Covid19 Europe 

Russia approves ‘game-changer’ antiviral drug to treat coronavirus

Russia has approved a ‘game-changer’ antiviral drug to treat the coronavirus and is ready to start giving it to infected patients next week.

The Health Ministry in Russia has approved Avifavir, following the promising results of the first phase of clinical trials of the medication.

Covid-19 patients given the drug recovered in half the time compared to those who took a placebo and that it cures 90 per cent of patients in 10 days, health chiefs claimed.

Russian officials modified a version of the generic drug favipiravir, a drug designed to treat flu in Japan, to make it specifically for Covid-19.

They said they would share the formula globally, saying they believe it is the ‘most promising anti-COVID-19 drug in the world’.

In the meantime, 60,000 doses of the drug will be delivered to hospitals in Russia over the course of June.

UK scientists have already started a trial of favipiravir on dozens of infected patients, admitting the early results have looked ‘promising’.

Evidence suggests it can be used to prevent severe Covid-19 when given at the early stages of disease – but it hasn’t shown to have much effect in critically ill cases.

But it has been linked to birth defects in animals. Japan’s Prime Minister admitted the side effects could be ‘the same as thalidomide’, which caused deformities in thousands of babies in the 1950s and ’60s.

Russian officials modified a version of the generic drug favipiravir (pictured), a well established drug used to treat flu in Japan, to make Avifavir specifically for Covid-19.

Drug-makers worldwide are rushing to develop treatments and vaccines for the virus that has killed 372,000 people globally – a tenth of which are in the UK.

The Russian Direct Investment Fund (RDIF) made the Avifavir in a 50-50 joint venture with Russian pharmaceutical firm ChemRar.

RDIF said Avifavir had proved highly effective in treating patients with coronavirus in the first phase of its clinical trials led by IM Sechenov First Moscow State Medical University.

WHAT IS AVIFAVIR?

Russian specialists modified the generic drug favipiravir to enhance its efficacy for treating COVID-19, the respiratory disease caused by the novel coronavirus. The result was Avifavir.

Favipiravir is the active ingredient in a Japanese anti-flu medicine called Avigan, which is also being trialled against Covid-19 in Japan but has not been approved for use yet.

Avigan is manufactured by a subsidiary of Fujifilm, which is better known for its cameras. The drug was approved for use in Japan in 2014 as a new flu treatment.

One of the first trials of favipiravir was on 340 patients in China. Patients who took favipiravir recovered quicker and showed greater lung improvement compared with patients not given the drug.

It was given to a small number of patients in Shenzhen, who had negative results for the coronavirus an average of four days after being diagnosed, meaning there was no trace of the virus in their body. This compared with 11 days for those who were not treated with the drug, according to local media.

X-rays showed improvements in lung condition in nine in ten of the patients who were treated with favipiravir, compared to six in ten of those without the drug.

Favipiravir has been effective, with no obvious side-effects, in helping coronavirus patients recover, Zhang Xinmin, an official at China’s Science and Technology Ministry, told reporters.

‘It has a high degree of safety and is clearly effective in treatment,’ Mr Xinmin said, according to The Guardian.

It’s unknown which branded favipiravir drug the patients were given.

Contradictory clinical trials suggest favipiravir will not be useful in patients who have more severe illness.

The first phase of a clinical trial is to assess if a drug is safe and prove it has some sort of effect against the virus.

Kirill Dmitriev, head of RDIF, told Reuters: ‘The drug showed very good results in randomised clinical tests. After four days, 65 per cent of patients did not have the virus.’

This was two times higher compared to those on standard therapy.

By 10 days this number had increased to 90 per cent.

During the trial, only 40 patients were treated with the drug, so the results will need verifying with a larger number of participants.

No side effects were noted in this trial but these would become apparent in larger trials, the scientists said.

Mr Dmitriev said it was not suitable for pregnant woman, likely nodding to animal studies which have shown Avigan – another drug based on the same generic ingredient – can affect foetal development. Some doctors say they would not recommend it for children or adolescents.

The final stage of clinical trials is under way, with the participation of 330 patients.

‘We believe this is a game changer,’ Mr Dmitriev said. ‘It will reduce strain on the healthcare system, we’ll have fewer people getting into a critical condition, and for 90 per cent of people it eliminates the virus within 10 days.

‘Avifavir more than halves the duration of the disease, ensuring most patients are free of infection after the fifth day of treatment, which helps to more successfully fight the virus and protects Russian hospitals from being overwhelmed.’

Mr Dmitriev said the roll-out of the drug across the country would curb how many people need to be admitted to hospital because it was particularly effective for patients suffering mild symptoms.

Patients will start receiving the antiviral from next week, a move that is thought to speed up a return to normal economic life.

Russian hospitals can begin giving the drug to patients from June 11, with enough to treat around 60,000 people per month, the head of Russia’s RDIF sovereign wealth said.

Once Russia’s own medical needs were covered, Mr Dmitriev said it would look to export Avifavir with countries in the Middle East and Latin America expressing interest already.

‘We believe that the drug is key to resuming full economic activity in Russia,’ Mr Dmitriev said.

‘Avifavir is not only the first antiviral drug registered against coronavirus in Russia, but it is also perhaps the most promising anti-COVID-19 drug in the world.’

Avifavir was developed on the basis of a drug known generically as favipiravir. It is unclear if the products contains other ingredients.

Known as an RNA polymerase inhibitor, it stops viruses from making copies of themselves to spread through the body.

The drug was approved for use in Japan in 2014 as a new flu treatment under the name Avigan, manufactured by Toyama Chemicals, a subsidiary of Fujifilm which is better known for its cameras.

The drug was approved for use in Japan in 2014 as a new flu treatment under the name Avigan (pictured), manufactured by Toyama Chemicals, a subsidiary of Fujifilm

SIX HOPES FOR A CORONAVIRUS TREATMENT

REMDESIVIR 

Investors are closely watching the trials of this antiviral drug, which was originally developed as a treatment against ebola.

Every titbit of information about the treatment has resulted in huge swings in the stock market.

The US government’s top infectious disease expert, Dr Anthony Fauci, last week said early results from one trial showed remdesivir had a ‘clear-cut, significant, positive effect in diminishing the time to recovery’. Several trials are ongoing – including one at University College London.

TOCILIZUMAB 

This drug, made by pharmaceutical giant Roche, stops the ‘cytokine storm’ that happens when the immune system starts attacking the body, something that is seen in very ill coronavirus patients. Originally developed as a treatment for rheumatoid arthritis, Roche has also used tocilizumab in the last few years for cancer patients undergoing its risky but extremely effective CAR-T therapy. These patients sometimes suffer cytokine storm as a side effect of the cancer treatment, and tocilizumab has been effective at minimising the danger when this happens. Tocilizumab is part of three major trials involving British patients – with the first results expected by June or July.

HYDROXYCHLOROQUINE

Anti-inflammatory drugs hydroxychloroquine and chloroquine have been used since the 1940s against malaria and autoimmune conditions such as rheumatoid arthritis and lupus. They both have antiviral properties and hydroxychloroquine is part of several UK studies for the treatment of early-phase coronavirus.

FAVIPIRAVIR 

A Japanese flu drug that blocks the ability of a virus to replicate itself, favipiravir has been shown to cut recovery time from 11 days to four days in coronavirus patients. A trial of the drug was launched last week at Chelsea and Westminster Hospital in London.

LOPINAVIR-RITONAVIR 

A combination of two antiretroviral HIV drugs, this was part of the treatment protocol for Covid-19 in China and is now being trialled by Oxford. The treatment is used to prevent the HIV virus becoming the Aids disease. It targets an enzyme called protease which viruses use to replicate themselves. Without this, when the virus takes over a cell it is unable to make copies of itself, so the infection stops at that cell.

ANTIBODY PLASMA

By the end of May 5,000 NHS patients a week will be receiving blood donated by coronaviorus survivors. The use of ‘convalescent plasma’ relies on the theory that people who survive coronavirus have developed antibodies against the virus which could help patients struggling to produce their own.

Japan has been trialling Avigan for Covid-19 patients with the support of $128million in government funding, but it has yet to be approved for use.

Japan’s Prime Minister Shinzo Abe has been pushing for Avigan as a treatment for coronavirus despite no hard-proof evidence it works.

He said at a news conference on May 4 he wanted the drug approved for use against COVID-19 by the end of the month, despite conceding it had side effects which caused birth defects.

But he warned of side effects ‘the same as thalidomide’ –  a drug which caused thousands of women to lose their pregnancies or give birth to babies with missing or malformed limbs in the 1950s and 60s.

Evidence of birth defects in animal trials led Japan to put unusually strict controls on the pill’s use and production. It had been given to humans only during clinical trials and in desperate attempts to treat Ebola, the New York Times reports.

China has also trialled favipiravir, although it is not clear what brand, with similar findings to Russia.

In a trial of 80 patients, those given the drug tested negative for the virus after an average of four days, while it took 11 days for those not treated with it, according to Japanese public broadcaster NHK.

A small trial is being conducted in the UK after British scientists said favipiravir could be a ‘promising’ treatment for Covid-19.

A total of 450 hospital inpatients across four hospitals with mild to moderate symptoms of the disease will be recruited to take part the randomised controlled trial.

It will see some receive favipiravir, some a combination treatment of hydroxychloroquine, zinc and azithromycin, while a third group will be given existing standard care for Covid-19.

Chelsea and Westminster Hospital and West Middlesex University Hospital in London are participating in the trial, which also involves Imperial College and the Royal Brompton Hospital.

University Hospitals Leuven in Belgium aims to start a trial on up to 200 patients at a later date.

Pallav Shah, professor in respiratory medicine at Chelsea and Westminster Hospital and the study’s chief investigator, said the Pioneer trial aims to find a drug which prevents Covid-19 progressing, reducing the length of hospital stay.

Patients with symptoms such as breathlessness and a fever will be approached to take part in the study before swab results even come back to ensure treatment can be given early.

Under the study, patients will be kept in hospital initially for at least a day and receive 10 days worth of treatment.

Professor Shah said of small studies in China: ‘Hypothetically it looks very useful, very promising; when you look at the drug’s effectiveness in vitro, it looks very good.

‘But being a clinician and a scientist, we always want to see the data … before we can recommend it.’

‘I’m confident that we will gain some knowledge and this will give us some very good answers. We wouldn’t know whether it’s effective until we get the results.’

In the UK it is not licensed or recommended, according to a document released by Public Health England last September.

Current standard of care for Covid-19, which most patients in the UK receive, includes being given oxygen, fluids, a broad-spectrum antibiotics and any treatment to reduce complications caused by the virus.

Only one potential direct antiviral has been given the approval for use in the UK – remdesivir, which works in a similar fashion to favipiravir.

After the approval last week, Health Secretary Matt Hancock called remdesivir the ‘biggest step forward’ in treating Covid-19 since the outbreak spiralled out of control.

He said scientific studies have already shown promising results and suggest it may speed up people’s time to recovery by four days.

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