate counselling. A counselling plan should be implemented to ensure retention in care going forward and to address reasons for disengagement.

    We recommend performing a VL measurement before re-initiating ART, then 3–6-monthly thereafter. The choice of ART regimen to restart will depend on prior treatment history.

    Return after stopping a TDF + FTC (or 3TC) + NNRTI regimen

    In patients returning to treatment after disengaging from a TDF + FTC (or 3TC) + NNRTI regimen:

    • If the patient was treatment-adherent prior to disengaging, with a suppressed VL, and has only disengaged once or twice, then they could either be restarted on the same regimen or restarted on TDF + 3TC (or FTC) + DTG. If a patient restarts an NNRTI-based regimen, then switching to a second-line regimen should be considered if the VL is not < 1000 copies/mL at 3 months after restarting.
    • If the patient has a history of poor adherence with multiple episodes of disengaging from treatment, then we suggest re-initiating therapy with a second-line regimen of: AZT + 3TC + DTG; or AZT + 3TC + PI/r; or TDF + FTC + PI/r. We do not recommend TDF + 3TC (or FTC) + DTG in this scenario, as there may be resistance to TDF and 3TC – multiple episodes of treatment interruption, particularly beyond the first year of ART, and poor adherence can result in resistance to all drugs in the first-line regimen.
    • Hospitalisation with an AIDS-defining condition and a CD4+ count < 50 cells/μL represents another scenario in which a patient may be restarted immediately on second-line ART when returning to care after disengaging. Such patients are considered to be at high risk of mortality if restarted on first-line therapy to which their virus may be resistant; and they require an ART regimen that is guaranteed to be effective immediately. This decision should typically be taken by the hospital-level clinician.
    Return after stopping a dolutegravir-based regimen

    In patients returning to treatment after disengaging from a DTG-based regimen:

    • Restart the same regimen. Assess the VL at 6 months and follow standard guidance in response to the result.
    Return after stopping a TDF + FTC (or 3TC) + PI/r regimen

    In patients returning to treatment after disengaging from a second-line PI-based regimen:

    • Either restart the patient on the same regimen or switch to AZT + 3TC + DTG (if they had failed a first-line TDF + 3TC (or FTC) + EFV regimen). Assess the VL at 6 months and follow standard guidance in response to the result.
    Return after stopping a third-line regimen

    In patients returning to treatment after disengaging from a third-line regimen:

    • Restart the same regimen and assess VL at 6 months. Follow standard guidance in response to the result.

    Common pitfall: Performing a resistance test after an ART treatment interruption of > 4 weeks. Such testing is of limited value. Many resistance mutations are overtaken by wild-type virus when ART is stopped and thus the resistance test may not accurately reflect the true resistance pattern.