Gilead Expands Access For Experimental Coronavirus Drug

Gilead Sciences, Inc, is switching to "expanded access" from a "compassionate use" program to fast track the emergency use of the experimental anti-coronavirus drug, remdesivir for severely ill patients.

Daniel O' Day, Gilead's Chairman and Chief Executive Officer, reported that multiple clinical trials are studying the effect of the new drug for coronavirus, remdesivir, in COVID-19 patients in China and other countries.

The report on first clinical data will be available in April, as remdesivir is being tested in two trials in mild to moderate and severe COVID-19 patients in Wuhan, China

Compassionate Use to Expanded Access Program

Under the compassionate use program, Remdesivir was given to over 1,000 patients, requiring each application to be reviewed individually. Such programs are normally reserved for a small number of cases, report shows.

U.S. President Donald Trump recently highlighted remdesivir as a promising anti-COVID-19 treatment. The said announcement triggered an exponential increase in requests, overwhelming the company where each application needed to be reviewed individually, Daniel O' Day, Gilead's Chairman and Chief Executive Officer said.

Numerous doctors asked for access to the drug, of which the demand overwhelmed the company. On March 22, Gilead ceased assessment of the new individual applications for emergency access to Remdesivir outside clinical trials, except for pregnant women and children. Access of the drug is in the process of transition where hospitals and physicians can apply for multiple patients at a time.

According to O' Day, "With expanded access, hospitals or physicians can apply for emergency use of Remdesivir for multiple severely ill patients at a time". The said approach, he added, will ultimately accelerate emergency access for more people.

A promising therapeutic candidate

Remdesivir is not available as a pill or a shot. It can only be administered by intravenous infusion for 30 to 120 minutes.

In January of this year, a World Health Organization panel hailed Remdesivir as the "most promising therapeutic candidate", anchoring its assessment on the broad antiviral spectrum and existing database on human and animal studies. The drug was initially developed for Ebola and Marburg viruses and was studied in patients in Eastern Congo.

In an article published in Antimicrobial Agents and Chemotherapy, authors of the study suggest that the most promising COVID-19 antiviral is remdesivir, which gets combined into viral RNA, preventing it from being synthesized, thereby stopping viral replication. However, more clinical data is required before the drug can be approved for use.

Despite all these positive reviews, the effectiveness of the drug will not be known until clinical trial results are out, with the first expected from China in the coming weeks.

Affordability and accessibility

The urgency of clinical trials comes from knowing the desperate need among patients and the lack of any approved treatment. It is the company's responsibility, however, to ensure that remdesivir is effective and safe before it is distributed worldwide, O' day said.

If the said switch is approved, Gilead, Inc., a Foster City, California-based company, will ensure that affordability and access to make the drug available to patients with the greatest need, he added.