Address the supply and demand barriers limiting access to immediate-release flucytosine and liposomal amphotericin B in low- and middle-income countries
current phase of drug development
updated 1 Mar 2022
Cryptococcal meningitis is one of the leading causes of death in people with advanced HIV. About 180,000 people a year, mostly in Africa, die from HIV-related cryptococcal meningitis. While undiagnosed and untreated fungal meningitis is fatal, over 70 percent of people can survive if they receive early and optimal treatment. However, despite advancements in access to antiretroviral therapy, many low- and middle-income countries (LMICs) have no access to diagnostics, such as the cryptococcal antigen lateral flow assay (CrAg LFAs), and essential medicines, including immediate-release (IR) flucytosine (5FC) and amphotericin B (AmB) recommended by WHO for the treatment of cryptococcal meningitis.
Results from the AMBITION-cm study released at the 11th IAS conference in 2021 demonstrated that single, high-dose liposomal amphotericin B (LAmB), given with flucytosine and fluconazole, is as good in avoiding death after 10 weeks as the current WHO-recommended standard of care. Moreover, this combination was associated with a significant reduction in adverse events. As with 5FC, access to LAmB, which is also recommended for use across several other diseases including visceral leishmaniasis, is extremely limited in LMICs.
In collaboration with key partners, DNDi plans to address access barriers for the IR 5FC formulation and LAmB to unblock market failures limiting access to the two medicines in LMICs. Key priorities include identifying alternative quality-assured manufacturers of injectable LAmB, implementing activities to bring at least one product to the LMIC market, and tracking progress toward improved access to reach public health targets. In addition, we will undertake demand creation activities for both LAmB across key indications and IR 5FC for cryptococcal meningitis, alongside implementing mechanisms to track progress towards public health targets for advanced HIV disease.
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