Publications
- A drug used to treat parasites in animals has been touted as a possible Covid-19 treatment
- However, the SAHPRA stated the evidence available to support the use of this drug is currently "poor"and "underpowered"
- Professor Ian Sanne, an infectious diseases specialist, told Health24 the MAC and drug rapid review does not support the use at this time
Ivermectin, a parasiticide, has been getting attention as a possible Covid-19 treatment.
The drug works by paralysing and killing parasites in animals, and is used to treat a range of tropical diseases in humans not commonly seen in South Africa as well as scabies and head lice, notes the South African Health Products Regulatory Authority (SAHPRA).
In South Africa, ivermectin is registered for use in animals, allowing veterinarians and other trained personnel to prescribe it as an antiparasitic agent for a variety of animals.
However, it is not currently registered for human use, although the SAHPRA stated it had occasionally granted permits for its use as treatment for individuals with conditions such as scabies or head lice.
Ivermectin for Covid-19?
However, the SAHPRA said on Wednesday 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", adding the World Health Organisation also did not currently recommend the use of the drug for the treatment or prophylaxis of Covid-19 infections.
The SAHPRA also pointed to researchers who have recently investigated the use of ivermectin as a treatment for Covid-19 via clinical trials, and made reference to a study conducted by Dr Andrew Hill of the University of Liverpool.
Although the report of the trial concludes that the use of ivermectin in the management of Covid-19 infections is associated with a shorter duration of hospitalisation, among other findings, it has, however, not yet been published in a peer-reviewed scientific journal, and, according to Hill, additional randomised clinical trial data was needed to confirm the clinical benefit of this drug in Covid-19 patients.
Hill also identified several limitations of the study.
The SAHPRA, therefore, concluded that "the overall quality of the randomised clinical trials involving ivermectin in Covid-19 patients is poor and underpowered".
FDA says not for treating Covid-19
Ivermectin is a Federal Drug Administration-approved treatment in the US - in some instances - but the FDA is clear about it not being recommended for treating Covid-19.
"While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of Covid-19.
"You should not take any medicine to treat or prevent Covid-19 unless it has been prescribed to you by your healthcare provider and acquired from a legitimate source," it said.
While research has been conducted on the effect of ivermectin on SARS-CoV-2, the FDA pointed out this was in a laboratory setting.
"These types of laboratory studies are commonly used at an early stage of drug development.
"Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat the coronavirus or Covid-19."
What an expert says
Professor Ian Sanne, an infectious diseases specialist and CEO of Right to Care, reiterated this stance to Health24, saying ivermectin was not approved for use in humans for Covid-19 by regulatory bodies, including the SAHPRA and the FDA.
"There is no prospective clinical trial conducted under ICH [International Conference on Harmonisation]/GCP [Good Clinical Practice] to support the use of ivermectin."
Sanne, who is also a member of the Ministerial Advisory Committee (MAC), said the MAC and drug rapid review did not support the use at this time and that, in his personal capacity, he did not understand how a medicine used for parasite infections had a biologic activity for a respiratory virus in humans.
"I do not support the use until a correctly designed and executed study has been completed.
"I certainly do not support the use as prophylaxis in unknown doses in humans as the toxicity profile includes blindness, neurological side effects and liver toxicity," he added.
Another expert weighs in
Professor Eric Decloedt from the division of clinical pharmacology, department of medicine at Stellenbosch University reiterated the SAHPRA's view, saying that although we are in a desperate situation and are therefore excited about the prospect of an inexpensive, accessible repurposed medicine, the current data supporting ivermectin for Covid-19 are "heterogeneous (different doses, study designs, sample size, etc.)".
Decloedt explained: "The data are not yet critically reviewed and published in peer-reviewed journals. This makes drawing definitive conclusions about efficacy not yet possible.
"There is a global urgency to critically review the existing data on preprint servers.
"Additionally, there are a number of larger trials on global registries which should soon provide more data to facilitate the decision on whether ivermectin should be part of the standard of care."
Decloedt added that the ivermectin studies are being conducted by various clinician investigators and not a pharmaceutical company that drives the development of a coherent submission dossier to the regulatory authorities.
He further commented: "Collating all of this data in an acceptable manner for regulatory authority review and approval is key.
"But there seems to be worldwide enthusiasm to assist with this task," saying that scientists are eagerly watching this space.
For now, Decloedt "strongly discourages the use of veterinary medicines for human consumption", as well as home self-injection using, what he presumes, is a veterinary source.
