The South African Health Products Council (SAHPRA) announced on Wednesday, January 27 it will allow the use of Ivermectin in controlled compassionate circumstances to treat COVID-19.
Ivermectin is a drug commonly used to treat parasites in animals. It has been flouted as a possible direct and prophylactic treatment for COVID-19, but studies so far have not been conclusive enough to convince doctors in South Africa that it should be used in humans.
Following an urgent court bid by Afriforum and some medical practitioners to have the drug approved for use, SAHPRA is issuing guidelines in the next few days to provide limited use for humans. The limitation has been put in place as the Council still don’t believe there is enough scientific proof for its use. SAHPRA says it will assess the safety.
“So, colleagues what you will note is that as a regulator we are saying we have heard you. We are putting in this a compassionate access programme that will be controlled. We will communicate in the next day or so with very clear guidelines in terms of what is controlled going to look like and again we’ve considered the risk-benefit of having this product available,” said SAHPRA’s Dr Boitumelo Semete-Makokotlela, according to SABC.
In an article published in the South African Journal of Medicine, doctors from a variety of specialisations did acknowledge there is evidence from randomised controlled trials (RCTs) and observational studies show its antiviral activity and anti-inflammatory activity in vitro against COVID-19.
Despite this, they did advise caution in using these results and a definitive endorsement.
“While they are certainly promising, caution should be exercised when interpreting these meta-analyses, as the pooling of heterogeneous trials with different methodologies, outcomes and comparators may make the conclusions drawn unreliable. Much of the currently available published and peer-reviewed evidence is from either observational or uncontrolled studies,” they explained.
South Africa is currently attempting to undertake studies into Ivermectin soon at the University of the Free State. Should it be successful, this could bolster future decisions by SAHPRA on the drug.
