Time to Approve Fluvoxamine for Early COVID Treatment

Another early treatment option would serve the public

If following the science is to have any credibility, then now is the time for NIH to officially approve use of fluvoxamine as an early COVID treatment.  A newly published review of data on the effectiveness of fluvoxamine in keeping COVID infected people out of hospitals provides compelling evidence.  There is no rational reason for the government to avoid approving this older drug for this new use.  It has a good safety record in its use to treat depression and other mental illnesses.

Here are key excerpts from the study.

“Widely available and affordable options for the outpatient management of COVID-19 are needed, particularly for therapies that prevent hospitalization.”

“In this systematic review and bayesian meta-analysis of 3 clinical trials, which accounted for varying prior probabilities coupled with a frequentist sensitivity analysis, there was a high probability (94.1%-98.6%) that fluvoxamine was associated with a reduced risk for hospitalization,”

“All 3 were placebo-controlled randomized controlled trials that recruited unvaccinated, symptomatic adults with microbiologically confirmed SARS-CoV-2 infection who were within 6 to 7 days of infection and not requiring oxygen.  … Overall, the median age of participants was between 46 and 50, 55% to 72% of participants were female, 44% to 56% were obese.  … No trials included vaccinated patients and all trials predated both the Delta and Omicron variants.”

“100 mg twice daily is the minimum effective dose.”

“Based on our analysis, and coupled with worldwide accessibility, decades of safety data, and a current price of approximately $1 per day, fluvoxamine may be a reasonable option for high-risk outpatients who do not have access to SARS-CoV-2 monoclonal antibodies, direct antivirals, or clinical trials.”

“Fluvoxamine is an immediately available, safe, and inexpensive management option with a high probability of moderate efficacy. It could be recommended as a treatment option for patients without contraindication, particularly in resource-limited settings or for individuals without access to monoclonal antibodies or direct antivirals.”

“These findings suggest that fluvoxamine, a widely available and inexpensive treatment for outpatients with COVID-19, was associated with a reduction in hospitalizations.”

“In this systematic review and meta-analysis of data from 3 trials, under a variety of assumptions, fluvoxamine showed a high probability of being associated with reduced hospitalization in outpatients with COVID-19. Ongoing randomized trials are important to evaluate alternative doses, explore the effectiveness in vaccinated patients, and provide further refinement to these estimates. Meanwhile, fluvoxamine could be recommended as a management option, particularly in resource-limited settings or for individuals without access to SARS-CoV-2 monoclonal antibody therapy or direct antivirals.”

In fairness, there are some issues that the public should be aware of.  The drug has long been used for various mental illnesses and, therefore, people who want a prescription for using it to treat COVID may face obstacles.  Their usual physicians may be unwilling or unable under their corporate employers’ guidelines to give prescriptions for COVID use.  There are a number of side effects and drug interactions that should be seriously considered by both the patient and physician.  And there may be uncertainties as to what dosage should be used for COVID treatment.