While new medications are available to treat COVID-19, they can be hard to come by and most definitely aren't for everyone.
They also need to be taken early in the disease to be most effective; oral antivirals must be started within five days of symptoms, while IV medications, which are even more scarce, can be taken within the first 10 days.
There are four currently approved therapeutics for those in the early days of COVID-19 who aren't hospitalized or requiring oxygen because of COVID-19, but are at high risk for severe COVID-19.
They are the oral antivirals Paxlovid and molnupiravir, the monoclonal antibody treatment sotrovimab, and the IV antiviral remdesivir.
The state of Georgia is distributing Paxlovid and molnupiravir through certain pharmacies. In Coweta, the only location is Walgreens at 3116 Highway 34 East.
Paxlovid, which is considered the first choice for those who are eligible, is much more scarce than molnupiravir.
Both medications received emergency use authorization from the FDA in late December, and production has not yet ramped up to reach the demand.
Paxlovid was found to be dramatically more effective in clinical trials than molnupiravir, though it is contraindicated in patients with severe liver or kidney disease and carries several drug interaction precautions. Clinical trials found it to reduce the risk of COVID-19 hospitalization or death by 89 percent, according to Pfizer. Patients may be able to discontinue some of their other medications while taking Paxlovid to avoid the interactions, in consultation with their physician.
Molnupiravir was found to be 30 percent effective and, under its EUA, should only be used if a patient is unable to obtain Paxlovid, sotrovimab or remdesivir.
On Friday, the U.S. Department of Health and Human Services COVID-19 Locater showed 11 courses of Paxlovid available at the local Walgreens, out of an initial allotment of 180. There were 374 courses of molnupiravir out of an initial allotment of 700.
As of Friday, there were only 56,604 courses of Paxlovid available in the entire country, according to the U.S. Department of Health and Human Services COVID-19 Locator. That's out of a total allotment of 194,700. Molnupiravir is much more abundant, with 361,035 courses out of a total of 660,280.
Monoclonal antibodies extremely scarce
Sotrovimab, the only monoclonal antibody treatment shown to be effective against the Omicron variant, doesn't appear to be available locally, but is offered at some Wellstar Health System locations.
The HHS shows that Georgia received 1,296 courses of Sotrovimab this week and 1,548 courses last week.
The monoclonal antibodies that were used frequently to treat the Delta variant, including REGEN-COV, are not effective against the currently circulating Omicron variant, and are no longer available.
There is also a monoclonal antibody product that is used for those who are severely immunocompromised to help keep them from getting COVID-19 in the first place. Evusheld is for "pre-exposure prophylaxis for those who either cannot receive a COVID-19 vaccine or who have a moderate to severe immune condition that may prevent them from mounting an adequate immune response to COVID-19 vaccination. It is only for patients who have not had a recent exposure to someone with COVID-19.
According to the HHS locator, Cancer Treatment Centers of America in Newnan received 24 courses of Evusheld in late December and lists no courses available. Some hospitals in the Atlanta-area also received Evusheld. While most no longer have it, some locations do have it available.
Antivirals not for everyone
When it comes to the oral antivirals, women and men of childbearing age must be careful if taking molnupiravir. It is not recommended for use in pregnancy and those taking it should use a reliable form of birth control while taking it and for four days afterward, according to the emergency use authorization. However, pregnant women at high risk "may reasonably choose molnupiravir therapy after being fully informed of the risks," particularly if they are more than 10 week pregnant, according to the National Institutes of Health. Men who are sexually active with women of child bearing age are asked to use a reliable form of birth control while taking it and for three months afterward.
While Paxlovid was approved unanimously by an FDA advisory panel, molnupiravir was approved by a vote of 13-10.
The two medications have different mechanisms of action. Molnupiravir stops the virus by introducing mutations as it tries to reproduce, shutting down reproduction. Paxlovid is a main protease inhibitor, which prevents the virus from making the proteins it needs to grow.
Some researchers have expressed concerns molnupiravir mechanism of action could lead to the rise of new COVID-19 variants, according to the journal Nature.
This could become an issue if someone doesn't take the full five day course and doesn't completely clear the virus, Sankar Swaminathan, the division chief for infectious diseases at the University of Utah Health in Salt Lake City and a member of the FDA advisory panel, told Nature. Swaminathan voted against the EUA for molnupiravir.
Nicholas Kartsonis, the senior vice-president of clinical research at Merck, said that no remaining virus was detected in the trial participants after the full five day course, according to Nature; however, the medication was not tested in immunocompromised people, who may have trouble clearing the virus.
The FDA is requiring Merck to establish a process to monitor for the emergency of variants.
There are also concerns that the drug could cause mutations in DNA, but animal studies indicated that the risk is low, according to Nature. However, that risk is the reason for the pregnancy and birth control recommendations, and why the medication is not approved for those under 18.
Other than that, there are no contraindications such as those with Paxlovid, and no drug interactions.
My symptoms all faded away
Molnupiravir worked dramatically well for Cowetan Kim Kramer, who tested positive for COVID-19 on Jan. 3.
Kramer, 62, has heart failure, which puts her at high risk for severe COVID-19. When she woke up feeling bad after her husband had contracted COVID-19, she took an at-home test and it was strongly positive.
Because of the heart failure, she knew she needed to let her doctor, Erika Martinez-Uribe, know, even on a Sunday. Though Kramer is vaccinated, her condition puts her at high risk.
Kramer had heard about the antivirals being approved, and her doctor asked if she would be willing to try molnupiravir.
"I said yes, because I completely trust Dr. Martinez," Kramer said. Her husband was able to pick the medication up the next day at Walgreens, even though she usually gets her medications elsewhere.
She took the first dose that night, and the second dose the next morning. By that afternoon, "I started to feel much better," Kramer said. By that night, my symptoms all faded away, and I didn't have any more symptoms ever again."
Her symptoms hadn't been severe, but she and her doctor wanted to make sure they didn't get that way.
"I didn't want to end up in the hospital," Kramer said. Heart failure can really exacerbate COVID-19 symptoms, she said. "It makes it so much worse."
Martinez-Uribe happened to be on call that Sunday, instead of one of her colleges. She had heard about the antivirals being approved and knew that they had to be given as soon as possible. But finding them was going to be the issue. There was less information about finding the medications than there is now.
"I was trying to figure out how to get this medicine. I had to research this on my own," she said. She had heard someone say they heard Walgreens had it. "It was like a rumor," she said.
She called and the pharmacist said they had some molnupiravir, but no Paxlovid. Martinez-Uribe did some research on the medication and then called in the prescription.
She said she has prescribed the antivirals for a handful of patients, all around the same time, and most have done very well with it, though one was still feeling bad after taking it but the patient recovered without incident.
She's had a lot more patients ask for it.
Martinez-Uribe said she had one patient who was in their mid 30s, vaccinated, with no underlying conditions.
She had to tell the patient she was sorry, but that they didn't qualify for the medication. She continues to encourage people to be vaccinated against COVID-19.
She said some of her colleagues, who have a lot of older patients with chronic medical conditions, have been prescribing it a lot.
"I have to take each case by case," Martinez-Uribe said. "These medicines, at this moment, are not for everyone." Instead, they are only for people with conditions that could cause them to have severe cases of COVID-19. "That is how we need to be using them," she said at least while they are so scarce. With more data and greater supply, maybe well expand to be able to provide it for our regular patients, she said. Right now were trying to focus on the high risk.
To see availability of Paxlovid and molnupiravir, visit https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/ .
Continued here:
COVID antivirals effective - if you can get them - Newnan Times-Herald
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