Availability of life-saving antifungal therapies

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The Global Action Fund for Fungal Infections (GAFFI) has compiled a report on the availability of antifungal therapies worldwide.

The world is in the grip of a global crisis that kills the equivalent of the populations of Philadelphia, Kampala or Prague – around 1.6m each year. Fungal infections attack the lungs and may spread through the body and, without the drugs to fight back, claim the lives of over 3,500 people every day. Now GAFFI (The Global Action Fund for Fungal Infections) has gathered together the most powerful weapon there is – knowledge – information that it plans to use to bring about change.

It has published the largest survey ever undertaken from 159 countries and found that two critical antifungal medicines for Aids patients are not available in over 95 countries. One of these antifungals has been available since the 1950s and the other since the 1970s.

Professor David Denning of the University of Manchester, president of GAFFI and the paper’s lead author says it beggars belief that hundreds of millions of people cannot access the optimal therapy for fungal meningitis and fungal lung infections. “It is doubly tragic,” he said, “That these antifungals have been used since the late 1950s in the case of amphotericin B. Yet the systems for delivering these drugs to the most needy are still not in place.

“Last year GAFFI called on governments to provide fungal diagnostics and antifungal drugs to all their citizens yet there has been a deafening silence. There is clearly a long way to go, but the tragedy is that every day thousands more people die needlessly while the world turns a blind eye,” he added.

Actor and GAFFI celebrity patron Rupert Everett declared that: “We have known for over 25 years that many people with Aids and cancer do die of fungal complications. And death is avoidable with treatment. Why on earth are commonly used antifungal medicines not provided to everyone who needs them?”

Dr Glenda Gray, president and CEO of the South African Medical Research Council and professor of paediatrics, faculty of health sciences, at University of Witwatersrand, said: “In South Africa we are addressing the HIV epidemic squarely on with greatly increased provision of anti-retroviral drugs and expanding testing.

“Fungal diseases in Aids have not received the priority they should have, although this is now changing with our national screening programme for Cryptococci meningitis. Clearly ensuring antifungal agents are available to all is a key component in reducing deaths and illness across southern Africa.”

Key findings of the study are that one of the critical drugs for fungal meningitis in Aids (amphotericin B) is not available in 42 countries. The other key drug for fungal meningitis, flucytosine, is unavailable in at least 95 countries. Yet both have been available in Europe and the US for over 40 years.

The World Health Organisation recommends they be used together to bring down mortality from 100% to 25%. Fungal meningitis is the commonest form of meningitis in sub-Saharan Africa because of Aids.

The 25 -year old drug, fluconazole is available in all countries and itraconazole is unavailable in just five countries. However, being available is not enough – price also matters as patients pay for their care in many countries. The daily cost of fluconazole varied from <$1 to $31 and itraconazole from <$1 to $102. In South Africa, which has the largest Aids burden in the world and a massive TB problem, itraconazole costs about £11.60 per day – unaffordable for most people there.

Abstract
Background: Antifungal therapy saves lives, if given early in life-threatening invasive infection, and also greatly reduces morbidity in hundreds of millions of patients worldwide.
Objectives: We have partially mapped by country systemic generic antifungal drug registration, availability and daily cost for intravenous deoxycholate amphotericin B (50 mg), flucytosine (5 g), oral fluconazole (750–800 mg) and oral itraconazole (400 mg).
Methods: Multiple publically available resources and local country contacts provided data for 159 countries with populations >1 million.
Results: Amphotericin B is not licensed in and unavailable in 22 of 155 (14.2%) and 42 of 155 (27.1%) countries, respectively, representing an unserved population of 481 million. The daily price of deoxycholate amphotericin B varied from <$1 to $171. Fluconazole was licensed in all 141 (88.6%) countries for which data were available although 2 countries appear wholly dependent on the Diflucan® Partnership Program, which is restricted to HIV/AIDS patients. The daily price of fluconazole varied from <$1 to $31. Itraconazole is not licensed in and unavailable in at least 3 of 123 (2.4%) and 5 of 125 (4.0%) countries, respectively, representing an unserved population of at least 78 million. The daily price of itraconazole varied from <$1 to $102. Flucytosine is not licensed in and is unavailable in 89 of 125 (71.2%) and 95 of 125 (76.0%) countries, respectively, representing an unserved population of 2898 million. The daily price of flucytosine varied from $4.60 to $1409.
Conclusions: National governments without access to antifungal drugs should address this health system deficiency urgently to improve clinical outcomes from serious fungal disease. The variability in the price of antifungals between countries is striking.

Authors
Matthew Kneale, Jennifer S Bartholomew, Emma Davies, David W Denning

University of Manchester material
Journal of Antimicrobial Chemotherapy abstract


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