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Merck’s COVID pill is last choice for U.S. patients, global use varies -Breaking

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© Reuters. FILE PHOTO: A COVID-19 treatment pill, called molnupiravir, developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, is seen in this undated handout photo released by Merck & Co Inc and obtained by Reuters on October 26, 2021. Merck & Co Inc/Handout

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Deena Beesley

(Reuters) – Merck & Co’s new antiviral pill, once touted as a potential game changer for treating COVID-19, is the last choice among four available options for at-risk patients given its relatively low efficacy and potential safety issues, U.S. doctors, healthcare systems and pharmacies told Reuters.

Another oral treatment alternative from Pfizer Inc (NYSE :), Paxlovid is highly sought-after, closely followed by intravenous antitherapy therapy by GlaxoSmithKline NYSE: and Vir Biotechnology NASDAQ:

Omicron is causing doctors to turn their attention because supplies are limited. Gilead Sciences Inc (NASDAQ:) – Remdesivir is an antiviral drug that must be administered as three infusions daily to high-risk COVID patients.

Merck and Ridgeback Biotherapeutics shared initial data that showed molnupiravir halved the likelihood of hospitalization late last year. This was widely acclaimed as a breakthrough treatment for COVID.

When full data revealed that the drug was effective at 30%, enthusiasm began to wane. This was further undermined by the discovery that Paxlovid could reduce hospitalization rates by as much as 90% GSK’s sotrovimab, Gilead’s Remdesivir – sold under the name Veklury- reduced hospitalization risk by 87% and 85% respectively.

According to data from the U.S. Department of Health and Human Services, approximately 265,000 Paxlovid and over 1.1 million molnupiravir courses have been sold. This early data shows that Merck’s drug is still available in pharmacies and hospitals across the nation.

“The Merck product is only 30% effective so we’re not dispensing it,” said Jim Mangia, president of St. John’s Well Child and Family Center, a network of public health centers in South and Central Los Angeles.

He stated that the center already had 200 molnupiravir course from the federal governments and was requesting only new Paxlovid deliveries.

Reuters spoke to more than a dozen health care providers from more than half a dozen different countries. Most of them said that they only prescribe molnupiravir if there are better options.

Merck responded to a question about molnupiravir’s status as the last choice among U.S. doctors by saying that demand for it will increase with more data from clinical trials and real world.

Eliav Barr from Merck’s global medical affairs, stated that “there is a lot to learn over the coming weeks and months.”

Pfizer’s and Merck’s regimens were both used five days earlier than the onset of symptoms. They allowed for at-home treatment rather than cumbersome infusion therapies that are administered in hospitals.

Dozens upon dozens of generic drugmakers have lined up to make Merck’s drug for low income countries. However, future demand remains uncertain.

    Sales of molnupiravir, under the brand name Lagevrio, are expected to top $5 billion this year, while Pfizer’s Paxlovid is expected to rake in nearly $23 billion, according to Wall Street estimates compiled by Refinitiv.

“CAN’T GIVE MOLNUPIRAVIR AWAY”

    The U.S. government, which has spent around $2.2 billion on molnupiravir and $5.3 billion on Paxlovid, has offered about 85% of the supplies to states and sent the remaining 15% directly to community-based health centers.

    “I can’t give molnupiravir away,” said Steve Moore, pharmacist and owner of Condo Pharmacy in Plattsburgh, N.Y.

Paxlovid is a flying drug that flies off the shelves, even when there are drug interactions,” he stated. He was speaking about Paxlovid’s potential for interfering with your body’s ability clear some other drugs.

Moore claimed that only 70 courses of molnupiravir remain in stock. All 40 Paxlovid courses sold out quickly. Moore has an open waiting list for the next shipment.

Both oral treatments are different.

Molnupiravir can introduce errors in the gene code of coronavirus. Both men and women who take it should use birth control to avoid potential safety problems. Paxlovid is a 2-drug combination that contains the antiviral Ritonavir, which can boost effectiveness but also affect the side effects of other medications. It blocks the production of an enzyme known as protease. This allows the virus to reproduce.

Governments in other countries are closely monitoring molnupiravir use.

    In the UK, high-risk patients can volunteer for a clinical trial to receive the Merck medication but it has not rolled out broadly. France has canceled its order and is no longer using the medication.

    In Italy, each region has its own rules but often a general practitioner must first refer patients to COVID health groups that can prescribe molnupiravir.

Generic versions of Molnupiravir can be purchased at affordable rates in some countries with low income.

Molnupiravir in Bangladesh is much cheaper than other drugs and it is widely being used by the general public. Generic Paxlovid, however, is being prescribed to large corporations that purchased generic Paxlovid for their patients. Dr. Sayedur Rahman is chairman of Department of Pharmacology at Bangabandhu Shaikh Mujib Memorial University.

    In India, the national health agency does not recommend molnupiravir. Although the drug is readily available in Mumbai and Delhi, its usage has been restricted to those with serious health issues, Dr. Ambrish Mitchell, chair, endocrinology, Max HealthCare in New Delhi.

    In the Philippines, versions of molnupiravir are widely prescribed through hospital pharmacies. Patients have reported improvement in two- to three days, according to doctor.

GRADERING THE OPTIONS

Paxlovid has been recommended by the U.S. National Institutes of Health to be the preferred treatment for high-risk patients. GSK’s sotrovimab comes in second place, with remdesivir coming in third. This medication has been prescribed since the beginning of the pandemic, and was recently authorized to treat high-risk COVID sufferers.

Merck’s pills, also known as nucleosides analogues have been associated with birth defects in animal research. Merck claims that animal tests of the drug have shown it doesn’t cause cancer or birth defects in animals.

    Infectious disease specialist Dr. Rajesh Gandhi said his hospital, Boston’s Massachusetts General, is just beginning to use the new oral antivirals. Paxlovid will be prescribed to most of the patients that are eligible, Dr. Rajesh Gandhi said.

“As far as molnupiravir, I would use it in a person who is at high risk for severe COVID but only if other options – like Paxlovid, sotrovimab or remdesivir – are not available or cannot be given,” he said.

Dr. Tara Vijayan, infectious disease specialist at UCLA Health, said Los Angeles County authorities have prioritized underserved communities for the pills, limiting the hospital’s access.

The over 400,000-member healthcare system was temporarily without sotrovimab last weekend and began scaling up the use of remdesivir in outpatients.

“We were able to find one pharmacy within Los Angeles County that carried Paxlovid. She said that the rest of them had molnupiravir which we do not consider as effective.

According to Onisis Stefas, chief pharmacy officer at Northwell Health in New York State, the largest provider of healthcare services, Northwell Health is still waiting on supplies for Paxlovid and molnupiravir.

For high-risk patients diagnosed with COVID, he said Northwell recommends that physicians hew to NIH’s recommendations. “On the very bottom is the molnupiravir.”

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