Paxlovid, the oral drug, reduces the risk of COVID-19-associated hospitalisation or death by 89 per cent in those who receive treatment within three days of symptom onset
The fight against coronavirus received yet another boost last Friday when the World Health Organization (WHO) “strongly recommended” Pfizer’s COVID-19 antiviral pill Paxlovid for patients with milder forms of the disease who were still at a high risk of hospitalisation.
The WHO’s experts said in the BMJ medical journal that the United States’ pharma giant Pfizer’s combination of nirmatrelvir and ritonavir was the “superior choice” of treatment for unvaccinated, elderly or immunocompromised people with COVID-19.
The new recommendation was based on the findings of two trials involving almost 3,100 patients, which showed that Paxlovid reduced the risk of hospital admission by 85 per cent.
The recommendation applies to people over the age of 18, but not to pregnant or breastfeeding women.
It also does not apply to patients with a low risk of complications from the disease, because the benefit would be minimal.
Paxlovid is a combination of Pfizer’s investigational antiviral PF-07321332 and a low dose of ritonavir, an antiretroviral medication traditionally used to treat HIV.
Experts say that the drug disrupts the replication of SARS-CoV-2 in the body by binding to the 3CL-like protease, an enzyme crucial to the virus’ function and reproduction.
Experts have said that patients have to take three pills orally twice a day for a total of five days — that is, a total of 30 tablets. The USFDA authorised Paxlovid for use only up to five consecutive days.
An interim analysis showed that Paxlovid reduced the risk of COVID-19-associated hospitalisation or death by 89 per cent in those who received treatment within three days of symptom onset.
Paxlovid was granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) in December last year.
The European Medicines Agency (EMA) issued advice that Paxlovid can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.
Pfizer has said that the drug works against Omicron. So far, at least three laboratory-based studies claim to back this up — two of those studies were conducted by Pfizer, while the third was done by Pfizer in partnership with the Icahn School of Medicine at Mount Sinai. These studies have not yet been published in peer-reviewed medical journals.
It has been reported that Paxlovid doesn’t cause any serious side effects and is a well-tolerated drug. However, since it’s cleared by the kidneys, those suffering from severe kidney disease or who are on dialysis have been instructed not to take the drug.
The Pfizer anti-COVID pill has received a massive boost in the market after the Joe Biden administration secured the purchase of 20 million treatment courses of Paxlovid.
The Associated Press reported that the White House was stepping up outreach to doctors, letting them know they shouldn’t think twice about prescribing the pill to eligible patients. Additionally, the drug would now be distributed directly to pharmacies, in addition to existing distribution channels run by states.
“Paxlovid will be widely available everywhere in America,” said Dr Ashish Jha, the White House COVID-19 response coordinator.
Interestingly, US vice president Kamala Harris, who tested positive for COVID-19 on Tuesday, is being treated with antiviral drug Paxlovid.
Paxlovid in India
In March, the Medicines Patent Pool (MPP) had signed a licence agreement with 35 generic drug makers to manufacture the generic version of Pfizer’s oral COVID-19 treatment. Of these, 19 firms are Indian including Torrent Pharma, Cadila Pharma, Hetero, Biocon, Strides, Glenmark, Granules, Macleods, Sun Pharma, and Cipla among others.
A report published by the Business Standard on 25 April said that the drug is expected to be available this week in India. Hyderabad-based firm Hetero has already received the Drugs Controller General of India approval to launch the drug.
Doctors in India are upbeat about the drug in the fight against coronavirus. “The introduction of Paxlovid in India is a very welcome addition to the COVID-19 drugs arsenal. The studies have shown that this is a powerful agent in non-hospitalised patients in the early stages of COVID-19 to reduce the risk of hospitalisation or death by 89 per cent. This is one of the most powerful oral therapies now available to combat COVID-19 infections,” Praveen Gupta, principal director, and head, the department of neurology, Fortis Memorial Research Institute, Gurugram told Business Standard.
With inputs from agencies
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