The Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP) provides broadly based scientific support to accelerate the development of novel drugs, formulations, and technologies for the treatment and prevention of HIV and related epidemics. The LEAP Process to facilitate drug and formulation development begins with a landscape analysis, identifying knowledge gaps and barriers, simulating best product characteristics, communicating potential solutions, and then tracking product outcomes. The Program serves as a focal point for the global conversation on the development of LA/ER formulations, and has brought many of the world's key stakeholders into this conversation. LEAP's seminal accomplishments include foundational input for FDA draft guidance on the development of LA/ER formulations for HIV; promoting development of the first candidate LA/ER formulations for tuberculosis and malaria; organizing the first conference on use of LA/ER formulations for HIV in children, adolescents, and pregnant women; producing the first publically accessible website devoted to LA/ER anti-infective products and strategies; and supporting development of novel devices like anti-HIV implants and microneedles through its Modeling and Simulation Core. Established in 2015, LEAP is now poised to apply its acquired expertise to new challenges. During the next five years, we will leverage the infrastructure we have created to: 1) apply our scientific resources to identify and facilitate development of the most promising new drugs and drug delivery platforms in order to overcome the limitations of available products; 2) build upon our existing modeling and simulation expertise to develop better ways to more rapidly identify those approaches with the most desirable pharmacologic properties; and 3) expand the scope of LEAP to include diseases that overlap the HIV epidemic, where the availability of LA/ER drugs and formulations could most profoundly affect treatment and prevention ? specifically, tuberculosis, hepatitis B virus, and hepatitis C virus infections. Expected outcomes include an increased number of new long-acting drugs and formulations in preclinical and clinical development, enhanced funding mechanisms to bring more such products into testing, and accelerated pathways for more rapid translation of laboratory-based research into clinical trials and eventual drug approvals.
Current treatment and prevention of HIV, tuberculosis, and viral hepatitis requires taking pills every day for long periods of time. LEAP encourages the development of long-acting injectable and implantable drugs by providing access to scientific, pharmaceutical, regulatory, and community-based experts and services. This could results in the replacement of daily oral regimens with products given as infrequently as once per year.
