Research Roundup: FDA approves monthly injectable HIV treatment, US recommits to WHO and joins COVAX, and Eli Lilly says antibody can prevent COVID-19 infection
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The US Food and Drug Administration (FDA) on Thursday approved Cabenuva as the first long-acting injectable HIV treatment for patients in stable condition. Cabenuva—a combination of cabotegravir and rilpivirine, injected separately—was shown in clinical trials to suppress HIV to undetectable levels for two years when administered once a month. The monthly injectable medication regimen, developed by ViiV Healthcare, will pose an alternative to existing HIV treatment methods that require daily pills. However, the Cabenuva approval covers only stable HIV patients—those who took daily pills and had undetectable HIV levels before entering the trial—while an ongoing trial is evaluating its efficacy in people unable to take regular oral medications. The list price of the newly approved treatment is roughly $6,000 for the initial dose, followed by around $4,000 per month.
Newly inaugurated President Joe Biden last week reversed the former administration’s request to withdraw the United States from the World Health Organization (WHO) and indicated the country will support the WHO-led Access to COVID-19 Tools (ACT) Accelerator, including its global vaccine initiative known as COVAX. The ACT Accelerator aims to ensure all countries have access to COVID-19 treatments, diagnostics, and vaccines, with COVAX intending to secure and distribute 2 billion vaccine doses by the end of 2021—a goal for which fundraising targets remain unmet. The United States has historically been the largest donor to WHO, providing financial support for a wide range of program areas, including pandemic preparedness. In remarks during the WHO Executive Board meeting Thursday, Dr. Anthony Fauci announced the United States’ commitment to WHO and the global COVID-19 response, and WHO Director-General Tedros Adhanom Ghebreyesus welcomed the renewed partnership.
On Thursday, Eli Lilly announced its monoclonal antibody prevented COVID-19 infections in a clinical trial among nursing home residents and facility staff. The trial results, released in a press release from the company and currently not published or peer reviewed, showed symptomatic COVID-19 infections were reduced by 57 percent among all participants and by 80 percent among just nursing home residents. Eli Lilly’s chief scientific officer emphasized that the antibody should not be seen as competition to vaccines, but that it could be useful during COVID-19 outbreaks in places vaccines have not reached. The antibody, bamlanivimab, was authorized by the FDA in November to treat COVID-19 patients at risk of severe disease, and Eli Lilly plans to discuss with the FDA whether a new emergency authorization is needed for use in COVID-19 prevention.