Clinical trial for remdesivir begins
2/6/20
Experimental drug remdesivir moved closer to being approved for treatment as a stage-three clinical trial for the antiviral medication started in Wuhan on Thursday. Led by teams from the China-Japan Friendship Hospital and Wuhan Jinyintan Hospital, the trial was set to involve 761 patients, of whom 308 had mild to average symptoms and 453 were in serious condition.
Remdesivir was developed by US-based Gilead Sciences to treat Ebola but has been repurposed to treat the new coronavirus. It has not been approved by any country.
Gilead Sciences has agreed with China’s ministry of health to fully support clinical trials, including providing the drug for free to use in the trials, according to Beijing-based media group Caixin.
The first coronavirus patient in the US was treated with remdesivir and his condition improved, according to his doctors in a study published in The New England Journal of Medicine last week.
Remdesivir Being Evaluated Against Novel Coronavirus
2/5/20
Gilead Sciences has announced collaboration with Chinese, US, and global health officials in order to investigate the safety and efficacy of its investigational antiviral compound remdesivir (GS-5734) against the novel coronavirus (2019-nCoV). Gilead is working with Chinese health authorities to establish a randomized, controlled clinical trial.
Remdesivir is a nucleotide analogue prodrug initially developed as a treatment for Ebola virus and Marburg virus infection. Although remdesivir is not a licensed or approved drug anywhere in the world at present time, the treatment has shown activity against other coronaviruses such as severe acute respiratory syndrome (SARS) in animal models.
In its statement on the matter, Gilead noted that the first US case of 2019-nCoV led to the administration of the drug for compassionate use after the Washington state patient developed pneumonia. In the Washington state 2019-nCoV case, physicians initiated treatment with intravenous remdesivir on day 7 of care based on the patient’s worsening clinical status. No adverse events were associated with the infusion.
How experts plan to treat the new coronavirus
2/5/20
“In recent years, perhaps encouraged by the successful development of HIV anti-virals, which proved it might be feasible to do more, our armamentarium has greatly expanded,” Morse said. Even so, developing brand-new drugs requires a huge investment of both time and resources, he added. So “while you’re waiting for the new miracle drug, it’s worthwhile looking for existing drugs that could be repurposed” to treat new viruses, Morse told Live Science.
That’s exactly the route doctors took to treat a 35-year-old man in Washington state, the first U.S. patient to have been infected with the new coronavirus. When his symptoms worsened, the man was given an unapproved antiviral drug called remdesivir that was originally developed to treat Ebola, according to a case report published Jan. 31 in The New England Journal of Medicine.
Doctors gave this drug to the patient by making a “compassionate use” request to the Food and Drug Administration (FDA), which allows experimental drugs to be given to people outside of clinical trials, usually in emergency situations. The patient, who was recently released from the hospital, didn’t seem to experience any side effects of the drug.
Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV)
Foster City, Calif., January 31, 2020
Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences:
“Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir. Together with the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (DHHS), the China CDC and National Medical Product Administration (NMPA), the World Health Organization (WHO), and the U.S. National Institute of Allergies and Infectious Diseases (NIAID), and along with individual researchers and clinicians, Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting 2019-nCoV.
Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. At the request of treating physicians, and with the support of local regulatory agencies, who have weighed the risks and benefits of providing an experimental drug with no data in 2019-nCoV, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options.
Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.
While there are no antiviral data for remdesivir that show activity against 2019-nCoV at this time, available data in other coronaviruses give us hope. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to 2019-nCoV. There are also limited clinical data available from the emergency use of remdesivir in the treatment of patients with Ebola virus infection.
Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide.”
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