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Clinical Research
Antiviral May Offer New Treatment Option
New antiviral drug tested for COVID-19 patients
Favipiravir clinical trial
The potential for outpatient distribution for favipiravir makes Houston Methodist an ideal location for testing the drug.
An antiviral drug, favipiravir, is now under clinical investigation at Houston Methodist to treat the SARS-CoV-2 coronavirus. The Phase 2, multicenter, randomized trial, sponsored by Fujifilm Pharmaceuticals U.S.A., Inc., will help determine the safety and efficacy of the drug to treat COVID-19, the disease caused by the SARS-CoV-2 coronavirus. Favipiravir was approved under the brand name “Avigan®” for manufacture and sale in Japan in 2014 as an influenza antiviral drug for novel or re-emerging influenza virus infections in which other influenza antiviral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses. Avigan is not approved for distribution in the U.S. Favipiravir works by selectively inhibiting a viral enzyme necessary for making viral RNA. This assists in impeding the virus’s ability to replicate itself. In addition to being developed to treat flu, favipiravir is currently being studied to treat COVID-19 and has been studied to treat rabies, Ebola, Lassa fever and norovirus. Coronaviruses (the virus that causes COVID-19) and these other viruses are in the same group of RNA viruses as influenza virus. Madiha Ashraf, MD, assistant professor of clinical medicine, Department of Medicine, is leading efforts on this clinical investigation at Houston Methodist. She has hope that its previous testing and existing data for treating other viruses make it an effective treatment option for COVID-19 patients.
Madiha Ashraf, MD, and Siraya Jaijakul, MD
Madiha Ashraf, MD, (left) and Siraya Jaijakul, MD, hope that previous testing of favipiravir for treating other viruses may make it effective tor treating COVID-19.
Without many proven treatments for COVID-19 in existence, favipiravir offers our hospitalized patients another option to combat this disease. Since it is an oral medication, it is promising in its potential to reduce the number of days of hospitalization.
Madiha Ashraf, MD
Assistant Professor of Clinical Medicine Department of Medicine Houston Methodist
Hospitalized patients with mild to moderate COVID-19 symptoms are eligible to enroll in this trial, which excludes intubated patients. The clinical trials team attempts to get patients enrolled within 72 hours of a positive test result, with 14 days of treatment and a follow up period of 60 days, including time after discharge. Ultimately, the goal is to find its use in outpatient settings where COVID-19 patients can be prescribed the antiviral drug while visiting their primary care physician. Houston Methodist was chosen as a site for this clinical trial by Fujifilm Pharmaceuticals U.S.A., Inc., at a time when new cases were growing in Texas. The potential for outpatient distribution for favipiravir makes Houston Methodist an ideal location for testing the drug. Siraya Jaijakul, MD, assistant professor of clinical medicine, Department of Medicine, is investigating favipiravir alongside Ashraf. She has kept open lines of communication with colleagues in her home country of Thailand to learn about the drug’s efficacious qualities, adding an additional level of collaboration to the study. Both Ashraf and Jaijakul are hopeful that favipiravir will be effective in treating COVID-19 and helping to mitigate the spread of the SARS-CoV-2 coronavirus through limiting the duration of the disease.
About Avigan® Tablets Avigan Tablet (generic name: favipiravir), developed by FUJIFILM Toyama Chemical, was approved for manufacture and sale in Japan in 2014 as an influenza antiviral drug. The drug is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses. The Fujifilm Group is currently conducting clinical studies on Avigan targeting COVID-19 patients in Japan and the U.S., and recently announced an agreement among FUJIFILM Toyama Chemical, Dr. Reddy’s Laboratories Ltd. (headquartered in India) and Global Response Aid (headquartered in Dubai), under which FUJIFILM Toyama Chemical has granted Dr. Reddy’s and GRA the exclusive right to develop, manufacture and sell Avigan outside of Japan, excluding China and Russia.
Laura Niles, July 2020
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