GAP-f progress update – September 2018

Satellite session at AIDS 2018

The GAP-f satellite session at AIDS 2018 presented key principles for acceleration – and how these are brought together by the GAP-f – for different areas of the continuum, with a focus on: (1) prioritization and clinical research of priority formulations, (2) development and regulatory approval of paediatric drug formulations, and (3) uptake and procurement of optimal formulations for children. Panellists discussed the value and opportunities for an integrated approach to paediatric medicines and the business case and ideas around innovative funding to move the initiative forward. WHO announced its commitment to co-lead the GAP-f initiative with CHAI and work closely with partners to refine and initiate the GAP-f business plan.

See slide sets and watch the recording here | See pictures here

Toolkit for research and development of paediatric antiretroviral drugs and formulations

Various efforts have enabled better alignment and convergence around key principles in paediatric drug development. These principles now need to be crystallised and promoted, so that higher standards in paediatric drug research and development can be ensured. The toolkit was initiated by the WHO and its Paediatric ARV Working Group (PAWG) in collaboration with Unitaid, IMPAACT and PENTA. The toolkit identifies the challenges and outlines possible solutions for promoting and accelerating timely and high-quality research and development of antiretroviral drug formulations suitable for infants, children, adolescents, and pregnant and breastfeeding women.

Access the toolkit here | Access an online version with slide sets here

Join one of our dissemination webinars covering different modules of the toolkit:

  • Trial design / Pharmacokinetic modelling / Coinfections – 4 October, 14:00-15:30 CET – Register here | See agenda here
  • Acceptability / Target product profile / Product commercialization – 16 October, 14:00-15:30 CET – Register here
  • Regulatory filing / Pharmacovigilance – 8 November, 14:00-15:30 CET – Register here
  • Community engagement – 16 November, 14:00-15:30 CET - Register here
  • Pregnant and breastfeeding women – 30 November, 14:00-15:30 CET – Register here

2018 optimal formulary and limited-use list for paediatric ARVs

The WHO 2018 guideline update promotes the use of optimal treatment regimens in all populations. Though new, more effective and better tolerated options with a higher genetic barrier to resistance are now available for adults, optimized treatment options for children lag significantly behind.

This fifth edition of the optimal formulary and limited-use list supports the transition to optimal WHO-recommended regimens for infants and children, while giving due consideration to the rapidly evolving treatment landscape and the risks inherent in the uncertain timelines for paediatric drug development.

Read the policy brief here

Transitioning to an optimal paediatric ARV formulary: Implementation considerations

Antiretroviral treatment (ART) optimization is a key pillar in the AIDS Free agenda to reach the goal of ensuring 95% of all infants and children have access to lifesaving treatment.

This policy brief outlines key considerations to facilitate effective transition to more clinically appropriate regimens as optimal ARV medicines and dosage forms become available.

Read the policy brief here

Webinar for francophone countries on optimal paediatric ARV formulations

On 9 October, 10:00-11:30 GMT, the ARV Procurement Working Group (APWG) will host a webinar for francophone West and Central Africa on optimal paediatric ARV formulations. The webinar will cover the 2018 WHO recommendations and 2018 optimal formulary and limited-use list for paediatric ARVs. Supply chain challenges and mitigation strategies will also be discussed.

Register for the webinar here

Supplements in JAIDS and JIAS

Recently, the IAS CIPHER supported the development of two collections of scientific publications focused on paediatric HIV. Both issues feature pieces that promote collaborative efforts to advance research on drug optimization and accelerate development and introduction of priority ARVs :

  • Mind the Gap: Filling Knowledge Gaps in Paediatric and Adolescent HIV for an AIDS Free Generation – JAIDS, 2018, 78(S1)
    Access the supplement here
  • Paediatric and Adolescent HIV and the Sustainable Development Goals: the road ahead to 2030 – JIAS, 2018, 21(S1)
    Access the supplement here

FDA guidance for industry

Two important FDA guidance documents have been released recently:

Sustaining high-level commitments

Following the High-Level Dialogue on Scaling Up Early Diagnosis and Treatment of Children and Adolescents convened by the Holy See in 2017, stakeholders will re-convene on 6-7 December to review progress and plan efforts to address remaining gaps for paediatric drug formulations. The meeting will also examine challenges and solutions to improving access to innovative, high-quality, and affordable diagnostics for paediatric populations.

Stay in touch and contribute

Efforts to further develop the GAP-f and explore synergies between different stakeholders and disease areas are ongoing, and we welcome your input. Please do not hesitate to be in touch with any question or comment you may have, either by email or through the online form at http://www.gap-f.org/Contact.