UK Covid patients will not yet get a ‘changing’ pill that halves the risk of being hospitalized or dying from the disease, it was revealed today.
US drug giant Merck today announced landmark results from a trial of its antiviral molnupiravir.
Hospitalization and death rates were twice as high in infected patients receiving a placebo, compared to those receiving the actual pill.
But there are no plans to make it immediately available in the UK, although Merck has committed to getting approval for its use in Britain. The United States has already agreed to buy 1.7 million courses of the drug.
Merck Scientific Director Daria Hazuda told a press briefing with health and science reporters that the results were an exciting step in the global fight against Covid. She described it as “a game changer”.
Molnupiravir works by disrupting the ability of the Covid virus to reproduce in the human body.
“It is incorporated into the genetic material of the virus and introduces errors,” she said. Over time, the errors make the virus less able to replicate itself.
Covid patients who took molnupiravir were half as likely to die or require hospitalization as the placebo group, according to the results of Merck’s latest trial of the experimental pill. Only 7.3% of patients who took the molnupiravir pill died or required hospitalization, compared with 14.1% of patients who died or required hospitalization among those who took the placebo pill. This means that Covid patients who took molnupiravir halved their chances of dying
US-based Merck & Co today announced the results of a trial on Covid patients of its antiviral pill molnupiravir
Compared to other anti-Covid drugs that must be administered by doctors, molnupiravir could be taken by patients at home.
Dr Hazuda also said that molnupiravir may also have potential to fight other viruses, similar to Covid, and the inevitable next pandemic.
Medicines proven to be effective in the fight against Covid
Made by: AstraZeneca, Orion Pharma and Mylan
Who is it given to: over 65 or at risk over 50
What studies have shown he can do: Experts at the University of Oxford found that within two weeks, 32% of people recovered from Covid by taking the drug through an inhaler, compared to 22% without. Budesonide is a corticosteroid, which means it reduces swelling inside the body and helps control immune responses
What it costs: around £ 15 for an inhaler
Mark: Ozurdex and Baycadron
Made by: Companies including Aspen and Hikma Pharmaceuticals
Who is it given to: Some patients hospitalized with the virus
What studies have shown he can do: A trial by the RECOVERY group found that the inexpensive steroid can prevent the death of one in eight ventilated coronavirus patients and one in 25 on life support. The steroid prevents the release of substances in the body that cause inflammation, which makes it difficult to breathe in Covid patients. It is given as an injection or as a daily tablet
What it costs: around £ 5 per patient
Mark: RoActemra and Actemra
Made by: Companies including Roche
Who is it given to: some Covid patients hospitalized
What studies have shown he can do: A RECOVERY trial found that arthritis medications reduced the risk of death by an additional four percent, in addition to the 20 to 35 percent reduction given by dexamethasone. This means that an additional life could be saved for 25 people receiving the drug. It was also found to cut hospital time by five days. It prevents a reaction in the lungs and airways that causes breathing problems. It is given to patients by injection into the veins and lasts four weeks at a time
What it costs: A typical 480 mg dose costs £ 614.40
“It is active on several coronaviruses, influenza and several other RNA viruses,” she said.
“We are really excited about the results, not just because of the potential for this to play a role in the current pandemic.
“Even potentially to prevent future pandemics and future outbreaks of other coronaviruses, which I’m sure will happen.”
If approved, it will be added to the arsenal of drugs already available to NHS doctors.
Dexamethasone was the first to receive the green light last June, but it is only given to already ill hospitalized patients.
And tocilizumab, which is given by injection, is also only given to hospital patients.
But budesonide, an inhaler medicine, can be prescribed for those over 65 or over 50 who are at risk of contracting the virus.
British doctors hailed the results of the trial as a breakthrough in the fight against Covid, although some also called for caution until more details are revealed.
UK Bioindustry Association president Ruth McKernan said preventing Covid infection in the first place through vaccination was the priority. But she added that an oral anti-Covid pill would be a valuable weapon.
“In order to protect people and the NHS as much as possible, we need all the disposable tools and it’s great to have the first oral medicine with very high quality data,” she said.
“We need a full package of treatments from preventive vaccines, oral treatments for those infected and additional drugs for hospital use.”
Dr Simon Clarke, a cell microbiologist at the University of Reading, called the trial results promising.
“Although the data from the trials has yet to be peer reviewed, the 50% reduction in hospitalizations and deaths in early-stage infections would be impressive,” he said.
However, Dr Clarke said more details on the potential side effects of the investigational drug are needed.
UK antiviral task force chief Eddie Gray declined to comment on talks to roll out the drug in the UK.
It’s unclear how much the drug would cost the NHS if approved in the UK, but the US government has purchased millions of drugs for $ 706 (£ 520) per patient.
“We are involved in carefully considering all of the options available, but we are really unable to give the details of specific conversations at this time,” he told reporters today.
Pressed for more details, Gray said: “The emergence of phase three data tends to speed up all such processes, but I couldn’t give you a precise date.”
“I have chosen to come today to be here, read whatever you like,” he added shyly.
Merck Scientific Director Daria Hazuda said she believes the results of the latest molnupiravir trial were ‘game-changers’
No 10 Antivirals Task Force leader Eddie Gray refused to appeal if UK was in talks on the drug molnupiravir with Britain
The trial followed 775 adults with mild to moderate Covid who were considered to be at higher risk of serious illness due to health issues such as obesity, diabetes or heart disease.
Of the patients taking molnupiravir, 7.3 percent were hospitalized or died after 30 days, compared to 14.1 percent of those receiving the dummy pill.
There were no deaths in the drug group after this period, compared to eight deaths in the placebo group.
The results have been published by the company and have not been peer reviewed, but Merck says he plans to present them at a future medical meeting.
An independent group of medical experts overseeing the trial recommended stopping it early because the intermediate results were so strong.
“It went beyond what I thought the drug might be able to do in this clinical trial,” said Dr. Dean Li, vice president of research at Merck.
“When you see a 50% reduction in hospitalizations or deaths, that’s a substantial clinical impact. “
Side effects were reported by both groups in the Merck trial, but were slightly more common in the dummy pill group. The company did not specify the problems.
The results of previous studies have shown that the drug did not benefit patients already hospitalized with serious illness.
Prime Minister Boris Johnson announced in April he was assembling a team of scientists to find ways to get people to recover from the virus without going to the hospital, because the UK must “learn to live with this disease, as we live with other diseases”.
Antivirals were a treatment touted by the Prime Minister, with Mr Johnson saying at the time that the drugs could “provide another vital defense against any future increase in infections and save more lives.”
And it is hoped that they will help prevent the new variants from making people seriously ill – the mutated strains make it more likely that a person will get sick even after vaccination.