December 16, 2019

Research Roundup: GSK seeks licensing for child-friendly HIV pill, reports say TB R&D funding still falling short, and Gavi to stockpile Ebola vaccines

Ansley Kahn
Senior Program Assistant
PATH/Evelyn Hockstein

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British drug maker GlaxoSmithKline (GSK) applied for a license to market its HIV drug, dolutegravir, in a child-friendly formulation that, if approved by regulators, will become the first new generation HIV medicine available in a child-friendly form. Developed by GSK’s HIV drug division ViiV Healthcare, this new formulation of dolutegravir is designed to be easier for babies and children to swallow. Because there is no licensed version of dolutegravir for children, doctors often prescribe older HIV medicines that can be less potent, harder to take, and have more side effects. GSK plans an initial rollout of the child-friendly formulation at “cost of production” early next year, pending licensure by US and European regulators, and is also planning licensing agreements with two generic drug makers who aim to make cheaper versions of the medicine available within months of the initial rollout. According to UNAIDS, approximately 1.7 million children are living with HIV, most of them in sub-Saharan Africa.

According to reports released by Treatment Action Group (TAG) and the Stop TB Partnership, global funding for tuberculosis (TB) research and development (R&D) has reached an all-time high, though funding targets for efforts to eliminate the disease remain far from being met. According to the TAG report, TB R&D funding reached its highest level in 2018 at US$916 million, representing three consecutive years of funding increases. However, the Stop TB Partnership’s updated Global Plan to End TB—which aligns with the commitments made at the United Nations High-Level Meeting on TB in September 2018—calls for $2.6 billion per year for R&D for new diagnostics, drugs, and vaccines, in addition to the $13 billion needed for TB prevention and care. The Stop TB Partnership notes that reaching these funding goals would help provide care for 40 million people living with TB, enable 30 million to get preventive treatment, and put new diagnostics and treatment tools within reach by 2030.

A new program approved by the board of Gavi, the Vaccine Alliance (Gavi), will fund a global emergency stockpile of Ebola vaccines that will be open for use by those in need of outbreak and prevention efforts. The program will be funded for $178 million through 2025 and will focus on low- and middle-income countries who will have access to the stockpile free of charge and will also receive support for the operational costs of vaccination campaigns. The World Health Organization’s SAGE Working Group on Ebola Vaccines and Vaccinations state that the stockpile should maintain 500,000 licensed doses of vaccines. In addition to the Ebola vaccine stockpile, Gavi will allocate another $1.6 million in funding for the RTS,S malaria vaccine implementation program from 2021-2023, which is ongoing in three African nations, which will evaluate the vaccine’s effectiveness in reducing childhood deaths when used in real word settings.