The first oral antiviral drug for the treatment of COVID has been added to World Health Organization (WHO) guidelines and provisionally approved in Australia.
The drug, molnupiravir, has been provisionally approved by the Therapeutic Goods Administration (TGA) and has already been approved in the US, UK, Canada and Japan.
The Australia government has bought 300,000 doses.
A new study says molnupiravir can eliminate the virus from the body in three days.
A report on medicalxpress says the drug removed the “infectious SARS-CoV-2 virus by day three of starting therapy, while many participants who received a placebo took up to five days and in some cases longer”.
This latest randomised, placebo-controlled, double-blind trial was conducted by Dr Julie Strizki and colleagues of the pharmaceutical company Merck & Co., which manufactures molnupiravir under the brand name Lagevrio.
She said the trial showed a five-day course of molnupiravir was effective in rapidly eliminating COVID-19 from the body, provided it was administered within five days from the onset of symptoms.
Results on day three of treatment showed the virus was not detected in any of the 92 participants who received the drug.
The medicalxpress report said: “Results demonstrated that on day three of treatment, infectious SARS-CoV-2 was detected in zero of 92 of participants with infectious virus at baseline who received molnupiravir, compared with 21.8 per cent (20/96) of participants who received the placebo. At day five, the virus was detected in 0.0 per cent (n=0/91) in the molnupiravir arm compared with 2.2 per cent (n=2/89) in the placebo arm.”
Dr Strizki said the study provided additional evidence that molnupiravir helped those infected clear the virus faster and supported the trial’s primary finding that molnupiravir can lower the risk of progression to serious illness in those at high risk.
The TGA says the advantage of oral medications is that people can receive the treatment in their own homes without the need to be admitted to hospital.
The WHO said in a report tabled in early March that the drug was a new medicine and that there was little safety data. Because of that, it recommended molnupiravir be provided only to non-severe COVID patients with the highest risk of hospitalisation: people who had not received a vaccination, older people, people with immunodeficiencies and those living with chronic diseases.
It had based that recommendation on data from six randomised controlled trials involving 4796 patients.
Writing for the Conversation, Dr Oliver Rogoyski said the most common adverse reaction for single-dose participants was a headache, affecting 13 per cent of people, although, interestingly, headaches were more common among those receiving a placebo, affecting 19 per cent. Among multiple-dose participants, the most common reported side-effect was diarrhoea – although that occurred at the same rate among those taking the placebo (affecting 7 per cent of people in each case).
“No clinically significant or serious adverse effects related to the drug were seen,” he wrote. “Later human trials that gave the drug to over 700 people also recorded no major adverse events associated with the drug.”
Rick Bright, formerly head of the US Biomedical Advanced Research and Development Authority, has written that “similar experimental drugs in this class had been shown to cause reproductive toxicity in animals”.
The UK health regulator doesn’t recommend using molnupiravir during pregnancy and emphasises that women should be careful not to conceive during treatment.
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