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?

[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