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Merck Advances Oral Antiviral Therapy for COVID-19

On October 1, 2021, Merck announced the results of the planned interim analysis of the MOVe-OUT Phase 3 clinical trial, which is investigating the safety and efficacy of an oral antiviral treatment for non-hospitalized patients with mild-to-moderate COVID-19. The investigational new drug, molnupiravir, consists of one pill that is taken four times per day for five days. Based on the results of the planned interim analysis, Molnupiravir reduced the risk of hospitalization or death by approximately 50 percent. Notably, zero deaths occurred among those that received molnupiravir while eight patients in the placebo group died and the drug demonstrated efficacy across the Gamma, Delta, and Mu variants. Incidence of adverse events between the molnupiravir and placebo groups was comparable and fewer patients in the molnupiravir group discontinued therapy following an adverse event compared to the placebo group. In consultation with an independent monitoring committee and the U.S. Food and Drug Administration (FDA), Merck has suspended enrollment in the clinical trial to allow the company to file the results of the clinical trial with the FDA to support an Emergency Use Authorization (EUA) for molnupiravir. Merck has the capacity to manufacture and ship 10 million courses of treatment of molnupiravir by the end of the year and the U.S. government has already purchased 1.7 million courses of treatment.

Molnupiravir functions similarly to remdesivir by targeting the RNA-dependent RNA polymerase (RdRp), which is responsible for carrying out replication and transcription of the coronavirus genome. Because of the way this drug acts on viral RdRp, it has shown to be effective at inhibiting viral replication for several coronaviruses, including SARS-CoV, SARS-CoV-2, and MERS-CoV. While the incidence of replication errors can produce viral mutations and additional coronavirus variants, molnupiravir causes a disruption of replication fidelity to such a degree that it makes new viral copies non-viable. Exposure to molnupiravir has not demonstrated mutagenicity to human DNA during DNA replication, but additional research is needed to confirm that molnupiravir will not have unintended adverse effects.

Compared to options currently available for patients with COVID-19, molnupiravir is positioned to have a significant impact on global efforts to end the coronavirus pandemic. While remdesivir and monoclonal antibody treatments are currently available, both of those treatments are given by intravenous infusion, which is labor-intensive and often cumbersome to administer. Also, both remdesivir and monoclonal antibody treatments are expensive. Compared to monoclonal antibodies, molnupiravir is less effective overall but the drug will likely be more affordable and have greater availability to patients. Additionally, clinicians have administered remdesivir less frequently to patients with COVID-19 because it has shown to only have modest benefits.

While great need exists for new COVID-19 treatment options, a treatment has not yet been developed that has proven to be more effective at preventing hospitalization and death compared to getting vaccinated against the virus. If you have not yet been vaccinated against COVID-19, Pandemic Patients recommends consulting with your health care provider to discuss getting vaccinated as soon as possible.

FDA Grants Emergency Use Authorization for Merck’s Molnupiravir

On December 23, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for molnupiravir, which is a treatment for COVID-19 manufactured by Merck. The EUA for molnupiravir authorizes its use for the treatment of patients with mild-to-moderate COVID-19 who are at high risk of severe COVID-19 and who are unable to utilize alternate treatment options.

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FDA Grants Emergency Use Authorization for Pfizer’s Paxlovid

On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Paxlovid, which is an oral antiviral treatment for COVID-19 manufactured by Pfizer. The EUA for Paxlovid authorizes its use for the treatment of adults and children over the age of 12 with mild-to-moderate COVID-19 who are at high-risk of severe COVID-19.

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