Regulatory Focus™ > News Articles > 3 > MSF to WHO on Updated Guideline: Those Who Need These Medicines Cannot Afford Them

MSF to WHO on Updated Guideline: Those Who Need These Medicines Cannot Afford Them

Posted 07 March 2018 | By Zachary Brennan 

MSF to WHO on Updated Guideline: Those Who Need These Medicines Cannot Afford Them

The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) on Wednesday took issue with updated guidelines from the World Health Organization (WHO) on treating cryptococcal disease.

According to the WHO, cryptococcal disease is an infection that occurs primarily among those with advanced HIV disease.

“By far the most common presentation of cryptococcal disease is cryptococcal meningitis, which accounts for an estimated 15% of all AIDS-related deaths globally, three quarters of which are in sub-Saharan Africa. An estimated 223,100 cases of cryptococcal meningitis resulted in 181,100 deaths among people living with HIV in 2014,” WHO said.

MSF, however, is raising concerns that the updated WHO guidelines include recommendations for a combination of amphotericin B deoxycholate and flucytosine as the first-line treatment option. The price of flucytosine is approximately $120 for a week-long course, which makes it out of reach for many, especially in sub-Saharan Africa, MSF said.

WHO acknowledges in the guidelines that flucytosine had just three manufacturers in 2017 and “is not registered and largely unavailable in most low- and middle-income countries, especially in sub-Saharan Africa ... Although registering standard formulations of flucytosine is the current priority, 100 mg/kg/ day dosages of flucytosine given four times a day are problematic in resource-limited settings, and WHO has issued a Prequalification Expression of Interest for slow-release formulations of flucytosine that may permit twice-daily dosing.”

GUIDELINES FOR THE DIAGNOSIS, PREVENTION AND MANAGEMENT OF CRYPTOCOCCAL DISEASE IN HIV-INFECTED ADULTS, ADOLESCENTS AND CHILDREN

MSF

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe