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Author Topic: hcv news...for those of us who are coinfected  (Read 4574 times)

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Offline next2u

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hcv news...for those of us who are coinfected
« on: April 29, 2009, 09:36:49 pm »
Studies: Drug shows promise against hepatitis C
By ALICIA CHANG, AP Science Writer Alicia Chang, Ap Science Writer
Wed Apr 29, 5:02 pm ET
 
LOS ANGELES – An experimental drug greatly increased the number of people who appear to be cured of hepatitis C infection, according to results of mid-stage testing. The findings also suggest the drug telaprevir, made by Vertex Pharmaceuticals Inc., which sponsored the two studies, can cut treatment time from one year to six months. However, those taking the drug reported more side effects including severe rash, nausea and anemia than those on standard treatment alone.

Still, telaprevir and similar drugs that other companies are testing offer hope of a major advance against the disease, which afflicts about 3.2 million Americans and 180 million people worldwide. It is caused by a bloodborne virus that can lead to liver scarring or liver cancer.

Treatment is aimed at helping the immune system eliminate the virus. Current therapy combines the drugs peginterferon and ribavirin, but less than half on it are cured. Telaprevir and similar drugs under development are a potential game-changer because they specifically attack the hepatitis C virus.

In the two studies, roughly two-thirds given telaprevir with standard therapy for six months showed no signs of the virus after six months, which doctors considered being cured of the disease. That's compared to 40 to 50 percent on standard treatment alone.

"We can now sit down with our patients and tell them that 2 of 3 patients can be cured with a 24-week course of therapy," said Dr. John McHutchison, a Duke University doctor who led one study and has consulted for Vertex, based in Cambridge, Mass.

Telaprevir is in late-stage testing and is not available commercially; the company plans to seek government approval next year.

Results were published in Thursday's New England Journal of Medicine.

Hepatitis C is a huge and growing problem because for years there was no way to screen the blood supply for the virus. Infection often doesn't produce symptoms for many years, so many of these cases are just now being recognized even though they may stem from transfusions a decade or more ago.

The virus is mainly spread through contact with the blood of an infected person. It can be contracted by sharing dirty drug needles, getting pricked with a hospital needle with infected blood or being born to an infected mother.

About a quarter of people exposed to hepatitis C clear it out of their bodies without treatment. But the rest develop a lifelong infection that attacks their livers. There is no vaccine against hepatitis C.

In one study of 250 people with chronic hepatitis C in the United States, 61 percent who took telaprevir with standard therapy for six months cleared the virus, compared with 41 percent on standard therapy alone. Among those who took the drug and standard therapy for a year, 67 percent had no signs of infection.

However, twice as many on telaprevir stopped treatment because of side effects.

In another study of 334 people in Europe, 69 percent on telaprevir and standard therapy for six months had undetectable virus levels compared with 46 percent on standard treatment alone.

The European study was led by Dr. Christophe Hezode of Henri Mondor Hospital in France. Hezode has consulted for Swiss drug maker Roche, which makes peginterferon and ribavirin.

Testing of even shorter treatment times did not show benefit in either study.

"Telaprevir appears to be a material advance in the therapy of hepatitis C, beginning a new era of treatment," Dr. Jay H. Hoofnagle of the National Institute of Diabetes and Digestive and Kidney Diseases wrote in an accompanying editorial.

Other doctors were more cautious.

"The new drug does show promise. However, its side effects remain a concern," said Dr. James Ou, a hepatitis expert at the University of Southern California's Keck School of Medicine.

Other companies developing similar drugs include Idenix Pharmaceuticals, Schering-Plough Corp. and InterMune Inc.

___

On the Net:

New England Journal: http://www.nejm.org

midapr07 - seroconversion
sept07 - tested poz
oct07 cd4 1013; vl 13,900; cd4% 41
feb08 cd4  694;  vl 16,160; cd4% 50.1
may08 cd4 546; vl 91,480; cd4% 32
aug08 cd4 576; vl 48,190; cd4% 40.7
dec08 cd4 559; vl 63,020; cd4% 29.4
feb09 cd4 464; vl 11,000; cd4% 26
may09 cd4 544; vl 29,710; cd4% 27.2
oct09 cd4 ...; vl 23,350; cd4% 31.6
mar10 cd4 408; vl 59,050; cd4% 31.4
aug10 cd4 328; vl 80,000; cd4% 19.3 STARTED ATRIPLA
oct10 cd4 423; vl 410 ;); cd4% 30.2
jun11 cd4 439; vl <20 ;); cd4% 33.8 <-Undetectable!
mar12 cd4 695; vl ud; cd4% 38.6
jan13 cd4 738; vl ud; cd4% 36.8
aug13 cd4 930; vl ud; cd4% 44.3
jan14 cd4 813; vl ud; cd4% 42.8
may14 cd4 783; vl *; cd4%43.5
sept14 cd4 990; vl ud; cd4% *
jun15 cd4 1152; vl ud; cd4% *
july15 - STRIBILD
oct15 cd4 583; vl 146; cd4% 42
mar16 cd4 860; vl 20; 44

Offline next2u

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Re: hcv news...for those of us who are coinfected
« Reply #1 on: April 29, 2009, 09:48:22 pm »
can someone move this to research news?
midapr07 - seroconversion
sept07 - tested poz
oct07 cd4 1013; vl 13,900; cd4% 41
feb08 cd4  694;  vl 16,160; cd4% 50.1
may08 cd4 546; vl 91,480; cd4% 32
aug08 cd4 576; vl 48,190; cd4% 40.7
dec08 cd4 559; vl 63,020; cd4% 29.4
feb09 cd4 464; vl 11,000; cd4% 26
may09 cd4 544; vl 29,710; cd4% 27.2
oct09 cd4 ...; vl 23,350; cd4% 31.6
mar10 cd4 408; vl 59,050; cd4% 31.4
aug10 cd4 328; vl 80,000; cd4% 19.3 STARTED ATRIPLA
oct10 cd4 423; vl 410 ;); cd4% 30.2
jun11 cd4 439; vl <20 ;); cd4% 33.8 <-Undetectable!
mar12 cd4 695; vl ud; cd4% 38.6
jan13 cd4 738; vl ud; cd4% 36.8
aug13 cd4 930; vl ud; cd4% 44.3
jan14 cd4 813; vl ud; cd4% 42.8
may14 cd4 783; vl *; cd4%43.5
sept14 cd4 990; vl ud; cd4% *
jun15 cd4 1152; vl ud; cd4% *
july15 - STRIBILD
oct15 cd4 583; vl 146; cd4% 42
mar16 cd4 860; vl 20; 44

Offline Ann

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Re: hcv news...for those of us who are coinfected
« Reply #2 on: April 30, 2009, 08:55:21 am »
can someone move this to research news?

Anything for you, sweetness! ;)

This is exciting news, Next...

...but I couldn't help but wonder about the people who stopped this new drug due to side-effects.


However, those taking the drug reported more side effects including severe rash, nausea and anemia than those on standard treatment alone.

//snip//

However, twice as many on telaprevir stopped treatment because of side effects.


Unless the side-effects were life-threatening (and it doesn't really sound like it) I just don't get it. In the over-all scheme of things, putting up with debilitating side-effects for six months when having a good chance of curing something that will probably kill you eventually (and liver cancer and/or cirrhosis aren't nice ways to go) seems like a no-brainer to me. What's six months of hell compared to a lifetime? Compared to having good health?

Dunno. Maybe these people were actually stopping therapy due to the depressive side-effects of the base therapy of peg/riba. The depressive side-effects can  be life-threatening. As for the anemia aspect, there are remedies for that and I can't see all those people not responding to them.

I suffered from many of the side-effects of the peg/riba therapy, and the one thing that kept me going (for 52 weeks!) was the knowledge that the side-effects weren't forever and I stood a good chance of a cure.

Ann


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Offline sam66

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Re: hcv news...for those of us who are coinfected
« Reply #3 on: April 29, 2011, 06:09:31 am »
    Telaprevir  has been approved

    UPDATE 3-Vertex hepatitis C drug gets glowing endorsement
   
    FDA panel recommends drug in 18-0 vote
    Sales projections as high as $5 billion a year


    SILVER SPRING, Md., April 28 (Reuters) - Vertex Pharmaceuticals (VRTX.O) won a U.S. advisory panel's overwhelming support for a potential blockbuster drug seen transforming hepatitis C treatment by nearly doubling the chances of curing the serious liver disease.

The Food and Drug Administration committee voted 18-0 on Thursday to recommend approval of telaprevir, one of two new proposed medicines offering higher cure rates and often shorter treatment for a virus that can destroy the liver.

The panel vote moves Vertex closer to bringing its first drug to the market and turning its first profit. Some industry analysts project telaprevir sales topping $5 billion a year.

Panelists said the drug's ability to wipe out the virus in 79 percent of newly treated patients clearly trumped concerns about serious rashes seen in a fraction of patients. The cure rate for the current standard of care is about 40 percent.

"I really think this is a stunning success, so I wholeheartedly endorse approval," said Dr. Lawrence Friedman, medicine department chair at Newton-Wellesley Hospital in Newton, Massachusetts.

Others also gushed about the drug's effectiveness and said they were eager to provide the medicine to their patients.

  Reuters

  http://uk.reuters.com/article/2011/04/28/vertex-hepatitis-idUKN2816226720110428
   
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