The South African Health Products Regulatory Authority (SAHPRA) is encouraging the submission of clinical trials aimed to establish the safety and efficacy of Ivermectin in the management of COVID-19 infections for both treatment and prophylaxis (action taken to prevent a disease).
Ivermectin is a drug widely used for the treatment and control of parasites in animals. It is used to treat several tropical diseases in humans such as scabies and head lice in other countries.
There are growing calls for its use to treat coronavirus cases since several investigators have reported that when tested in the laboratory, Ivermectin inhibits replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
However, the SAHPRA says more trials are needed to get evidence to justify the use of the drug.
“SAHPRA notes that to date, there have been no positive recommendations for the use of Ivermectin in the management of COVID-19 infections by any regulatory authority with which SAHPRA has reliance agreements, e.g. USFDA, EMA, MHRA, etc., and that the WHO does not currently recommend the use of Ivermectin for the treatment or prophylaxis of COVID-19 infections,” says the organisation in a statement.
In a recent study sponsored by Unitaid, University of Liverpool’s Dr. Andrew Hill concluded that the use of Ivermectin in the management of COVID-19 infections is associated with faster time to viral clearance, shorter duration of hospitalisation, and higher rates of clinical recovery and 75% improvement in survival rates.
However, Hill also believes that further clinical trials are needed to deal with the limitations of his study including, among others, the fact that the results were based on limited randomised trials, there was potential for publication bias, and that the individual trials reviewed had limited statistical power.
Legal challenges in SA
While Ivermectin is used to treat some human diseases in others countries, the drug is currently not registered for human use in South Africa.
“In South Africa, Ivermectin is registered for use under Act 36 of 1947 (Department of Agriculture) for use in animals. This means that veterinarians and other trained personnel are allowed to prescribe it as an antiparasitic agent for a variety of animals,” says SAHPRA.
The regulatory body has so far not received applications to register Ivermectin for either prophylaxis or treatment of COVID-19 but commits to fast track the review of any such application should it be submitted.
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SAHPRA says it will continue to evaluate any emerging peer-reviewed publications or data on the use of Ivermectin for the treatment of COVID-19.
“SAHPRA will also consider enabling access to approved formulations of ivermectin intended for human use, including through Section 21 authorisation, provided such a request is supported by evidence for the indication requested and is justified based on a risk-benefit assessment that includes safety and clinical efficacy data.”
SAHPA statement on the use of Ivermectin to treat COVID-19 patients:
Growing calls for the use of the drug in SA
A specialist at the Lenmed Shifaa Hospital Dr. Farida Amod is one of those advocating for the use f Ivermectin.
Amod says while the vaccine is being procured, Ivermectin can help to reduce the number of coronavirus infections and COVID-19 related deaths.
“Ivermectin in some randomised controlled trials and in some epidemiologic settings where they’ve used it for mass programmes has been shown to have been very positive So I think when you have a situation where the need is so dire and immediate, we can’t wait for new drugs because that takes time. So, to use re-purposed drugs like ivermectin is an excellent idea.”
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The National Freedom Party (NFP) says it is willing to go to court if the government does not refuses to administer the drug to South Africans who have contracted the virus
The push for Ivermectin comes as the number of new coronavirus cases continues to rise in the country.
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