New evidence for Ivermectin use in Covid-19, but Sahpra won’t budge

A recently published review of scientific evidence supporting the efficacy of Ivermectin in treating Covid-19 has failed to sway the South African Health Products Authority’s position on allowing the use of the drug locally.

Ivermectin is a drug used for treatment of parasitic nematode worms, mites and insects in livestock. It is also used to treat parasitic infections in domestic animals and onchocerciasis (river blindness caused by infection with the parasitic worm Onchocerca volvulus) in humans.

Previously the health consumer watchdog said there was no data available to conclude that the drug’s use on humans is safe and effective. Sahpra maintains that the quality of clinical trials involving Ivermectin in treating Covid‐19 patients is poor and underpowered.

This was after randomised control trial evidence showed that Ivermectin appears no better than placebos in terms of viral load reduction or clinical progression. There was also no evidence of any reduction in mortality.

However, a new review of 18 randomised controlled treatment trials of Ivermectin in treating Covid-19, has found large, statistically significant reductions in mortality, time to clinical recovery and time to viral clearance. The review was published in the American Journal of Therapeutics.

Results from numerous controlled prophylaxis trials report significantly reduced risks of contracting Covid-19 with the regular use of Ivermectin. Finally, the many examples of Ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of Covid-19 had been identified.

Sahpra’s stance hasn’t changed

“Our stance is very clear. We have made public statements before and our stance remains,” Sahpra spokesperson Yuven Gounden said, before referring The Citizen to the body’s past statements made amidst a fierce court battle by rights group Afriforum over the use of the drug.

Sahpra requires such information to be formally submitted formally before it is considered, Gounden said. Thus, the body will not be changing its stance on the drug, regardless of the body of evidence supporting its use.

A slow vaccine roll-out threatens to worsen the effects of the Covid-19 pandemic in South Africa.

Also Read: ‘Ivermectin cream registration not for Covid-19,’ says SAHPRA

A Gauteng high court ruling has allowed any qualifying registered pharmacist or medical practitioner to compound and sell medicine that contains ivermectin as an active ingredient.

“Registered medical practitioners who are entitled to prescribe medicines in schedule 3 of the act may, in their professional discretion, prescribe Ivermectin to be compounded into a medicine that contains Ivermectin as an active ingredient for the treatment of their patients, on condition that the medicine is compounded by the holder of a licence,” the April 2021 order says.

Body of evidence

The review suggests there may be significant efficacy in the use of Ivermectin in treating Covid-19, but the majority of trialled agents have failed to reproduce results in a way that provided definitive proof.

Mentioned in the review is that further evidence supporting the efficacy of Ivermectin as a prophylaxis agent was published recently in the International Journal of Antimicrobial Agents. A group of researchers analysed data using the prophylactic chemotherapy databank administered by the WHO along with case counts obtained by Worldometers.

When they compared the data from countries with active Ivermectin mass drug administration programmes for the prevention of parasite infections, they discovered Covid-19 case counts were significantly lower in the countries with recently active programmes, to a high degree of statistical significance, meaning there was a less than one 1/1000 chance of being wrong.

Simnikiweh@citizen.co.za