Avigan tablets Photo: REUTERS file
health

Fujifilm's Avigan inconclusive in COVID-19 patients in Japan trial

8 Comments

A clinical trial of Fujifilm Holdings Corp's Avigan drug yielded inconclusive results as a treatment of COVID-19, Japanese researchers said on Friday.

Although patients given the drug early in the trial showed more improvement than those who got delayed doses, the results did not reach statistical significance, Fujita Health University researcher Yohei Doi said.

The results, announced at a news conference on Friday, followed the completion of a clinical trial conducted between March and May on 89 patients across Japan.

Japanese Prime Minister Shinzo Abe had said he hoped the drug would be approved as a COVID-19 treatment in May, but a shortage of patients in Japan delayed the progress of clinical trials. It has been approved as a COVID-19 treatment in Russia and India.

Known generically as favipiravir, Avigan was developed by a subsidiary of Fujifilm and it was approved in Japan as an emergency influenza treatment in 2014.

Interest in the drug soared in March after a Chinese official said it appeared to help patients recover from COVID-19. It is now the subject of at least 25 clinical trials around the world.

The Japanese government called on Fujifilm to triple national stockpiles of the drug and pledged to give it away to countries asking for it.

Concerns remain about the drug as it has been shown to cause birth defects in animal studies.

© Thomson Reuters 2020.

©2020 GPlusMedia Inc.

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Apology accepted from the poster(s) who said I was wrong in pointing out the government should not be pre-approving drugs just because other nations were. This is why. Didn't they also pour billions into it? Something else I said they shouldn't rush to do.

0 ( +0 / -0 )

Didn't they also pour billions into it? Something else I said they shouldn't rush to do.

So they should not pour billions to develop something and see if it works?

how else do you suppose they find out then? they money invested in producing a drug is nothing compared with the money used to develop it in the first place and for testing it appropriately.

4 ( +4 / -0 )

The government would love a Japanese drug to be the miracle cure, but studies have not shown it actually works. Approving a drug without proper testing is gambling with lives. Money above people, yet again.

4 ( +4 / -0 )

Evidence on the ground from doctors has also shown that hydroxychloroquine taken together with vitamin C, D and zinc as a preventive measure or during the early stages has been very effective in preventing symptoms developing to the serious stage. But apparently it's useless once patients are seriously/criticially ill, like on a ventilator.

The media bashed it because of Trump, but partly because it's cheap and out of patent, so there's very little money to be made on it.

Yet there is some sanity among all the fear mongering and vaccine-pushing:

One of the lead researchers, Prof Sir Nicholas White from the University of Oxford, said: "Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomised controlled trial."

Co-investigator Prof Martin Llewelyn, from the Brighton and Sussex Medical School, said: "Although rates of coronavirus are low just now in the UK, healthcare workers are still being affected across the NHS and a second wave of infection this winter is widely expected. 

"In terms of finding an intervention that could protect key workers by this winter, hydroxychloroquine is by far the most realistic prospect. The recent post-exposure prophylaxis study confirmed its safety and indicated that it could be protective if given as pre-exposure prophylaxis. This is what COPCOV will find out."

(From https://www.bbc.com/news/health-53233070)

-5 ( +0 / -5 )

kyronstavic:

Evidence on the ground from doctors has also shown that hydroxychloroquine taken together with vitamin C, D and zinc as a preventive measure or during the early stages has been very effective in preventing symptoms developing to the serious stage.

The BBC report provides nothing - nor does it intend to - in the way of evidence. It is simply reporting that a suspended trial is restarting; specifically, the UK part of the study is restarting in the UK. The quotes (bold mine), "could be protective if given as pre-exposure prophylaxis", and "Hydroxychloroquine could still prevent infections" are both from investigators on the trial, and indicate no conclusion. And it is clear that they are only speaking of prevention, not treatment during early stages, and will have no data to offer and no conclusion to suggest about what it may or may not do in the early stages of the disease. Let alone anything about vitamin C, D, and zinc.

This is how the study is presented on the COPCOV website:

"The drugs [chloroquine and hydroxychloroquine] have been in the news a lot because they have been tested in small trials for the treatment of COVID-19. Some of these studies claimed success, others failure, but all these studies were too small to give a definite answer about their efficacy or safety. Larger trials are ongoing to determine whether these drugs are effective for the treatment of COVID-19. COPCOV is a very large study, enrolling 40,000 participants, and will give a definite answer whether the drugs are effective and safe. COPCOV studies chloroquine and hydroxychloroquine for the prevention of COVID-19, which is different from the treatment of patients that already have the disease COVID-19, who carry a much higher load of the virus."

It is abundantly clear that they have reached no conclusion about these drugs yet, and aren't even close.

It's also well worth mentioning that three other trials that people (excitable right wingers, libertarians, conspiracy theorists, antivaxers) have been pointing to are the French one, which was a very poor-quality study presided over by Didier Raoult, a highly controversial but not highly trusted figure, and with good reason; some half-arsed largely anecdotal stuff coming out of China; and a minuscule Texas nursing home trial headed by Robin Armstrong, a politically motivated physician who is active in an organization called Black Voices for Trump. His claimed results have been astonishingly successful, but you'd kind of expect them to be. Some of his subjects had middle-stage dementia, by the way, so their consent as participants has been questioned. Basically, the whole trial was a farce and riddled with ethical issues.

https://retractionwatch.com/2020/04/06/hydroxychlorine-covid-19-study-did-not-meet-publishing-societys-expected-standard/

https://www.npr.org/2020/04/10/830348837/covid-19-patients-given-unproven-drug-in-texas-nursing-home-garnering-criticism

3 ( +4 / -1 )

wipeout

"The drugs [chloroquine and hydroxychloroquine] have been in the news a lot because they have been tested in small trials for the treatment of COVID-19. Some of these studies claimed success, others failure, but all these studies were too small to give a definite answer about their efficacy or safety. Larger trials are ongoing to determine whether these drugs are effective for the treatment of COVID-19. COPCOV is a very large study, enrolling 40,000 participants, and will give a definite answer whether the drugs are effective and safe. COPCOV studies chloroquine and hydroxychloroquine for the prevention of COVID-19, which is different from the treatment of patients that already have the disease COVID-19, who carry a much higher load of the virus."

And yet after all the (dubiously, as it is turning out) negative publicity, COPCOV is still proceeding with the study on this drug, indicating that they think they see some merit in it as a potential protective treatment. Otherwise they wouldn't waste their time and money, especially You can attempt to tar me with the usual leftist ad homs, but doing so doesn't address the issue. I don't see anyone saying this is a miracle drug, but it has been showing proactive results.

I'm genuinely curious - are you claiming that it's useless, or are you willing to keep an open mind on it?

-4 ( +0 / -4 )

And yet after all the (dubiously, as it is turning out) negative publicity, COPCOV is still proceeding with the study on this drug

So what? No one denies it.

However, you're advancing a considerably more credulous viewpoint than that of the two COPCOV researchers quoted by the BBC. You stated outright that evidence has shown that hydroxychloroquine "taken together with vitamin C, D and zinc as a preventive measure or during the early stages has been very effective in preventing symptoms developing to the serious stage". This takes what very little evidence is available, and most of it from problematic sources, at face value. The COPCOV study does the exact opposite, and proposes a far closer look with a vastly larger number of participating subjects, to assess both safety (not yet established) and efficacy (also not yet established):

"COPCOV is a very large study, enrolling 40,000 participants, and will give a definite answer whether the drugs are effective and safe."

I'm genuinely curious - are you claiming that it's useless.

The COPCOV trial? No. In fact that's why I quoted their own words, to make clear what they are and what they are not attempting to establish, and how they are intending to do it. Their aims and pronouncements are not remotely similar to those of Raoult or Armstrong.

2 ( +3 / -1 )

This medicine showed positive effects in trials of China and Russia.

Russia has even begun using it as an official treatment

-1 ( +1 / -2 )

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