Today, the World Health Organization strongly recommended the use of the first drug that comes in pills and was authorized for patients with COVID-19 who may suffer from severe cases. It is the drug developed by the company Pfizer that contains two antivirals: nirmatrelvir and ritonavir. It is recommended for people who have not yet been vaccinated, who are over 60 years of age or who are immunocompromised.
The drug bears the trade name Paxlovid and according to WHO it is for patients with mild and moderate COVID-19 at higher risk of hospital admission. The health agency experts published the work in the specialized journal The BMJ and rated it “as the best therapeutic option for high-risk patients to date”.
Despite their positive assessment, experts also pointed to some barriers that could hinder access to the drug against COVID-19 in developing countries. According to a WHO statement, “availability, lack of price transparency in bilateral agreements made by the producer, and the need for rapid and accurate testing before administration, are making this life-saving drug a major challenge for low-income countries and media”.
Consulted by Infobae, Fernando Tortosa, physician and consultant for the Pan American Health Organization on COVID-19 therapeutic interventions, gave his opinion on the benefits and access to the drug. “The drug that includes the antivirals nirmatrelvir and ritonavir was authorized for emergency use in the United States last December. In Argentina it is not yet authorized for commercialization,” said Tortosa.
Based on clinical trials that evaluated efficacy and safety, Paxlovid “would have better benefits in patients who have not yet been vaccinated against COVID-19 and at high risk of developing serious illness. In this group, with a potential failure of the immune system response, medication reduces the risk of hospitalization,” added Tortosa.
By containing the antiviral nirmatrelvir, the drug inhibits a coronavirus protein to prevent the replication of the virus. In addition, with ritonavir, it slows down the breakdown of nirmatrelvir to help it stay in the body longer at higher concentrations.
It is given as three tablets (two of nirmatrelvir and one of ritonavir) taken together orally twice daily for five days, with a total of 30 tablets. “The use of Paxlovid is not authorized for more than five consecutive days,” the United Nations health agency clarified.
The WHO recommendation is based on data from two randomized controlled trials involving 3078 patients. Data show that the risk of hospitalization is reduced by 85% after treatment. In a high-risk group (more than 10% hospitalization risk), that means 84 fewer hospitalizations per 1000 patients.
On the other hand, WHO advised against “the use of Paxlovid in patients at lower risk, as the benefits proved to be negligible”. He insisted on differences between countries according to income levels.
For low- and middle-income countries, that the drug can only be administered when the disease is in its early stages can be an obstacle. This is because rapid tests for COVID-19 are not widely available to the population. Even during the last month, the Pan American Health Organization has called for not to reduce the number of tests even further.
Data collected by FIND show that the average daily testing rate in low-income countries is as low as one-eighth of the rate in high-income countries. Improving access to testing and early diagnosis in primary care settings will be critical to the global implementation of this treatment.
“WHO is extremely concerned that, as happened with COVID-19 vaccines, low- and middle-income countries will again be relegated to the back of the queue when it comes to accessing this treatment,” he said. The lack of transparency on the part of the company is making it difficult for public health organizations to get an accurate picture of the drug's availability, which countries are participating in bilateral agreements and what they are paying for. In addition, a licensing agreement signed by Pfizer with the Medicines Patent Pool limits the number of countries that can benefit from the production of generics of the drug,” they said.
Based on the recommendation of the expert group, the drug Paxlovid was included in the WHO prequalification list today. But generic products are not yet available from quality-assured sources. “Several generic companies (many of which are covered by the Medicines Pool and Pfizer licensing agreement) are in talks with WHO prequalification, but it may take some time to meet international standards to be able to supply the drug internationally,” the health agency explained.
WHO “strongly” recommended that Pfizer “make its prices and agreements more transparent and expand the geographical scope of its license with the Medicines Patent Pool so that more generic manufacturers can start producing the drug and make it available more quickly at affordable prices.
“The target population that could benefit from the drug is very high. It is important that the health agency recommends that measures be taken to facilitate access for all so as not to have problems of equity due to cost and distribution,” said Tortosa.
In addition to the strong recommendation for the use of nirmatrelvir and ritonavir, WHO also updated its recommendation on remdesivir, another coronavirus drug. Previously, I had advised against its use in all patients with COVID-19, regardless of the severity of the disease, because all the tests in that had little or no effect on mortality.
Following the publication of new data from a clinical trial analyzing the outcome of hospital admission, the health agency updated its recommendation. WHO has now suggested the use of remdesivir in patients with mild or moderate COVID-19 who are at high risk of hospitalization. The recommendation for the use of remdesivir in patients with severe or critical COVID-19 is currently under review.
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