Indigenous Services eyeing Canadian trial of antiviral drug that could prevent COVID-19
AFN regional Chief Kevin Hart says Ottawa should consider exemption to allow use of favipiravir
Indigenous Services Canada is watching for the results of the world's first trial to determine whether an antiviral medication developed in Japan could be used to prevent COVID-19, according to a letter provided to CBC News.
The potential of favipiravir, which received clearance from Health Canada for trial on May 18, has the attention of the department's First Nation and Inuit Health Branch (FNIHB), according to the letter written by a senior federal official.
"Recent studies suggest favipiravir may have potential utility for the treatment of COVID-19," wrote Keith Conn, assistant deputy minister for regional operations at FNIHB, in a June 5 letter to Assembly of First Nations Manitoba regional Chief Kevin Hart.
"At this time favipiravir is only being used in Canada in the context of research studies. ISC will be monitoring the results of these studies."
'First Nations should be high on the list'
Hart said First Nations should be prioritized if favipiravir is found to be effective against COVID-19.
"First Nations should be high on the list when it comes to antivirals or vaccines," Hart said in an interview with CBC News.
"When it comes to infections and clusters, we are one of the most vulnerable populations."
ISC referred CBC News' questions to Health Canada. Health Canada said it couldn't respond to the questions on the antiviral until next week.
Halifax-headquartered biotechnology firm Appili Therapeutics is funding the trials of favipiravir, which is now into its second phase, involving 760 patients in 16 long-term care facilities in Ontario. Those facilities have seen over 1,600 COVID-19-related deaths.
Appili Therapeutics CEO Armand Balboni said in an email statement that the trials aim to determine whether favipiravir can be effective not only as a treatment, but also as a prophylaxis to prevent COVID-19 illness.
Can be taken as tablet
Balboni said the antiviral drug can be taken in tablet form, meaning it doesn't need to be administered in a hospital and could be distributed easily and quickly to contain any COVID-19 outbreaks.
"The results of the trial, if in fact they are positive and show the potential to safely protect vulnerable populations from COVID-19 outbreaks, would certainly have implications for remote communities and other segments where clusters of outbreaks may occur," the statement said.
"Being able to control outbreaks has implications worldwide, and this trial is the first step in applying rigorous scientific study to that hypothesis."
Balboni said his firm "would intend to communicate" with ISC if favipiravir received approval for COVID-19 treatment in Canada.
Hart says ISC has been slow to consider suggestions from First Nations on additional ways to help communities prepare for COVID-19 beyond the ongoing community lockdowns and supplying limited amounts of personal protective equipment.
"The messages I get from First Nation leadership is that they say they are giving the federal government a failing grade when it comes to their response for COVID-19," said Hart.
It took over a month for the federal government to respond to Hart's April 23 letter, addressed to four ministers, urging Ottawa approve use of favipiravir under the federal Access to Drugs in Exceptional Circumstances provision.
"I once again reiterate my requests that Canada take urgent action to procure, stockpile, distribute and mobilize these antiviral drugs and other resources in First Nations in order to respond to the SARS-CoV-2 pandemic and to the existing and potential outbreaks of COVID-19 disease in First Nations," Hart wrote in his letter, which followed two others that received no response.
Favipiravir, which is also known by its brand name Avigan, was developed by a Japanese company in the 1990s that was bought by Fujifilm Toyama Chemical, according to the Japan Times.
Fujifilm donated favipiravir to Appili for the trials, the company said. The medication was approved by Japan in 2014 for influenza treatment and to stockpile in the event of a pandemic influenza outbreak, according to Appili, which has a long-standing relationship with the Japanese firm.
The drug is used against RNA viruses such as influenza. It inhibits a cell's potential to become the factory for new virus parts that spread the infection, said Balboni. The drug targets the viral protein that makes new virus parts that leads to the spread of infection, he said.
It can be harmful to pregnant women as it can cause mutations in an embryo.
Best suited for elderly
"While there is potential toxicity that makes it best suited for the elderly, this risk can be managed in other populations," Balboni said.
"It is common in the industry to have this potential adverse event and put processes in place to manage the risk around it."
Russia recently announced it had approved a tweaked version of favipiravir to treat COVID-19 after its trials found it could reduce the length of illness from 11 to four days.
The drug is currently being studied in Japan for COVID-19 treatment to mixed results, and India is also considering approving the drug for emergency COVID-19 treatment, according to reports in foreign media.
Balboni said the Canadian trial is focused on long-term care homes because they present an "unmet need" and account for the largest proportion of COVID-19 deaths in the country.
"There is clearly a need here to find a solution and prevent these outbreaks as much as possible," Balboni said.
"With vaccines at least a year away ... the elderly and immune-compromised population [may not be] able to benefit from vaccines the way 'younger' patients would."