One day and counting…On the move…A new drug for Covid-19 treatment…

Another piece of art was offered for sale at the ship’s auctions.

I can’t tell you how many readers have written about the new drug treatment for Covid-19, Paxlovid. At first, my sister Julie wrote and suggested we get our hands on this drug. Since then, countless readers have written with the same suggestion.

But, that isn’t as easy to do as you’d think in the UK. First, we’d have to find a doctor willing to prescribe it, and secondly, we’d have had to be seen in person by a doctor.

Here’s some information about this drug from a reliable site:

1. How does Paxlovid work?

Paxlovid is an antiviral therapy that consists of two separate medications packaged together. When you take your three-pill dose, two of those pills will be nirmatrelvir, the drug that inhibits the SARS-CoV-2 protein from replicating. The other is ritonavir, a drug that was once used to treat HIV/AIDS but is now used to boost levels of antiviral medicines. 

As a COVID-19 treatment, ritonavir essentially shuts down nirmatrelvir’s metabolism in the liver so that it doesn’t move out of your body as quickly, which means it can work longer—giving it a boost to help fight the infection.

2. When should I take Paxlovid?

You have to take Paxlovid within five days of developing symptoms.

Like all antivirals, Paxlovid works best early in an illness—in this case, within the first five days of symptom onset, says Jeffrey Topal, MD, a Yale Medicine infectious diseases specialist who is involved in determining COVID-19 treatment protocols for Yale-New Haven Hospital patients.

“Once you’ve been ill with the virus for more than a week, the damage done to the body in a severe case can’t be undone by the antiviral,” he says.

3. How often do I take Paxlovid?

You take three Paxlovid pills twice a day for five days for a full course that adds up to 30 pills. It helps that the pills are packaged in a “dose card,” basically a medication blister pack that allows you to punch out the pills as needed.

4. Is Paxlovid similar to Tamiflu?

“I think it’s a good comparison,” says Dr. Roberts. Tamiflu is an antiviral drug that reduces flu symptoms. Both are prescription-only oral antiviral pills given early in illness.

Tamiflu is taken twice a day for five days, and it must be started within 48 hours of flu onset. “When you give a patient Tamiflu beyond that, it doesn’t really change the course of their flu,” Dr. Roberts says.

But there are also differences between the two, starting with the way they were studied, Dr. Topal adds. Researchers showed that Paxlovid can prevent hospitalization and death. But since influenza causes fewer severe cases, clinical trials focused on whether Tamiflu could shorten the length of flu illness—which it did, he says.

5. Can anyone get a Paxlovid prescription?

The FDA authorized Paxlovid for people ages 12 and older who weigh at least 88 pounds. But in order to qualify for a prescription, you must also have had a positive COVID-19 test result and be at high risk for developing severe COVID-19. 

That means you must either have certain underlying conditions (including cancer, diabetes, obesity, or others) or be an older adult (more than 81% of COVID-19 deaths occur in people over age 65). The more underlying medical conditions a person has, the higher their risk for developing a severe case of COVID-19, according to the CDC.

The hope is that the restrictions will be relaxed over time. The FDA granted the EUA in December, just as a staggering number of people were infected with Omicron and the need for care skyrocketed, leading to supply issues.

However, the supply has improved so that patients who meet the criteria for Paxlovid can now easily receive it, adds Dr. Topal.

6. How well does Paxlovid work?

When it applied for FDA authorization, Pfizer presented data from a clinical trial conducted between mid-July and early December in 2021. The data showed that participants (all of whom were vaccinated) who were given Paxlovid were 89% less likely to develop severe illness and death compared to trial participants who received a placebo. (While the recommendation is to take Paxlovid within five days of symptom onset, participants in the clinical trial took the drug within three days.)

Scientists will continue to study the drug’s effectiveness as it is used to treat patients in the real world.

7. What do we know about how Paxlovid works in kids?

Pfizer launched a clinical trial in March to study the safety and efficacy of Paxlovid in children and teenagers ages 6 to 17 who have COVID-19 symptoms and test positive for the virus, and who are neither hospitalized nor at risk for severe disease.

While Paxlovid is authorized for use in adolescents and teenagers ages 12 and up, and weighing at least 88 pounds, that age group wasn’t tested in the original clinical trial. But because many children reach 88 pounds—considered to be an adult weight—the FDA has allowed extensions of EUAs for medications such as monoclonal antibodies and remdesivir in younger age groups, adds Dr. Topal.

“Based on the pharmacokinetics of the drugs in Paxlovid, the differences in metabolism and excretion—liver and kidney function specifically—of these drugs in this age group are thought to be similar to that of adults,” Dr. Topal says.

8. Does Paxlovid work against Omicron?

Paxlovid’s clinical trials took place before Omicron became predominant, but Pfizer says the drug works against the highly contagious variant. So far at least three laboratory-based studies claim to back this up—two of those studies were conducted by Pfizer, while the third was done by Pfizer in partnership with the Icahn School of Medicine at Mount Sinai. These studies have not yet been published in peer-reviewed medical journals.

9. What are the side effects of Paxlovid?

Most people who take Paxlovid should not experience serious side effects, explains Dr. Roberts. “Paxlovid is usually very well-tolerated,” he says. Common side effects, which are usually mild, include:

  • Altered or impaired sense of taste
  • Diarrhea
  • Increased blood pressure
  • Muscle aches

Since Paxlovid is cleared by the kidneys, dose adjustments may be required for patients with mild-to-moderate kidney disease, explains Dr. Topal. “For patients with severe kidney disease—or who are on dialysis—or those with severe liver disease, Paxlovid is not recommended; the levels of the drug can become too high and could cause increased side effects,” he says. “For these patients, molnupiravir may be another oral option for treatment.”

It’s worth noting that Paxlovid is still being studied, so it is possible that all of the risks are not yet known. (The FDA has provided a fact sheet on Paxlovid with a full list of known side effects.)

10. Can I take Paxlovid if I’m taking other medications?

There is a long list of medications Paxlovid may interact with, and in some cases, doctors may not prescribe Paxlovid because these interactions may cause serious complications.

The list of drugs that Paxlovid interacts with includes some organ anti-rejection drugs that transplant patients take, as well as more common drugs like some used to treat heart arrhythmias. Paxlovid also decreases the metabolism of anticoagulants, or blood thinners, that many older adults depend on, driving up levels of those medications in the body to a point where they are unsafe, Dr. Topal explains.

It also interacts with cholesterol-lowering medications like Lipitor, but that’s less challenging for patients to overcome. “If you stop taking your Lipitor for five days, nothing bad is going to happen,” he adds.

If you are pregnant or breastfeeding, the FDA recommends discussing your options and specific situation with your health care provider, since there is no experience using the drug in these populations. If you could become pregnant, it’s recommended that you use effective barrier contraception or do not have sexual activity while taking Paxlovid. 

11. If I’m not eligible for Paxlovid, is there something else I can take?

For those who are unable to receive Paxlovid—perhaps because it would interact with another medication—there are other alternative therapies, such as molnupiravir, the other oral medication, as well as sotrovimab and remdesivir, which are IV medications.

The NIH recommends the following treatments, in order, for people at risk for severe disease:

  • Paxlovid
  • sotrovimab (Xevudy)
  • remdesivir (Veklury)
  • molnupiravir

But comparisons or rankings such as these are tricky, adds Dr. Topal. “None of these drugs were studied head-to-head or with the same variants,” he says.

And then there is the matter of availability and resources. “Remdesivir, for example, requires three days of IV therapy in the outpatient setting, which is very resource-intensive. Thus, some hospitals won’t offer it,” says Dr. Topal. “But sotrovimab, which is a single injection, is readily available.”

12. Do I still need to be “up to date” on vaccination if Paxlovid is available?

Vaccination remains a key part of prevention, even as more drugs become available, says Dr. Topal. He pictures prevention as an upside-down pyramid. Vaccination, mitigation efforts, such as masking, and testing would be at the base—and medications at the top point.

“Early testing is key to making these drugs work,” he says. “It’s always been the Achilles’ heel of these antiviral drugs that most people don’t get tested—or they don’t have access to testing.

He encourages taking a test even if you think you only have a cold or allergies—and if you can get one. “Home testing is a huge part of the way to really ‘operationalize’ these medications,” he says, adding that while home tests may not be as highly sensitive as the laboratory-based polymerase chain reaction (PCR) tests, they are still very helpful in making a diagnosis.

Dr. Topal says people also should remember that Paxlovid, even with its high efficacy, is not perfect, and even if it were, viruses can mutate and develop resistance to antiviral medications. “Will some people still be hospitalized? Yes—no medication is perfect,” he says. “But for many high-risk patients, this medication can really reduce that risk.”

If you are experiencing symptoms of COVID-19 and think you are eligible for a treatment, you can visit the government Test-to-Treat Locater. You can use the site to search for the places near you where you can fill a COVID-19 prescription, or identify sites that provide testing, medical care, and COVID-19 medications. 

Information provided in Yale Medicine articles is for general informational purposes only. No content in the articles should ever be used as a substitute for medical advice from your doctor or other qualified clinicians. Always seek the individual advice of your health care provider with any questions you have regarding a medical condition.”

As always, we state emphatically to contact your health care professional to access your personal medical situation.

 With over 100,000 new cases in the UK each week, getting an appointment through the NHS would have been impossible. When we were here in 2019 and needed a prescription refill, it took me days of phone calls and frustration to finally get an appointment. It is the same for citizens of the UK and the national health system.

As it turned out, this drug must be taken within three days of a positive test, and by the time I heard about this, this three-day window had passed. By the time we would have been able to secure an appointment, five or more days would have passed. Besides, at the time, we were too sick to be making calls all day and eventually heading out for an appointment. It just didn’t work out.

We are on the mend. Only the tiredness and cough remain, each improving a little each day. There is nothing more we can do at this point.

We would love to be able to return to South Africa with a supply of Paxlovid but based on restrictions in prescribing this drug. There is no way this will be possible.

However, I would like to get another booster before we leave the US, preferably not another J & J but a different brand. I am not entirely confident about J & J providing the protection we need.

Are we hesitant about cruising after this experience? Sure. It would be hard not to be. But that doesn’t mean we will cancel all of our remaining cruises. However, we do ask ourselves what we could have done differently.

We know the answer. It was too close contact with many groups of passengers. How do we avoid that? Did we stay up too late on most nights when we had such fun? We are very social. Surely, that’s what caused us to catch the virus. Then again, that’s a significant factor in us enjoying cruises. How do we work around that?

There is no easy answer. We’ve been safe in South Africa for the past 14 months. We’ve flown on several occasions. We visited the US and Zambia for visa stamps without issue. Certainly, our exposure resulted from being aboard a cruise ship of 1288 passengers.

Tomorrow morning the driver will pick us up to take us to London. If we have time, I will post before we leave or in the hotel once we arrive.

Note: We are working on getting the automatic emails working again. You may get two exact posts today since I sent one manually and our hosting company sent another. So sorry for this inconvenience.

Be well.

Photo from one year ago today, April 27, 2021:

This is One Wart. He only has one wart on the left side of his face and none on the right. Hence, his name. For more photos, please click here.