- Russia has fast-tracked the approval of anti-influenza drug Avifavir.
- The move comes amidst claims of shortened recovery time for coronavirus patients and a spike in COVID-19 cases in Russia.
- Clinical trials in up to 330 COVID-19 patients in several Russian hospitals to start from June 11, 2020
- Several trials are being conducted in different countries, including at least two in India for its generic version, Favipiravir.
Dubai: Scientists around the world had been hard at work to find antivirals specific to SARS-CoV-2, the virus that causes COVID-19.
Several drugs — such as chloroquine, arbidol and remdesivir and various other drug combinations — have undergone clinical studies to test their efficacy and safety in combating the coronavirus.
Trials had been done around the world — including China, Japan, South Korea, Europe, the US and India.
Now, Russia has licensed the antiviral drug Avifavir against the novel coronavirus.
Q: What was it meant for?
Avifavir is an anti-influenza medication. It has been repurposed to fight COVID-19. Preliminary trials are said to have shown that Avifavir could shorten recovery times for patients with the coronavirus.
On May 30, 2020 (Saturday) Russia’s Ministry of Health approved Avifavir for emergency use to treat COVID-19, after "encouraging" results from clinical trials of the drug (generic version: Favipiravir) in several countries, including China and Japan. It is Russia’s first COVID-19 drug.
Q: What is it based on?
Avifavir is based on Favipiravir, and originally sold in Japan under the brand name Avigan. It was developed by Japan’s Fujifilm Pharmaceuticals, approved in 2014, as an antiviral medication to treat influenza.
Favipiravir is a pyrazinecarboxamide derivative, and is also being studied to treat a number of other viral infections.
Q: How does it work?
Favipiravir works by blocking the ability of a virus to replicate inside a cell. Some doctors began trying Favipiravir to treat coronavirus patients early on, reasoning that its anti-viral properties would be applicable.
Initial results suggested the drug could help shorten recovery time for patients.
China's Ministry of Science and Technology hailed it as yielding "very good clinical results".
Q: Where are the other Favipiravir trials being conducted?
There are several trials in countries, including the US, Italy and Japan and India, where Fujifilm announced it would be testing the drug's efficacy on a group of 100 patients through until the end of June.
The Japan study will involve administering the drug for up to 14 days to patients between 20 and 74 with mild pneumonia. The trials in hospitals are looking at a variety of factors: effects on fever, cough, oxygenation, recovery time and time spent in hospital — as well as how quickly the virus clears the system, along with X-rays or CT scans for pneumonia.
A significant reduction in clinical outcome and lower viral load from the Favipiravir group could lead to a larger-scale clinical trials.
On April 1, 2020, Medscape Drugs & Diseases, published preliminary results of Favipiravir’s (viral RNA polymerase inhibitor) "moderate antiviral effect” on COVID-19, following clinical studies in China. .
Avigan has been approved both in Japan and China for influenza and remains “investigational” for use in COVID-19.
There are some safety concerns: it has been shown in animal studies to affect foetal development, meaning it is not given to pregnant women, and some doctors say they would not recommend it for children or adolescents.
Q: How many COVID-19 patients in Russia will get the drug under trial?
In Russia, the final stage of Avifavir clinical trials involving 330 patients, are ongoing. Clinical trials in Russia showed that Avifavir reportedly shown high efficacy in treating patients with coronavirus.
At least two trials are also ongoing in India.
Q: Who is behind the Avifavir in Russia?
The drug will be delivered to hospitals this June. Russia’s sovereign wealth fund (Russian Direct Investment Fund, RDIF) has provided money for Russia’s development and production of the drug.
The Russian drug is a 50-50 joint venture with Russian pharmaceutical firm ChemRar.
Avifavir has reportedly demonstrated effectiveness in clinical trials performed by IM Sechenov First Moscow State Medical University, Lomonosov Moscow State University and other medical and academic institutions.
Q: Avifavir/Favipiravir vs. Remdesivir vs. Hydroxychloroquine: What’s the difference?
They’re all existing drugs that had been “repurposed” for COVID-19.
A French study showed the anti-malaria drug hydroxychloroquine, used alongside azithromycin, has shown promise in treating severe coronavirus infections.
On March 29, 2020, the US FDA issued an "emergency use authorisation" for hydroxychloroquine and chloroquine, both malaria drugs, for coronavirus. On April 10, the clinical trial of hydroxychloroquine for COVID-19 treatment started in the US.
Trump once touted he’s taking the anti-malaria drug “everyday”, to keep COVID-19 at bay.
Remdesivir, an antiviral from Gilead Pharma designed to fight Hepatitis C and Ebola drug, has also been repurposed for COVID-19. Studies have shown that it helped coronavirus patients with “moderate” disease recover more quickly when they received it for five days.
Statnews reported that while Remdesivir helped patients with “moderate” disease recover more quickly, the benefit was not statistically significant when given for 10 days.
There's an on-going debate of exactly how effective Remdesivir, Hydroxychloroquine and Favipiravir are and in what group of patients.
It is also being studied to treat a number of other viral infections. It is a derivative of pyrazinecarboxamide.
Avigan has been around since 2014, after it was developed in Japan and has been tried and approved for emergency use in a range of viral infections.
Q: What do the early trials on Avifavir show?
Preliminary trials appeared to show that it could shorten recovery times for patients with COVID-19.
Data from an earlier clinical trial of the drug in China showed that 65 per cent of the 40 patients tested negative for coronavirus after five days of treatment.
This information is an important bit: It means it was twice higher than in the standard therapy group, the Russian state fund RDIF and ChemRar stated.
On June 1, it was reported that the final stage of Avifavir clinical trials involving 330 patients are ongoing, the RDIF and ChemRar said in a joint statement.
Q: What does Russia’s approval of Avifavir mean?
“It’s a major, major step forward,” said RDIF CEO Kirill Dmitriev. “We believe there are now only two antiviral drugs against the virus that are really effective: those are remdesivir, done by the US, and this favipiravir, which also has significant promise,” he told CNBC.
Q: How many courses will be delivered to hospitals?
RDIF and the ChemRar Group said on Monday they will deliver 60,000 courses of Avifavir to Russian hospitals this month (June).
“Avifavir is Russia’s first COVID-19 drug and has shown high efficacy in treating patients with coronavirus during clinical trials. Avifavir has received a registration certificate from the Ministry of Health of the Russian Federation. Thus, Avifavir has become the first Favipiravir-based drug in the world approved for the treatment of COVID-19,” they said in the statement.
Q: Why is Russia interested in Avifavir?
Avifavir is derived from Japan’s Avigan (generic name: Favipiravir). In March, Interest in Avigan soared after a Chinese official said that it appeared to help patients recover from COVID-19.
It is one of the more promising drugs being repurposed to treat COVID-19 patients, especially those who contract severe cases. Avigan is now the subject of at least 14 clinical trials around the world.
Q: When was Favipiravir first approved, and for what disease?
Japan tested Favipiravir against a range of viruses, and was finally approved in 2014 — but only for emergency use against flu epidemics. It was licensed in China where it has since gone off patent, according to Medscape.
Favipiravir, sold under the brand name Avigan, is an antiviral medication used to treat influenza in Japan. It is also being studied to treat a number of other viral infections. It is a derivative of pyrazinecarboxamide.
Q: Will the joint Russian venture behind Avifavir make money from the drug?
It’s not clear. There are many existing antiviral drugs being "repurposed" for COVID-19 — and competing for research funding.
For example, Avigan, has won plaudits from Prime Minister Shinzo Abe and $128 million in government funding.
Camostat, a 35-year-old pancreatitis drug made by Osaka-based Ono Pharmaceutical Co, has also captured the interest of scientists in Japan and overseas.
The two compounds are among dozens undergoing testing around the globe.
These whole slew of repurposing of existing antiviral drugs, alongside the development of 100 or so vaccines for COVID-19, demonstrates how the race to develop treatments and vaccines is still wide open. Politicians (i.e. Abe and Trump) have promoted the potential benefits of certain drugs.
Gilead's Remdesivir has pulled into the lead after promising early trial results prompted emergency approval in the US, Japan and China.
Meanwhile, the search continues for additional treatment options.
Q: How many coronavirus cases are recorded in Russia?
As of June 2, 2020 (Tuesday) Russia has the world's third-highest number of confirmed coronavirus cases, with 424,000, according to data collated by Johns Hopkins University. The official death toll, however, remains low, at 5,037.
Q: What is the role of Russia in the global fight against COVID-19?
RDIF CEO Dmitriev urged for greater global cooperation in the fight against COVID-19.
He said RDIF and cheerer had taken a “major risk” to invest in the drug and production facilities before it was approved.
He said Russia should be looked at “as a positive player for the world.”
“I think it’s important for many countries to cooperate.... There’s no doubt that we were able to succeed only by sharing our information with other countries, receiving our information from other countries. Japan has been a great partner, and only by working together we can really address this issue.”
“It’s very negative that lots of people are trying to be competitive with other nations and I think it’s very important with coronavirus to put political differences aside. I expect many articles saying, ‘Russia is claiming this about this drug’.
“We are not claiming, we are sharing very positive news that the world needs to come together, and the world, everybody, should share positive information, useful information to fight the virus.”
Q: What’s the latest on vaccine development?
On Thursday (June 4, 2020) the UK is due to host a virtual Global Vaccine Summit with the aim of increasing international investment in vaccine research and development.
Global cooperation on health issues faces a major hurdle: US President Donald Trump said Friday (May 29, 2020) that the US is "terminating" its relationship with the World Health Organisation (WHO), the multilateral agency leading the global fight against the pandemic.
Trump argues the agency failed to do enough to combat the initial spread of the virus, and accused the global health body of being a "puppet" of China.