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South Africa’s drug regulator has approved “controlled” access to a controversial parasite drug to treat surging coronavirus infections in the country, saying it will be administered on “compassionate” grounds.
Doctors and advocacy groups had urged the government and the South African Health Products Regulatory Authority (Sahpra) to legalise ivermectin to treat Covid-19 patients, claiming international studies showed it was effective against the virus.
The drug, co-developed by Irish Nobel Prize winner William C Campbell, is used globally to treat parasitic diseases in livestock and humans. But it was registered to treat animals only in South Africa.
However, a campaign to have it legalised for human use has gained traction in recent weeks after it emerged that some doctors had been administering it to seriously ill patients since mid-December, when virus infections in South Africa began to surge.
Earlier this month 100 doctors publicly backed a Durban-based GP who wrote to President Cyril Ramaphosa asking him to set up an urgent special council to conduct a rapid review of the antiparasitic.
In her open letter Naseeba Kathrada said scientific evidence was emerging daily that showed the positive effects of ivermectin on Covid-19 patients.
Afrikaner civil rights organisation Afriforum was also scheduled to take Sahpra and health minister Zweli Mkhize to court next month on behalf of a doctor and two patients who want ivermectin approved for use against Covid-19.
Livestock products
Experts had also warned that people with severe cases of Covid-19 were beginning to take ivermectin-based livestock products to treat their symptoms, because there was a lack of alternative treatments.
The increased demand for ivermectin has led to the emergence of a lucrative black market in South Africa for the drug, according to the authorities.
On January 6th a man was arrested at Johannesburg international airport with 2,500 ivermectin tablets after disembarking a Dubai flight. He has since been charged with the possession of unregistered medicines worth 100,00 rand (€5,400).
Sahpra had indicated earlier this month it would continue to prohibit ivermectin’s full registration for use against Covid-19, saying stronger evidence was needed to support its effectiveness and safety, as the research done so far was limited.
However, the severity of the second wave of Covid-19 to hit South Africa appears to have prompted the regulator to soften its stance, although it has insisted the drug will not be easily available.
Sahpra chief executive Boitumelo Semete-Makokotlela said on Wednesday that medical professionals must apply to it for permission to administer the drug, to ensure they take responsibility for its safety and monitor its efficacy.
‘Promising’ data
Infectious diseases physician Graeme Meintjes said that although the data gathered from the ivermectin studies and trials done to date was promising, it was critical the correct review processes were followed before it became a registered Covid-19 treatment.
“There are still steps to assess the quality of the ivermectin trials that must be followed before we can deem the drug fit for use,” said Prof Meintjes, who leads a research programme at the University of Cape Town’s department of medicine.
“An updated meta-analysis on ivermectin that has been commissioned by the World Health Organisation (WHO), which should be released soon, will give us a much better idea of the drug’s efficacy,” he concluded.
Independent investigators are expected to report back to the WHO on the drug’s potential as a Covid-19 treatment in the coming weeks, and South Africa’s government has said it will follow the body’s advice in relation to it.
South Africa has recorded more than 1.4 million coronavirus infections and 43,000 fatalities.