Three keys to the pill against COVID-19 approved in Peru

This week, the General Directorate of Medicines, Supplies and Drugs (Digemid) of the Ministry of Health (Minsa) granted conditional health registration to the Molnupiravirantiviral pill developed by the pharmaceutical company Merck Sharp & Dohme (MSD) for the treatment of severe cases of COVID-19.

However, yesterday the Minsa indicated that it will not use the pill. First, Alexis Holguin, General Director of Strategic Interventions, explained that it is because there is insufficient scientific evidence on its use. Later, the head of the sector, Hernán Condori, told Congress that “This medicine has not been and will not be bought because it has low efficacy”. Next, we will review everything that is known about the Molnupiravir.

1. How does the Molnupiravir?

The MSD drug was originally developed to treat the flu. It works by attacking the enzyme that use the virus to replicate, preventing its multiplication in the body, keeping the viral load at low levels and preventing the disease from reaching a serious level.

2. What scientific studies support the efficacy of the drug?

On December 16, 2021, in “The New England Journal of Medicine”, an article was published with the Phase III clinical trial “Molnupiravir for the oral treatment of COVID-19 in non-hospitalized patients.

This trial was conducted with 1,433 participants, unvaccinated, with less than five days of symptoms and risk factors for developing severe disease. Although the study indicates that the drug reduces the risk of hospitalization or death by 50%, the epidemiologist Álvaro Taype-Rondán considered that these benefits are not reliable for several reasons. “This is a single study, which was stopped early and had only 14 deaths. Also, no benefit was found in those who had been infected at the start of the study.”he indicated.

Speaking to RPP, Alexis Holguín stated: “East medicine it was tested in unvaccinated with a different variant and an initial efficacy of 50% and after its approval, a study came out reporting that it was 30%. When we did the review with the INS, the study group that had studied this drug was very small. So there is not enough information..

3. What are its side effects and contraindications?

According to the pharmaceutical company –based on the clinical trial–, the most common adverse effects are diarrhea (in 2% of the participants), nausea (1%) and dizziness (1%). “It was similar to what happened in the control arm that received placebo,” said Dr. Alberto La Rosa, medical manager of MSD in Peru.

However, Dr. Gregory Poland, an infectious disease expert and director of the Mayo Clinic Vaccine Research Group, noted that the drug has limitations. “They cannot use it in patients with kidney or liver failure and women of childbearing age, women who are pregnant, women who are breastfeeding, and men who have sex with women of childbearing age.”

Regarding the latter, Dr. Elmer Huerta warned in RPP: “It can cause congenital malformations. So if you are going to use this medicinethey should have a test to see if they are pregnant.”

More data

• A panel of the European Medicines Agency (EMA) will discuss next week the authorization for the use of Molnupiravir. “The Financial Times” reported that approval is unlikely due to its low rate of success.
• Given the Minsa’s refusal, Molnupiravir could be marketed in Peru through pharmacies and clinics.

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