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    Introduction of TLD in South Africa Yogan Pillay

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    Bhekisisa Health
    In November 2019, South Africa launched a new HIV treatment combo containing the drug dolutegravir. In this presentation, deputy director-general for the South African national health department Yogan Pillay reviews the process of adopting the roll out and new ways government will be monitoring the possible small risk of birth defects that could be tied to the drug.

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    Introduction of TLD in South Africa Yogan Pillay

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    Bhekisisa Health
    12K views14 pages
    In November 2019, South Africa launched a new HIV treatment combo containing the drug dolutegravir. In this presentation, deputy director-general for the South African national health department Yogan Pillay reviews the process of adopting the roll out and new ways government will be monitoring the possible small risk of birth defects that could be tied to the drug.

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    In November 2019, South Africa launched a new HIV treatment combo containing the drug dolutegravir. In this presentation, deputy director-general for the South African national health department Yogan Pillay reviews the process of adopting the roll out and new ways government will be monitoring the possible small risk of birth defects that could be tied to the drug.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    12K views14 pages

    Introduction of TLD in South Africa Yogan Pillay

    Uploaded by

    Bhekisisa Health
    In November 2019, South Africa launched a new HIV treatment combo containing the drug dolutegravir. In this presentation, deputy director-general for the South African national health department Yogan Pillay reviews the process of adopting the roll out and new ways government will be monitoring the possible small risk of birth defects that could be tied to the drug.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 14

    Introduction of TLD in South Africa

    YOGAN PILLAY
    DEPARTMENT OF HEALTH
    Outline of the presentation

    • WHO guidance
    • Advantages of TLD
    • Risk benefit: TEE V TLD
    • Mitigating NTDs
    • Revised guidelines
    • Preparing for Rollout
    • Launch of TLD
    • Conclusions

    2
    WHO guidance on TLD (July 2019)

    3
    WHO guidance on TLD (July 2019)

    4
    Why transition from TEE to TLD for those eligible?

    • “The risk-benefit models suggest that the benefits of DTG for women of
    childbearing potential newly initiating ART, which include greater maternal
    viral suppression, fewer maternal deaths, fewer sexual transmissions and
    fewer mother-to-child transmissions, are likely to outweigh the risks, such
    as adult morbidity resulting from DTG-associated weight gain and neonatal
    deaths among the infants of pregnant women with DTG-associated weight
    gain. DTG is also predicted to be more cost-effective, resulting in more
    disability-adjusted life-years averted at a lower cost than EFV” (WHO, 2019).

    5
    6
    What is the likely impact of dolutegravir (DTG) on neural tube
    defects (NTDs)?
    • NTDs are generally believed to be multifactorial in aetiology, and a number of genetic and environmental factors have
    been implicated and shown to be important in their occurrence and recurrence. The most important environmental
    factor is dietary folic acid; since the fortification of staple foods in SA, the number of affected births has declined by
    about 30% (Teckie, et al, 2013)
    • The background prevalence of NTDs in South Africa after the introduction of folic acid supplementation (maize and
    wheat products) in 2003 was 0.98/1000 births (Krzesinki and Urban, 2019)
    • Data from Botswana showed an increase in NTDs with the use of TLD from 1:1000 to 3:1000 when used at the time of
    conception – until NT closure by the 4th week of pregnancy (WHO, 2019)
    • “Data on birth outcomes, including neural tube defects, among pregnant women exposed to other integrase inhibitors
    are reassuring so far, although the number of prospective periconception exposures is limited and most reports come
    from high-resource settings with national food folate fortification. Continued surveillance is needed to more
    definitively confirm or refute the neural tube defect signal, and several studies are ongoing to address this” (WHO,
    2019)
    • Pregnancy registries will be expanded from the current at KZN (Prince Mysheni Hospital) and in Western Cape
    (Gugulethu and Worcester MOUs) to include sites in Gauteng as well – will be used to monitor NTDs

    7
    Revised SA guidelines

    • “The preferred first-line ART regimen is tenofovir disoproxil fumarate-


    lamivudine-dolutegravir (TLD) for those clients initiating ART, experiencing
    side-effects to EFV, or for those who prefer to use DTG after being given all
    the necessary information.
    • However, due to concerns around safety of TLD in the first 6 weeks of
    pregnancy, tenofovir disoproxil fumarate-emtricitabine-efavirenz (TEE) is
    recommended for women of childbearing potential wanting to conceive. For
    this reason, integration of family planning and ART services are of
    paramount importance, and issues of family planning and contraception
    should be discussed at every clinical interaction to understand the client’s
    current fertility desires and healthcare needs.”

    8
    9
    NHC 3 October 2019
    Proposed TLD guidance for South Africa
    • The guidance was updated to be in sync with 2019 July WHO
    guidance, and addresses the TLD risk, as well as the newly
    identified weight gain signal
    • At this stage, despite robust data from 2 African studies, not
    enough is understood about the mechanism driving weight
    change
    – Local and international studies are planned to investigate
    • Guidelines recommend monitoring weight as well as lifestyle
    changes to address any weight gain; obese patients may be
    considered for EFV.
    10
    Preparing for TLD rollout
    • Establish technical team
    • Ensure sufficient number of suppliers registered with SAPHRA
    • Issue tender to ensure competition and lowest possible prices
    • Consultation and finalisation of ART guidelines (including phone apps)
    • Consultation with women living with HIV and civil society led by WHO
    • Strengthen pregnancy registry and overall pharmacovigilance
    • Development of IEC material
    • Re-training health workers on the new guidelines
    • Strengthening supply chain
    • Presentations and approval by the NHC

    11
    Launch of TLD & post-launch activities

    • Launch date: 27 November 2019


    • Launch district: Ugu
    • All provinces to fully roll out TLD by March 2020, starting 1 December
    • Monitoring of rollout by NDOH
    o Quality of training and initiation (esp. quality of info provided for
    decision-making)
    o Supply chain (to ensure no stockouts)
    o Reactions of patients to the new FDC (including adverse reactions)
    • Monitor new research for evidence of expanded use of TLD

    12
    Take home messages

    • Advances in new, safe, affordable ARVs are important – investing in


    local research, and using evidence to inform practice
    • TLD has undergone significant assessments and WHO guidance
    useful to countries
    • SA guidelines: women to be provided all information necessary to
    make decisions
    • Opportunities to better integrate and strengthen family planning and
    TB prevention services
    • Ongoing support and implementation monitoring critical

    13
    I thank you!

    14

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