UPMC: Study Still Needed On Remdesivir
UPMC officials are waiting for more data about antiviral drug remdesivir and its effects on COVID-19.
Earlier this week, Gilead Sciences officials announced the company can produce several million rounds of the drug — approved Friday for emergency use by the Food and Drug Administration — in the next year to help patients fight COVID-19, with more than 140,000 rounds to be produced by the end of May. In a study of 1,063 patients sick enough to be hospitalized, remdesivir shortened the time to recovery by 31% — 11 days on average versus 15 days for those just given usual care, officials said. The drug also might be reducing deaths, although that’s not certain from the partial results revealed so far.
Remdesivir was being evaluated in at least seven major studies, but the National Institutes of Health study was the most strict. Independent monitors notified study leaders recently that the drug was working, so it was no longer ethical to continue with a placebo group, according to the Associated Press.
No information was given on side effects. Dr. Anthony Fauci of the National Institutes of Health, said full results would be published in a medical journal soon. He said final numbers might change a bit but that the study’s overall conclusion would not.
Remdesivir is among dozens of treatments being tried against the coronavirus but was the farthest along in testing. It’s given through an IV and blocks an enzyme the virus uses to copy its genetic material. In animal tests against SARS and MERS, diseases caused by similar coronaviruses, the drug helped prevent infection and reduced the severity of symptoms when given early enough in the course of illness.
During a news conference Thursday, Dr. Rachel Sackrowitz, chief medical officer of the UPMC ICU Service Center, discussed how the UPMC system is incorporating remdesivir into its existing REMAP clinical trial of COVID-19 treatments.
“So as you know or have probably heard, there have been recent communications about studies about remdesivir,” Sackrowitz said. “There’s some recent hope that we may have an optimistic path forward to reducing the duration of the illness of COVID-19 responsive to remdesivir. I think that right now we are thinking about REMAP as a way to learn about all the potential therapies that might be effective in COVID-19 and remdesivir would certainly be on the docket for future study.”
Another study testing remdesivir in severely ill patients in China was stopped after only 237 of a planned 453 patients were enrolled. Partial results published Wednesday in the British medical journal Lancet suggest the drug did not speed recovery in that study, but it was too small to be definitive.
“It’s very early on in the remdesivir story right now,” said Dr. Donald Yealey, chair of emergency medicine at UPMC. “As you know there are really two recent trials — one that showed no benefit at all and another that showed a modest benefit. We want to learn, once the full set of data are available, and we want to do this smartly. There is a strong desire to do things in the middle of a pandemic like that. I think what you expect from us is not just to do things, but to do the right things. That’s where being careful, thoughtful and using a novel platform like REMAP can really be helpful not only to the people we treat here, but in our region and the country.”
UPMC-REMAP-COVID19 opened in mid-April across UPMC’s 40-hospital system and began with multiple treatments tested simultaneously in different combinations — including hydroxychloroquine, steroids and medications called immunomodulators that alter the responsiveness of the immune system. Yealey there may be an update in the coming weeks about UPMC researchers’ work creating a specific antibody that would protect individuals from COVID-19 in lieu of a vaccine while Sackrowitz said the REMAP study is ready to add new forms of treatment for clinical trial.
“I would add that we are leveraging our REMAP program to really attain more knowledge about all of these therapies,” she said. “I believe that last time Dr. Angus spoke he mentioned the two treatment arms currently being studied through the REMAP program are hydroxychloroquine and steroids in critically ill patients. Very soon we are adding three additional treatment options to that initiative, including convalescent plasma, vitamin C and anticoagulation. Hopefully we should be very rapidly able to accumulate knowledge that could inform these conversations.”