The World Health Organization (WHO) has included the antiviral molnupiravir, developed by the pharmaceutical company MSD (known as Merck in the United States and Canada), in the list of recommended drugs to treat Covid.
The recommendation made this Wednesday (2) is conditional and restricted to patients with mild to moderate Covid and at high risk of progressing to hospitalization. The new protocol does not recommend the drug for healthy and young patients, including children, pregnant and lactating women, or people with severe Covid.
According to the WHO, patients at high risk of hospitalization are the unvaccinated, elderly patients or patients with chronic diseases such as diabetes, and those who are immunosuppressed.
The WHO guidelines for the treatment of Covid are constantly updated by a panel of experts based on controlled, randomized, double-blind clinical studies (considered the gold standard in clinical trials). The new edition, published this Wednesday (2) in the scientific journal BMJ (The British Medical Journal), replaces the others.
For the inclusion of molnupiravir, the Guideline Development Group (GDG) evaluated six new clinical studies of the drug including a total of 4,796 patients. Study participants did not receive Covid immunizations.
The results showed moderate effectiveness in reducing the risk of hospitalization and the disappearance of symptoms 3.4 days earlier than without treatment. The effectiveness for reducing mortality, however, was low.
The recommendation for using the drug is the same as that made by the pharmacist: two 800 mg tablets for five days, preferably in the initial phase of the infection (up to five days after the onset of symptoms).
According to the group that analyzed the data, the number of people who can benefit from the treatment is small, since in the population at high risk of hospitalization, other mitigation measures, whether at the population level (such as the advancement of vaccine coverage and herd immunity) ) or individual (such as assessing the risks and benefits of antiviral treatment) should be considered.
High treatment costs were also noted for the recommendation, the panel says. “The difficulty of access for low- and middle-income countries must also be considered, as this poses an additional obstacle,” the note said. For this reason, drug recommendation is conditional rather than definitive.
For the entity, it is important in these places that primary care strategies are adopted and that communication about available treatments is widely disseminated to the entire population.
The WHO also recommended pharmacovigilance of the drug’s use, since the safety data found in clinical and pre-clinical trials showed a still small benefit in relation to the potential risks of the drug.
The difficulty of access for low- and middle-income countries must also be considered, as this poses an additional obstacle.
In Brazil, MSD sent a request for authorization for emergency use of molnupiravir to Anvisa (National Health Surveillance Agency) in November, but is still awaiting a decision from the agency, which requested new information.
Anvisa’s response period after the application is submitted is 30 days, but the counting of this period is paused when the agency asks the manufacturer for additional information. In a note, the agency informed that the request is within the regulatory deadline and that, therefore, it is not possible to anticipate details or deadlines.
In addition to molnupiravir, the updated protocol restricts the previous conditional recommendation of using the monoclonal antibodies casirivimab and imdevimab, known by the trade name Regen-Cov, only to patients with confirmed cases of infection with variants of concern of Sars-CoV-2, such as delta. So far, the set of drugs has not shown efficacy against the micron and should not be used without knowing the variant responsible for the infection.
Finally, the WHO said it is re-evaluating the use of the antiviral remdesivir based on new clinical trials. In November 2020, the agency contraindicated the use of the antiviral, the first drug approved by Anvisa in Brazil for the treatment of Covid.
According to the new publication, data from four randomized, double-blind, controlled trials with 7,333 hospitalized Covid patients are being analyzed by the panel. The new assessment is expected to be published in the next update to the coronavirus guidelines.
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