In 2023, an estimated 39.9 million people globally were living with HIV, there were 1.3 million people who acquired HIV, and 630,000 people died from AIDS-related illnesses worldwide (World Health Organization [WHO]). Among people living with HIV (PLWH), morbidity and mortality is increasingly driven by co-infections. The risk of tuberculosis (TB) progressing from latent to active disease is estimated to be up to 20 times greater in PLWH than among those without HIV, with fatality rates of 16-35%. For HIV-associated hepatitis, WHO estimates that 2.6 million PLWH are also living with Hepatitis B Virus (HBV) and 2.75 million are also living with Hepatitis C Virus (HCV) worldwide.
Given the burden of life-long HIV treatment regimens and need for prevention modalities with longer windows of protection and/or less frequent administration, long-acting/sustained release (LA/SR) antiretrovirals represent a major therapeutic advancement for PLWH. Through maintaining consistent and effective drug levels for extended periods of time and providing effective drug concentrations at reduced drug dosing intervals, LA/SRs are able to significantly simplify dosing requirements, enhance convenience, improve adherence, and have the potential to reduce emergence of drug resistance and conceivably lower the associated costs of healthcare overall. Therefore, support for Investigational New Drug (IND)-enabling pre-clinical activities to rapidly advance lead LA/SR formulations to clinical trials is needed.