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Hep C Discussion Forum -> General Discussion -> Sovaldi First Look at Post Approval Safety
Post Info TOPIC: Sovaldi First Look at Post Approval Safety
Loopy Lisa


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RE: Sovaldi First Look at Post Approval Safety
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Isiscat2011 wrote:
Loopy Lisa wrote:

All drugs carry a certain amount of risk, but most people will cure and never regret trying. I hope this article does not discourage people from attempting to cure!

Hi Lisa:

The intent of the report is to inform not to persuade.  The target audience of the informatics company that prepares these reports is people who work in the health care industry.  How individual consumers interpret the information is up to them.

I wouldn't worry too much about people not wanting Sovaldi at this point.  On the contrary, the problem will be people wanting it desperately but being unable to get it.  Gilead has been on a campaign to win the hearts and minds of HepC sufferers for some time and their intention is to persuade.  So far it appears Sovaldi is outperforming all other HepC drugs both in efficacy and safety so hopefully the public's faith in it will be justified.  

 Indeed, but I always like to state these things as newly diagnosed will still be in the throws of fear stage, my post was aimed at them. We ourselves forget the fear as we have got used to being infected and carry on with daily life. For us we are more worried about curing, that takes time to sink in "cure verses the fear stage." Have a good day :)



__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 
Isiscat2011


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Gator Man: 

The photo of you holding the baby gator reminds me of something I saw on Animal Planet.  Have you ever seen a kitty cat smack a gator? 

www.animalplanet.com/tv-shows/bad-dog/videos/the-cat-who-bitch-slaps-gators.htm



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Isiscat2011


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Loopy Lisa wrote:

All drugs carry a certain amount of risk, but most people will cure and never regret trying. I hope this article does not discourage people from attempting to cure!

Hi Lisa:

The intent of the report is to inform not to persuade.  The target audience of the informatics company that prepares these reports is people who work in the health care industry.  How individual consumers interpret the information is up to them.

I wouldn't worry too much about people not wanting Sovaldi at this point.  On the contrary, the problem will be people wanting it desperately but being unable to get it.  Gilead has been on a campaign to win the hearts and minds of HepC sufferers for some time and their intention is to persuade.  So far it appears Sovaldi is outperforming all other HepC drugs both in efficacy and safety so hopefully the public's faith in it will be justified.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Gator Man


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Congratulation Rob. I think you will find the sx to be minimal with Sovaldi/Olysio. Stay out of the sun or cover up, take the Olysio with food and drink lots of water. Insomnia seems like a common sx. After discussing it with my doctor, I took melatonin every night which helped. He also gave me a script for Ambien if needed.

My gym workouts are nowhere near the weight levels you are at RH, but I do run around 15-20 miles a week and try to get in a swim and bike session. I've started training for a sprint triathlon and actually added to my workouts around the time I started tx. Wasn't sure that it was a good idea at the time, but decided I could always back off if I got too fatigued.  I never had any shortness of breath or cardio issues while on Sovaldi. I also cleared it with my doctor first.

Every appointment with my doctor starts with questions regarding all medication taken and any adverse symptoms. Giving honest and complete answers should help minimize the risks of taking either drug. At this stage, hopefully being SVR in a couple of weeks, I think I am a lot better off taking the slight risk with Sovaldi/Olysio, than the continued downward spiral of advanced liver disease. I certainly have no regrets at this point.

Good luck!

 

 

 

 

 



__________________

Geno 1b, compensated cirrhotic, 54 yo, prior null responder. Pre tx VL approx 595,000, tx with Sovaldi/Olysio (no Riba) started 1/8/14. VL 40 @ 2 weeks, UND @ 4 weeks. Still UND @ EOT + 1 year.

Gator Man SVR12, Dragon 0, Final Score.
Loopy Lisa


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I suspect that most of the people that passed away had Hep C complications in the first place. It can be heart problems, health problems and not enough checks on their blood work. It sounds to me that some were anemic and they were not checked. Also it was not clarified how far they were gone with liver damage. Sometimes data is no good without clarification. All drugs carry a certain amount of risk, but most people will cure and never regret trying. I hope this article does not discourage people from attempting to cure!



__________________

Genotype: 3b

VL.�over 15, 000 000

Failed TX 2014: Interferon/Riba.

Cured using Sof/Dak combination.

I can eat cake again! <3 
Isiscat2011


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longld wrote:

15,000 die per year from Hep C (US)........has now passed HIV death rate.....


___________________________________________________________________________________________________________

I get your meaning, longid, but 3.2 million people have HepC in the U.S.  Many are very healthy.  No need to kill them in the process of trying to save some of that 15,000 (many of which will die anyway, even if they do get rid of the virus).  Drugs need to be as safe as possible, that's all.   

We are living in a culture of fear surrounding this disease that could lead to some serious repercussions if we aren't careful.

 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
longld


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15,000 die per year from Hep C (US)........has now passed HIV death rate.....



-- Edited by longld on Monday 2nd of June 2014 12:06:21 AM

__________________

62 Yrs Old, CHC Geno 3, Cirrhosis, Kidney Transplant (13 yrs), On Sovaldi/Riba Treatment (24 week) since Feb 01,2014

Viral Load 7M on 1/8/2014,  UND at EOT 7/18/2014
Isiscat2011


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Kay wrote:

Do we know what the 19 deaths were from? How many patients did this survey?Is this site reputable? I have heard nothing but good things about Sovaldi. Insomnia. If 20 people had died wouldnt we at least hear about it? Unless that is 20 out of millions then it is still low and probably not Sovaldi but the initial sickness Sovaldi was treating. 

 Hi Kay:

Good questions and if you click on the link in the original post you can find all the details about specific adverse events and their outcomes.  

This was not a survey.  The report was prepared by an informatics company that provides post-approval safety data.  Their primary market is physicians, hospitals, insurance providers, and pharma.  Adverse events are often (but certainly not always) reported to the FDA.  The FDA maintains records of the reportings that are available under the FOI (Freedom of Information Act).  Informatics companies compile and analyze data to make it accessible and understandable for businesses that need this type of info.  

As far as I can tell the company does not accept financing by pharma or patient advocacy groups; they function independently.  You can learn more about the company that prepared the report at Adverseevents.com or by googling them. 

The conclusion the report reached is that Sovaldi is the safest hepc tx drug available.  That is the most important take away for me.  No drug is 100% safe for all people.  They will continue to monitor Sovaldi as well as other newly approved drugs.  I consider this information highly reliable but you can judge that for yourself. 

In response to your question "wouldn't we hear about it?"  the answer is probably not, but the media and the information it provides, is a whole other can of worms.



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Kay


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Do we know what the 19 deaths were from? How many patients did this survey?Is this site reputable? I have heard nothing but good things about Sovaldi. Insomnia. If 20 people had died wouldnt we at least hear about it? Unless that is 20 out of millions then it is still low and probably not Sovaldi but the initial sickness Sovaldi was treating. 



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Isiscat2011


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Fireman Rob wrote:

I just found out yesterday I finally got approved for Sovaldi/Olysio! 

 

         ___________________________________________________________________________________________________________

 

This is exciting news.  You have been waiting for this for some time.  Was it the 2nd appeal?   Congrats!!  

I don't know why Olysio isn't on there yet.  If I run across anything I'll post it. 



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Fireman Rob


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Hi Isiscat,

The charts in that link are very comforting! Do you know why Olysio isn't on there? I haven't seen much on that drug lately.



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Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Fireman Rob


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Thanks RH!

Great fitness levels too by the way! I've been hitting the cardio pretty hard lately, preparing for the summer fire season. I just found out yesterday I finally got approved for Sovaldi/Olysio! 

I wasn't going to announce it until I physically had the meds in hand but my questions probably gave it away.? I'm soooo excited and anxious to start Tx but really nervous at the same time. I'm just hoping I can still do my job during the worst summer months of the year.

Thanks Buddy! Your info will definitely put my mind at ease tonight. Stay fit my friend and may SVR be in our near future!



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Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Isiscat2011


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Fireman Rob wrote:

Sovaldi is still the best and safest option out there. 

____________________________________________________________________________________________________

Exactly, and safer not by a little but by a lot, based on the data available so far.   If you look at the Rx scoring chart (in the link) Sovaldi comes in at 15.36; the average for hepc tx drugs appears to be around 50 (on a scale of 0-100 with 0 being the safest).  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
HR


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Fireman Rob wrote:

RH, 

With your experience in mind, what are your thoughts about strenuous physical activity while using Sovaldi? Would you or anyone else advise mitigating physical activity during Tx?  The reason I ask is that I may not have a choice once I begin. Still gotta pay the bills...

-Rob

 

 Rob

I lift weights twice a week with a trainer. He pushes to the max.

Bench work out

10 reps @135

6 reps @ 185

5 reps@ 225

3 reps @ 275

1-2 reps @315

drop set

10 reps @. 225

10 reps @185

So this is just the bench work out and other body parts are similar to this type workout.

That is why I couldn't believe I damn near drowned.

i do the same things now I did before treatment without any problem whatsoever. For me these meds cause not much if any sides. 

My advice would be to stay out of the ocean or lake without a life jacket:)



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14
Fireman Rob


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RH, 

With your experience in mind, what are your thoughts about strenuous physical activity while using Sovaldi? Would you or anyone else advise mitigating physical activity during Tx?  The reason I ask is that I may not have a choice once I begin. Still gotta pay the bills...

-Rob

 



__________________

Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
HR


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Fireman Rob wrote:

The report elludes to possible lack of oxygen in the blood as a possibility for some deaths. Other deaths may be related to cardiac arrest. It's hard to say what percentage was caused by what exact factors. I doubt the reportees really know for certain. Thanks for the informative link! 

Sovaldi is still the best and safest option out there. The disturbing part of deaths to me was the average age of deaths linked to the drug. 48 yrs old! Crazy...

 Funny thing is, I damn neared drowned at SPI last year because I couldn't catch my breath. I'm in fairly decent shape and can swim. I believe I posted this on the ION-3 thread last August. 



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14
Isiscat2011


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Fireman Rob wrote:

I doubt the reportees really know for certain. Thanks for the informative link! 

 

__________________________________________________________________________________________________________________ 

That's right, Rob, and the report states this very clearly.  

Personally, I think some people's biochemistry and health status, combined with certain drugs, is just a recipe for disaster.  Unfortunately, they just don't know how any drugs will effect everyone.  

I recall reading that most Incivek deaths, particularly those related to the skin disorders, were preventable had people gotten medical help and stopped taking the meds.  Good lesson there that we do need to seek medical help when our sx are severe or unusual.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Isiscat2011


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TazKat wrote:

I agree on the incivek. I hope the sovaldi is not doing anything but good things in me.. I can't do muster enough energy to do any more treatments. this one has been tough. do we know what the 19 deaths were from?

 Hi TazKat:

Hopefully, this is the very last one for you.   I know it has been tough but you've been a trooper.  

If you click on the link (thanks Tig) in the original post it explains.   



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
Fireman Rob


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The report elludes to possible lack of oxygen in the blood as a possibility for some deaths. Other deaths may be related to cardiac arrest. It's hard to say what percentage was caused by what exact factors. I doubt the reportees really know for certain. Thanks for the informative link! 

Sovaldi is still the best and safest option out there. The disturbing part of deaths to me was the average age of deaths linked to the drug. 48 yrs old! Crazy...



__________________

Age 33, Male. GT-1 for ten years. Diagnosed in March, 2014.

Treated with Sovaldi/Olysio: SVR 24 on February 16, 2015!
Isiscat2011


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I'm glad to hear it, RH.   I think some of us will just need a little extra DAA help to do the virus in once and for all and I'm happy you are getting that now.   :)



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
TazKat


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I agree on the incivek. I hope the sovaldi is not doing anything but good things in me.. I can't do muster enough energy to do any more treatments. this one has been tough. do we know what the 19 deaths were from?



__________________

TazKat Genotype 1A null responder x 3 riba & iterferon twice, relapsed from Incivek 2012 with only 12 weeks left to do. stage 4 mild cirrhosis 4/25/2014/ started sovaldi riba & interferon.. finished treatment 7/17/14  results 7/25  cleared..

 

 
HR


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Isiscat2011 wrote:
RH wrote:

 Man, I could've gone without reading the 19 deaths part. But hey, it's the safest HepC drug. I've taken Sof/Led for 29 weeks and have 7 weeks left. 12 weeks the first go around and 24 this time. Thanks for the info 

I have actually had this report for a few weeks and considered not posting it for this reason.  But, it is essentially a positive report on Sovaldi's saftety profile. Additionally, the source of the information appears to be about as reliable and objective as one can find.  It is very difficult to find objective info because most information is presented by a person or group that holds a vested interest in the outcome.  The media is of very little help because they are simply repeating what they are told and also have financial interests at stake. 

What it comes down to is a leap of faith but I prefer to make leaps based on some quantifiable evidence.  There is no question now that Vertex, the manufacturer of Incivek, was not forthright in its representations to the public.  Vertex's stockholders had sued the pharma co. for misrepresenting its clinical trial data even before it was approved.  After approval it received a black box warning for its safety issues and a reprimand from the gov for its misleading advertising campaigns.  While there were many Incivek successes there were also many bad outcomes and even deaths.  I am certainly hoping that Sovaldi is better, but I'd like to see some data that doesn't come from Gilead.  Unfortunately, there is not much of that around yet, and much of what will surface in the months to come is likely to be biased.  

One reason a forum such as this is so important, aside from providing moral support, is to share information.  We can get some idea of safety and efficacy from members here.  Speaking of which, I'm sorry you are still/again on tx.  How are you doing?

 Hey Isiscat

Im doing great, feeling good and all. Got 7 weeks to go and have been UND since week 4. I was UND the first time at week 4 also. Trial place says that some people need 6 months so we will see. The stress will start when I stop meds :) I hope you are doing well. Take care



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14
Isiscat2011


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RH wrote:

 Man, I could've gone without reading the 19 deaths part. But hey, it's the safest HepC drug. I've taken Sof/Led for 29 weeks and have 7 weeks left. 12 weeks the first go around and 24 this time. Thanks for the info 

I have actually had this report for a few weeks and considered not posting it for this reason.  But, it is essentially a positive report on Sovaldi's saftety profile. Additionally, the source of the information appears to be about as reliable and objective as one can find.  It is very difficult to find objective info because most information is presented by a person or group that holds a vested interest in the outcome.  The media is of very little help because they are simply repeating what they are told and also have financial interests at stake. 

What it comes down to is a leap of faith but I prefer to make leaps based on some quantifiable evidence.  There is no question now that Vertex, the manufacturer of Incivek, was not forthright in its representations to the public.  Vertex's stockholders had sued the pharma co. for misrepresenting its clinical trial data even before it was approved.  After approval it received a black box warning for its safety issues and a reprimand from the gov for its misleading advertising campaigns.  While there were many Incivek successes there were also many bad outcomes and even deaths.  I am certainly hoping that Sovaldi is better, but I'd like to see some data that doesn't come from Gilead.  Unfortunately, there is not much of that around yet, and much of what will surface in the months to come is likely to be biased.  

One reason a forum such as this is so important, aside from providing moral support, is to share information.  We can get some idea of safety and efficacy from members here.  Speaking of which, I'm sorry you are still/again on tx.  How are you doing?



__________________

Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
HR


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 Man, I could've gone without reading the 19 deaths part. But hey, it's the safest HepC drug. I've taken Sof/Led for 29 weeks and have 7 weeks left. 12 weeks the first go around and 24 this time. Thanks for the info

 

 



__________________

ION-3 Trial- Sofosbuvir/Ledipasvir 12 weeks.. UND 4 weeks, relapsed 12 week EOT. 

3-4 on Ischank scale

 

Retreat ION-3 Trial- Sofosbuvir /Ledipasvir 24 weeks

GT-1 (1-31-14) Week 1 VL 62 -Week 4,8,12,16,20 UND EOT 7-18-14
jimbob


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I have so much apathy from the other two that memory is not an issue at this point.

Thanx again for the info.

__________________

jimbob: 64 y/o, GT 1A, F1-F2, diagnosed 1996. Since 1970. SOT 3.5 mil VL on 3/10/14 with Sov/Rib/Peg for 12 weeks. Tx naive. UND @ week 4,8,12. EOT 6/2/14.
Isiscat2011


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There is a So. Cal based company that tracks safety info on new drugs.  Its clients are primarily hospitals, docs, insurance providers, and pharma companies. Their website is AdverseEvents.com.  They completed a report about Sovaldi's safety for the period ending on April 25, 2014.  The report is based on 407 adverse event reportings.    

Sovaldi was assigned the highest safety profile of all currently available HepC drugs with a score of 15.36.   (The scoring system goes from 1-100 with 0 being the safest.)  One side effect they noted that is not presently listed by the manufacturer is memory impairment which has been reported at high enough rates to be considered significant.  

There have been 19 Sovaldi related deaths reported but it is undetermined whether those deaths were primarily the result of advanced HepC or the tx. Unfortunately, people who are the sickest still tend to have the hardest time with all hepC meds.  There have been 48 hospitalizations in which patients were treated and then sent home.

The report is a bit hard to access.  Here is a pdf file cite (maybe Tig can do something great with it):

This link will prompt the PDF download:

 DSM-Sovaldi_A_First_Look_at_Post_Approval_Safety_Data.pdf 

 

 



-- Edited by Tig56 on Friday 30th of May 2014 08:41:44 PM

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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
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