HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
10. Set up a clinical study to determine in young children co-infected with HIV and TB to determine if dose adjustments are needed when the 4-in1 is used with a rifampicin-containing regimen.
11. Facilitate a clinical study to determine safe and efficacious dosage of the 4-in-1 in neonates.
58. Support MOHs to accelerate the introduction and roll out of optimized formulations in at least 6 countries: Kenya, Uganda, Tanzania, Senegal, Burkina Faso and Cameroon.
63. Work with ARV Procurement Working Group to ensure coordination of demand and supply of 4-in-1 and LPV/r pellets.
Commitment 10:
April 2021
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Study did not take place after consultation with various HIV stakeholders including WHO, investigators of the study, leading paediatricians in Africa, pharmacologist and DNDi Scientific Advisory Council
Commitment 11:
April 2021
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Completed
25. DNDi commits to continue supporting efforts to improve sustainable in-country access to 2-in-1 LPV/r by providing technical support on use of LPV/r pellets and granules through collaboration with Unitaid, APWG, other GAP-f partners, PEPFAR, MoHs, and HIV stakeholders in country.
26. DNDi, ICAP, and EGPAF commit to collaborate on product uptake for solid oral dosage forms of
LPV/r (2-in-1’s and 4-in-1), including:
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Development of healthcare workers’ training tools based on implementation research data generated by DNDi; and
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Acceleration of product uptake in selected countries with engagement of all stakeholders including MOH, civil society, FBOs, and communities of people living with HIV, and to share the training toolkit and experience by disseminating information globally.
Commitment 25:
June 2020
LPV/r uptake:
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DNDi has worked with Baylor’s College in Malawi to adapt video of administration of pellets to local context, in local language (chichewe), for wide dissemination by mobile phone. Malawi is now transitioning to LPV/r granules.
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DNDi provided support to the introduction of LPV/r granules in Tanzania via collaboration with EGPAF where 40 sites have been trained and remaining 62 sites to be supported in 2020.
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DNDi worked with Ministry of Health Ethiopia to adapt video of administration of pellets to local context, in local language (Amharic), for wide dissemination by mobile phone.
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DNDi provided support on training tools and training for South African Health care workers on LPV/r pellets.
Commitment 26:.
June 2022
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On May 24th, 2022, the South African Health Products Regulatory Authority (SAHPRA) approved the 4-in-1 for the treatment of children with HIV.
April 2021
4-in-1 development:
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Dossier of fixed dose combination of ABC/3TC/LPV/r 30/15/40/10mg granules is currently under FDA review with goal date of August 19, 2021 and pending inspection of Goa site.
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A study with 4-in-1 in children living with HIV weighing ≥3 and <25 kg is in Uganda to assess the pharmacokinetics, safety and acceptability of the new is now complete. Results will be published in 2021.
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DNDi is collaborating with EGPAF, ICAP and EVA in 6 countries (Kenya, Uganda, Tanzania, Senegal, Burkina Faso and Cameroon) in supporting the uptake of the LPV/r heat-stable formulations in country and to ensure smooth and rapid transition from 2-in-1 to 4-in-1 when 4-in-1 receives USFDA tentative approval.
June & October 2020
4-in-1 development:
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Two 4-in-1 relative bioavailability studies in adult healthy volunteers, required for USFDA filing of the 4-in-1, started in May 2019 and were completed in July 2019. Application currently under FDA review. Goal date is December 2020.
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A study with 4-in-1 in children living with HIV weighing ≥3 and <25 kg is ongoing in Uganda to assess the pharmacokinetics, safety and acceptability of the new. The study should complete by early 2021.
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DNDi is working with Stellenbosch University (Cape Town, South Africa) and Cipla to set-up the PETITE study in South Africa; this study aims to assess the pharmacokinetics of the 4-in-1 in the neonatal population. The recruitment has started in September 2020.
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DNDi is collaborating with EGPAF, ICAP and EVA in 6 countries (Kenya, Uganda, Tanzania, Senegal, Burkina Faso and Cameroun) in supporting the uptake of the LPV/r heat-stable formulations in country and to ensure smooth and rapid transition from 2-in-1 to 4-in-1 when 4-in-1 receives USFDA tentative approval. Training toolkit and administration materials for 4-in-1 are developed.
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DNDi, ICAP and EGPAF convened a consultative meeting with Country (Paediatric) HIV programme managers / focal persons and key experts in paediatric HIV held on 28th July 2020. The main goal of the meeting was to deliberate with country HIV program managers, paediatric HIV experts in countries and key partners, on lessons learnt from past paediatric HIV transitions and planning for future transitions given the planned availability of newer and better ARV formulations that will include the 4in1 and paediatric Dolutegravir in the near future.