Gilead Sciences Inc. announced on 13 April 2020 results showing clinical improvements in 68 percent of 53 hospitalized patients with severe complications of COVID-19.
Remdesivir is an investigational nucleotide analogue with broad-spectrum antiviral activity demonstrated both in vivo and in vitro models against various emerging viral pathogens, including Ebola, Marburg, MERS, and SARS.
In early 2020, Gilead has been providing emergency access to remdesivir for patients with severe complications of COVID-19 who are unable to enrol in ongoing clinical trials. Through individual compassionate use protocols, more than 1,800 patients have been treated with remdesivir.
The cohort analysis evaluated data from 53 patients in the United States, Europe, Canada and Japan who received at least one dose of remdesivir on or before 7 March 2020 on an individual compassionate use basis. Detailed results of this analysis were published in the New England Journal of Medicine on 10 April 2020.
Based on the results, 68 percent of patients showed an improvement in oxygen support class after treatment with remdesivir. The planned treatment was a 10-day course of remdesivir, consisting of a 200 mg loading dose administered intravenously on day 1, followed by 100 mg daily for the remaining nine treatment days.
75 percent of patients were men over the age of 60 years with comorbid conditions, including hypertentsion, diabetes, hyperlipidemia and asthma. Median duration of symptoms before initiation of remdesivir was 12 days.
There are limitations in the present results for compassionate use data, ongoing Phase III studies in first 400 patients with severe disease are expected to be released soon. This data will help to determine the safety and efficacy of remdesivir for the treatment of COVID-19. At the date of this article, remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for the treatment of COVID-19.
Gilead is conducting two Phase III clinical trials of remdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19, including Singapore. In addition, Gilead is supporting multiple clinical trials led by other organizations.
Gilead is currently scaling up the manufacturing of remdesivir to achieve 500,000 treatment courses by October 2020 and more than one million treatment courses by the end of this year. This represents 1.5 million doses or more than 140,000 treatment courses provided at not cost for use globally in clinical trials, compassionate use and expanded programs and following potential future regulatory authorizations globally.
Additionally, Gilead is in discussions with UNICEF, which is known for its rapid response in getting medicines and supplies to countries during emergency and humanitarian crises.
In an open letter issued on 4 April 2020, Daniel O’Day, Chairman & CEO of Gilead, shared, “Having a potential treatment in our hands comes with significant responsibility. Providing our existing supplies at no charge is the right thing to do, to facilitate access to patients as quickly as possible and in recognition of the public emergency posed by this pandemic.” [APBN]