Many countries do not have any antifungals for GAFFI’s target diseases, or the price is excessive. One of the key drugs, amphotericin B, takes some experience to use, and training is required. Flucytosine and natamycin eye drops are not registered in many countries, especially sub-saharan Africa, and so are unavailable. Itraconazole is approved, but not used, and is too expensive for long term use. It is also best monitored to ensure adequate concentrations in blood. The reliability of generic itraconazole formulations is not known
GAFFI will recommend and ensure that the following antifungal drugs are available to all countries that need them, based on caseload, at reasonable prices. GAFFI’s antifungal priorities are summarised below:
|Antifungal||Fungal infection(s)||Infection impact||Ease of use||Need for monitoring||Cost|
|Amphotericin B (IV)||Cryptococcal meningitis induction||Large||Medium||Renal function||Variable|
|Flucytosine (oral)||Cryptococcal meningitis induction||Moderate||Medium||Blood levels, unless short course||Variable|
|Liposomal amphotericin B (IV)||Histoplasmosis in AIDS||Large, as best agent of very ill patients||Medium||Almost none||High|
|Itraconazole (oral)||CPA, ABPA, SAFSHistoplasmosis||ModerateLarge||Medium||Blood levels, liver tests||Moderate|
|Natamycin (eye drops)||Fungal keratitis||Large||Easy (frequent)||No||Not available in most countries|
ACCESS TO ANTIFUNGAL MEDICINES
GAFFI’s vision to make at least generic antifungal agents available to at least 95% of the population by 2025 is in its ’95-95 by 2025’ Roadmap.
GAFFI has now mapped antifungal registration, availability and price for 4 key generic antifungals – amphotericin B, fluconazole, itraconazole and flucytosine – and made this publicly available (www.gaffi.org/why/burden-of-disease-maps/). Amphotericin B, fluconazole and flucytosine are now on the WHO Essential medicine List. GAFFI has re-applied for itraconazole capsules to be placed on this list (link).
In summary as of April 2016, the following table summarises antifungal availability for the countries that GAFFI could identify data for (Kneale et al. In press):
|Disease/status||Intravenous only||Intravenous and oral|
|Countries where not licensed||22/155 (14.2%)||0/143||4/121 (3.3%)||89/123(72.4%)|
|Countries where not available||42/155 (27.1%)||1/133 (0.75%)*||8/121 (6.6%)||94/120 (78.3%)|
|Population with no access to antifungals||480,963,000 (6.62% World)||22,920,000 (0.32% World)||151,652,000 (2.09% World)||2,898,245,000 (39.9% World)|
GAFFI is working with partners to improve access to these medicines.