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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

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WHO guidance on TLD (July 2019)

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WHO guidance on TLD (July 2019)

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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).

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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

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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.”

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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.
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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

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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

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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

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I thank you!

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