The US government began distributing remdesivir, an experimental drug recently approved for emergency use against Covid-19, to areas of the country struggling the most with the disease.
The Department of Health and Human Services (HHS) arranged for some 600,000 vials of Gilead Sciences' antiviral medication, shown to reduce recovery times for some patients, to be shipped to health authorities in New Jersey, Illinois, Michigan and three other states, to treat an estimated 78,000 hospitalised Covid-19 patients, said in an announcement on Saturday.
The shipments started on Thursday and will continue for the next six weeks, according to HHS. Gilead Sciences is donating another 900,000 vials of the medication worldwide.
"State health departments will distribute the doses to appropriate hospitals in their states because state and local health departments have the greatest insight into community-level needs in the Covid-19 response, including appropriate distribution of a treatment in limited supply," HHS said.
Under an "emergency use authorisation" granted by the US Food and Drug Administration on May 1, hospitals can administer remdesivir intravenously to patients on ventilators or requiring some form of supplemental oxygenation.
Covid-19 has killed about 77,000 people in the US since the first patient in the country was identified in January, and the number of cases, now at more than 1.25 million, continues to rise.
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Remdesivir was the first medication to be approved by a government health authority to treat Covid-19. The FDA awaits further test results before it will change the emergency use authorisation to full approval.
The regulator's authorisation was prompted by the preliminary results of a study by the National Institutes of Health (NIH), which showed that the medication shortened recovery times in 1,063 patients by 31 per cent, or about four days on average, for hospitalised Covid-19 patients.
Dr George Diaz, an infectious disease specialist who treated the first Covid-19 patient in the US, said on Monday that a remdesivir study under way at his hospital group was showing "early, but very promising" results. Providence Health & Services, which has a network of 51 hospitals on the US west coast, has been conducting a retrospective review of the hospitals' use of the medication in clinical trials.
Health care experts have cautioned, however, that remdesivir should not be counted on to end the pandemic because of limitations in how it is administered and an incomplete understanding of its possible side effects. Many say social distancing regulations enacted by health authorities worldwide will need to remain in place until a Covid-19 vaccine is found.
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"Remdesidivir needs to be given by IV so, it's hard to imagine it being scaled up so it can be used in mild cases, where it would be expected to have the greatest effect, but also where hospitalisation isn't necessary," said Dr Benhur Lee, Ward-Coleman chair in microbiology at the Icahn School of Medicine at Mount Sinai in New York.
"A game changer would be something that could be taken orally, with great bioavailability and pharmacokinetics to allow easy dosing " ideally once a day " and safe enough to be taken in the general population," Lee said.
Lee also warned that it is not known whether remdesivir has "a high enough barrier to resistance that widespread use would not compromise its effectiveness".
Gilead Sciences did not immediately respond to a query about the recipients for the remdesivir vials it plans to donate overseas.
"Gilead's overarching goal is to make remdesivir both accessible and affordable to governments and patients around the world, where authorised by regulatory authorities," the company said in an announcement on Tuesday.
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"Gilead is in discussions with some of the world's leading chemical and pharmaceutical manufacturing companies about their ability, under voluntary licenses, to produce remdesivir for Europe, Asia and the developing world through at least 2022," it said.
The company is also "negotiating long-term voluntary licenses with several generic drug makers in India and Pakistan to produce remdesivir for developing countries".
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