Gilead Stops Phase 3 Remdesivir Trial in COVID-19 Patients

April 15, 2021 - Gilead recently announced that it has stopped the Phase 3 clinical trial studying remdesivir in high-risk, non-hospitalized COVID-19 patients.  

The company stated that it no longer believes that developing a multiple-day IV infusion treatment that requires administration in a healthcare setting addresses an unmet need for non-hospitalized patients. 

This conclusion was based on the current COVID-19 landscape and challenges enrolling patients in the trial.

Notably, the decision to stop the study is not due to efficacy or safety concerns and patients currently enrolled in the study will continue to be followed. 

“The primary unmet need for non-hospitalized patients with COVID-19 is for effective and convenient therapies that can be easily administered at home,” a Gilead spokesperson said.

“Gilead remains committed to developing treatment options for non-hospitalized patients with COVID-19 that address this need. We continue to develop investigational inhaled dosage forms of remdesivir and novel oral antivirals, with the goal of delivering effective, well-tolerated and significantly more convenient treatment options for patients,” the company continued. 

Gilead expects results from the ongoing proof-of-concept study in the remdesivir development program later this year. 

Remdesivir was previously used to treat Ebola back in 2013. But last February, the National Institutes of Health (NIH) sponsored the first controlled clinical trial in the US to evaluate remdesivir in adults affected with COVID-19. 

Two months later, a study published in the New England Journal of Medicine (NEJM) found that 68 percent of coronavirus patients who received remdesivir showed clinical improvement. Fifty-seven percent of these patients were receiving mechanical ventilation. 

At the same time, Gilead’s Phase 3 clinical trial results supported the positive findings. 

In Gilead’s trial, 397 patients received a ten-day treatment of remdesivir at 200 milligrams on the first day, followed by 100 milligrams on each day until day five or ten. These patients also received standard of care.

Patients achieved similar clinical improvement compared with those taking a five-day treatment course. The time to clinical improvement for 50 percent of patients was ten days in the five-day treatment group and 11 days in the ten-day treatment group. 

FDA authorized emergency use of remdesivir in May, which allowed for the drug to be distributed in the US and administered by healthcare providers in both children and adults with severe COVID-19. 

One month later, additional data on remdesivir showed that 65 percent of patients treated with the drug were more likely to see clinical improvement at Day 11 versus individuals receiving standard care. 

Notably, there was a 62 percent reduction in the risk of mortality compared with standard care.

A few weeks later, HHS secured over 500,000 treatment courses of remdesivir for US hospitals through September. And due to increased demand for the drug, Pfizer signed a multi-year agreement with Gilead to help manufacture and supply remdesivir at its Kansas facility. 

FDA broadened the original emergency authorization to include all hospitalized adult and pediatric patients with COVID-19 in September. And then in October, the agency approved remdesivir as the first COVID-19 treatment. 

The approval signed off on using the drug in adults and pediatric patients 12 years of age or older who are infected with the virus. The agency based its approval on multiple clinical trials that it assessed and evaluated throughout the year. 

Currently, remdesivir is widely available in hospitals and healthcare settings across the country and remains the standard of care for the treatment of hospitalized adult patients with COVID-19. 

Specifically, over half of all hospitalized patients in the US are treated with remdesivir. 

Gilead stated that it continues to study the efficacy and safety of remdesivir in hospitalized patients with ongoing unmet need, such as patients with renal impairment, children, and pregnant women.