- Sahpra says it will revisit a widely quoted analysis on the potential use of ivermectin for Covid-19
- But there is 'no evidence from randomised controlled trials for any reduction in mortality'
- Additional randomised clinical trial data are needed to confirm any clinical benefit in Covid-19 infections
The South African Health Products Regulatory Authority (Sahpra) says that it will revisit the analysis by Dr Andrew Hill of the University of Liverpool on the potential use of ivermectin, the medicine regulation body told Health24.
More evidence needed
Hill conducted an analysis of clinical trials on ivermectin as a treatment for Covid-19. The regulatory body says that the data have not been peer-reviewed and additional randomised clinical trial data are needed to confirm clinical benefit in Covid-19 infections, as well as to define an optimised dosing regimen.
“Sahpra, in its press release of 06 January 2021, has reiterated that it awaits data from current trials and will revisit the Hill meta-analysis when it is finalised and released at the end of this week,” according to the spokesperson of Sahpra, Yuven Gounden.
In a previous statement earlier this month, Sahpra said that the analysis did not provide sufficient evidence to approve the drug for human use against Covid-19.
“The overall quality of the randomised clinical trials involving ivermectin in Covid-19 patients is poor and underpowered.
"From the available randomised control trial evidence, ivermectin appears not to be superior to placebo in terms of viral load reduction or clinical progression.
"There is no evidence from randomised controlled trials for any reduction in mortality,” the statement reads.
Section 21 rejection
A Section 21 application is a form used to apply to Sahpra for the authorisation of the sale of unregistered orthodox medicine, complementary medicine, and veterinary medicine or devices for specific purposes.
The body tells Health24 that it has received many Section 21 applications for the use of ivermectin either in the treatment or prevention of Covid-19 infections, due to the current evidence being insufficient.
“There have been several Section 21 applications. But there have been no clinical trial or registration applications submitted to Sahpra to date,” says Gouden.
Sahpra says it will fast-track a sufficiently-powered randomised controlled clinical trial application and expedite a registration dossier for ivermectin for the treatment or prevention of Covid-19 infection when submitted.
“If there are clinical trial or registration applications submitted to Sahpra for ivermectin, these will be fast-tracked.
"The Section 21 applications will be reviewed pending the review of new data to support the use of ivermectin in the treatment or prevention of Covid-19 infections.