Fujita Health University Favipiravir Trial Evidences no Statistically Conclusive Benefit to COVID-19 Patients: A Question Mark for Favipiravir?

Jul 11, 2020 | Avigan, Challenging Results, Favipiravir, Fujita Health University, News, Popular Posts

Fujita Health University Favipiravir Trial Evidences no Statistically Conclusive Benefit to COVID-19 Patients A Question Mark for Favipiravir

Fujita Health University concluded a clinical study of the antiviral drug Avigan and report it has failed to demonstrate a clear efficacy in treating SARS-CoV-2 patients in the early stage of the infection. The Japanese university reports that the delta between those patients who were given Avigan (Favipiravir)  and those who took it later was not statistically relevant for purposes of statistically evaluating the effectiveness of the drug. Developed by a subsidiary of Fujifilm Holdings Corp (Toyama Chemical), principal investigator Yohei Doi acknowledged that the drug has exhibited impact in addressing COVID-19 and that the study size of 89 patients make it too small to yield a statistically meaningful difference.

Favipiravir (Avigan): Is it a Treatment or Not?

This depends on what part of the world one is in; who one speaks with and probably a number of other factors. Now a generic drug, it has been approved in China, India and Russia as an effective treatment for COVID-19. As TrialSite News reported recently, the “Dhaka Trial” showed “clear cut evidence” an effective outcome. Moreover, the drug’s developer, Fujifilm Toyama Chemical Co. is sponsoring clinical trials in key parts of the world, including the United States.

On the other hand, TrialSite News reported a large hospital just dropped use of the drug and rather picked up Remdesivir and Ivermectin. The hospital didn’t like the price point of FabiFlu (Glenmark Pharmaceuticals version of the drug) even though it is generic and found there were some side effects.

This study was small: 89 infected patients with either mild or not symptoms at all at 47 sites across Japan. After one patient pulled out during the middle of thee study,  88 patients were divided into two groups. One group of patients started with the drug on the first day of the study while patients from the second group commenced taking the drug on day six of the study.

Thereafter, study teams compared the two groups evaluating in the patients how long it took for COVID-19 to do away completely as well as on average the period of time it too for fevers to go down.

The Results

In 66.7% of patients who were administered on the first day, the virus disappeared by the morning of day six while with the delayed group (the ones that started taking Avigan on day 6 of the illness) the same pattern occurred where the illness started disappearing by the morning of the sixth day.

As far a fever reduction, Avigan starts kicking in on average in 2.1 days for the first group and 3.2 days on the second group.

Disappointment in Japan but…

The evidence here shows that Avigan has some effect but based on the study design it didn’t produce statistically meaningful outcomes. 

Apparently the Prime Minister of Japan himself, Shinzo Abe, was hopeful to see this Japanese drug get approved in Japan by the end of May. But these high hopes were deflated  after the university released an interim report by mid-May that clear efficacy was not a reality. The Japanese government still has every intent on approving the drug if efficacy can be proven, reports Yoshihide Suga, Chief Cabinet Secretary at a press release.

U.S Clinical Trials

Stanford University is conducting a Favipiravir clinical trial to determine if the antiviral medication can reduce symptoms and viral shedding in people with COVID-19. And a Phase 2 clinical trial sponsored by Fujifilm out of Boston is ongoing, including at Brigham and Women’s Hospital, Massachusetts Generla Hospital and the University of Massachusetts Medical School among other sites.

About Fujita Health University

Fujita Health University was formed by a predecessor school in 1964 and chartered as a university in 1968. Research and associated clinical trials focus on a number of therapeutic areas including the Fujita Cancer Center.

Lead Research/Investigator

Yohei Doi

Call to Action: TrialSite News will continue to monitor A) randomized controlled study results, B) real-world data points and, C) ongoing current events associated with Favipiravir to offer the TrialSite Network as much relevant, up to date information on the Favipiravir situation as possible. For daily updates, sign up for the daily newsletter.

Source: Reuters

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