How Safe Is Treatment?

This topic has 7 replies, 6 voices, and was last updated 9 years ago by klhilde.

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8 November 2015 at 3:59 pm #3512
Dr James
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- Guardian Angel
@fixhepc
There is no such thing as a 100% safe medical treatment. Sadly some people suffer side effects (sometimes severe) and even death with any drug treatment. With HCV DAA medications the risks are small but real. To put them into perspective first consider this graph:

Next consider that about 10% of all people with HCV are expected to die as a direct result, so there is absolutely nothing safe about having HCV.

Now let’s look at the figures. We know that currently 613,000 people worldwide have take Sofosbuvir and it can cause occasional problems:

http://www.bidnessetc.com/56898-gilead-sciences-inc-can-sovaldis-newly-found-safety-risk-be-shrugged-off-fo/

So here is the bottom line. A small number of people taking DAA treatment will suffer problems, but undertaking treatment is almost certainly a sensible thing to do given 100% of people with HCV will (or already are) suffering problems, and 10% will die.

YMMV
8 November 2015 at 6:56 pm #3515
Enkel
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@enkel
It is has higher risk for those taking sofosbuvir + other DAA?

Male, Fibro F1. Geno 1b. ALT 67 before treatment Viral load 5 million. My huge viral load replicates in my nervous system as I suffer anxiety.
Started Twinvir 12/12/15.
Two weeks
ALT 17 at 2 weeks
Viral Load UND at 2 weeks
ALT 13.5 at 7 weeks EOT
ALT 10.5 at 15 weeks EOT
ALT 13 at 27 weeks EOT, VL UND, Cured
8 November 2015 at 10:19 pm #3523
Jolie
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@jolie
from the article:

“Sovaldi was found to abnormally reduce heart rate in three out of 415 patients treated in the hospital last year.
All three patients had to be given a pacemaker within a week of treatment to keep their heart rates normal.
In March, Gilead issued an advisory warning against the use of Sovaldi with another anti-viral drug and amiodarone.
Gilead spokeswoman Cara Miller said in a statement: “It is important to note that sofosbuvir alone is not associated with cardiac conduction abnormalities.” She further pointed out that no complications were noted in patients taking Sovaldi in combination with ribavirin, a famous aging HCV drug.”

anyone here on tx noticed any heart beat abnormalities?? & or is being monitored for heart problems by their doctors ?

Geno 3, Fibro 8.7 pKA, tx experinced in 2005 – Peg/Riba, relapsed.
Started tx 1/12/2015 with Indian Sofo & Chinese Dac.
5 weeks result all normal, ALT 18 – down from ALT 73 at the start of tx.
5 weeks HCV PCR RNA – UND. – down from 2 ML
9 weeks HCV PCR RNA – UND.
8 November 2015 at 10:23 pm #3524
Enkel
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@enkel
I think with riba and ledipasvir is safe

Male, Fibro F1. Geno 1b. ALT 67 before treatment Viral load 5 million. My huge viral load replicates in my nervous system as I suffer anxiety.
Started Twinvir 12/12/15.
Two weeks
ALT 17 at 2 weeks
Viral Load UND at 2 weeks
ALT 13.5 at 7 weeks EOT
ALT 10.5 at 15 weeks EOT
ALT 13 at 27 weeks EOT, VL UND, Cured
8 November 2015 at 10:34 pm #3525
Jolie
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@jolie
Enkel wrote:

I think with riba and ledipasvir is safe

how do you know that?
Doc James said: “There is no such thing as a 100% safe medical treatment”.
Not even the meds we can buy over the counter are 100% safe.
It is always the question of what is more riskier living with HCV ? or treating with new DAAs that only been around for a few months.
The statistics say living with HCV is more riskier then treating it with risky new meds, so personally am going to take the risk & treat it.

from the article:
“Given that Gilead’s most successful hepatitis C product, Harvoni, is a nuanced version of Sovaldi itself, it is safe to assume that the toxicity risks apply to it as well. “

Geno 3, Fibro 8.7 pKA, tx experinced in 2005 – Peg/Riba, relapsed.
Started tx 1/12/2015 with Indian Sofo & Chinese Dac.
5 weeks result all normal, ALT 18 – down from ALT 73 at the start of tx.
5 weeks HCV PCR RNA – UND. – down from 2 ML
9 weeks HCV PCR RNA – UND.
9 November 2015 at 2:07 am #3527
Paul-Jarman-facebook
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@paul-jarman-facebook
Jolie wrote:

from the article:

“Sovaldi was found to abnormally reduce heart rate in three out of 415 patients treated in the hospital last year.
All three patients had to be given a pacemaker within a week of treatment to keep their heart rates normal.
In March, Gilead issued an advisory warning against the use of Sovaldi with another anti-viral drug and amiodarone.
Gilead spokeswoman Cara Miller said in a statement: “It is important to note that sofosbuvir alone is not associated with cardiac conduction abnormalities.” She further pointed out that no complications were noted in patients taking Sovaldi in combination with ribavirin, a famous aging HCV drug.”

anyone here on tx noticed any heart beat abnormalities?? & or is being monitored for heart problems by their doctors ?

Thats a very low sample size to make that recommendation and no info on how old or sick the any of the 3 were. They seem to be blaming the Daclatasfir not the Sofosbuvir so the article is misleading I think. The FDA sheds more light on the subject http://www.fda.gov/Drugs/DrugSafety/ucm439484.htm and it appears that amiodarone is the culprit. This is a drug taken to regulate heart rhythm and the warning is to not take this drug with Sof and Dac.

If Gilead could knock BMS out of the game they could potentially make more profit. No where in the FDA article did it apportion any blame on Daclatasfir (bms) yet that inference was drawn by Gilead spokesman.

cheers

Two time relapser.

SVR 4 achieved 12/16 at last
SVR 12 achieved 22/02/2017 The Bastard has been defeated

GT 3 – about 28 yrs with HCV
9 November 2015 at 5:25 am #3533
Vicki
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@vicki
In that case, we all should continue being monitored while on the treatment to note any possible side effects.
Drug companies store away a lot of money for pay outs of undisclosed side effects once they start treating the masses. there are records of many court cases of such events.
At my last visit to the Geelong Liver clinic the registrar said, it was impossible to really know of any life threatening side effects until millions of people were taking these new drugs. I thought she was a bit of a kill joy, but she had a point.
9 November 2015 at 11:36 am #3548
klhilde
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@klhilde
I agree with Paul …. this is Gilead propaganda and fits well with their general behavior pattern. Notice the Gilead spokesperson is implying rather than directly stating a risk difference between led and dac.

I’ve made two comments on the page …. when I left a link for this site it went to moderation and then disappeared … so I rewrote it with “dot” in the address. More of us should do the same.
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