As predicted several weeks ago, Bay Area-based Gilead is at the center of the international conversation about potential treatments for the novel coronavirus — technically called 2019-nCoV. But a flood of case-by-case requests for the drug to treat critically ill patients who have no other course of treatment has led to a necessary shift in how the company disseminates samples.
The company has an unapproved drug, remdesivir, that has shown some promise in treating coronaviruses — leading Chinese researchers to file their own patent for it in January, in violation of trade agreements and intellectual property law. President Trump last week made the mistake of touting it specifically as a potential cure, despite the fact that no clinical trial had yet been complete. After Trump's comments and others made by the World Health Organization in late February, Gilead was inundated with requests for individual shipments of the drug under its "compassionate use" program. Under such programs, drug-makers can ship doses of the drug to healthcare professionals in cases where a patient is likely to die and no further treatment is available.
On Sunday, unable to handle the volume of requests, the company ended that program in order to transition to a broader-based program for experimental, group-based distribution. In statements to the New York Times, a spokesperson for Gilead said the transition was unlikely to impact the amount of time it took for drug samples to be shipped, and it would continue to fulfill compassionate-use requests that had already been submitted over the last week.
Among those is one to treat 25-year-old New Jersey resident Jack Allard, whose mother spoke to the Times about her desperation to get treatment for her son — who after first showing symptoms on March 16, is now on a ventilator in a medically induced coma. A delay in getting test results from one lab, Quest Diagnostics, meant that doctors couldn't submit their request to Gilead until Saturday, just before the company announced an end to the program.
"I’m just, like, apoplectic at this point," says Genny Allard, Jack's mother, to the Times. "I have a kid who is sick and the doctor wants to give him the next medicine that is supposed to help."
The new program, Gilead explains, will allow them to collect some data on the samples they send — allowing doctors at hospitals around the country to administer the drug to specific groups of patients in a loose clinical trial. Otherwise, as one public health expert tells the Times, the company is mailing out doses of remdesivir from a dwindling, limited supply, and not getting back critical information about how well patients respond to treatment, and at what point in the illness's trajectory.
The company said the switch will "both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients." Gilead says it has a stockpile of the drug that it is drawing on — a reserve supply it had manufactured to treat an ebola outbreak in Africa, although the drug turned out not to be effective against ebola in trials. It is also ramping up production of the drug in anticipation of potential broader distribution.
Currently, remdesivir is part of six different clinical trials around the world, as the Times reported last month, with the first having began in Wuhan in January. Some of the first patients in Italy — two Chinese nationals who fell ill while traveling — were being treated for the virus at the time in Rome using a combination of remdesivir and an HIV drug called ritonavir. And others were treated with another antiviral called lopinavir — and not enough data yet exists to point to what combination might be most effective. Some excitement in the American medical community came out of a single story of a COVID-19 patient in Washington who was treated with remdesivir and appeared to improve after taking it.
The remdesivir trial that took place in Wuhan, China won't be announcing its early results until late April — long after many thousands more Americans are likely to be hospitalized and in need of treatment.
As biopharma magazine STAT reported last week, the World Health Organization is launching "a multiarm, multicountry clinical trial for potential coronavirus therapies," including remdesivir, with ten countries participating. (The U.S. was not one of those initial ten.) And as the Times reported Monday morning, there are currently 69 different drugs being tested against 2019-nCoV.
Under the new program, Gilead hopes to be running small-scale "trials" of the drug's use on critically ill patients nationwide, and perhaps a better picture will emerge in the coming weeks — and sooner than late April — about its efficacy.