29 Apr 2020
Posted in Pharma
Gilead’s remdesivir new standard of care against COVID-19, according to Fauci, but logistics of remdesivir distribution remains unclear
Following the news that Gilead’s antiviral remdesivir has met its primary endpoint in a clinical trial run by the National Institute of Allergy and Infectious Diseases (NIAID) in moderate to severe hospitalized COVID-19 patients and NIAID Director Dr. Fauci describing remdesivir as likely the new standard of care;
Philipp Rosenbaum, PhD, Infectious Diseases Analyst at GlobalData, a leading data and analytics company, offers his view:
“If the numbers hold up to scrutiny, this could be a real breakthrough for the fight against the disease that killed more than 200,000 people worldwide in just a few months. However, how many patients will benefit from Gilead’s drug is unclear. With the company already struggling to meet the high demand, the question of distribution, given that remdesivir is administered intravenously, and uncertainties about drug pricing is being voiced.
“The primary endpoint in the randomized, double-blind NIAID study was time to recovery for remdesivir versus a placebo. Gilead’s drug was able to reduce the time to recovery significantly from 11 to 15 days, and more detailed data is supposed to be released in the coming days. Additionally, released data from SIMPLE, one of Gilead’s own studies in severe COVID-19 patients, showed that a five-day treatment regimen of remdesivir is as effective as a ten-day regimen. Gilead acknowledged that this would significantly help to treat more COVID-19 patients with remdesivir, given the current supply of the drug.
“Furthermore, the SIMPLE trial showed improved outcomes in COVID-19 patients who received the drug within ten days of infection (early hospital release in 62% of patients) versus patients who were treated more than ten days after symptom onset (49% early release). So far, remdesivir clinical trials had mixed outcomes, several trials in China being suspended or cancelled due to lack of COVID-19 patients, studies without comparators (compassionate), and data leaks prior to availability of a complete published study.
“These results are in line with what we see in the treatment of other viral diseases, such as seasonal influenza. Early administration of influenza drugs like Tamiflu show the best outcome. However, given that remdesivir has to be administered intravenously, the logistics of how and when to administer the drug to patients with initially mild symptoms who might be hesitant to see a doctor or go to a crowded hospital during the ongoing pandemic, is unclear.
“Until a COVID-19 vaccine is available, everything boils down to a massive increase in COVID-19 testing. Once more studies confirm remdesivir’s effectiveness against COVID-19 and supply is guaranteed, be it by a large increase of Gilead’s own production output or in cooperation with other pharmaceutical companies, stakeholders have to develop a way to make remdesivir available to high-risk patients that might not involve hospital visits and makes price a non-issue.”