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Fauci’s guidance on pre-vaccine coronavirus treatments

Antibody drugs and various medicine cocktails against the coronavirus are progressing and may provide some relief before vaccines.

The big picture: Everyone wants to know how and when they can return to “normal” life, as vaccines are not expected to be ready for most Americans for at least a year. Two therapies are known to be helpful, and more could be announced by late September, NIAID Director Anthony Fauci tells Axios.

Where it stands: The FDA has not approved any treatments or vaccines to address COVID-19 yet, but there are 316 treatments and 202 vaccines in various stages of development. “There’s treatment for late disease and treatment for early disease,” Fauci says.

For people who are hospitalized with advanced disease, remdesivir and dexamethasone have been found to be helpful.

Remdesivir shortens hospitalization by around 30% for patients with pulmonary issues, and many trials are testing it with other drugs.Dexamethasone helps those with severe respiratory symptoms and on ventilators or requiring oxygen, but not at the early stages, when it might actually be detrimental, he says.”[T]hat validates our concept of pathogenesis — that early on, you need to attack the virus and not interfere with the immune system, whereas later, the virus has already done its deed. You don’t have to ignore it, but you’ve really got to focus on dampening” its impact, Fauci says.

To address the disease at an earlier stage, Fauci says they hope to get positive news from results expected in September from monoclonal antibodies trials that target the virus specifically.

Plus, a pre-print of the Mayo-led study of 35,322 patients indicates a transfusion of plasma from people who’ve recovered from COVID-19 within three days of diagnosis may yield “significantly reduced” mortality, although the trial didn’t use a placebo.”This is a work in progress,” Fauci says. There are ongoing randomized placebo-controlled trials to confirm what seems to be “a strong hint of efficacy.”Mayo tells Axios that the study has been submitted for peer review, and “planning is underway to transition smoothly to Emergency Use Authorization.”

Why it matters: “It will take a while before we’re talking about broad distribution of a vaccine” and likely “well into 2021” before most people will have access to a vaccine, says Esther Krofah, executive director of Faster Cures at the Milken Institute.

“Meanwhile, the treatment story is going to continue — more data will come out, more evidence will come forward, and more treatments will be added through that period,” she tells Axios.

What’s happening: The urgency of the pandemic has fostered international collaboration and promoted a newer type of trial — the master protocol clinical trial.

Those trials offer a more adaptive, faster way of testing multiple treatments at the same time on groups of patients — WHO says this reduces overall time by 80%.Leaders in the adaptive trials say the programs are working: more clinics and hospitals are joining and enrolling patients, and therapies are being added/dropped as evidence accumulates.However, others point out there are some issues in how these trials differ from conventional trials.

Multiple adaptive platforms are underway, including NIH’s ACTT, WHO’s Solidarity, REMAP-CAP, the U.K.’s RECOVERY and the I-SPY COVID-19 Trial. So far, data from them suggests:

Not helpful: Hydroxychloroquine and lopinavir/ritonavir, although some trials are continuing to study if they work better in a drug combo.Helpful: Remdesivir and dexamethasone.Under study: Various antibodies, antivirals, antibiotics, steroids, immunotherapies, anticoagulation, antiplatelets and vitamins.

Between the lines: Scientists continue grappling with the confounding range of manifestations of this novel disease, which barely affects some but can also seriously damage the lung, heart, kidney, brain, immune and blood systems.

For now, this means patients may need a cocktail of treatments depending on what they are experiencing.”In an ideal case, there would be a single mechanism targeted by a single drug in a precision medicine framework. … That model comes under threat when the disease we’re studying has a very complex biology,” Chris Seymour, a program director in the University of Pittsburgh’s Department of Critical Care Medicine, tells Axios. UPMC was the first U.S. hospital system to join REMAP-CAP.”I personally believe it’s unlikely that any agent will have a dramatic effect on the disease course. I think in general, inflammatory diseases are difficult to treat and most drugs that treat them, on average, reduce the disease severity by 20 or 30%,” says Elliott Levy, SVP of global development at Amgen, which is part of a drug company consortium called the COVID R&D Alliance and has a drug being tested in the I-SPY trial.Levy does say, however, he’s “cautiously optimistic that out of that mix we’ll find another one or two that have a meaningful level of activity.”

What they’re saying: Derek Lowe, a drug discovery scientist who writes a blog for Science Translational Medicine, says he doesn’t expect there to be a small molecule cure for this virus, as it would take six-to-ten years to develop one for a complex disease that will need the drug to focus on different mechanisms.

“The only thing that I see getting us back to normal life is a vaccine and monoclonal antibodies,” Lowe says.


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