New therapies for COVID-19 are making their way to San Francisco pharmacy shelves.
This week, an expert advisory panel for the Food and Drug Administration voted to approve emergency use authorization for an oral antiviral pill from Merck and Ridgeback Biotherapeutics to treat COVID. The vote passed narrowly, 13-10.
The FDA typically follows recommendations from advisory panels, but it is not required to do so. In the meantime, medical experts in San Francisco and the Bay Area are getting ready for new treatments to hit stores as early as the New Year.
“We do expect supplies to ramp up and you can go to pharmacies to pick these up. It is very exciting and great to have those options around the corner,” San Francisco Health Officer Susan Philip told The Examiner on Wednesday, following a press briefing about the omicron variant that was detected in San Francisco.
So, what’s out there?
The list of COVID-19 drug treatments is evolving rapidly, and several local scientists and medical experts are leading the way in determining their efficacy.
In October, Merck released results from a study of 775 global participants showing patients who took its antiviral drug, called Molnupiravir, were half as likely to be hospitalized or die from COVID-19 compared with those taking a placebo.
In addition, an oral antiviral treatment for COVID from Pfizer called Paxlovid is also planned for FDA review soon. Pfizer claimed in November that after 28 days after treatment, individuals who used Paxlovid within three days of initial symptoms reduced their risk of COVID-related hospitalization or death by 89% compared to those who took a placebo.
At the Quantitative Biosciences Institute at UCSF, a team dedicated to COVID research is comparing these drugs side by side to determine what options might be most safe and effective and for which patients. While several have shown promise, it’s likely a combination of solutions that will be most beneficial to those who seek pharmaceutical treatments.
“What we need is a cocktail of treatments, just like for HIV. That was the big breakthrough with that virus,” said Nevan Krogan, director at QBI. “The question is which combination of drugs works?”
It could still be weeks or even months before over-the-counter drug treatments are a common option for those with COVID, Philip said.
Once approved, these therapies will first be available in limited quantities and distributed throughout the state based on population and COVID cases.
As supplies become more available into the new year, then they will start stocking shelves, Philip said. “I think it will be after the beginning of the year. There are also other candidate drugs that look promising. We will be hearing more on that, but for now, I think we are well poised with our neighborhood vaccine efforts to make sure San Franciscans have every opportunity to benefit.”
The FDA has approved one drug, remdesivir, for the treatment of COVID in hospitalized patients 12 and older. Other medications such as dexamethasone, an anti-inflammatory, also have been approved for treating extremely ill COVID patients.
But first, vaccines
While drug treatments could open up a new recovery path for the pandemic, medical experts are still urging people to get vaccinated and boosted, which remains the strongest form of prevention from the virus.
“I’m a little concerned. I’d rather have people focus on prevention with vaccines and masking and not rely on a particular drug,” said Aruna Subramanian, a clinical professor of medicine and infectious diseases at Stanford University. “It works by promoting mutagenesis, and I worry that if people don’t take the whole dose, we could actually run into more problems.”
Subramanian was referring to the possibility of new mutations and variants developing if treatment doses are not properly followed. While new variants are to be expected, creating opportunities for even more variant development could lead to new surges. That’s what happened with the delta variant this summer in San Francisco.
“I am excited about outpatient therapies and I look forward to seeing more data, but right now I have some concerns about the Merck drug,” said Subramanian. “It would be easier to use oral agents over an IV, but people shouldn’t be falsely lulled into going with those (pill treatments) if they have access to monoclonal antibodies. I think those are still the best option.”
Over-the-counter drug treatments could be an easier option for some than receiving monoclonal antibodies, one popular COVID treatment that’s used to restore or enhance the immune system’s ability to attack cells.
But monoclonal antibody treatments can only be administered in health care settings with immediate access to medications to treat issues such as severe allergic reactions. That can be difficult for individuals in areas without robust hospital systems or access to emergency care. In those cases, Subramanian says drug treatments could be a powerful tool.
One of the trickiest hurdles with bringing oral COVID treatments online will be ensuring people who take them have timely access to testing. Identifying symptoms and a positive case early is essential for the drugs underway to have the most effect.
“We will need easier testing and more testing. There’s no point if it takes three days to get back and you’re trying to treat people early,” said Subramanian. “People are still having trouble signing up for testing.”
San Francisco is scattered with more than 100 vaccination and COVID-19 testing sites that public health officials claim are within a 10- to 15-minute walk for most residents. But that’s not the lived experience for everybody in The City.
“Since the pandemic started I’ve been raising concerns about access to testing,” said San Francisco resident Julie Roberts-Phung, who has at times struggled to find timely and close testing when her kids needed it. “DPH and the city of San Francisco are setting up a testing infrastructure that seems to have treated schools and families as separate. Many students don’t have access to immediate turnaround testing.”
At this point, San Francisco officials say testing options and protocols aren’t expected to change dramatically when drug treatments become more widely available.
“We will refine the messaging, but it won’t be wholly different for testing,” said Philip. “If you have symptoms or if you were exposed to someone with COVID, you need to get tested.”