Gilead Sciences Statement on Positive Phase 3 AMBITION Study Findings for the Treatment of HIV-Associated Cryptococcal Meningitis
Foster City, Calif., July 21, 2021 -- Gilead Sciences welcomes the positive findings of the AMBITION clinical trial that were presented today at the 11th International AIDS Society (IAS) Conference on HIV Science. The study found that an investigational dosing regimen of a single dose of AmBisome® (liposomal amphotericin B) given with 14 days of flucytosine and fluconazole is non-inferior to the current standard of carei of seven days of amphotericin B plus seven days of flucytosine, followed by seven days of fluconazole, in the treatment of HIV-associated cryptococcal meningitis (CM).
“The results of the AMBITION trial have important implications for resource-limited countries where there is a high prevalence of advanced HIV disease (AHD),” said Professor Joe Jarvis of the London School of Hygiene and Tropical Medicine and Botswana Harvard AIDS Institute Partnership, AMBITION trial chief investigator. “This has the potential to transform the management of CM in HIV programs in Africa. We now need to get key stakeholders together, including private and public partnerships in our fight against AHD and to end CM deaths by 2030.”
Gilead will continue to provide AmBisome for the treatment of HIV-associated CM at non-profit pricing in high burden countries. The company is also in discussions with several global health organizations and key stakeholders to help bring together a working group to build a sustainable global response.
“We are committed to working across industry, governments, the healthcare community, NGOs and patient advocacy groups to identify solutions that will achieve lasting and sustainable change. All of these stakeholders together must set a collective and ambitious goal, with a sustainable framework for action in which outcomes are transparently monitored and reported," said Harald Nusser, PhD, Vice President, Head of Global Patient Solutions at Gilead Sciences.
AMBITION was led by researchers from the London School of Hygiene and Tropical Medicine. Gilead donated study drug for the trial through the company’s Investigator-Sponsored Research program.
AmBisome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other product components unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk. For information about the use of AmBisome in the U.S., please see the full Prescribing Information available at www.gilead.com.
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i World Health Organization. Guidelines for the Diagnosis, Prevention and Management of Cryptococcal Disease in HIV-Infected Adults, Adolescents and Children.