Urgent action needed to make recommended treatment accessible to all
NEW YORK/GENEVA, APRIL 20, 2022—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) welcomes the updated World Health Organization (WHO) guidelines for the management of cryptococcal meningitis, an opportunistic fungal infection that is the number two killer of people living with HIV/AIDS after tuberculosis.
“With timely and effective diagnosis and treatment, people living with HIV/AIDS can survive opportunistic infections like cryptococcal meningitis,” said Dr. Freddy Mangana, HIV-TB medical supervisor for MSF in the Democratic Republic of Congo. “We are optimistic that the new treatment regimen recommended in the WHO guidelines will be adopted quickly by countries as it is much simpler to give, can be started immediately in some settings, is better tolerated, and will hopefully lead to shorter hospital stays for many patients.”
The new guidelines endorse a simplified regimen of a single high dose of liposomal amphotericin B (L-AmB) combined with two weeks of flucytosine and fluconazole. While it is critical for all countries to urgently adopt these guidelines to save lives and meet new WHO global targets, access to L-AmB and flucytosine remains a significant challenge in low- and middle-income countries. These drugs are often not included in national guidelines and countries are not submitting requests to the Global Fund to Fight AIDS, Tuberculosis and Malaria and PEPFAR to fund the procurement of these medicines.
To begin addressing the challenges of accessing L-AmB and flucytosine, governments need to: update national cryptococcal meningitis clinical guidance; include these medicines in funding requests to major donors; and increase screening for cryptococcal meningitis among people living with HIV. Governments also need to work with pharmaceutical companies and urge them to increase production and expand registration of these medicines to meet the expected increase in demand as countries start to implement the new guidelines.
“The limited availability of quality-assured L-AmB and flucytosine means that treatment providers working in sub-Saharan Africa struggle to treat people with cryptococcal meningitis, or risk treating them with suboptimal treatments when these medicines are not available,” said Dr. Mangana. “The good news is that this new regimen also uses less L-AmB and requires less monitoring, which could reduce the overall price for countries to implement as compared to the previous L-AmB regimen if urgently adopted into national guidelines.”
Additionally, US-based pharmaceutical corporation Gilead—the main supplier of quality-assured L-AmB—has failed to deliver on its promise of providing this lifesaving medicine at the access price of $16.25 per vial to treat cryptococcal meningitis as promised to 116 countries in 2018. This price would allow for the inclusion of L-AmB at approximately $195 per person under the new recommended treatment protocol. More than three years later, Gilead has still only provided L-AmB to fewer than half of the eligible countries at the access price. Furthermore, Gilead has done little to register L-AmB where it is needed most, with registrations in only two countries in all of sub-Saharan Africa. In addition, despite multiple quality-assured generic manufacturers of flucytosine in the market, few have been registered and made available in low- and middle-income countries.
“This lifesaving treatment remains out of reach and unaffordable for far too many people who need it,” said Jessica Burry, HIV pharmacist for MSF's Access Campaign. “To ensure we meet the new WHO targets for decreasing deaths from cryptococcal meningitis, Gilead needs to do everything it can to make good on its promise to provide L-AmB at their access price. In addition, there needs to be a significant effort from countries to prioritize the use of L-AmB and flucytosine, and from manufacturers to start registering and supplying these medicines.”