Question NW788 to the Minister of Health
01 April 2022 - NW788
Ismail, Ms H to ask the Minister of Health
Whether, in light of the fact that research shows that the Molnupiravir and/or Paxlovid pills lower the likelihood of hospitalisation and death in patients at high risk of falling seriously ill if they are taken within the first five days of COVID-19 symptoms, and since the vaccine injections do not actually eradicate the virus, but also assist in eliminating the risk of death and the likelihood of hospitilisation, of which the pill can do the same probably at a lower cost, his department will consider the availability of COVID-19 pills once authorised by SA Health Products Regulatory Authority; if not, what is the position in this regard; if so, what are the relevant details?
Reply:
Molnupiravir and Paxlovid® (ritonavir-boosted nirmatrelvir) are oral antiviral agents that have been reviewed by the National Essential Medicines List (NEML) Ministerial Advisory Committee (MAC) on COVID-19 Therapeutics for the treatment of COVID-19 in ambulant patients.
The current rapid reviews or advisories, based on available published evidence at the time are accessible from the National Department of Health website. As evidence on COVID-19 therapeutics is emerging rapidly, the MAC on COVID-19 Therapeutics reviews are routinely updated when new evidence becomes available. The MAC on COVID-19 Therapeutics considers a range of factors apart from efficacy and safety when making recommendations.
The rapid review of molnupiravir, issued on 20 December 2021, was based on the available published evidence at the time which was a single randomised controlled trial by Bernal et al. (2021). Based on this data, a conditional recommendation was proposed by the MAC on COVID-19 Therapeutics that molnupiravir not be used for the management of COVID-19 in ambulant unvaccinated patients.
However, in March 2022, more information has been released by the World Health Organization (WHO) in the form of a supplement to the published WHO living guidelines: Safety and efficacy of molnupiravir compared to standard care/placebo. The NEML MAC on COVID-19 Therapeutics will thus be reviewing this additional evidence to update the rapid review. Based on this new data, the recommendation may or may not be revised.
Similarly, for ritonavir-boosted nirmatrelvir (Paxlovid), a conditional recommendation was proposed against it’s use for the treatment of COVID-19. The evidence base for the rapid review report dated the 14 March 2022, was a single randomised controlled trial of ambulatory unvaccinated adult patients with confirmed COVID-19, who were at high-risk for progression to severe COVID-19. This antiviral has the potential for many drug-drug interactions (including anti-epileptic and anti-diabetic medicines, protease inhibitors amongst others) and therefore given the potential safety risks associated with its use patient and healthcare worker- education would be required.
Products have yet to be registered in South Africa, and the NEML MAC on COVID-19 Therapeutics will be updating the review, when there is more information on the availability and pricing of generic products.
Both antivirals requires rapid access to definitive diagnosis and initiation within five days of the onset of symptoms and is contra-indicated in pregnancy, requiring women of childbearing potential to take effective contraception.
However, it is important to note that these oral antiviral formulations do not replace vaccination for prevention of COVID-19, but as treatment, once infection occurs.
END.