When will new treatment be available?

[soldieradvocate]

Patient just diagnosed with Hep C Genotype 1. Has joint aches, body aches, extreme fatigue, insomnia, depression, feels like feet are swollen and painful. Doctor said these symptoms aren't from diagnosis and dismissed his complaints. He doesn't know what to believe. He is having ultrasound on liver next week. He is trying to decide if he should wait for the new treatment or do traditional. Is there any news about when the new treatment will be available? He is so discouraged and doesn't know what he is going to be able to manage. Is his likely to continue to feel badly? What can he do for symptoms?

[soldieradvocate]

Armed with the information you have given me, I met with his hepatologist today to get questions answered in order to make an informed decision. My "awareness" helped me hone in on what I needed to know. It became apparent, waiting for the new protocols is the best choice for him. The provider was very forthcoming with information and pleased that I am taking such an active role in his treatment. Could not have done it without this forum. Feel so relieved. Now just waiting for the new medications to be released. Thanks!

[dontworry_behappy1]

There is a list of treatments in trials and their current status at......

pipelinereport.org.

2013 EASL Update

[Dee1956]

Here is some information about the new treatments, both were scheduled to be reviewed by the FDA by the end of this year.  Not sure how the shut down affected them.
http://blogs.jwatch.org/hiv-id-observations/index.php/both-simeprevir-and-sofosbuvir-likely-approved-by-2014-clinicalethicalpharmacoeconomic-dilemmas-loom/2013/06/11/

[orphanedhawk]

I admit to not fully reading all the replies so forgive me if I'm being repetitive.

The first thing anyone needs to know when considering treatment is how much, if any liver damage, they have. If there is none or little, than waiting for better treatment options or doing a clinical trial are good options.

As far as when these new meds will become available, nobody can see into the future ( including doctors) and all we can do is guess when the FDA will approve anything. My bet would be within the next couple of years but that is nothing more than a guess.

Good luck.

[Willy50]

http://finance.yahoo.com/news/fda-issues-positive-review-gileads-125506209.html
"FDA said adding Gilead's sofosbuvir to the standard drug cocktail cured 90 percent of patients with the most common form of the virus in just 12 weeks.

The agency's reviewers state that the "shorter 12-week duration translates into a better tolerated side effect profile," adding that "no major safety issues associated with sofosbuvir have been identified to date."

Foster City, Calif.-based Gilead Sciences is one of a half-dozen drugmakers working to develop more effective treatments for hepatitis C, though many analysts predict the company's drug will eventually outperform its competitors. The FDA is expected to make a decision on the drug by Dec. 8. "
=======================
compare to;

http://finance.yahoo.com/news/fda-j-j-hepatitis-c-132122807.html

....."For most of the last 20 years, the standard treatment for hepatitis C involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Then in 2011, the FDA approved two new drugs from Merck and Vertex Pharmaceuticals that raised the cure rate to about 65 and 75 percent, respectively, when combined with the older treatments.
J&J's new drug appears to raise the level of effectiveness again: simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA. "

willy

[Dee1956]

You advice was very good.  I appreciate you sharing

[Dee1956]

Hi I am really sorry, I could not see the forest for the trees :)

If his biopsy is normal, I would wait for the new drugs.  I have heard the time is shorter and the side effects not as harsh.

Here is a very long thread about the newer tx.  I hope some of this may help

http://www.medhelp.org/posts/Hepatitis-C/Starting-Sofosbuvir-GS-5885/show/1875802

[Dee1956]

Congratulations! Very happy for you. Sorry just saw your post.
I know how hard tx is and wanted to congratulate you
Dee

[Dee1956]

Hello, you have received excellent advice from every one.  As you can see everyone cares very much and wants to help.

The first thing he needs to do is to have a biopsy.  He can't really decide what to do until he knows how much damage he has.

When I was diagnosed, my blood work did not indicate how damaged my liver was.
So...I went from advice of "take your time, it moves slow" to "Oh my, you must treat asap"

Maybe you could print this out to give you your friend, or just take the important parts to give him.

You are a very good friend.  I wish I had someone like you when I was diagnosed.
I felt very alone and isolated.  In reality I was, no one I knew understood  anything about hep c til Natalie Cole was diagnosed they had not heard of it.  Even then it was a lot of misinformation.  Don't even get me started on Pamela Anderson :)


Take care
Hang in there

[dontworry_behappy1]

Your Welcome!  Worked for me too.

[Juliettegirl1980]

Thank you for this post.

[pooh55811]

"I actually think we agree on many points."
-----------------------------------------------------

Sorry, but I do not agree with you on much of anything. You are quite wrong on that point. You can draw conclusions for yourself, but please have the courtesy to refrain from drawing conclusions for me.

[Willy50]

Maybe it seemed scarey, but all I posted were possible outcomes.

I feel no differently, that my words were used to portray something differently.

The thrust of what I said was get more information, choose carefully, the patient does not have enough info to make an informed decision, based on what I have read.

We are all different people, our thought processes are different.
If there are counter indications, drug warnings.....it's a medical forum......
expect that these will be discussed, and that both sides will be discussed, not only the benefits.

Regarding my friend who suffered from floroquinalone toxicity, only about 1/20 had the drugs prescribed as recommended by the FDA.  Doctors at times do a dismal job of staying up on drugs that they prescribe.  So often in antibiotics they are prescribed incorrectly.
If my attempt to warn you was taken as a scare tactic, please accept my apology.  Someone else might have misinterpreted it quite differently.

Regarding the possible negative sides I have had..... I do not know if there will be a black box warning for any new drugs that are approved, but I heard (via gilead) that only less than 1% dropped out of trials.  I believe that some of the triple therapy courses of treatment have had about +20%  discontinuation.

In spite of my damage.....and I am nearly the only one I am aware of...... I can tell you that the sides and the damage may have been threshold pre-existing, or caused by another issue.  Whatever they are, they are not that bad.....

.........because today I ran in a local 5k race, in spite of the fact I have not completely recovered from my treatment.

I did OK.  In the actual race I beat last years time by about 20-30 seconds.

Last year my best time would have placed me in the top 25% of the finishers, and only about 30 people were older than me out of 1000+ 5K race participants.  I'll have my hard data trial results tomorrow, but I would guess that I'm still in the approximate top 25%, that I'm very close to my best running time from last year, that I beat my race time of last year and twice I have come within 15 seconds of my fastest time from last year.

I think that is pretty impressive for a guy who had his HGB drop about 33% (17.3 to mid 11.'s in July).  My last score was 14.5 about 5 weeks ago.  You'll have to admit, most triple therapy people are not doing this 40 days after ending TX.  : )

And so I assert; yeah, I got hurt...... but terribly.  : )

I was writing this after I got back from the race..... and I thought I would see how I did so I went downtown to find out.

I don't have all the stats but I came in second in my age demographic.
I was 105th guy to cross the finish line.  Last year there were about 500+ guys who ran.

I think that speaks a little bit about how gentle this treatment is compared to current triple therapy.

Yes.....I ended TX September 10 and finished second in my age demographic this year, October 20.  (hahahhahaahah I'm 60 this year running in 60-64 years, that helps.  : ) )

I have my reasons for believing what I believe, others have their reasons.  
I actually think we agree on many points but cannot bring ourselves to admit it. : )

~willy

[pooh55811]

"Neither of you yet know the patients staging, IL-28 genotype, the patients sub-genotype, (1a or 1b) and yet you seem to suggest it is imperative they treat now or face cirrhosis. "
--------------------------------------
Willy, you need to carefully and thoroughly re-read my posts and quite (falsely) stating that I said things I never said. I never said he needs to treat now irregardless of medical problems, psychiatric problems, autoimmune problems, or liver fibrosis stage.  What I said was this:

*He should see a competent Gastroenterologist or Hepatologist (liver doctor) who is experienced and knowledgeable in treating Hepatitis C.
*He should also get tested for his Genotype.
*He should also have a liver biopsy to determine what his liver fibrosis stage is. Once he knows what his liver fibrosis stage is, *****then he can better decide how urgent it is to treat.
*He appears to have a lot of extrahepatic manifestations of Hepatitis C so, ***** if there are no medical reasons for him not to treat,***** treating sooner rather than later is most likely a good idea.
Then I said:
*If he is Genotype 1, the current treatment is Interferon, Ribavirin, and a Protease Inhibitor.
*However, there are some new drugs that are awaiting FDA approval. They may be available early next year.
*The new drugs for Genotype 1 will still include Interferon and Ribavirin, and they will also include Sofosbuvir.
*In addition, there are other new drugs that are in the pipeline and may be available in the near future.

Then I said:
*If the symptoms he is having are extrahepatic manifestions, then some of them, or possibly all of them, may disappear after he treats and gets rid of his Hepatitis C. He needs to treat and get rid of the Hepatitis C in order to improve extrahepatic manifestation symptoms.
*He should be seen by a psychiatrist who can evaluate and treat his depression.
*it may be beneficial to be seen and evaluated by a Rheumatologist for his joint and body aches and his fatigue and feet pain. Hepatitis C can trigger autoimmune diseases and other diseases which can cause his symptoms.
*The feet swelling can be caused by many things so he should have that evaluated as well.  

*Then I gave the OP the correct information about how long treatment will be depending on various factors.
*Then I reiterated the importance of knowing the liver fibrosis stage.
*Then I again stated how important it is to know liver fibrosis stage so he will know how urgent it is to treat.  


In a later post you said there may be medical reasons not to treat. Well, my post covered that. Again, re-read my posts. I covered all of your concerns about medical problems and psychiatric problems.

Another thing, just because someone has a history of depression does not mean they cannot treat. I have a long history of endogenous depression, including one episode in 2011. I had just gone on antidepressants in May of 2011. That did not stop me from treating. I might add, that I had ZERO mental problems, depression problems, anger problems, etc. while I was on treatment. I sailed through treatment mentally and emotionally exceptionally stable.


Your said: "MY little story was to illustrate; THINK, and then act. Don't be impulsive. "

My posts absolutely never suggested being impulsive. They suggested getting thoroughly examined (for everything), evaluated, tested, and then making decisions based on all of the information to do so. Your post gave an analogy that has nothing to do with reality and, in my opinion, was used as a scare tactic.  

This forum is here in order to try to give people facts and information and to help them with their diagnosis of Hep C and Hep C treatment. Trying to scare people away from treating is not, in my opinion, very helpful.

As another example of this scare tactic technique, in another thread, when I said I had started on Plaquenil, you immediately dug up and posted the 1 worst possible side effect that Plaquenil can cause (even though it is extremely rare). Well, that might have scared some people from taking a drug that can be immensely helpful to them. Of course, it did not scare me, but then, I am a medical person and I have a distinct advantage over many who are not. In addition, I have had some serious Hepatitis C related health problems/extrahepatic manifestations in my life and I know that some drugs can make the difference between living and dying. Choosing to live is a no brainer for me.

[soldieradvocate]

I appreciate everyone's time and energy around this issue. I will continue to reread your posts to try to assimilate the implications. All I really know is he tested positive for Hep C, his ultrasound was deemed "normal", he is fatigued, achy and his feet continue to hurt. The doctor who dismissed his symptoms was his primary care doctor but he is now under the care of a hepatologist who offered treatment now or later. He mentioned something about the doctor checking viral levels at 4 weeks to see if clear so that is in line with what you have said. He already has tintinitus from being hit by an RPG, PTSD, insomnia and anxiety so it is hard to separate the symptoms from the causes. The analogy of throwing gasoline onto a fire is powerful. He is going to hear that as soon as he wakes up. Hope he listens at least to that. Again, thanks.

[can-do-man]

Willy this is from your own words. Treatment was stopped on these new drugs. So how can you say there will not be any bad effects or FDA warning?
-------------------------------------

"Essentially as the trial progressed the neuropathy increased, but I was working so much I really didn't notice it for what it was.  I mentioned it a few times, but I thought it could be due to the work, the long long days, the physical nature of my work; whatever, it kind of escaped my notice.

My feet were more sensitive and might keep me from sleeping..... but I thought it was maybe the riba just keeping me awake.

About mid point through my riba was cut in half; 1200 to 600 mg.
And things improved as I became less anemic.
I started complaining more about the issue, and I could also dismiss it less.

At about week 19 I work up with tinnitus, something I could not dismiss or think; this is something different than what it is.  I also thought, I seem to possibly have two nerve related issues going on right now.

I asked about both.... in my week 20 blood draw and I thought made it very clear I was worried that these were both TX related and I wanted to know that they would reverse.  I got no answer....
over the weekend the neuropathy clearly was working up my legs.

I asked a few doctor friends/clients who seemed to think I was correct, both in my diagnosis if ailments and the cause.

I stopped the drugs Sept 10.  
I still have both issues."

http://www.medhelp.org/posts/Hepatitis-C/Starting-Sofosbuvir-GS-5885/show/1875802#post_9564980

[can-do-man]

"That's the option?  Treat now or face cirrhosis?"

Willy please do not put words in my mouth, I am cirrhotic and don't want anyone to risk that... This is what I said.... "Your friends does not want to become cirrhotic like I am"
-------------------------------------------
"2 New drugs are about to be FDA approved that will not have black box warnings accompanying them (such as Incivek and Victrellis) "

Nobody, not even you know what warning the FDA might end up putting on these new drugs
-------------------------------------------
"Neither of you yet know the patients staging, IL-28 genotype, the patients sub-genotype, (1a or 1b) and yet you seem to suggest it is imperative they treat now or face cirrhosis.'

Nor do you,
---------------------------------------------

As for interferon and Ribavirin that's all some have talked about, just how bad they are. I'm sorry but if something is that bad or terrible then any is to much whether it's for 3 or 4 months or 6 or 7 months. You can't have it all ways here......... If somebody shots someone once or twice, they still have been shot...Correct?

[Willy50]

One more before turning in

I wanted to address the patients sides;
"Patient just diagnosed with Hep C Genotype 1. Has joint aches, body aches, extreme fatigue, insomnia, depression, feels like feet are swollen and painful. Doctor said these symptoms aren't from diagnosis and dismissed his complaints."


Pooh and I agreed on many of these things, in her post and my subsequent first post which followed hers
(Pooh wrote)
"He appears to have a lot of extrahepatic manifestations of Hepatitis C so, if there are no medical reasons for him not to treat, treating sooner rather than later is most likely a good idea. "

And I agree with that notion too, particularly when the patient also is interested in treating sooner...... but.......

Are the medical reasons for a patient to wait?

Well, here are a few;

Depression...... interferon is counter indicated for depression, it at minimum adds a whole new level to consider, particularly longer treatments with IFN.

Some of the symptoms *could* be RA or auto-immune issues, which could get worse with treatment, or which could be triggered into full blown issues with treatment or mere exposure to IFN

" feels like feet are swollen and painful."  Hmmmmmm if the liver is "normal", whatever that means, I am less concerned about advanced staging issues,.......but he could be suffering from neuropathy due to inflammation.  What is going to happen to that early neuropathy when you put the patient on victrellis, which is known for inducing even deeper anemia than SOC?
My feet were not that bad, but I still have neuropathy in my feet, but it was up past my knees when I stopped the riba, and I was on half dose at week 12.5 that would have put me barely into the victrellis treatment when I dropped.  So what effect will an anemia inducing TX have on the current foot issues?

One other final issue....is the doctor..... the one who said none of these issues has to do with hep c, the one who said the staging was "normal" instead of providing a stage, the one who said treat now.  Hey.... the doctor may be fine..... since this is all second or third hand information, but..... if I was treating and I had those many issues, counter-indications..... I would want the best doctor.

Flip side...... if your doctor isn't as great as some world class..... I would want a more simple course of medicine with fewer sides, because all doctors just are not equal.

This whole thread is just for information.  You can see where I am coming from.  It's fine with me if others disagree.  It's fine with me whatever the patient chooses.  If the reader learns something, that's what it's all about.

best,
Willy

[Willy50]

That's the option?  Treat now or face cirrhosis?

2 New drugs are about to be FDA approved that will not have black box warnings accompanying them (such as Incivek and Victrellis)

This isn't really about interferon, since in waiting for the most recently approved drugs will end up involving interferon.  
Where the issue of interferon comes to play is that if you use a less efficacious drug, the response could be less or slower, thereby meaning a longer treatment risk in a percentage of those who treat. (and thereby greater exposure to IFN.)

Neither of you yet know the patients staging, IL-28 genotype, the patients sub-genotype, (1a or 1b) and yet you seem to suggest it is imperative they treat now or face cirrhosis.

Is that really going to happen before sofosbuvir is approved in December? Or Simeprevir is also to likely to be approved in December, and Daclatasvir very soon as well.
We will soon see what happens with writing off label soon after that.  From what I have read, some doctors are ready to try it.  We will soon see if providers will as well.

MY little story was to illustrate; THINK, and then act.
Don't be impulsive.

Gilead has it's meeting with the FDA the 25th of this month......
Gilead has its quarterly financial review the the 29th of October
Gilead will attend and have presentations in the 1st week of November at AASLD.

Information may be revealed at any one of these meetings which may be very useful to the person who is going to soon treat.  If either of you think they should treat right now with victrellis without even knowing the patients staging, sub-genotype, or il-28 genotype, just say so. : )  

I suggested they get more information.

best,
willy

willy

[can-do-man]

Why the scare tactics? And from someone who never even treated before. I also treated, twice as a matter of fact and now SVR. Your friends does not want to become cirrhotic like I am....... Good luck to him

[pooh55811]

I just noticed a typo in my previous post:

My post said: "With Telaprevir, if the person is Undetectable at week 4 then the person treats for 24 weeks. If the person is Detectable at week 8, then the person treats for 48 weeks. Most people ckear early and are able to treat for the shorter period of time. "

It should have said: With Telaprevir, if the person is Undetectable at week 4 then the person treats for 24 weeks. If the person is Detectable at "week 4," then the person treats for 48 weeks. Most people ckear early and are able to treat for the shorter period of time. "

Don't let any of the forum posters, especially posters who have never treated with interferon, scare you or your friend away from doing treatment. Treatment is no picnic but it is generally very doable.

I did 48 weeks of treatment with Interferon, Ribavirin, and Incivek. Like I said, it was no picnic, but in ABSOLUTELY NO WAY did it remotely compare to hitchhiking in the middle of the night in winter, below freezing to a car which had been left 6 hours away by driving. That scenario does not even remotely resemble treatment and, in my opinion, there is no legitimate reason to scare people away from treatment.

I attained SVR (cure) but, if I had not attained SVR, I would treat again in a heartbeat because I know that Hepatitis C can cause major health problems and it can kill.

[Dee1956]

You have been given really the best advice by the people above.

I really like Willy's, it is well thought out and helpful as far as sharing what tx might be like.  Everyone's advice is very good.

I just wanted to add that your friend drinking on top of HCV is like throwing gas on a fire. It can make the HCV damage worse.
At least that was the analogy I was given.

I never drank after hearing that.

I hope you can print this out to help you friend.  You are a good friend to go looking for help. Everyone needs a friend while going through this, the virus is very isolating.
Dee

[pooh55811]

The current recommended treatment for Genotype 1 is Interferon, Ribavirin, and a Protease Inhibitor (either Boceprevir or Telaprevir). The treatment is response guided. That means that the length of treatment depends on when a person becomes Undetectable. If the person is on Boceprevir, and the person is Undetectable at week 8, then the person treats for 28 weeks. If the person is still Detectable at 8 weeks, then the person treats for 48 weeks. With Telaprevir, if the person is Undetectable at week 4 then the person treats for 24 weeks. If the person is Detectable at week 8, then the person treats for 48 weeks. Most people ckear early and are able to treat for the shorter period of time.

There are other factors that play into the length of treatment. If the person has Cirrhosis, they treat for 48 weeks. Previous response also determines length of treatment.

Your friend has never treated before so that is not a factor in his situation.

In one of your posts you said your friend was having an Ultrasound. Then today you said the Biopsy results were normal. Are you sure he had a biopsy already, or did you mean the Ultrasound was normal.

I ask because it is important to know his stage of fibrosis. The Ultrasound may show normal even if he has Stage 1, 2 or 3 liver fibrosis. The liver biopsy will give a more accurate determination of his actual liver fibrosis stage and how urgent it is to treat soon.

My Ultrasound was normal but my liver biopsy was Stage 2. I was diagnosed in July 2011. I chose to treat immediately and not wait. I started treatment in Se[pt. 2011 and I treated with Telaprevir, Interferon, and Ribavirin. I am now cured. I am exceptionally happy that I treated right away.

I had a lot of extrahepatic manifestations prior to treatment. I was quite symptomatic including having severe fatigue. All of that fatigue is totally gone and I feel better than I have in 20 years.

Your friend is symptomatic so he may wish to treat and get rid of the Hep C before he develops any more extrahepatic manifestations. That may be why he is so anxious to treat.

If he has not had a liver biopsy, he does need one so he know how urgent it is to treat and how long he should treat.

[Willy50]

Sorry...I didn't make it clear that my car had been left 6 hours away by driving....and i would be trying to hitchhike in the middle of the night in winter, below freezing..... really ill advised.

Your friend my be getting fine advice. I really don't know his liver damage staging, don't know if the specialist is a hepatologist..... I kind of knew/assumed that "Boceprevir" was being offered.... It's called Victrellis now.

A blood test can show what il-28 genotype your friend is...... if he is a TT type...... his odds of success w/ victrellis will be diminished.  I also do not see if he is genotype 1a or a 1b.  If you factor in a few things like that....or staging.....which I do not know....... other than "normal"..... his chances could be good or bad.  I don't know since there isn't information.

I DO know that either of the new drugs being offered quite soon would likely have a better chance at success and could mean the difference between success or failure, a longer treatment or a shorter treatment, and more sides of less sides.  In the case of a drug treatment which can cause anemia and compromise some peoples ability to perform their jobs..... there is a huge difference between having to treat 6 months versus 12 months........

I am not suggesting he do one or the other.....
I'm just suggesting that he better knows the risks and rewards of each type of treatment, and the game plan if things don't go as planned.

I believe that Sofosbuvir (to be used with IFN and RBV) will be approved in early December.... but I don't know when the VA will start treating with it.

FWIW..... I just finished treating in a trial with the newest form of treatment.
I'm 60, a stage 2, a geno 1a (which is harder to treat than 1b), and a C/T il-28 genotype (which is also a middle negative success predictor-non-CC).
I went from a viral load of 3 million ml/iu to below quantification in my first week- and that's about the norm.

This new form of TX will be available in just a little over a year, probably no longer than early 2015. I recently read that the scuttlebutt was approval late 2014.  My trial arm pretty much was the longest running arm and most of us finished dosing this month...... in 3 and 6 months post TX the data is all collected, so data may be provided to the FDA in advance of that, but the 6 month PCRs will be done 3 months into 2014, the 3 month PCR's are actually now recognized as sufficient; they would be done the first of the year......
Approval takes about 6 months.  
We will *see* when it gets approved and may hear more at the end of this month at a quarterly Gilead meeting.

There will also be more data presented on the new therapies in very early November at the AASLD liver conference.

I'm just saying....picking a treatment is closer to like buying a house, than buying a set of tires.

Good luck in whatever he decides, there is risk in waiting and risk in treating.  My point is for him to understand better before he chooses.

Understand also.....I am very atypical and waited 10 years to treat.  I passed up a comparable treatment to what he is now being offered 5 years ago.  So take my advice with a grain of salt.

best,
willy