Ivermectin is an anti-parasitic drug that is used to treat parasitic infections like onchocerciasis, intestinal strongyloidiasis, head lice, rosacea, and scabies. It is also widely used as an anti-parasitic in animals in formulations intended specifically for animal use.
Ivermectin has been proposed as a potential therapy against SARS-CoV-2 based on in vitro cell culture analysis. However, ivermectin is not approved for the treatment of any viral infection, including SARS-CoV-2 infection.
2. What’s the hype about?
Earlier in 2020, the FDA issued a warning that ivermectin products intended for use in animals should not be used to treat COVID-19 in humans4.
There are reports of ivermectin use in the management of patients hospitalised for COVID-19 which has drawn media attention and social media promotion of the repurposing of the medicine for this indication5.
No ivermectin products are locally approved by the South African Health Products Regulatory Authority (SAHPRA) for use in humans. On 28 January 2021, SAHPRA released a document to clarify the process to follow for controlled compassionate access to ivermectin in terms of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965).3
3. What is Fedhealth’s position on ivermectin?
Various clinical trials assessing the use of ivermectin in the management of COVID-19 are currently underway. Results from one retrospective analysis concluded that the association of ivermectin with a lower mortality during treatment of COVID-19 needs to be confirmed in randomised, controlled trials. In addition, a preprint meta-analysis by Hill et al concluded that large controlled, randomised trials are required to provide sufficient results for review by regulatory authorities16.
Furthermore, there is no consensus on the established safe and efficacious dose of ivermectin for the treatment or prophylaxis of COVID-19. Ivermectin use in the management of COVID-19 patients is not included in local5 and international clinical guidelines10,20. In addition, no ivermectin products have been locally approved for human use and the experimental use of ivermectin in the treatment and prevention of COVID-19 infections will require access in terms of Section 21 of the Medicine Act for compassionate use3.
Based on the very limited and low quality data available to support the use of ivermectin for the management of COVID-19, including the lack of safe dosing recommendations and the non-inclusion in local and international guidelines, the use of ivermectin for the treatment and prophylaxis of COVID-19 is not supported.
Ivermectin has been added to the list of ‘investigational drugs’ by the Council for Medical Schemes in its Updated COVID-19 Guidelines, so discretionary funding rules would apply for medical schemes.
Fedhealth has taken the same funding stance for Ivermectin as it has with all other investigational therapies namely, no upfront funding will be permitted and cases will only be assessed on motivation and on an individual, case-by-case basis.
1. MicroMedex, https://www.micromedexsolutions.com/micromedex2/librarian/CS/312D81/ND_PR/evidencexpert/ND_P/evidencexper t/DUPLICATIONSHIELDSYNC/BB64BF/ND_PG/evidencexpert/ND_B/evidencexpert/ND_AppProduct/evidencexpert/ ND_T/evidencexpert/PFActionId/evidencexp.
3. SAHPRA, Section 21 Access to Unregistered Medicines 28 January 2021, Ivermectin Controlled Compassionate Use Programme, https://www.sahpra.org.za/wpcontent/uploads/2021/01/Section_21_Ivermectin_Controlled_Compassionate-UseProgramme_Jan21_FINAL.docx.pdf.
4. FDA letter to Stakeholders Do not use ivermectin intended for animals as treatment fo COVID-19 in humans, 10/04/2020, https://www.fda.gov/safety/medical-product-safety-information/ivermectin-intended-animals-letterstakeholders-do-not-use-humans-treatment-covid-19.
5. NDOH_Rapid review of Ivermectin for COVID-19 21 December 2020, http://www.health.gov.za/wpcontent/uploads/2020/12/Rapid-review-of-Ivermectin-for-COVID-19_21December2020.pdf.
10. National Institutes of Health (NIH), COVID-19 Treatment Guidelines 2019, Last updated on 17/12/2020, Accessed on 28/12/2020, https://www.covid19treatmentguidelines.nih.gov/
16. Hill et al., on behalf of the International Ivermecting Project Team, Preprint, Preliminary Meta-analysis of randomized trials of ivermectin to treat SARS-CoV-2 infections, Research Square, doi:10.21203/rs.3.rs-148845/v1, 19 January 2021, https://www.rese
20. Infectious Disease Society of America Guidelines (IDSA) 02 December 2020, https://www.idsociety.org/practiceguideline/covid-19-guideline-treatment-and-management/.