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Why SA's drug regulator cannot recommend ivermectin to treat Covid-19

21 Jul 2021

  • Sahpra has warned against the use of ivermectin to treat Covid-19.
  • The regulator says there is no conclusive study to confirm it has clinical benefits in preventing or treating the disease.
  • Sahpra's leadership briefed Parliament on Wednesday.

Current evidence from studies is still not conclusive on whether ivermectin has any clinical benefits against Covid-19, according to the South African Health Products Regulatory Authority (Sahpra).

Sahpra says there is no evidence that ivermectin increases viral clearance or reduces hospital admissions, disease complications or mortality.

On Wednesday, Sahpra CEO Biotumelo Semete-Makokotlela briefed the portfolio committee on health about the government's vaccination rollout and approvals of various vaccines.

"Ivermectin should not be used routinely in the management of any stage of Covid-19, except in the context of sufficiently powered Randomised Clinical Trials (RCTs), with well-defined study endpoints intended for regulatory marketing authorisation," Semete-Makokotlela told the committee.

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Semete-Makokotlela said there was currently insufficient evidence to recommend ivermectin use in those infected with Covid-19.

"Much of the RCT evidence consists of trials of low methodological quality, for the most part, with small sample sizes and disparate interventions and controls, limiting the confidence in any conclusions with respect to ivermectin. No evidence of clinical or virological benefits," she said.

Ivermectin should not be used routinely in the management of Covid-19, except in the context of a clinical trial.

In January, Sahpra agreed to allow doctors to start ivermectin treatment in cases deemed urgent as soon as a Section 21 application had been submitted, without waiting for the application's outcome.

Section 21 allows Sahpra to authorise the sale of an unregistered medicine for a certain purpose, for a specified period.

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Since implementation on 28 January, to 9 July, 632 applications for the use of ivermectin had been approved.

The authority rejected 60, one is still pending, and five were duplicates.

She also said, so far, there was no application to the register ivermectin to treat Covid-19 infections.

She said:

Sahpra has registered an ivermectin cream formulation (Soolantra 10mg/g cream) for human use, which is indicated for the topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea in adult patients. Sahpra has also recently received an application for ivermectin tablet formulation for registration for use for tropical diseases. This application is currently under review.

Responding on the matter, Sahpra board chairperson Helen Rees said: "Doctors who are prescribing in the primary care sector, they desperately want medication that they can give to ambulant patients that they look after to stop them progressing into a more serious disease.

"Unfortunately, this is an area where the research is extremely difficult to do, and there is much less data on early treatment interventions than there is on an advance treatment for hospitalised patients. There is even less data for medication that would prevent infections."

Meanwhile, hospital group Mediclinic on Wednesday echoed Sahpra's position - that there is currently still insufficient clinical data to recommend the use of ivermectin for the prophylaxis or treatment of Covid-19.

"It is therefore not recommended in evidence-based guidelines but rather in a research setting until such time as there is sufficient proof of its efficacy," the group said in a statement.

Earlier this week Dr Emmanuel Taban, a pulmonologist at Mediclinic Midstream in Midrand, had raised concern in a Facebook post over a significant number of Covid-19 patients admitted to the hospital who had been taking ivermectin.

In the post, Dr Taban said the patients had been taking ivermectin "prescribed by doctors" and as a result, he said, patients felt "falsely protected".

Dr Taban also further said that he had "lost five patients due to liver failure from ivermectin".

Mediclinic's statement confirmed the pulmonologist's claims regarding rampant ivermectin use from patients admitted to the hospital: "Dr Emmanuel Taban observed that two out of three patients presenting for Covid-19 related care at Mediclinic Midstream during this third wave have been exposed to ivermectin as they believed it would prevent them from contracting Covid-19 or from progression to severe disease."

But further added re Dr Taban's claims over patient deaths: "Although some of the recorded side effects observed from the use of ivermectin include deranged liver function tests, post-mortems were not performed on his deceased patients who were using ivermectin."

The hospital group said that it backed Dr Taban "in his commitment to provide the best possible care for patients and believe that this must be done within the specific regulated environment that governs our industry".

Source: News24

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