Share this:

Like this:

New user-friendly COVID substances are here, but hard to find

Simple, easy and effective COVID control pills arrive at California pharmacies and provide hope as cases increase and immunity decreases.

But the powerful new drugs - Pfizer's Paxlovid and Merck's molnupiravir - are in short supply, forcing doctors to make difficult choices about who will benefit most from treatment.

There is another challenge: The pills must be taken within five days after the onset of symptoms when the virus is still multiplying. This means that it is important to find a test, pronto.

"Quick is the trick," said San Jose's Dr. Walter Newman, Medical Director of the United Farmworkers Union. This week, he prescribed the pills to two newly infected patients who were at risk for severe COVID-19 due to age and diabetes.

As more than 100,000 Californians get infected every day, "we're flooded," he said. "This will keep cases that are mild or moderate from developing into serious illness and death."

Dana Ludwig acknowledged that his sick 86-year-old brother-in-law, on a visit from Huntington Beach, was facing potential danger.

In just three hours, doctors at UC San Francisco's COVID-dedicated emergency room provided a PCR-confirmed diagnosis - and a prescription. Now, four days after treatment, his severe cough continues, but his temperature has stabilized.

"He now has a better chance of surviving this thing," said Ludwig, a computer scientist living in Berkeley. "Even though he looked good, he could have fallen through the floor in a week."

The U.S. Food and Drug Administration approved the two drugs in late December - just as vaccinated Americans' antibody levels dropped and the highly contagious omicron variant began to overtake the delta.

Antiviral drugs are designed to turn life-threatening COVID-19 infections into genes. Patients simply pick up the medicine at a pharmacy, like any other prescription.

"We are currently challenged to treat COVID because of the limited treatments available to us," said Deepak Sisodiya, Director of Pharmacy Services at Stanford Health Care. "And with oral therapies, patients do not have to come in. They can be taken at home."

"By preventing serious illness, this approach is" a game-changer. It really helps protect our hospital resources, "said UCSF infectious disease expert Dr. Peter Chin-Hong.

Researchers stress that vaccines are still the best line of defense because they lower the risk of infection and exposure if you become ill. But to save the unvaccinated and those with "breakthrough" cases, they recognized that they needed a drug that could help people who are already ill.

The pills arrive at a time when some of the traditional tools to fight the virus - called monoclonal antibodies - are losing their effectiveness. Antiviral drugs are easier to take than monoclonal drugs because they do not require an intravenous infusion.

And unlike vaccines or monoclonal drugs, the drugs do not create protective antibodies. Instead, they attack the virus itself.

Pfizer's drug blocks an enzyme that the virus needs to reproduce. The Merck drug also stops viral replication, but in a different way. It is based on a false version of the genetic material of the virus; when the virus multiplies, it dies.

The results of clinical trials were encouraging. The Pfizer drug reduces the risk of hospitalization or death in high-risk adults by 89%. The Merck drug is significantly less effective and reduces hospitalizations and deaths by 30%.

They counteract all current variants. And although there is a risk of interaction with other drugs, there are few side effects.

Both drugs are given for five days. Pfizer's cure with three tablets is taken morning and evening. Merck's are four capsules, twice a day.

However, there is a shortage, so they are only offered to people who meet all three of these criteria: positive test results, symptoms of mild to moderate COVID-19 disease and high risk of developing serious disease.

"The provider makes the clinical assessment," Sisodiya said. "When supply does not meet demand, how do you make the difficult choices? Our approach at Stanford has been very conscious. We (classify) patients based on risk."

The highest priority goes to people who are unvaccinated, partially vaccinated or vaccinated but immunocompromised due to illness or age, doctors said. Priority is also given to those with cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, obesity, pregnancy and sickle cell disease.

"We have all the patients we want to treat, but we just can not, based on our supply," said Katherine Yang, a pharmacologist specializing in infectious diseases at UCSF Health.

Why is there so little supply?

The mass production of small molecule drugs is logistically complicated, according to drug chemist Derek Lowe in the journal Science. The drugs are made from a wide variety of chemicals, called reagents that come from offshore suppliers, mostly in China. And production must take place on an industrial scale. For example, the production of 10 million courses Paxlovid requires about 16.5 tons of material, he estimates.

"There is a lack of the things used to make things," he wrote. "This is how it goes in the fine chemistry industry - there is a connection that no one really cares much about - before they do."

Federal decision-making is also blamed for the shortcoming. Early on, the United States did not place an order for mass production of pills, as it did with vaccines, Dr. Eric Topol, founder and director of the Scripps Research Translational Institute in La Jolla.

When the pill made an early promise, "Pfizer approached the administration to say 'Do you want to place large orders with Paxlovid?'" Topol said. In confidence in the power of vaccines "it fell."

The federal government is now working with companies to increase production. But it takes six to eight months to make Pfizer's pill. Merck's pill is easier to manufacture. The United States has bought enough Paxlovid to treat 20 million people; 10 million will now be distributed, with 4 million courses available at the end of January and a further 10 million coming in June. It has committed to buy enough molnupiravir for 3.1 million people.

Distribution to states is based on population. This week, the federal government sent California 9,560 of its 99,960 courses of Paxlovid and 38,480 of the 399,920 courses of molnupiravir.

Leave a Reply

Your email address will not be published. Required fields are marked *

Share this:

Like this:

%d bloggers like this: