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In-Depth: As doctors ration COVID treatments, some turn to fluvoxamine

Fluvoxamine
Posted at 6:35 PM, Jan 06, 2022

SAN DIEGO (KGTV) – With coronavirus cases at record highs and treatments scarce, out-patient clinics in San Diego are being forced to ration antiviral COVID therapies that can keep people out of the hospital.

Medical staff are triaging treatments to the most at-risk patients. Even though risk factor scores and formulas guide these decisions, there's an uncomfortable reality for many doctors: the unvaccinated are getting priority over the vaccinated.

If you're vaccinated and under age 65, you likely will not find an antiviral treatment right now, said Dr. Christian Ramers, an infectious disease specialist at Family Health Centers of San Diego.

"It is a special kind of irony," he said. "It's the unvaccinated people that are at highest risk of dying. We have sworn an oath to protect life and they're the ones sapping these limited resources now."

Rather than leave otherwise eligible patients untreated in the early stages of infection, some doctors are turning to a widely available drug called fluvoxamine.

The decades-old drug is FDA-approved to treat obsessive-compulsive disorder and depression. In two randomized clinical trials, it reduced the risk of emergency care or hospitalization by about 30 percent.

That's far less than Pfizer's new COVID pill, Paxlovid, which reduced hospitalizations by 88 percent in a clinical trial. But it's similar to the 30 percent benefit of Merck's antiviral molnupiravir, noted Dr. David Boulware, a professor of medicine at the University of Minnesota who is studying fluvoxamine.

"Clearly, if you have access to Paxlovid, if you have access to monoclonal antibodies, those are your first choice. But in my mind, this is sort of a third choice because it's actually available. An available medicine is better than a theoretical medicine that doesn't exist," he said.

Fluvoxamine is not under patent protection and does not have the backing of a major pharmaceutical company, Dr. Boulware said. A typical treatment course costs about $5 compared to more than $500 for Paxlovid or more than $700 for molnupirarvir, he said.

Fluvoxamine does not attack the virus head-on. Instead, it reduces inflammation, which can spiral out of control during COVID. That means it's likely unaffected by the omicron variant, said Boulware.

Although any doctor can prescribe fluvoxamine for COVID "off-label," Dr. Boulware submitted paperwork to the Food and Drug Administration last month seeking an updated authorization to use it for COVID. The agency has not yet taken action on the application.

The National Institutes of Health's current guidelines say there is "insufficient evidence" to recommend for or against the use of fluvoxamine.

Dr. Robert Schooley, an infectious disease specialist at UC San Diego and the editor-in-chief of the journal Clinical Infectious Diseases, said he was skeptical of the existing data on the drug.

"I think it's another one of these things that people would love to believe, but the data are very weak about it. And we're only a week or two away from having access to drugs that are much, much better," he said.

However, other health officials are taking note of fluvoxamine. In December, health officials in Ontario, Canada added it to the list of drugs doctors can consider for people with mild COVID symptoms.

Two clinical trials in the U.S. are still underway, including one overseen by Dr. Boulware. Patients can sign up and have pills shipped to their home.

"Is a 30 percent benefit worthwhile or not? For Merck and molnupiravir, a 30 percent benefit was sufficient for a new medicine with a limited safety track record to be newly granted an [emergency use authorization]," he said.

Boulware said fluvoxamine has a long safety record. It can cause headache, nausea, diarrhea, and other side effects. In a clinical trial in Brazil, about 25 percent of the volunteers stopped taking the drug before the end of the 10-day course because of side effects.

Those who could tolerate at least 80 percent of the pills saw a 64 percent reduction in COVID hospitalizations.

"I do know of colleagues that hey, if there's nothing else, this is relatively low toxicity with pretty good efficacy. It might be what we reach for next," Dr. Ramers said. "I'm basically right on the edge of writing my first [prescription]."