Cape Town - Doctors Without Borders (MSF) has slammed the SA Health Products Regulatory Authority (Sahpra) for delaying the registration of an anti-fungal medicine which could help cure meningitis in HIV patients.
MSF and the Treatment Action Campaign (TAC) have called for the registration of flucytosine, which is used to treat cryptococcal meningitis (CM).
The application for the product’s registration has been with Sahpra since December 2019, they say.
MSF said the medicine’s registration could help prevent thousands of deaths of HIV patients who are infected.
Dr Rosie Burton, an infectious diseases physician, said: “Flucytosine is an anti-fungal medicine which is very effective in treating cryptococcal meningitis when used in partnership with other medicines.
“Specifically, having flucytosine means we can give the partner drug, which is called amphotericin B, for one week rather than two weeks, which reduces the risk of side effects from amphotericin B – amphotericin B is a bit toxic,” she said.
CM is a neurological disease mainly affecting those with weakened immune systems due to HIV. Flucytosine has been identified by Burton as the safest option for patients to undergo treatment, but unfortunately it was not registered for use in many African countries.
“The evidence shows that patients receiving the flucytosine-based regimen had 53% reduced odds of death compared to those on other regimens,” Burton said.
Dr Tom Ellman, MSF Southern Africa Medical Unit director, said: “Ensuring that flucytosine is available throughout sub-Saharan Africa is the low-hanging fruit when it comes to preventing deaths from CM, and South Africa has the opportunity to play a leadership role in the promotion of this life-saving medicine. But Sahpra needs to approve its registration.”
Sahpra said the application for registration was still under review.
“The application is at an advanced stage of review,” Sahpra communications manager Yuven Gounden said.
“Sahpra anticipates finalisation soon. However, like any other review, a lot is dependent upon the applicant submitting adequate data to support safety, quality and efficacy. Applicants also need to provide timeous responses to all the queries raised by SAHPRA.”
While registration was awaited, a South African flucytosine clinical access programme was established by MSF in partnership with the National Department of Health in 2018, and later handed over to the Clinton Health Access Initiative.
The access programme aimed to make the medicine freely available to tertiary hospitals in South Africa.
Said Burton: “CM is curable. In fact, with early diagnosis and optimal treatment, mortality could be reduced by over 70%. Achieving this at the population level, by ensuring everyone with the disease was managed well, would help to avert hundreds of thousands of deaths between now and 2030.”