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  • Thời gian cập nhật 05/11/2021
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The United Kingdom has approved an antiviral pill that promises to reduce the risk of death in COVID-19 patients by half, shifting focus to advances in treatment options for the illness and raising questions about whether Canada will follow suit.

The antiviral pill, molnupiravir, is produced by American pharmaceutical companies Merck & Co. and Ridgeback Biotherapeutics, and has been hailed as a “game changer” by British Health Secretary Sajid Navid. Clinical trials revealed the drug could reduce death or hospitalization due to COVID-19 by half.

The pill’s approval in the U.K. comes at the heels of another significant advancement in COVID-19 treatment: On Friday, Pfizer said its own experimental pill — Paxlovid — reduces the risk of hospitalization or death by 89 per cent.

The U.K. is moving ahead to purchase 480,000 courses of molnupiravir, with the first shipment expected this month. It has also ordered 250,000 courses of the new Pfizer treatment.

Merck’s molnupiravir is still pending approval from Health Canada after Merck Canada Inc. filed an application Aug. 13, with Canadian regulators saying they’re still receiving additional information. The company told the Star a supply agreement has not yet been reached with Canada, though talks continue. According to Health Canada’s website, Pfizer has not yet submitted an application for its treatment drug.

The developments in treatment come as many Canadian provinces are lifting more pandemic restrictions, including Ontario, which recently lifted all capacity limits at stadiums and restaurants. Cases across Canada have been declining, though they’ve risen in Ontario this week, and the rate of new vaccinations has dropped.

“There’s still a need to double down to get every single person vaccinated who is eligible,” said Dr. Zain Chagla, an infectious diseases physician at St. Joseph’s Hospital in Hamilton. But he added that treatment development is “the new era of how we deal with COVID-19” and those who get sick should be given an option to reduce severe illness or death.

Molnupiravir is one of three antivirals for COVID under review by Health Canada. The others are favipiravir, originally used to treat influenza in Japan, and baricitinib, typically used to treat arthritis. But molnupiravir is unique — the antiviral treatment can be taken alone as a pill, meaning a patient does not need to be hospitalized to use it. It’s also potentially effective in both vaccinated and unvaccinated people.

Pfizer’s treatment is also an oral drug, with three pills taken twice a day for five days. But it works differently than the Merck pill, which introduces errors into the genetic code of the virus. Pfizer’s pill instead blocks an enzyme the virus needs to multiply.

While there are no publicly released peer-reviewed studies of the Merck pill, results shared by the company from a global clinical trial involving 775 COVID-19 patients showed the pill reduced the risk of hospitalization or death by about 50 per cent. There were no deaths in the group of patients that were given the pill, and eight deaths in the group of those who were given a placebo. Trial results indicate the pill is most effective when taken within the first five days of COVID-19 symptoms developing.

“It’s cautiously good news,” said Chagla of molnupiravir’s approval in the U.K. He said that while early data is promising, the amount of data available so far on the drug’s effectiveness to the scientific community and the public is still limited. “All we have is a press release from Merck on their website,” he said. “… but no peer-reviewed studies or anything along those lines.”

Chagla said it’s possible the company has provided additional data to U.K. regulators, as the outcomes of the clinical trial are still emerging. Both Merck and Pfizer stopped recruitment into their study earlier than expected due to the positive results observed.

Most of the recruitment for the Merck pill occurred in Latin America, which Chagla noted could affect trial outcomes, as the rate of hospitalization from COVID-19 is higher in middle-income countries where there is typically less access to health care. This raises questions about whether the drug’s rate of success would be similar in Canada, with more universal health-care access, Chagla said.

Chagla noted that the drug requires those sick with COVID-19 to take it in the first five days after symptoms start, a challenge when many people get tested late into their illness, and rapid testing is difficult to come by. Pfizer’s pill was given to patients within three days of Covid symptoms starting.

Health Canada said it can’t predict when a decision on the Merck drug will come, as timing depends on getting additional data and meeting safety requirements set out by the regulatory body. Chagla said he’s confident Health Canada is doing its due diligence to ensure the drug is safe and effective, especially for older or immunocompromised populations whom it is mainly targeted for.

Other treatment options for COVID-19 outside antivirals are also being explored, including at a clinic run by Chagla, where Ontario’s first Monoclonal Antibody Therapy Clinic is being piloted. Chagla said the therapy, which involves feeding antibodies into a patient, has been shown to reduce hospitalizations and death by about 70 per cent in the unvaccinated.

The issue, Chagla said, is that antibody therapy requires a patient to drive to a hospital or clinical setting where they can get this treatment. “The nice advantage of oral therapy is that once it’s delivered to that patient’s doorstep, they can just start taking it.”

Nadine Yousif is a Toronto-based reporter for the Star covering mental health. Follow her on Twitter: @nadineyousif_
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