Cryptococcal meningitis is one of the leading causes of death in people living with HIV – second only to tuberculosis. It accounts for 15% to 20% of HIV-related deaths.
To understand the complexities involved, we look at the history of access to CM treatment in South Africa.In the early days of the HIV pandemic in South Africa, the only treatment available for CM in the country was the drug fluconazole. To demonstrate how high prices limited access to the life-saving medicine, Zackie Achmat, the former head of the Treatment Action Campaign, imported generic fluconazole into the country in 2000 in defiance of pharmaceutical company Pfizer’s patents on the drug.
Results from the Antifungal Combinations for Treatment of Cryptococcal Meningitis in Africa trial, published in March 2018, showed that the addition of flucytosine to CM treatment regimens improves CM survival at one year to more than 70%. In other words, the addition of flucytosine to treatment regimens for CM cuts deaths by almost half. This is an astounding survival benefit from the simple addition of an old, oral medicine to an existing package of care.
So, why then is it taking so long to roll out flucytosine in South Africa? There are at least five factors involved.In order to provide flucytosine to CM patients, it needs to be manufactured and available for procurement. For many years it simply was not. “We followed up from the HIV Clinicians Society regularly with Sahpra, to make sure that you know that this registration process was fast-tracked… we wrote to Sahpra several times. And I think that helped… [but] it did take two years,” he says.that 250mg and 500mg flucytosine tablets from Mylan were registered in December 2021.
While the department must still negotiate a price with Mylan, it is anticipated that the threshold price will be met, since Mylan is currently supplying flucytosine to the Clinton Health Access Initiative for use in South Africa’s flucytosine access programme at a cost of R1,470 per pack. Each pack contains 100 500mg scored tablets.