
FDA approves new drug to treat influenza - skolos
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624226.htm
======
Broken_Hippo
_... 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.

~~~
ChrisRR
Just 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.

~~~
pavel_lishin
Parents, too - if I think I'm coming down with the flu, and know there's an
early timeframe treatment available, I'll absolutely make it a point to see
the doctor early.

~~~
icegreentea2
Yeah, I think this stuff is great for when you're living with someone.

A few years ago, I got the the flu while visiting home during the holidays. My
family took me to the clinic to get some antibiotics to deal with some
secondary infections (I also had wisdom teeth stuff going on at the same time
lol). I remember the doctor offering tamiflu to my family as prophylaxis, or
to come back the moment they felt symptoms for tamiflu.

------
dssu
_Additionally, 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
> 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
People 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)

------
stephengillie
> _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
It'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
Whoa stay away from that placebo.

~~~
eli
Interestingly, 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-
gr...](https://www.scientificamerican.com/article/placebo-effect-grows-in-u-s-
thwarting-development-of-painkillers/)

~~~
leekyle333
If 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
I'd rather die than live a lie.

------
refurb
Apparently 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.

~~~
chrisweekly
Dropping the viral shedding period from 3d to 1d is amazing. Radical impact on
incidence rate.

------
thrower123
Yikes, 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
Indeed, it's unfortunate that some people can't even continue to work from
their homes while sick.

~~~
Mvandenbergh
If you have the flu, you are not going to be working.

~~~
LeftTurnSignal
Not 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
For 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.

------
kevin_thibedeau
Tamiflu 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.

------
mrfusion
Can you combine this with tamiflu for super recovery?

~~~
Alex3917
The 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
Wait. 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?

~~~
skolos
Randomized study of the efficacy and safety of oral elderberry extract in the
treatment of influenza A and B virus infections.

[https://www.ncbi.nlm.nih.gov/pubmed/15080016](https://www.ncbi.nlm.nih.gov/pubmed/15080016)

Edit: Symptoms were relieved on average 4 days earlier and use of rescue
medication was significantly less in those receiving elderberry extract
compared with placebo.

~~~
refurb
All right, so it was tested in a randomized clinical trial. However it was 30
treated patients, so pretty small. And a trial not actually signed off on by
the FDA.

Also, I’m surprised symptoms were alleviated 4 days (96 hours) sooner when the
Tamiflu trial said total duration of symptoms were 78 hours for the placebo.

~~~
Alex3917
> All right, so it was tested in a randomized clinical trial.

Three or four actually.

> Tamiflu trial said total duration of symptoms were 78 hours for the placebo

And again, the Tamiflu data was faked. You can read the background on this
here:
[https://www.bmj.com/content/345/bmj.e7303](https://www.bmj.com/content/345/bmj.e7303)

When the real data was finally FOIA'd or whatever, it became clear that it no
longer had even the minimal efficacy that was originally claimed. The way that
FDA trials work is that you need two phase III studies showing a drug is more
effective than placebo, but you're allowed to conduct unlimited trials that
don't find any advantage over placebo without being required to make the data
from these other studies public. That's what happened in this case, there were
one or more additional studies that showed it wasn't effective, and when you
included the data from the additional studies to calculate the overall effect
the advantages disappeared.

There are several books about this, but since every time I link to books
people complain that I'm trying to trick them into reading, here's an Internet
article about what happened instead:
[https://articles.mercola.com/sites/articles/archive/2015/10/...](https://articles.mercola.com/sites/articles/archive/2015/10/21/major-
tamiflu-scam.aspx)

The main caveat on elderberry, other than the lack of FDA monitored clinical
trials, is just that the stuff you're likely to find in your local drug store
is Sambucol, which isn't the best quality. But you can go and buy this online
that's actually good quality and not that expensive:

[https://www.amazon.com/Gaia-Herbs-Black-Elderberry-
Syrup/dp/...](https://www.amazon.com/Gaia-Herbs-Black-Elderberry-
Syrup/dp/B00F43LEKS/)

------
mrfusion
Is this only for flu or could it become a general purpose anti viral?

~~~
refurb
Pretty sure it targets an enzyme only found in influenza.

