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Next winter, there may be a new drug for people who contract influenza — one that appears to be able to shut down infection quickly and, unlike anything else on the market, can be taken as a single dose.

The Food and Drug Administration on Tuesday said that it would give the drug, baloxavir marboxil, a priority review, and approval has the potential to upend the way influenza is treated.

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  • There are so many unknowns here that can be problematic. Side effects in various age groups, specific age groups tested, effectiveness if taken outside the 1st 48 hours, effect of more than one tablet, interaction with other drugs being taken (especially in older patients), half-life of this med, etc. Has this been tested in a culture proven real world setting? Can viral resistance develop with this class of drugs?
    Many other questions requiring answers.

    • Yes, there are lots of unknowns. And that will always be the case in the early stages of a drug’s life cycle. Companies do the studies that are critical to bring a drug to market – does it work? is it safe? what’s the correct dose? Later studies look at things like does it work if given later? (I mentioned that studies will be done to see if it’s useful in hospitalized patients — those will almost exclusively be people who are outside the 48-hour window.)
      The half-life is apparently long.
      Resistance can develop; a mutation that can confer resistance has already been identified. (see: It’s not clear yet how big a problem resistance will be. It seems that viruses that acquire resistance to the drug pay a fitness cost — ie they are weakened by the mutation. That may make them less capable of spreading. Too soon to know. But the fact that resistance can develop to an antiviral drug is not surprising and would not be reason to block it from the market.

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