Aa
Good news
Today in NYT:
http://www.nytimes.com/2010/05/26/health/research/26drug.html?adxnnl=1&hpw=&adxnnlx=1274879114-Yys2ByFyekUA2aGA8AvwMg
(if you cannot open it, go to NYT front page and scroll down to "health" department)
http://www.nytimes.com/2010/05/26/health/research/26drug.html?adxnnl=1&hpw=&adxnnlx=1274879114-Yys2ByFyekUA2aGA8AvwMg
(if you cannot open it, go to NYT front page and scroll down to "health" department)
Only problem here is they always announce results for "naive". Would be nice if the pharmaceutical companies would release results for null responders. Naturally, this will effect the stock investments and also confuse if not produce questions by the FDA. At any rate, I guess at this point, myself and others here, are willing to try...
Mag
Mag
I have to agree, that is scarey. We have had much better care since going to a teaching hospital that does research trials for hep c. If my husband had responded to the normal cookie cutter protocol, I guess it wouldn't have mattered, but when he was non-responsive to the standard recipe, it mattered a lot.
Best Wishes,
Ev
Best Wishes,
Ev
I went to see my gastro doctor who wants me to start treatment immediately, I told him about wanting to wait until telaprevir comes out for shorter treatment, scary thing is he did not know what telaprevir was, he needed to go and google it, while I was in his office waiting, then he came back and said well what I read on telaprevir it is for non responders, so go ahead and treat now and if you don't respond then you can always try telaprevir later.
the insurance companies do have an incentive in us being cured and not having to pay for treatment several times.
Main google news page:
Chart of the Day: Vertex Pharmaceuticals (VRTX)
Sumfolio.com - 41 minutes ago - all 86 articles »
http://sumfolio.com/chart-of-the-day-vertex-pharmaceuticals-vrtx-580/
Investor standpoint for those of you who bought vertex a long time ago.
Same stuff but nice to see on front page newslines anyways!
Chart of the Day: Vertex Pharmaceuticals (VRTX)
Sumfolio.com - 41 minutes ago - all 86 articles »
http://sumfolio.com/chart-of-the-day-vertex-pharmaceuticals-vrtx-580/
Investor standpoint for those of you who bought vertex a long time ago.
Same stuff but nice to see on front page newslines anyways!
But analysts expect the drug to cost tens of thousands of dollars for a course of treatment. "
Why that is simply shocking (not).......so cost of inf @ 6 months plus riba plus tele - the insurance companies better go for it!!!!!!!
Why that is simply shocking (not).......so cost of inf @ 6 months plus riba plus tele - the insurance companies better go for it!!!!!!!
Hepatitis C Drug Raises Cure Rate in Late Trial
By ANDREW POLLACK
Published: May 25, 2010
An experimental drug for hepatitis C from Vertex Pharmaceuticals sharply increased the cure rate in a clinical trial, while reducing the time needed for treatment.
Experts say the results could herald a new era in treating a sometimes fatal disease that is often overlooked, despite afflicting as many as 3.9 million Americans and 170 million people worldwide.
About 75 percent of patients in the trial who got the standard dose of Vertex’s drug in combination with the existing treatment were essentially cured, compared with 44 percent of those who got only the existing therapy.
The results were as good as or slightly better than expected. Vertex’s stock was up more than 12 percent in after-hours trading, after the company’s announcement of the results late in the afternoon.
Yaron Werber, an analyst at Citigroup, estimates that global sales of telaprevir could reach nearly $3 billion a year by 2015. The drug is expected to make Vertex profitable after about two decades of losses, including a loss of $1.5 billion in the last three years alone.
“These data support the vision that we have long had for fundamentally changing the treatment for hepatitis C,” Dr. Robert Kauffman, Vertex’s chief medical officer, said in a conference call with securities analysts.
The results also keep Vertex at the front of a crowded field that has made hepatitis C one of the fiercest battlegrounds in the pharmaceutical business. Merck is expected to announce late-stage trial results of a similar drug, boceprevir, this year. And numerous other companies, from pharmaceutical giants to small start-ups, are in hot pursuit.
Both Vertex’s telaprevir and Merck’s boceprevir block an enzyme known as protease that is made by the virus. Most of the other new drugs also work by blocking viral enzymes. This direct antiviral approach has been used with great success in treating H.I.V. and AIDS.
Vertex itself says it expects results from two additional Phase 3 trials of telaprevir in the third quarter and will then apply to the Food and Drug Administration for approval of the drug.
Some 2.7 million to 3.9 million Americans are estimated to have hepatitis C, and 12,000 die from it each year, according to a recent report by the Institute of Medicine.
The disease can cause cirrhosis, which is a scarring of the liver, as well as liver cancer. The virus is transmitted by blood, so most people who have hepatitis C either have injected illegal drugs or received blood transfusions or blood products before the early 1990s.
The existing treatment is a combination of alpha interferon, which is injected, and ribavirin, an oral drug. It is not quite clear how those drugs work.
For patients with the type of hepatitis most prevalent in the United States, which is called Genotype 1, the treatment lasts nearly a year and can cause side effects that include flulike symptoms, anemia and depression. It is so arduous that many patients opt not to get treated or drop out before completing the course.
But in Vertex’s trial, about 70 percent of those who achieved an effective cure were able to do so in 24 weeks, or about six months. That shorter time line, plus a higher chance of success, could entice more people to be treated, experts say.
“If you can promise them six months with a reasonable chance of a cure, that’s a meaningful advance,” said Dr. Scott L. Friedman, chief of the division of liver diseases at the Mount Sinai School of Medicine in New York.
If approved, telaprevir would have to be used initially with the existing drugs to prevent the virus from evolving resistance. But experts hope that eventually several of the pills now in development could be used together, much as AIDS is treated, doing away with the need for interferon.
Vertex’s clinical trial enrolled 1,095 patients in the United States and abroad who had Genotype 1 hepatitis C and had not been treated previously. Patients got either 12 weeks or eight weeks of telaprevir or a placebo. The standard therapy of interferon and ribavirin was given for either 24 weeks or 48 weeks, depending on how the patients were faring after four weeks and 12 weeks.
Of those who got 12 weeks of telaprevir, 75 percent had a sustained viral response, meaning the virus was not detectable in their blood 24 weeks after completing treatment. That is seen as essentially a cure. The rate was 69 percent for those who got eight weeks of telaprevir.
The drug can cause a nasty rash and increases the rate of anemia. About 7 percent of the patients getting telaprevir dropped out of the trial, about double the figure for the control group.
Lorren Sandt, chairwoman of the National Viral Hepatitis Roundtable, an advocacy group, called the trial results impressive. But she added, “The community hopes that if telaprevir is approved by the F.D.A. that it will be accessible and affordable to everyone.”
Vertex, which is based in Cambridge, Mass., has not said what it would charge. But analysts expect the drug to cost tens of thousands of dollars for a course of treatment.
By ANDREW POLLACK
Published: May 25, 2010
An experimental drug for hepatitis C from Vertex Pharmaceuticals sharply increased the cure rate in a clinical trial, while reducing the time needed for treatment.
Experts say the results could herald a new era in treating a sometimes fatal disease that is often overlooked, despite afflicting as many as 3.9 million Americans and 170 million people worldwide.
About 75 percent of patients in the trial who got the standard dose of Vertex’s drug in combination with the existing treatment were essentially cured, compared with 44 percent of those who got only the existing therapy.
The results were as good as or slightly better than expected. Vertex’s stock was up more than 12 percent in after-hours trading, after the company’s announcement of the results late in the afternoon.
Yaron Werber, an analyst at Citigroup, estimates that global sales of telaprevir could reach nearly $3 billion a year by 2015. The drug is expected to make Vertex profitable after about two decades of losses, including a loss of $1.5 billion in the last three years alone.
“These data support the vision that we have long had for fundamentally changing the treatment for hepatitis C,” Dr. Robert Kauffman, Vertex’s chief medical officer, said in a conference call with securities analysts.
The results also keep Vertex at the front of a crowded field that has made hepatitis C one of the fiercest battlegrounds in the pharmaceutical business. Merck is expected to announce late-stage trial results of a similar drug, boceprevir, this year. And numerous other companies, from pharmaceutical giants to small start-ups, are in hot pursuit.
Both Vertex’s telaprevir and Merck’s boceprevir block an enzyme known as protease that is made by the virus. Most of the other new drugs also work by blocking viral enzymes. This direct antiviral approach has been used with great success in treating H.I.V. and AIDS.
Vertex itself says it expects results from two additional Phase 3 trials of telaprevir in the third quarter and will then apply to the Food and Drug Administration for approval of the drug.
Some 2.7 million to 3.9 million Americans are estimated to have hepatitis C, and 12,000 die from it each year, according to a recent report by the Institute of Medicine.
The disease can cause cirrhosis, which is a scarring of the liver, as well as liver cancer. The virus is transmitted by blood, so most people who have hepatitis C either have injected illegal drugs or received blood transfusions or blood products before the early 1990s.
The existing treatment is a combination of alpha interferon, which is injected, and ribavirin, an oral drug. It is not quite clear how those drugs work.
For patients with the type of hepatitis most prevalent in the United States, which is called Genotype 1, the treatment lasts nearly a year and can cause side effects that include flulike symptoms, anemia and depression. It is so arduous that many patients opt not to get treated or drop out before completing the course.
But in Vertex’s trial, about 70 percent of those who achieved an effective cure were able to do so in 24 weeks, or about six months. That shorter time line, plus a higher chance of success, could entice more people to be treated, experts say.
“If you can promise them six months with a reasonable chance of a cure, that’s a meaningful advance,” said Dr. Scott L. Friedman, chief of the division of liver diseases at the Mount Sinai School of Medicine in New York.
If approved, telaprevir would have to be used initially with the existing drugs to prevent the virus from evolving resistance. But experts hope that eventually several of the pills now in development could be used together, much as AIDS is treated, doing away with the need for interferon.
Vertex’s clinical trial enrolled 1,095 patients in the United States and abroad who had Genotype 1 hepatitis C and had not been treated previously. Patients got either 12 weeks or eight weeks of telaprevir or a placebo. The standard therapy of interferon and ribavirin was given for either 24 weeks or 48 weeks, depending on how the patients were faring after four weeks and 12 weeks.
Of those who got 12 weeks of telaprevir, 75 percent had a sustained viral response, meaning the virus was not detectable in their blood 24 weeks after completing treatment. That is seen as essentially a cure. The rate was 69 percent for those who got eight weeks of telaprevir.
The drug can cause a nasty rash and increases the rate of anemia. About 7 percent of the patients getting telaprevir dropped out of the trial, about double the figure for the control group.
Lorren Sandt, chairwoman of the National Viral Hepatitis Roundtable, an advocacy group, called the trial results impressive. But she added, “The community hopes that if telaprevir is approved by the F.D.A. that it will be accessible and affordable to everyone.”
Vertex, which is based in Cambridge, Mass., has not said what it would charge. But analysts expect the drug to cost tens of thousands of dollars for a course of treatment.
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
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.
