An experimental drug, remdesivir, which looks as though it could reduce recovery time in cases of Covid-19, will soon be available on the NHS.
On 27 May, Matt Hancock said the drug was “probably the biggest step forward in the treatment of the coronavirus,” and the Department of Health and Social Care say it “will be used in adults and adolescents hospitalised with severe Covid-19 infection who meet clinical criteria, suggesting they have the greatest likelihood of benefiting”.
Remdesivir will be made available to patients across the UK under the Early Access to Medicines Scheme which allows limited usage before clinical trials have been completed.
The UK is not alone. The drug was also authorised under similar schemes by the governments in the US and Japan. On 18 May the EU’s medicines agency suggested the EU may fast track the drug’s approval for sale, ahead even of the US.
Remdesivir was developed in the US by biopharmaceutical company Gilead Sciences. It is a broad-spectrum antiviral drug and had been tested during the Ebola outbreak with limited success, but is generally viewed as safe to use. Gilead has stated it was in discussions with manufacturers to produce the drug for Europe and Asia until at least 2022, according to a report from Reuters. They are also negotiating long-term licenses with generic drug makers in India and Pakistan.
The company is now winding down their clinical studies of the antiviral. By the end of May, the drug will be distributed in the US solely under an emergency use authorisation, as approved by the US Food and Drug Administration (FDA), despite limited information on its safety and effectiveness. Public health officials took the decision after a clinical trial run by the National Institutes of Health (NIH) showed “promising results,” said US health secretary Alex Azar in a statement.
The drug was found to improve recovery times by 31 per cent, according to the NIH study, which analysed data from a randomised, controlled trial involving 1,063 hospitalised patients. Those taking the drug recovered after an average of 11 days, compared with 15 for those given a placebo. In addition, the mortality rate also trended lower for the remdesivir group at 8 per cent versus 11.6 per cent for the placebo group.
These results may sound modest, but they they prove that the virus can be blocked by medication. And in a televised meeting at the Oval Office on 29 April, leading immunologist Dr Anthony Fauci from the US coronavirus task force told reporters that remdesivir sets “a new standard of care,” as researchers investigate whether other drugs can be paired with this treatment. One possible combination currently being tested, for example, involves the use of the anti-inflammatory drug olumiant.
Given the public health emergency, Dr Fauci took the then unusual step of announcing these findings before the report was submitted to a peer-reviewed medical journal.
In January, remdesivir was used to treat the first person confirmed as having Covid-19 in the US. The 35-year-old man, described only as a local resident, who had recently visited Wuhan, was brought to the infectious disease ward of Providence Regional Medical Center in Everett, Washington with typical Covid-19 symptoms, such as a fever, cough, and generalised fatigue. A few days into his illness, however, he began to exhibit shortness of breath and low oxygen levels, with saturation levels below 94 per cent. He had developed pneumonia.
From 20 January onwards, Dr George Diaz, the section chief of infectious diseases at the hospital, treated the patient with remdesivir, then available through an “expanded access” programme, similar to the UK’s Early Access To Medicines Scheme. Now, under the new FDA guidelines, hospitals are permitted to order the drug through its normal processes.The drug will still only be allowed for patients suffering severe cases of pneumonia, however, after taking remdesivir, the patient made a quick recovery.
“His fevers significantly improved, and the patient stayed afebrile the rest of the time he was in the hospital,” says Dr Diaz. “He did not have any ill-effects from the antiviral, and he was able to come off oxygen within about 24 hours.”
Dr Diaz’s patient was discharged from hospital within five days of that first dose and put under the care of the county health department, who have observed no sequela – the term for further conditions arising from a disease.
“Patients that receive remdesivir appear to have an improved or reduced mortality compared to those patients who do not receive remdesivir,” says Dr Diaz. “Those results are early, but very promising, and we are awaiting a peer review before discussing further data.”
Still, remdesivir is not a cure; it is an important therapy in the interim period for those who are sick while researchers develop a vaccine that can prevent infection. As an antiviral drug, doctors also need to be “very careful” in how they apply this medication, adds Dr Diaz, because Covid-19 could develop a resistance to it, as has happened with other treatments for influenza.
Division chief of hospital medicine at Stanford University, Dr Neera Ahuja, who is a principal investigator of the NIH-sponsored trial, says she is also “very excited” by the results, but she agrees with Dr Diaz.
“This is not a panacea,” she explains. “We don’t know if this is the best treatment. It’s an intravenous drug at this time and can’t be given outside the hospital. We still need to look for the most effective drug.”
Patrick Mulholland is a reporter in North America for the Financial Times