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FDA approves new drug to treat influenza
- stephengillie 8y ago> The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis. I wish the article listed the frequency or likelihood of getting these reactions. Given the choice between flu and bronchitis, I'll take the flu.
- refurb 8y agoIt's in the prescribing information.[1] Adverse event - Xofluza(%) - Placebo(%) Diarrhea - 3% - 5% [higher in placebo] Bronchitis - 2% - 4% [higher in placebo] The FDA requires that the manufacturer list the most common adverse events, even if they are unrelated to the drug in question. [1]https://www.gene.com/download/pdf/xofluza_prescribing.pdf https://www.gene.com/download/pdf/xofluza_prescribing.pdf
- aaaaaardvark 8y agoWhoa stay away from that placebo.
- eli 8y agoInterestingly, placebos have been getting stronger and more effective over the years. It’s a real bummer for people running clinical trials. https://www.scientificamerican.com/article/placebo-effect-grows-in-u-s-thwarting-development-of-painkillers/ https://www.scientificamerican.com/article/placebo-effect-gr...
- leekyle333 8y agoIf you're ever board and you want to watch something on placebos I highly recommend watching this lecture by Dr. Irving Kirsch. Placebos are pretty nuts and probably really undervalued. https://www.youtube.com/watch?v=ISptt3CRAqc&t=15s https://www.youtube.com/watch?v=ISptt3CRAqc&t=15s
- acct1771 8y agoI'd rather die than live a lie.
- hn_throwaway_99 8y agoWow, what an interesting study! Especially since the effect was only seen in the US.
- bsder 8y agoThen don't read the side effects for aspirin ...
- qwerty456127 8y agoChances are you are going to get diarrhea and bronchitis anyway if you get flu, whether you take the cure or not. I would be more curious about how well does it play together with something like ambroxol hydrochloride - I used to get bronchitis as a complication every time I get cold in the past but as soon as I've discovered ambroxol hydrochloride I've forgotten about ever having bronchitis as a bad dream.
- giarc 8y agoDiarrhea is not very common in patients with influenza. Perhaps a little more in children but not so much in adults.
- wahern 8y agoThe flu can also cause bronchitis. More often than not I end up with bronchitis after a severe flu or cold. I don't even bother with the doctor anymore (unless I have a fever) because I'm not interested in the codeine and I can just buy Primatene (ephedrine + guaifenesin) over the counter. Both my doctor and a pharmacist have admitted they could do no better.
- craftyguy 8y ago> unless I have a fever How often do you get the flu (actual flu, not a bad cold) and not have a fever? I've only had the flu once in my life (30-something years), and it was like being hit by a bus, having said bus park on your body, and having said bus catch on fire and slowly burn.
- wahern 8y agoI meant if I have a fever with persistent, unproductive coughing after the flu itself has seemingly subsided. A fever would suggest a lung infection, either causing the bronchitis or vice-versa, but which in any event might require antibiotics lest it degenerate into pneumonia. I've had pneumonia at least twice as an adolescent, but which went untreated for awhile because it was typical for me to have prolonged coughing and lethargy after a respiratory illness. So while I'll treat my own bronchitis, I have to be mindful that the bronchitis could be secondary, or could have resulted in an infection.
- refurb 8y agoApparently the main value of this new product is that it reduces the infectious time period (“viral shedding”) from 3 days (using Tamiflu) to only 1 day. Would be interesting to see what impact that has during flu season.
- giarc 8y agoThe other value add is 1 dose vs 10 doses.
- chrisweekly 8y agoDropping the viral shedding period from 3d to 1d is amazing. Radical impact on incidence rate.
- GarrisonPrime 8y agoIndeed. But if this drug doesn’t treat someone any better or faster, it may prove difficult to convince them to use it if it’s more expensive.
- baddash 8y agoHmm, given that Xofluza is better in this respect and the same in all other respects, could it be said that it is the superior option?
- mrfusion 8y agoCan you combine this with tamiflu for super recovery?
- Alex3917 8y agoThe evidence for the efficacy of Tamiflu was faked, it doesn’t actually do much if anything. I’d be more interested on how it combines with elderberry syrup, which ostensibly does actually work.
- refurb 8y agoWait. Did you just call the efficacy of an FDA approved product “fake” while heaping praise on a compound that’s never gone through a clinical trial?
- gotocake 8y agoWell the efficacy of Tamiflu is very questionable, but I’ll admit the “elderberry syrup” thing threw me. Maybe a broken clock thing?
- deleted 8y ago[deleted]
- Falling3 8y agoWait. Did you just assume something hasn't gone through a clinical trial because of how it sounds? There have been trials done of the effectiveness of elderberry syrup.
- AnimalMuppet 8y agoWhat were the results? For that matter, do you have a reference?
- taf2 8y ago
- mrfusion 8y agoIs this only for flu or could it become a general purpose anti viral?
- refurb 8y agoPretty sure it targets an enzyme only found in influenza.
- dssu 8y agoAdditionally, compared with placebo, baloxavir treatment significantly reduced the following: The duration of flu symptoms, by more than 1 day (median time, 53.7 hours vs 80.2 hours; P <.0001); The duration of fever, by nearly 1 day (median time, 24.5 hours vs 42.0 hours; P <.0001); The length of time viruses continued to be released from the body (median time of viral shedding, 24.0 hours vs 96.0 hours; P <.0001); and The levels of virus in the nose and throat from 24 hours through 120 hours. Relative to oseltamivir, baloxavir treatment resulted in similar median time to alleviation of symptoms (median, 53.5 hours for baloxavir vs 53.8 hours for oseltamivir; P = .7560) and similar time to resolution of fever reduction (median, 24.4 hours vs 24.0 hours; P = .9225), respectively. However, baloxavir treatment was associated with significantly reduced viral shedding duration (24.0 hours vs 72.0 hours; P < .0001) and significantly lower levels of virus in the nose and throat at 24 hours and 72 hours. "It is unclear why the time to alleviation of symptoms was similar in the baloxavir group and the oseltamivir group even though baloxavir showed greater antiviral activity," the authors write. "The findings suggest that the symptom benefit of antiviral agents may have a ceiling in self-limited influenza illness in adults, perhaps because viral replication levels are decreasing by the time of presentation and illness pathogenesis is linked to host proinflammatory responses." Overall, baloxavir was well-tolerated and had a lower incidence of adverse events reported (20.7%) compared with placebo (24.6%) or oseltamivir (24.8%). The most common adverse events were diarrhea (3%), bronchitis (2.6%), nausea (1.3%), and sinusitis (1.1%). "The antiviral effects that were observed with baloxavir in patients with uncomplicated influenza provide encouragement with respect to its potential value in treating complicated or severe influenza infections," the authors write.
- mmastrac 8y ago> a lower incidence of adverse events reported (20.7%) compared with placebo (24.6%) Isn't that an odd result? Unless the drug is treating underlying viral issues that might not have been identified prior, it should be on par with placebo, no?
- lwf 8y agoPeople may be attributing symptoms of a continuing cold to the drug. > The knowledge about taking medication or the anxiety about medication effects and illness course can cause patients to monitor symptoms in more detail, resulting in an amplified perception of benign sensations and physical symptoms. [1]: https://dx.doi.org/10.1001/archinte.166.2.155 https://dx.doi.org/10.1001/archinte.166.2.155
- kevin_thibedeau 8y agoTamiflu only reduces symptoms by one day when taken within 48 hours of their onset. Who knows they have the flu and not a cold at that point? Looks like this is a similar joke: > In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment.
- thrower123 8y agoYikes, more and more efforts to combat the flu seem to be marginal or counter-productive. Too bad we can't just stay home and quarantine ourselves when we feel like death...
- stephengillie 8y agoIndeed, it's unfortunate that some people can't even continue to work from their homes while sick.
- deleted 8y ago[deleted]
- cleeus 8y agoI think it's more unfortunate that some people have to work at all while sick.
- Mvandenbergh 8y agoIf you have the flu, you are not going to be working.
- LeftTurnSignal 8y agoNot for all. I'd like to think that most people could take a few days off for it, but can't pay for rent and food without working. Even working on the farm, I rarely could take a sick day. Cows won't milk themselves and you can't tell them to hold it for a few days either.
- Mvandenbergh 8y agoFor most people, if you actually have the flu rather than a bad cold - and there's no easy way to tell since symptoms are similar, an actual flu will have you bed-ridden for at least a day. I don't mean that people should take a few days off, they should, but that may not be possible, I mean that you'll have a period where you're not capable of more than basic tasks.
- Broken_Hippo 8y ago... who have been symptomatic for no more than 48 hours. This is a serious issue with these drugs. In general, I won't go to the doctor in that time frame. This is especially the case if one gets symptoms on a friday afternoon - the doctors do not open until Monday. By the time I decide I*m sick enough to visit the doctor, I've already passed the time frame (Exceptions apply, of course). And I know I'm not the only one. To me, this is a major downfall of such remedies. This could seriously make a difference in the way the flu spreads, but for that to really happen, we need more ways to get seen by doctors or nurse practitioners. We should encourage folks to see the doctor for "little" things. We need to make sure everyone can get seen. We probably need to make sure folks in service industries get seen immediately and won't lose their jobs over such things. This is mostly because service industry workers can spread these to a wide population easily without controls.
- emiliobumachar 8y agoMostly agree. But, can even a good doctor diagnose influenza at an early stage, with enough confidence to be worth the odd false positive? Or are the symptoms too much like too much else?
- Broken_Hippo 8y agoI think this can be solved. Seriously, we have nurse practitioners at pharmacies that can test for strep throat and treat that: I see no reason why we can't have something similar for influenza. Ideally, I think it would work best if we had a care level that was between normal doctor and urgent care that was open 24 hours a day. It'd mostly be to treat things like this. But until then, surely we can simply do tests for everyone.
- ChrisRR 8y agoJust because this may not help you, doesn't mean it may not help more at-risk people who may show signs much sooner, such as the elderly, children, people with compromised immune systems, etc. The aim isn't to have one magical drug that works for everyone, but an entire set of tools in your arsenal.