Bay Area firm key in virus struggle
Gilead’s injectable drug raises hopes during trials
As the new coronavirus continues to spread across the globe with no known cure, an experimental drug made by Foster City’s Gilead Sciences — in one of the highestprofile clinical trials under way for coronavirus patients — is generating excitement.
The drug, an injectable antiviral called remdesivir, was given in late January to the first confirmed case of coronavirus in the United States, a 35yearold man in Washington state, after he returned from Wuhan, China, and his symptoms worsened after a week in the hospital. His condition improved the next day.
By Feb. 6, Gilead began enrolling patients in China’s Hubei province, believed to be where
the virus originated. The company will examine the drug’s effects on 760 people, some with severe cases of coronavirus and some with mild to moderate symptoms. Results for both trials are expected in April, said Gilead spokeswoman Sonia Choi.
Gilead is now amping up manufacturing of remdesivir, even though it’s too early to say whether it would be safe or effective against the new coronavirus named COVID19. It was given to the Washington patient on a “compassionate use” basis — when the FDA allows unapproved drugs to be used on small numbers of patients facing lifethreatening diseases as a lastditch effort because other treatments are not working.
“In anticipation of potential future needs, we have accelerated manufacturing timelines to increase our available supply as rapidly as possible,” Choi said in a statement. “We are doing this before knowing whether remdesivir will be determined to be safe and effective to treat patients with COVID19 . ... We have expanded our network of manufacturing partners to increase capacity and production, casting a wide net to engage new partners in multiple geographies.”
In the past, remdesivir has shown some effectiveness against two other types of coronavirus diseases, SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome), in animals or in test tube experiments. It has also been given to Ebola patients in a clinical trial in the Democratic Republic of Congo, but was discontinued in 2019 after other drugs were found to be more effective.
Gilead has provided remdesivir to “a small number” of coronavirus patients in the U.S. and Europe, but declined to specify the location of the compassionate use cases or how many doses it has provided.
There are no antiviral drugs that have been approved to treat the new coronavirus. Other antivirals, including an HIV drug made by AbbVie, are also reportedly being tested by China’s National Health Commission as a potential coronavirus treatment. AbbVie said it has donated $2 million of the HIV drug Aluvia to Chinese health authorities.
Antivirals did not play a significant role in helping curb previous coronavirus outbreaks — SARS and
MERS largely went away on their own through public health measures that helped contain the spread. But antivirals have played a major role in containing other epidemics like HIV and herpes, said Dr. Yvonne Maldonado, an infectious disease physician and professor at Stanford University School of Medicine.
Infectious disease experts are tracking the remdesivir trial with interest. It could end up being used as an investigational emergency drug — drugs that are not formally approved or marketed for widespread use but can be obtained by health care providers to treat patients with severe cases of diseases for whom more common treatments are ineffective or cause harmful side effects, said Dr. David Witt, an infectious disease specialist at Kaiser Permanente.
Investigational drugs, for instance, have been granted for patients with malaria, highly resistant tuberculosis, and the parasitic diseases Leishmaniasis and African sleeping sickness, said Witt, who estimates that in his own practice he has obtained the investigational drug sodium stibogluconate to treat Leishmaniasis patients three times in the past 10 to 15 years.
“This is not a rare thing to have that happen, at least in infectious diseases,” Witt said. “There are diseases so infrequent here companies can’t go through hundreds of millions of dollars to get marketing approval when it’s going to be used on a few dozen patients a year.”
The majority of coronavirus patients are not receiving experimental drugs. The recommended treatment is similar to that for pneumonia or respiratory infections: bed rest, hydrating, using an inhaler for trouble breathing, taking ibuprofen to bring down a fever and, in very severe cases, using a ventilator for oxygen. Antibiotics are not effective against viruses.
“There’s really no treatment or preventive measure at this point,” Maldonado said. “Most of the time you’re doing supportive care — you’re treating the symptoms. If you have severe respiratory failure, most of those people will need ventilator care or oxygen. They’re going to need to be hydrated because they may not be able to eat or drink on their own.”
Many of the 15 confirmed coronavirus patients in the United States have had mild to moderate symptoms and have not needed hospitalization. At least five have been hospitalized — two San Benito County residents who were treated at UCSF, the Washington state patient and two in San Diego. Others have selfisolated in their homes to avoid contact with others and monitor their symptoms.