Model-informed microarray patches design for anti-retroviral drugs to treat children with HIV

The main questions to address in this collaboration were regarding the patch size and the dosing regimen to select for 4 different anti-retroviral drugs. The context was a feasibility project for developing model-informed microarray patches (MAP) for anti-retroviral drugs to treat children with HIV and eventually support drug selection.

19.06.2023

About the case

  • Therapeutic area: Infectious disease
  • Phase IV
  • Impact of Model Informed Drug development: Informing

Conclusion

The deliverable was used to support Go-No Go decision for the development of MAP with anti-retroviral drugs to treat children with HIV and was submitted to NIH. PATH has obtained a 3-years founding from NIH to pursue this work.

Estimated-monthly-patch-sizes
  • Main challenges were the initial lack of information of the Map release performance, the complex pharmacokinetics properties of the pre-selected anti-retroviral drugs, and the challenging timelines driven by the interaction with NIH.
  • Pharmetheus performed hands-on modelling and prepared the deliverable to be shared with NIH.
  • Methodologically, a physiologically based pharmacokinetics (PBPK) approach was chosen for this analysis to handle the complex pharmacokinetics of anti-retroviral drugs, the need of age-dependent scaling of ontogeny, and the physiology and scaling of the site of application.

Linked publications

[1] PAGE 30 (2022) Abstr 10101