First Remdesivir Benefit-Risk Study Confirms it Helped COVID-19 Patients

The UK’s Drug Safety Research Unit (DSRU), a nonprofit that studies the safety of medicines, has published the first benefit-risk analysis for Gilead Sciences’ antiviral remdesivir, finding that it has a favorable overall profile, although questions remain about the drug’s safety.

The DSRU’s assessment — which looked at trial data from peer reviewed journals and some trial data yet to be published — showed the drug was beneficial for infected COVID-19 patients.

The data analysis found that the drug provided a faster recovery time and reduced the need for ventilation and supportive oxygen. The analysis included data from the NIH’s Adaptive COVID-19 Treatment Trial (ACTT), which demonstrated a median recovery time of 11 days for remdesivir patients compared to 15 days for patients on placebo (DID, May 26).

The DSRU noted, however, that there are limited safety data for the drug, leaving questions about the possibility of serious adverse events, such as cardiac arrest, hypotension and arrythmias. The limited safety data meant that the researchers could not determine whether the serious adverse events were caused by COVID-19 or remdesivir.

“The paucity of safety data means we will need to keep reviewing and updating our benefit-risk analysis. To that end, we have designed a framework for our study that means we’ll be able to update it quickly as new data becomes available,” said DSRU Director Saad Shakir.

The limited supply of remdesivir continues to be a major concern. Gilead is ramping up its production and has agreed to nonexclusive voluntary licensing agreements with multiple generic makers for manufacturing the drug in India and Pakistan (DID, May 13).

The U.S. is set to ship its last batch of the drug from the Strategic National Stockpile in the week of June 29, an HHS spokesperson said. The department said that less than 10 percent of its stock of donated remdesivir is being reserved in case of coronavirus hotspots in the coming weeks.

“We are currently in conversations with Gilead to determine what inventory will be available and when,” the HHS spokesperson said. — James Miessler