Geneva and Washington – Thanks to a licence agreement announced today between the Medicines Patent Pool (MPP) and the University of Washington (UW) through CoMotion, people living with HIV in low- and middle-income countries (LMICs) might, one day, be able to get a monthly injection that will offer an alternative method of delivery to existing oral therapies.

The licence covers the patents and expertise relating to a long-acting injectable (LAI) drug combination candidate that is being developed for use in HIV treatment, with support from Unitaid. The LAI formulation is enabled by UW’s drug combination nanotechnology. Currently at a pre-clinical stage, the LAI developed by the Targeted, Long-acting and Combination Anti-Retroviral Therapy (TLC-ART) program based at UW has the potential to transform the WHO-recommended daily oral dosage of TLD (tenofovir/lamivudine/dolutegravir) into a simple subcutaneous monthly injection. This LAI candidate, if proven safe, effective, and acceptable, could contribute to reducing pill burden, improving adherence for certain people, and reducing stigma associated with the necessity of taking daily pills.

“The fixed-dose combination of tenofovir, lamivudine and dolutegravir (known as TLD), in its oral form, is the preferred WHO-recommended first-line regimen for HIV treatment.  Thanks to our licensing agreements with ViiV Healthcare and the work of our partners, around 10 billion doses of dolutegravir-based products had been distributed at affordable prices in LMICs by the end of 2020,” said Charles Gore, Executive Director of MPP. “The LAI being developed by UW offers an exciting new avenue for HIV treatment which could complement our current efforts. We are very proud to be partnering with UW and Unitaid through the GLAD project to ensure these innovations, if proven safe and effective, are available in LMICs as soon as possible.”

28.2 million people worldwide are currently on antiretroviral therapy.  Streamlining antiretroviral treatment could simplify treatment for people living with HIV and help them stay on antiretroviral therapy, which keeps the virus suppressed and prevents the risk of transmission and further infections.

“Long-acting technologies are the next frontier for sustained suppression of HIV worldwide, and we are delighted to sign this licence agreement to ensure our innovation, if proven effective and safe, will be made available in LMICs,” said Prof. Rodney Ho, Director of the TLC-ART program and the GLAD project at UW’s Department of Pharmaceutics. “UW’s three-drug combination in one injection is based on a drug-combination nano-particle platform (DcNP) technology which allows up to four drugs to be integrated into a single injectable suspension and can be scaled up for generic manufacturing production, thus ticking all the boxes for effective, easy to administer, affordable access in LMICs.”

“A long-acting alternative to HIV treatment could free patients from daily pills, make it easier to start and stay on medicines and reduce the burden on health systems. Unitaid is proud to support efforts that we hope will provide additional options, reach more people and contribute to achieving the UN goal that 95% of all people who know their HIV status receive treatment,” said Dr Philippe Duneton, Executive Director of Unitaid.

The licence agreement covers all low- and middle-income countries and is royalty free in both public and private markets.

More information on the licence agreement

More information on MPP’s work in long-acting therapeutics