Deciding who should receive the Covid pill will be difficult

Scientists who have been hesitant to talk about any new Covid-19 treatment suddenly use the term “game changer” to describe the Pfizer Paxlovid antiviral pill. But the modified game will include rationing.

It is no coincidence that it works the same way as the drugs that changed everything with the AIDS epidemic. Called protease inhibitors, they have turned HIV from a death sentence into a manageable disease.

Doctors treating Covid-19 patients are delighted that Paxlovid received emergency use approval earlier this month, but ramping up supplies amid the current massive pandemic wave could spark a grievous ethical conflict over who should have priority. Among those whose lives could be saved are those who are vaccinated and stimulated but immunocompromised, as well as those who are intentionally unvaccinated. If people were angry with unvaccinated patients overloading medical staff and occupying hospital beds, wait for the outcry about who will get the new pill.

In clinical trials, Paxlovid reduced the risk of hospitalization by 89% when people with multiple risk factors received the drug within five days of symptom onset. Because it’s a pill, it doesn’t require a medical facility like monoclonal antibodies do, and new evidence shows that most of these antibody treatments won’t work against omicron in any way.

“I think it’s a game-changer,” said Roger Seheult, intensive care physician and pulmonologist in California, who spoke to me this week just after completing a shift in intensive care. But he wonders how the few hundred thousand doses promised by the US government will withstand the rising tide of disease. Noting that 200,000 people contract the virus every day, he said: “We could see a million of them a day once this thing hits its peak.”

He referred to Colin Powell as someone who could have been saved by Paxlovid. Powell, who died of Covid-19 last fall, had suffered from multiple myeloma – a disease that interferes with the body’s ability to make antibodies in response to infection or to vaccines.

But millions of people are either immunocompromised or have skipped the vaccine. Seheult said that in his hospital’s intensive care unit he was also seeing a number of people with multiple health risks who skipped the highly recommended booster shots.

The supply problem will not be easy to solve, said Derek Lowe, medical chemist and author of Science In the Pipeline magazine’s pharmaceutical blog. Raw materials are the problem, he said. The manufacture of this type of complex drug requires several steps, each requiring different materials. “And each of those things has to be researched – how many can they do real quickly, and do it with sufficient purity and get it delivered,” Lowe said, adding, “You’ve got five, 10, a dozen, 20? different chemicals that you have to worry about in the same way. “

The process often involves multiple countries. “At the end of the day, we depend on other countries that still have a big, ugly, dirty, smelly fine chemicals industry,” he said.

Merck has also developed an antiviral pill, molnupiravir, which initially showed equally promising results, but now appears to be only about 30% effective in preventing hospitalization. The drug Merck has also raised concerns that its ability to induce mutations in the virus may become “fertile ground” for new variants.

Seheult and other doctors still see it as a safeguard. Paxlovid can potentially interfere with other medicines, so it may not work for patients who cannot take a break from their normal medicines for even a few days.

Paxlovid is basically two drugs. One is the true protease inhibitor, which works by shutting down a key enzyme needed for the virus to reproduce. Such a direct attack should work even on those whose immune systems are not functioning.

The other part, ritonavir, is an older anti-HIV drug, which increases the effective dose of the antiviral part by slowing down the liver’s ability to metabolize and destroy it. This is why it could have the unwanted side effect of causing other drugs to build up in toxic doses.

The two drugs that make up Paxlovid are similar to drugs given to HIV-positive patients for life, but for Covid-19, drug treatment would only take five days. No safety concerns have been raised in clinical trials. The need to give it within five days is a limitation, but people who know they are at high risk could, in theory, be prepared with home Covid-19 tests – provided that the supply of those- this can increase quite quickly.

Just as HIV drugs have changed the way society views sex and relationships and made the lives of many single people less stressful, the presence of an effective Covid drug could ease the emotional and social toll of the pandemic. . Vaccines have come a long way in this direction, but have left behind people who cannot fully benefit from them because they have weakened their immune systems due to age, disease, or the need to take. immunosuppressive drugs.

Should they be competing with people who are also at risk because of their choice not to get the vaccine? About half of unvaccinated people say they would refuse Paxlovid, according to a recent Harris poll, but that leaves a lot of potential demand in the other half – and many more could change their mind if they thought their life was was in immediate danger.

Then there is a whole gray area of ​​people who have failed to get a boost, despite being over 65 or suffering from diseases such as obesity and diabetes. Only about a quarter of American adults have received the booster, so this group may constitute the bulk of the demand for Paxlovid.

There is always the possibility that things will not go as planned. Doctors thought they should ration ventilators, but learned that many patients did better on supplemental oxygen. This time around, no one knows just how much omicron cases will cause a surge in hospitals.

Even as the supply increases, Lowe and other experts fear that if the drug is used too widely, it could potentially increase the chances of the virus developing resistance. The medical community will therefore need to exercise good judgment in prescribing this drug for the foreseeable future. The rest of us should temper hopes for an easy cure and get that booster.

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