When the Covid-19 vaccines were first rolled out less than a year ago, there was widespread hope that it marked the beginning of the end of the pandemic. However, as we head into another winter, things are far more uncertain than many people had hoped: As much as we’d love to put the pandemic behind us, the delta wave and vaccine hesitancy have left Covid-19 lingering. .
But there is another new development on the horizon that, when combined with vaccines, could really be a game changer.
In recent months, researchers have made some progress in figuring out how to treat Covid-19 once you’ve contracted it. Particularly promising are drugs that are available in a form that should be especially useful in the fight against the virus: pills. Pills are easy to store and ship, making them a more viable option for global distribution, and they don’t strain already overstretched hospital resources during a peak.
To understand why the development of anti-Covid pills is so important, think about how we’ve been able to treat Covid-19 so far. In the nearly two years since this coronavirus began to spread, we’ve learned a lot about how to care for patients who are so sick they need hospital care. Inexpensive, commonly available drugs such as dexamethasone have significantly reduced the hospital death rate from severe Covid-19.
But for sick people who have not been hospitalized, there are fewer options. The only outpatient treatment approved for emergency use and widely available in the US is monoclonal antibodies, which work quite well but must be given as a single IV infusion or a series of four injections in a medical setting.
The uptake of monoclonal antibodies is reportedly not like this: high as it should be, and the treatment itself, while free to US patients, is pricey, costing the US government $2,100 per dose.
So as effective as monoclonal antibodies have been, there’s still a big void in our arsenal of early treatments. When the virus takes hold in an area, hospitals become overwhelmed, meaning people who… need treatment, may not get it. Meanwhile, people with mild to moderate cases are being told to stay at home where they have very few options.
The lack of good early treatments for Covid-19 has led to a high demand for drugs that have gained adherents but are unlikely to help that much, from hydroxychloroquine to metformin to ivermectin. The effort to find out how and if those treatments work has been marred by widespread fraud in published research examining them.
But real progress has finally been made in identifying Covid-19 treatments that are not only highly effective, but are also available for Covid-19 patients to take at home.
Fighting Covid-19 with a pill
One pill that has been shown to be effective against the disease wasn’t even made to fight Covid-19.
Fluvoxamine is an inexpensive, generic antidepressant that has been around since the 1990s. It also appears to reduce hospitalizations and deaths from Covid-19 by up to 30 percent, according to the results of a randomized controlled trial, the first findings of which I reported in August. Results of the so-called TOGETHER trial, which tested fluvoxamine and some other treatments, were recently published in: the lancet medical journal.
How does fluvoxamine work in Covid-19? Researchers’ best guess is that it modulates the body’s inflammatory response and reduces lung damage while the immune system fights the coronavirus.
A 30 percent reduction in hospitalizations and deaths may not seem particularly high to you, but the drug is inexpensive (only $4 per dose) and has a proven track record of safety (it’s FDA-approved), which means the reason should be to add it to the global arsenal in the fight against the pandemic.
Despite encouraging research results and a great safety profile, the National Institutes of Health’s treatment guidelines for fluvoxamine have not been updated since April and the drug is not widely prescribed or recommended for Covid-19 patients. Doctors may call for fluvoxamine to be prescribed as an off-label treatment, but many may be reluctant to do so until the drug’s official guidelines include evidence from large, reputable clinical trials demonstrating its efficacy. Now that the SAMEN results have been published, doctors may be more willing to write those prescriptions.
An even more promising pill is Merck’s molnupiravir. Unlike fluvoxamine, it’s not yet FDA-approved, but it’s also been given a new purpose: Merck began developing the antiviral as a flu treatment. It is taken as a batch of up to four pills, twice a day for five days.
In Merck’s studies, molnupiravir reduced hospitalizations and deaths from Covid-19 by about half. The UK granted the drug “conditional approval” last week; the FDA has been reviewing the data since mid-October and will hold a hearing on Nov. 30 to discuss the data.
The US government has pledged to purchase 1.7 million courses of the drug for about $700 each once it is approved or authorized for emergency use. Merck has licensed the generic production of molnupiravir at a much, much lower price in more than 100 developing countries, and the success of that program will be critical for molnupiravir to make a difference worldwide.
Finally, Pfizer’s Paxlovid is a little further from widespread availability, but recent research suggests it could make a huge difference. Paxlovid is an antiviral drug specifically designed to specifically target Covid-19 by blocking a specific enzyme the virus needs to reproduce itself.
An interim analysis of an ongoing study published by Pfizer last week noted that Paxlovid reduced the risk of hospitalization or death by 89 percent for adults at risk for severe Covid-19. That’s a huge effect size, and it’s always wise to be a little skeptical about the results being this good.
But if the studies hold up — and more are underway that could support or refute the existing data — that could effectively spell the end of the pandemic. For many people, getting sick from Covid-19 would be much less dangerous.
Along the pike
There are many other early COVID-19 treatments in development and also in testing. For example, researchers in the UK found that inhalation of budesonide, a drug used to treat asthma, reduced recovery time, hospitalizations and deaths in Covid-19 patients; studies are underway to confirm those results and to check how budesonide interacts with other early treatments.
The antiviral remdesivir offers little benefit to Covid-19 patients and likely makes “little or no difference” in mortality, according to a systematic review of multiple studies of its effects. Gilead Sciences is developing a pill version for out-of-hospital patients in hopes that remdesivir could work better as an early treatment; some early evidence confirms that.
The FDA’s database of clinical trials for Covid-19 contains hundreds of studies of potential treatments, from recycled drugs to newly developed drugs to combination protocols of other promising drugs. The vast majority of those won’t come true, but only a few are needed.
I suspect I’m not the only one desperate for a return to normal – to concerts and indoor events, to children’s personal playdates, to frictionless travel – while still being aware of the fact that there are still more than a thousand people die from Covid-19 in the US every day.
The virus may be approaching endemic, but that number of deaths need not become a new normal. By developing better home therapies, we can reduce the disease in both vaccinated people with breakthrough infections and those who have refused to be vaccinated. There’s some really good news here, and we owe a big thank you to the scientists who worked to develop, test, and understand these drugs.
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