New drugs not for treatment naive patients?

[njlady365]

Hello everyone, I hope all is well.

I had a visit with my hepatologist last week and we discussed my biopsy results (see journal for details) and putting off treatments. During our conversation, he metioned the two new drugs that are in trials now, boceprevir & telaprevir. He said that once they are approved, they will NOT be available for treatment-naive patients, but of course there will be "off-label" prescribing, so we'll deal with that when I go back in 18 months and have lost the weight.

I am very much a "lay" person, (and I think I have the brain fog mentioned on this forum, but that may be a side effect of age/motherhood) so a lot of the information I read about the meds, treatments and so on, go over my head and make me cross-eyed.

I just was curious to get any input from you more experienced, knowledgable heppers regarding this. I was very well prepared for this last visit with the doc, but that one tidbit of information just threw me for a loop.

My stats are: 10/01/08 - Quest Labs - HCV RNA Genotype, LIPA - 1A, HEPTIMAX (R) HCV RNA - 157,000 <50 IU/mL, HEPTIMAX (R) HCV RNA - 5.20 <1.70 log IU/mL;  Needle biopsy - Grade 3, Stage 1

Thanks!

[GreatBird]

There is an arm of my boceprevir (tx naive) study that pulls patients off at 28 weeks (remember there is a 4 week pre-load of SOC) if they have cleared by 4 weeks of triple therapy. So, S-P is looking at a shorter tx duration.

[jmjm530]

I once heard that the first approvals would be for tx experienced patients but that doesn't mean that approval for tx naive patients will not follow shortly after. Also, if that indeed is the case, docs may be still able to prescribe it off label. The preceding is simply what I remember from a conversation with a doctor over two years ago, so I suggest anyone personally affected by this simply pick up the "mouse" and/or phone and research it out. And, please report back, of course.

-- Jim

[Willy50]

It seems likely that the drugs will be approved by the FDA but both Boceprevir and Telaprevir are still in phase 3 trials.  IF something happened either good or bad it could affect the value of these drugs when they come to market.  IF they come out with identical SVR rates it will drive pricing.  If there is a large gap between them it will affect pricing.  In the light of that I don't know how anyone could begin to guess what Vertex will price the compound at or what insurance companies will pay.

As mentioned in another thread yesterday Vertex may end up providing comparable cure rates to Boceprevir in half the tx time.  That means 24 weeks vrs 48 weeks for many people.  If so, that means half the SOC drugs.  One might assume there would be savings there even if the TVR were pricey.  (keep in mind also that many slow responders do even longer treatments than 48 weeks)

My opinion is that it will be far cheaper to treat a person once than to make them treat several times, the second time with a PI.  I don't follow where one would think that insurance companies would opt for SOC first and then triple therapy.

We will see what happens but I wouldn't assume the worst for the next 2 years.

best,
Willy

[pjhep80]

thats exactly my fear, i think the drug companis would be more than happy to make tx naive first go thru 6-12 months of current SOC and then when it doenst work make us pay again for triple therapy

more money for the drug companies....

the whole insurance situation in america makes me sick health care should not be a FOR PROFIT industry

they should ban the drug companies from advertising their products ad nauseaum all over the TV and make them spend that money on research and/or lowering the cost of needed medications

[HCA]

There's another factor that has not been mentioned in this thread
.Cost!
Just take telaprevir.
Vertex will have calcilated a pricing structure that will recoup the investment a deliver a profit.
How cost effective it will be for naives to jump straight in on tri-therapy remains to be seen.
Will insurance companies automatically cover for P.I enhanced therapy at the first treat?
I don't know the answers but you may be sure that these are big issues along the way.

[nygirl7]

Just remember also that the odds of clearing as a geno one are getting better all the time.  Advances with the dosages of meds in addition to testing to determine the proper length of treatment have helped a lot.

With addon drugs comes the chance of more side effects.  While they can decrease the time on treatment that is something that is also a risk.

As a stage 1 you certainly appear to have time to wait.  Make sure you do get further biopsy testing in teh future and then do what is needed.

Good luck

[fretboard]

Good answer, I hope you're right with what you think.  I know that I've heard it elsewhere that the PI's would be only for relapsers or non-responders at first, and I really hope that's not the case.  With all the big pharma competition that there is, I'm sure once they are approved other countries will be making copycat drugs.  Like in CSI you see those mass spectrometers, actually those are real medical devices.  Of course I don't know how well they work as far as giving the breakdown of chemicals in certain compounds, but they are used in labs all the time.  Oh I know the CSI stuff is just for tv.lol


fret

[Willy50]

It's late and I am just turning in but here is what I think I understand about it.
Let me see if I can define it a little bit better for you.

Telaprevir and Boceprevir are both in Phase 3 trials.  Telaprevir will probably finish and be approved first; before boceprevir.  That is about 2 years away.  The actual trial will be over in less than 18 months; at that point it is up to the FDA.   Lets say it takes 6 months to decide; that equals 2 years+/-.  Boceprevir could be approved soon after.
The deal is..... they will be approved for all types of TX; both for naives and for past TX failures.  This is what I believe will happen.  If so you or your doctor could chose either one.  You'll have trial data which will aid in your decision.

I believe that both drugs will be approved and for both naives and treatment experienced patients.  This of course assumes there will be no problems.

One other possible course of action which exists..... with much less chance is that the FDA could be asked to approve Telaprevir for early approval based on using Prove 3 as a registration run.  If the FDA were to approve it, the people who could treat would be limited to ONLY past treatment failures.  There could also be some type of qualification such as they must have certain advanced staging or other staging related complications that could necessitate treating very soon before the drug was approved (in about 2 years).

No one has a crystal ball so we don't know how the trials will pan out or what the FDA will decide to do.  I just wanted to break it down a little for you so that you can better understand what I believe will happen, what could happen.  It could be that this is what the Dr. was trying to explain.  

So far as the proposition that after approval the drugs would ONLY be available for past TX failures..... I think that is utterly false.  I've never heard that addressed by anyone, anywhere.  We will see what happens of course but my guess is that the idea is mistaken or incorrectly communicated.

best,
willy

[GreatBird]

Why would they be doing trials with tx naive patients?

[AKHepper]

that doesn't make any sense to me, at all

[fretboard]

"boceprevir & telaprevir. He said that once they are approved, they will NOT be available for treatment-naive patients"

Quite a number of doctors believe this statement to be true, but I don't see how they can say that unless they have a direct hand in the fda approval process.  By allowing only relapsers or non-responders to use these drugs that will put alot of infected heppers thru SOC only to tx again with one of these PI's.  Could be true, but it doesn't make sense to me.  Of course not alot is known about these PI's but surely they have already studied SVR's for at least 5 or so years.  anyone?