Welcome
Keynote: Carl Dieffenbach, Director, Division of AIDS, NIAID, NIH
December 2022 – Injectable Cabotegravir for HIV prevention receives a Grade A from the US Prevention Services Task Force, making it eligible for coverage by health plans under the Affordable Care Act.
The goal of LA formulations is to improve outcomes – chronic diseases are perhaps most amenable to this approach.
- Maintains more even drug levels, which is safer and minimizes side effects.
- Supports medication adherence.
- Changes the dynamics from one pill once a day to one injection lasting 4 weeks, 8 weeks, 12 weeks, and someday up to 6 months.
- Reduces stigma related to pill-taking and privacy, especially in vulnerable populations (children, adolescents, pregnant women, and people who inject drugs).
LEAP assists investigators working on LA approaches.
- LA development is complex, entails significant scientific and financial risk, and the field moves slowly – studies must encompass the time the drug is present in the body, adding time and cost.
- Centralizing and sharing information facilitates solutions to common problems in the development of LA products and accelerates development.
- We learn from each success and failure.
Looking forward to future challenges.
- LA formulations for chronic diseases relevant to PLHIV – a single-dose hepatitis C virus cure should be possible and LA TB treatment may be possible.
- Progress in HIV should continue to seed development in other fields of medicine and yield a more straight forward path to a LA product.
- Can we develop rules to guide medicinal chemistry in a more targeted way to achieve high therapeutic index and long biological half-life?
- How can rapid clearance and inherent long-term toxicities due to chemical structure be avoided?
et us continue the principles of LEAP to foster innovation.
- Serving as a resource to share knowledge to create a robust pipeline of concepts for HIV.
- Helping advance LA and sustained concepts to address unmet medical needs for other important comorbidities of PLHIV as well as applications in other fields of medicine.
“LEAP facilitates development of new and existing compounds because our knowledge base is so much greater… each new product that has been conceived and developed teaches us something new.”