Aa
Aa
A
A
A
Close
Avatar universal

Treatment for Hep C will disqualify you from clinical trials for new Hep C drugs

Why get treated for Hep C using ribavirin and interferon when it will disqualify you from clinical trials for new Hep C drugs? Some trials will accept non-responders to PEGYLATED interferon but will NOT non-responders to nonpegylated interferon. Would it be advisable, if one is a non-responder to non-pegylated interferon, to undergo treatment with the pegylated variety just so one can fail that treatment and become eligible for clinical trials that require non-response to pegylated interferon? There are a few clinical trial that accept non-responders to pegylated, but here are NO clinical trilas that are open to non-responders to non-pegylated. Please note that SVR for Genotype 1 using ribavirin and peg-interferon are extremely low (less than 40%). The only effective drugs are in clinical trials, and likely will not be accessible to you for 10 years. Telaprivir is going on 10 years since it was first discovered, and it is still not available to the public.
Best Answer
Avatar universal
Morningstar is initiating our issuer credit rating for Vertex Pharmaceuticals VRTX at B, reflecting our view that the firm is a highly uncertain credit despite its potentially groundbreaking hepatitis C therapy. As a result of several efficacy and convenience benefits seen in clinical trials, we believe Vertex's hepatitis C drug telaprevir will probably be approved by the Food and Drug Administration by the end of 2011. Also, trial data look so promising that if demand meets our expectations, Vertex could have a blockbuster drug on its hands, with more than $1 billion in sales within a couple of years of launch. This potential appears to be recognized by the equity markets already, and the firm currently enjoys a market capitalization around $7 billion. However, if the drug fails, Vertex shares would fall precipitously, and we've reflected this potential in our credit rating. If the drug succeeds, we'd consider upgrading our credit rating.
Given current market optimism, we wouldn't be surprised to see Vertex continue tapping the equity or credit markets to bolster its financial position before officially hearing back from regulators, especially given its expected cash needs during the next few years. We estimate that Vertex holds about $1.3 billion in cash and more than $500 million in debt. However, the company is still bleeding cash, as it has no other products on the market yet. Also, it intends to go it alone on U.S. marketing. While that could prove to be a very lucrative decision if the drug is a hit, the up-front salesforce investment will be large, and the risks that Vertex, a novice in commercialization, doesn't manage the launch properly are relatively large. From a credit perspective, we think Vertex may be well served to issue some additional equity to build its cash cushion for these efforts.

http://quicktake.morningstar.com/Stocknet/san.aspx?id=353863
25 Responses
Sort by: Helpful Oldest Newest
Avatar universal
Thank you, I appreciate you sharing that info.   Yep, you've got a full time job and then some.  I limped to the finish line on SOC and I can't not work.  Need the money and the insurance.  I have a lot of responsibility at home too and the side effects from Infergen worry me.  My whites tanked big time with SOC and I hated the effects of Neupogen about as much as the interferon.  I'm mulling the options over in my mind, don't need to make any decisions right now but regardless my head has to be right.  Actually, if biopsy shows I need to treat again sooner than later I'll see how I respond after 6-8 weeks with Infergen and a higher dose of ribavirin.  If I'm not making good progress I'll stop.  

Trinity
Helpful - 0
Avatar universal
4 months ago my doc returned from some kind of conference in CA on hep C and he was still pretty disappointed with the timelines. I also read those articles, since 2006, and every year the promise there is "another 12-18 months"... So, realistically, I tend to agree with my doc's estimate, nevertheless - it would be awesome if he is wrong. I personally chose not to wait but try to treat as soon as I could for 3 reasons.
First - the longer you have the virus, the harder it is to get rid of. And I suspect I was infected as a newborn in 1976.
Second, HCV is so unpredictable, I've known people who seemed to be able to manage their condition without treatment successfully for a long time and then their health detiorated drammatically within a very short period of time all of a sudden. I didn't want to take chances. I guess, one have to choose which risks he wants to choose - risks of sx or risks of losing your health too soon, too fast.
Third, on a personal level, I have long-term goals, my life is about to get crazy busy on a professional level. So, I chose to undergo tx now, and not to risk my career in case if sx are too harsh.
These post-tx month before you get your SVR or non-SVR verdict are pretty intense :) I am still waiting to know if infergen worked for me. 5 more months. I will post my results then.
Helpful - 0
Avatar universal
I am a stay-at-home mom now, so, no, I was not able to work... unless taking care of too super active 2 year olds (my twins) while my husband was deployed to Iraq doesn't count :) I would say my kids keep me very busy for 12-14 hours a day. And it's not like we sit around and relax, we are really active. I'd say when I did work and didn't have kids, my life was a lot more relaxing :)
I do understand that my "easy" tx on infergen was rather an exception than a rule. My hemoglobin dropped to 8 by the 4th months of being on this drug and only now is slowly getting back up. Other blood values were pretty scary. I remember when my regular PCM saw me she couldn't believe at first that I could make it myself to the office, as my blood values were so low. I lost 30 lbs during treatment. However, my liver doc was against using procrit, he simply managed me within the 8-9 hemoglobin range with riba reduction - my weight allowed it, as even 800 of riba a day was my max dosage as per weight, and I started tx with 1200 daily. So no matter what, even with reduction I was at pretty high riba levels. During last 2 months of tx I experienced some brain fog and heart murmurs - all of that is gone now, 1 month post tx. I am waiting for my PCM appointment to have my heart checked out now, just in case, as some heart conditions run in my family. Other than that - I definitely expected infergen tx to be much harsher than it was.
Helpful - 0
Avatar universal
Tired, not typing well

Correction:  at this point I don't feel like I've got a whole to to lose.
Helpful - 0
Avatar universal
"Will we still be alive to have it? Or be too old to have it?"

That's based on degree of liver damage.  I'm a stage a late state 3 and I did 72 wks of SOC to no avail except maybe slowing down the fibrosis.  It wouldn't be prudent for me to treat with SOC again and except different results.  You've never treated with pegylated interferon so you really don't know how you'll respond.  If it looks like the FDA is dragging their feet approving the PI's by next year and biopsy shows fibrosis is advancing I will consider Infergen.  My job is very demanding to and quite honestly I don't how the hell I'm going to do it but I'll do it even with a 25 percent chance of SVR.  Of course I want better odds but I also don't want to transition over to full blown cirrhosis.  This whole hepc thing is friggin balancing act, a game of chance and at this point I don't feel like I've got whole to loose.  Maybe an SVR or only stopping the fibrosis from advancing, to me either way it's a win win.

Trinity
Helpful - 0
Avatar universal
Were you actually told that your treatment with non-pegylated interferon disqualifies you or is it that you just don't see any trials that mention it specifically?
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.