Vertex Beats Merck in Hep C Battle

Vertex Beats Merck in Hep C Battle
By Adam Feuerstein 08/04/10 - 10:02 AM EDT

WHITEHOUSE STATION, NJ (TheStreet) -- Vertex Pharmaceuticals(VRTX) defeats Merck(MRK) in the first battle of the hepatitis C drug war.


Merck said Wednesday that between 63% and 66% of hepatitis C patients never treated before achieved a viral cure after receiving the company's experimental drug boceprevir plus the standard of care, according to top-line results from a phase III study known as SPRINT-2.

These boceprevir cure rates were significantly higher than the 38% of hepatitis C patients cured using standard of care alone. On these data, Merck said it will seek approval of boceprevir in the U.S. and Europe by the end of the year.

If approved, boceprevir may have a tough time competing against Vertex's hepatitis C drug telaprevir, which will also be filed for approval later this year. Results from a similar Vertex study in so-called "treatment-naïve" hepatitis C patients released in May showed that telaprevir plus the standard of care achieved a cure rate of 75%.

Moreover, patients can be cured of the hepatitis C virus using Vertex's telaprevir in as little as 24 weeks, while the shortest treatment duration with Merck's boceprevir is 28 weeks.

It's important to note that boceprevir and telaprevir have never been matched head to head in a single study, but that doesn't stop analysts and investors from comparing the efficacy and safety of the two drugs.

"The [boceprevir] data look ok from an efficacy and safety standpoint but we believe that they are inferior to what telaprevir has demonstrated thus far," wrote ISI Group biotech analyst Mark Schoenebaum in an email to clients soon after Wednesday's announcement.

In early trading, Vertex shares were up 5% to $37.04. Merck was essentially flat at $34.85.

Merck Wednesday also released data from a second phase III study known as RESPOND-2 which tested boceprevir in patients who previously failed to respond to treatment with standard of care.

In this study, cure rates for boceprevir patients (who also received standard of care therapy) ranged from 59% to 66%. By comparison, patients who were re-treated with standard of care achieved cure rates of 21%.

Vertex is running a similar study of telaprevir in treatment-experience hepatitis C patients, with results expected in September.

Full data presentations for both telaprevir and boceprevir will be made at the American Association for the Liver Disease (AASLD) annual meeting in early November.

-- Reported by Adam Feuerstein in Boston.

http://www.thestreet.com/story/10826842/2/vertex-beats-merck-in-hep-c-battle.html

[frijole]

Mike, I had read that and I am not sure I agree with it, having seen so much success, especially with re-treaters and Boceprevir.  It definitely looks like Vertex is going to beat BOC to the market, but I am just not so sure it is a more successul treatment.

Their stock did go up over $2 today, but  has come down some.  I would personally like to see a head-to-head study.

frijole  

[nygirl7]

You know that is funny because I too keep seeing the people we know respond so positively to Boce it seems to me that it is very skewed as a press release.  I can't remember anyone who did not respond positively to the Boce can anybody?

[jusjames]

i dont think it will be one drug or the other, they could both exist, or boc might win if its cheaper , success / cost ratio and all that

[mikesimon]

I cannot verify the information. I really don't know the statistics. And I've been burned before with the street BS so I know how this stuff works. I just saw it and thought it might be of interest to some members.

Mike

[pcds]

I agree, with the article.  Telaprevir will be out first, I think they will have a higher SVR rate, although it will be close.  The first out will be the leader, with so many people waiting in the wings for tx.  Boc has more anemia sx and Telapre has more rash sx.  For those of use who have tx before, like me, and had serious anemia issues, Telaprevir might be a better choice.  I plan to have a serious discussion with my doc about being ready to treat with some serious steriods if that horrible telaprevir rash hits me,  

[jusjames]

can you take steriods with hep c though? i heard you couldnt , topicaly it would be fine but i am not sure about oral use

[pcds]

I think if it's really, really bad, injectable steriods or solumedrol.  Not great with hep c, not really sure about it.  I will certainly discuss with mayo doc when I see him in Oct.  The rash is the biggest reason people discontinue tx with telaprevir.  When the meds are released I'm sure they will have dos and don'ts.  The main reason I'm going to Mayo is they will be most up to date on tx sx.  I have discovered from all the people on this site, the SOC is well SOC.  It's all about how you tx the sx to get you through tx.
So with new drugs there will be a new SOC and there won't be alot of experience with how to deal with the sx of this rash.  I think they already have their box of helper meds for anemia.  But this rash scares me.  I had a not so serious rash from the riba, and it drove me nuts.  If it's much worse then that, and it can be, I will need serious help.

So if you are a RVR with current SOC that's good news, because along with the new success of upcoming meds, there is an additional price of increased sx.
Judy

[mikesimon]

If you're talking about intravenous Solumedrol injections I don't think you'll be prescribed that. Heavy doses of steroids have been implicated in a few of the late relapse cases I've seen. I had a few of those "bolus injections" of a gram of solumedrol intravenously in a time-span of about 35 minutes and that isn't the ideal drug when you're trying to stimulate the immune system and eradicate a virus. It's shocking to say the least. I was in acute organ rejection and it fixed that up but was probably a factor in my developing diabetes.
I seriously doubt you'll be getting that type of drug unless you are in very serious trouble.

Mike

[spectda]

Steroids are immunosuppressant? it seems completely adverse to the immune system boost that is caused by taking interferon. It makes sense that they could be implicated in relapse.

[nygirl7]

Hell even prednisone is off limits on treatment unless the situation is totally dire.....

I think tele will obviously be out first barring anything amazingly bad but obviously it won't be for anyone who's developed autoimmune issues or other problems on previous treatments.  I have a feeling if I had to take it with the leftover problems I already have from SOC I'd be dead. I would rather deal with anemia rather than develop anymore autoimmune problems and rashes and thyroid issues (which is autoimmune based after all).

[djbn13]

Why is prednisone of limits? It's like a wonder drug for us people with lung infections.

[frijole]

http://www.reuters.com/article/idUSN0422054820100804?feedType=RSS&feedName=companyNews&rpc=33

It looks like Merck is going to go for FDA approval before year end too, not to be outdone by Vertex.  This should be an interesting fight.  Per this article

"The drug, boceprevir, was one of the most important experimental products gained by Merck through its acquisition of Schering-Plough Corp last year."

This is really the first time I have seen the value of Boceprevir presented on the stock market analyses for Merck.  The writer gives Vertex the edge, but I am going to love the race regardless of the outcome.  


NYgirl - I agree with you  The Boceprevir results have been outstanding on this board but I do remember seeing some nonresponders.  It seems to me there have been more drop outs on with Vertex.  I think the anemia issue can be overcome with Epo.

frijole

[pcds]

Let's hope they have some solutions for the tetaprevir rash when it hits the market.  Those of use who have been on tx and have past experiences will help the MD decide which drug is best for them.
I worry ahead of time, something counsel others not to do.  I dont know if I'll get a rash or not.  Not sure what will be the solution, I hope there is one.

[banarep]

the rash was not that bad for me, after I got some meds.

[spectda]

It's interesting that the vertex study showed 44 percent success with soc plus placebo as apposed to the boceprevir study which was 38 percent for soc plus a placebo. I guess the vertex placebo has some antiviral qualities. My guess is that in reality they are very close. I think they both act on the same parts of the hcv molecule.

http://www.nytimes.com/2010/08/05/health/05drug.html

Merck said that in one trial of 1,097 patients getting treatment for hepatitis C for the first time, 66 percent of those who had a 48-week regimen that included boceprevir had a sustained virologic response. That compared with 38 percent for those who got the existing therapy plus a placebo.

The corresponding figures from Vertex’s Phase 3 trial were 75 percent and 44 percent.

[Cory255]

can you take steriods with hep c though? i heard you couldnt , topicaly it would be fine but i am not sure about oral use

Studies show that, over time, anabolic steroids can take a heavy toll on a person's health.  Abuse of injectable or oral anabolic steroids is associated with increased risk for heart attacks and strokes, and the abuse of most oral anabolic steroids is associated with increased risk for severe liver problems, including hepatic cancer.  People who share needles or use nonsterile injection techniques can put themselves at risk for contracting dangerous infections, such as HIV/AIDS, hepatitis B and C, and bacterial endocarditis.  Anabolic steroids abuse can also cause undesirable body changes, "Men may develop enlarged breasts and women's bodies may become masculinized.

The drug was developed in the 1930's by Adolf and now has several uses.  There are several reasons why someone would take anabolic steroids.  One use is to treat Hypogonadism.  "Hypogonadism" is when the testes don't produce enough testosterone for normal growth, reproduction, and sexual purposes.  Other medical reasons would be for sexual impotency and to treat certain effects of HIV and other diseases as well.  Anabolic steroids are a synthetic version of male testosterone called androgens.  It's main effect is to accelerate and improve body growth.  They do this by promoting growth of tissues and skeletal muscles which enhances male features of the body.  

The side effects of improper steroid use can be severe.  The effects on men can cause entire reproductive organs to be at stake.   Temporary and even permanent impotence is a possible side effect.  Steroids can also lead to lower sperm count, shrinking of the testes, impotency, baldness, and can even cause urination troubles.  The effects on women are growths similar to a male like a much deeper voice and abnormal growth of body hair.  The use of anabolic steroids can be extremely dangerous and should never be done without a licenses professional, the supervision of a licenses professional, or a doctor.  Cory.  

[copyman]

Seems the rash issue has been addressed and wasn't as bad in the phase 3 study. My rash was minor and nothing more then you would get with the regular riba rash. I think telaprevir formula was changed for the phase 3 trial. If indeed the rash is no longer an issue then that gives Vertex another jump over Merck.

[Cory255]

If approved, boceprevir may have a tough time competing against Vertex's hepatitis C drug telaprevir, which will also be filed for approval later this year. Results from a similar Vertex study in so-called "treatment-naïve" hepatitis C patients released in May showed that telaprevir plus the standard of care achieved a cure rate of 75%.

I think the information in the article is good.  It's interesting to see not every study is going to have the same set of #'s.  Looks like Telaprevir has better results like I've read all along.  I also read that 39% of Telaprevir participants had the rash in one article.  

[Cory255]

Several members had solutions to the rash.  Here's a link to take a look at.  

http://www.medhelp.org/posts/Hepatitis-C/telaprevir-trials-and-helper-meds/show/1301240?personal_page_id=1353766#post_5954865

[mikesimon]

Prednisone/Solu-medrol are not anabolic steroids. They are corticosteroids. They are synthesized cortisone which is a natural substance in the body. Corticosteroids are primarily used to control inflammation and manage pain. They exert a profound effect on the immune system and can be used to control acute organ rejection in a transplant recipient.

Anabolic steroids are "synthetic versions of male testosterone and increase protein synthesis in cells and thus promote muscle growth and mass. Prescription steroids are part of therapy to increase appetite in people with diseases such as Cancer and Aids, promote growth, induce puberty, and stimulate bone growth."

I was referring to corticosteroids when I said they would not be good in a HCV/treatment situation because of their immunosuppressive properties.

Mike

[Cory255]

Clarifying the difference between different types of steroids.  Much similar to interferon, there are several different types.  Can generally be referred to as Peginterferon.  There's Roche's Pegasys, peginterferon alfa-2a.  Schering-Ploughs Pegintron, peginteferon alfa-2-b.  I've also heard of consensus interferon, and then the company three rivers.  AND then infergen which is suppose to be difficult from what I heard.  

Cory

[nygirl7]

Cory I think you are a bit confused - Consensus interferon is INFERGEN.   Pegasys is just a brand name.

[Trinity4]

Consensus interferon is Infergen

[Trinity4]

Booyah or otherwise known as boo to the yah!

[nygirl7]

HA I have the stick today........you can have it tomorrow but I beat ya by one minute. Jez we are great minds ;)

[mikesimon]

You might consider researching steroids.  Anabolic,/Androgenic Steroids are not anything like Corticosteroids except for the fact that their structure is chemically based on a steroid nucleus. When we're talking about the immunosuppressive characteristics of Corticosteroids (Prednisone/Solu-Medrol) and you start talking about Anabolic Steroids it's clear that you do not understand what is being discussed.

"...Different Types of Steroids

There are two types of steroids present within the body. Corticosteroids are produced in the adrenal gland located above the kidney. These hormones include aldosterone, which helps regulate sodium concentration in the body, and cortisol, which plays many roles in the body, including serving as part of the body's stress response system to decrease inflammation. Commonly prescribed corticosteroid medications, like prednisone, prednisolone, and dexamethasone are available to be taken by mouth, intravenously, or by intramuscular injection and may be used to treat diseases like asthma, rheumatoid arthritis, inflammatory bowel disease, and systemic lupus erythematosus in which inflammation is part of the disease process. The use of steroid ointments and creams on the skin, like triamcinolone and betamethasone, is common in the treatment of dermatitis (derm=skin + itis=inflammation).

The second group of steroids, the androgenic/anabolic steroids, are hormones made in the body to regulate the manufacture of testosterone in the testicles and ovaries. The androgenic part of testosterone is involved in developing the male sex characteristics, while the anabolic part is involved in increasing the amount of body tissue by increasing protein production. The pituitary gland, located at the base of the brain, helps regulate testosterone production and hormone secretion. Growth hormone and follicle stimulating hormone (FSH) are among the hormones that stimulate testis and ovary function and are two of the many hormones secreted by the pituitary.

Anabolic and androgenic steroids are available as prescription medications to be used in cases in which the body does not make enough hormone and supplementation may be required. Some hormone supplements in this pathway include growth hormone and testosterone itself. These medications are legally prescribed by health-care providers, but this group of drugs is often used illegally and abused to help increase athletic performance and improve body appearance. When used in a well-nourished body, anabolic steroids will cause weight gain primarily due to an increase in muscle mass...."

http://www.emedicinehealth.com/steroids/page2_em.htm

Mike

[susan400]

I know you are just the messenger, so trust, me I won't "kill the messenger"  ha-ha.   I am just stating for the record that I really have no plan whatsoever to jump on the bandwagon of Telaprevir when it gets approved.  I am no as gung-ho about this 'miracle-drug' as the rest of the hep-c community appears to be.  It is my uneducated prediction that there we still be gobs of other people who will have a severe rash and will not wish to continue on w/the Telap.  I mean look at all the people who can't even handle straight SOC and drop out before completion.  Do you really think that those who get a rash so bad that it causes hives the site of quarters over a large portion of their body, to where it appears they've been splashed with boiling water..., are really going to want to continue it?  I may be totally wrong and I'll be the first to admit that it won't be the first time.  I'd rather take my chances with anemia and neutropenia of Boce and a longer treatment run, and include rescue drugs, before I'd want to go through that h*ll of Telap again.  

Susan400

[nygirl7]

I think you are very wise to wait and see Susan - once it's open to the general public (and not so closely controlled a population) we will see what happens.

[mikesimon]

I can't disagree with you Susan. I don't know enough about them to have a firm opinion about it.

Mike

[pcds]

Trials are different from final medical treatment when released to public.  There will be treatment options for side effects not available to trial participants with room for MDs to manage pt side effects. Trials offer little wiggle room for tx of sx.  
Judy

[spectda]

Some trials offer complete freedom to use rescue meds at the discrection of the Dr. Especially trials in the later stages. During the earlier stages, I think they may not often offer the rescue drugs because they are often trials primarily about safety and dosing and rescue drugs would skew the results.

My friend is enrolling in a trial for BMS-79005 (phase 2b), I think they can use all the rescue drugs at the doctors discretion. The boceprevir trial that many of are currently enrolled in is a different situation because if is a trail that was specifically approved by the fda to learn how to manage anemia induced by boce/riba combo. Therefore one of the arms of this trial is to randomize to either reduced riba or epo.

You can't throw all trials in a bucket together. You have to look at them individually and understand the downside and make a decision about the risks compared to the gains and how far along your disease is of course will play a big roll in your choice.

People with more advanced disease will naturally be willing to try some of the earlier phase trials because they feel they have less choices.

- Dave

[susan400]

I was allowed to use steroidal cream on my rash and it basically had no effect whatsoever.  I was only allowed the over the counter strength.  I still will choose to say "I'll pass on the Telaprevir", but that's just me and my choice.  When you live in Florida in this heat that last thing that I want to have to do is walk around in Aug in a long sleeve shirt and pants with sunscreen underneath my clothes and steroidal cream all over me, just to deal with a d*rn Telaprevir rash and that's what it was like for me when I was on the Telaprevir.  Susan400

[spectda]

The boceprevir anemia is very manageable with procrot as always. I have found little sides brom boce besides anemia and a little harsh on the gi tract, but for me not bad. I also would want to treat longer with geno 1a.

I am not convinced about the 24 week tx period with some of the new drugs. Telaprevir sounds like a great drug if you don't get the rash, I would want to use it for longer then 24 weeks, or at least spend some time after the 24 weeks just taking inf and riba.

[Diamando6]

Hello everyone , when I was on a previous therapy, two years ago, >I had lots of rash problems. I went to a very good dermatologist. He said, that is absolutely wrong to take corticosteroids, while on therapy specially, and gave me a cream, which helped me really. If I find prescription, with latin name ingrediants, I will post it to you all.

[billm57]

thats funny i just read where boceprevir posted the highest svr rate for first timers ever - but duration of treatment was longer

[billm57]

also a higher percentage of drs say they will use telaprevir  - probably due to earlier projected release date