The results of a study released Friday prior to being peer-reviewed are alarming some Bay Area infectious disease specialists because they may mislead other doctors or the public, or discourage insurance companies from paying for the experimental drug remdesivir for severe COVID cases. And they contradict results already found in what they say were more rigorously conducted trials.
Gilead's drug, originally developed to treat ebola, has been discussed as showing promise in reducing the severity of COVID infections since early in the pandemic when it was being deployed at hospitals in Wuhan, China in January and February. And a federally funded double-blind study, the results of which were released in late April, showed significant impact on the speed of recovery among COVID patients who took the drug, compared to those who didn't.
But the World Health Organization on Friday publicized the results of a study that was not double-blind — the patients knew they were getting the drug — but was large in its sample size, and the results suggested little to no impact on mortality from taking remdesivir.
UCSF expert Dr. Peter Chin-Hong dismisses this, telling the Chronicle that first of all, no one had been touting the drug as reducing mortality. "The previous studies have shown decreased time to recovery, so people got better faster," Chin-Hong said. "I think it was on the order of 4 or 5 days, and that is pretty significant."
Dr. Andre Kalil, a principal investigator for the earlier National Institutes of Health trial of remdesivir at the University of Nebraska Medical Center in Omaha, tells NBC News that the WHO trial (which had 11,200 subjects spread across 30 countries) had "No data monitoring, no placebo, no double-blinding, no diagnostic confirmation of infection," and he adds, "Poor-quality study design cannot be fixed by a large sample size, no matter how large it is."
UCSF meanwhile is continuing to conduct a double-blind study on the effectiveness of remdesivir in combination with interferon, a drug used to treat multiple sclerosis. And as Chin-Hong told the Chronicle back in August, he saw remdesivir not as a "gold-medalist" in the fight against this disease, but as a "silver-medalist" that may prove effective in a cocktail with other drugs.
Foster City-based Gilead Sciences is also studying an inhalable form of remdesivir, with researchers suggesting that it may be most effective when received at home, prior to hospitalization, in order to prevent hospitalization. At present, remdesivir is only being administered to patients whose disease has progressed and who are hospitalized, in intravenous form.
Remdesivir attacks the virus itself and the process through which it replicates itself. Doctors believe a cocktail of drugs will likely be necessary to effectively treat COVID-19 infections, like those used to treat HIV — with another drug or drugs used to treat the inflammation associated with the infection itself. In the UCSF study, 1000 patients were being given remdesivir, while half would also get interferon — and the other half would receive remdesivir with a placebo. The results of that study still are not in.
President Trump was treated with remdesivir among several other experimental drugs when he was briefly hospitalized with the disease two weeks ago.
Gilead, which will market remdesivir under the name Veklury, pushed back on the WHO study results, pointing to another double-blind study in the respected New England Journal of Medicine on October 8 that concluded "remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection."