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An oral treatment for Covid-19 infection has received interim authorisation under the Pandemic Special Access Route (PSAR) from Singapore's Health Sciences Authority (HSA).
HSA announced this on Feb. 3, saying that the Paxlovid oral tablet, by Pfizer, is the first oral tablet to be approved in Singapore for treating mild to moderate Covid-19 infections in adult patients at high risk of severe disease.
The medication "will be prescribed and prioritised to those at higher risk of severe Covid illness, as directed by the Ministry of Health", said HSA.
Results of ongoing study
HSA said it reviewed clinical data based on rolling submission of the results from an ongoing study.
The study involved over 2,000 adult participants aged between 18 and 88, who had one or more risk factors for severe Covid-19 infection.
The study compared the outcomes of participants who had received Paxlovid within three days of having symptoms with those who had received a placebo, and found that Paxlovid reduced the risk of Covid-19 related hospitalisation or death by 88.9 per cent.
When participants received Paxlovid within five days of having symptoms, the drug was found to reduce their risk by 87.8 per cent as compared to the placebo group.
Separate data from lab tests showed that Paxlovid "is active against the prevailing variants of concern, including the Delta and Omicron variants", HSA added.
Safety of the treatment
According to HSA's statement, safety data showed that Paxlovid is "well-tolerated", with a "generally low" rate of adverse events reported in the clinical study.
Common adverse events reported included "mild to moderate" effects such as "altered sense of taste, diarrhoea, vomiting, hypertension, muscle pain (myalgia) and chills".
HSA also said that Paxlovid may interact with other medications and lead to "serious adverse events" by increasing the amount of these medications in the blood. Examples of such medications are:
- Medicines for irregular heart rate
- Medicines for migraines
- Medicines for cholesterol
Other medicines, such as those for epileptic seizures, could result in a loss of anti-viral efficacy as they reduce the levels of Paxlovid.
"The potential for drug interactions should be carefully considered by the prescribing doctor prior to treatment initiation," said HSA.
It added that there is still "a favourable benefit-risk profile" for the treatment of mild to moderate Covid-19 in adults who are at high risk of progression to severe Covid-19, and that the benefits of Paxlovid outweigh the risks.
However, HSA also said that "PSAR interim authorisation may also be terminated at any time; for example, if new data suggests that the benefits no longer outweigh the risks."
The authority added that Pfizer will be required to continue submitting updated data from its ongoing clinical studies.
As the approval under PSAR is an interim authorisation, the company is also required to submit a complete dataset based on prevailing international standards to obtain a full registration.
More about the treatment
Paxlovid is an oral tablet, to be taken twice daily for five days.
Treatment "should be initiated as soon as possible after a diagnosis has been made, within five days of the onset of Covid-19 symptoms", said HSA.
It comprises two medicines:
- Nirmatrelvir, an antiviral medicine
- Ritonavir, a medicine used to maintain the blood level of nirmatrelvir for antiviral efficacy
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Top image from Pixabay
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