Sunday, December 31, 2006

End of one year and beginning of another

Well I made it!!! Christmas was good. I had all the kids and the granddaughter and my mom here for Christmas along with one of the kids friends who needed a friendly place to have Christmas dinner. Ithought the day would be hard but really I was so busy that it was all good. We also resurrected the Boxing Day gathering at my brothers house that had gone by the boards a few years back. It was really good and we had all of his kids and grandkids, my kids (minus Dave and Allie and Christina who had other plans) and our Mom there along with Jack, a long time family friend and now a part of the family who also happens to be the father of my son Josh. Both days were full of fun, laughter and good food. I was totally at ease and enjoyed it immensely.

I was off for 4 days and then back to work for 3 and now off for the New Year long weekend. I was on the forum this morning and saw a post about the VX-950 and am going to post the pertinent parts here.

NEW YORK, Dec 13 (Reuters) - Vertex Pharmaceuticals Inc. said on Wednesday the effectiveness of its experimental drug VX-950 for hepatitis C was similarly impressive in a trial involving hundreds of patients as in two smaller previous studies, but the company's shares slipped on safety concerns.

Vertex said 88 percent of patients who took its drug for 12 weeks in combination with two standard medicines, interferon and ribavirin, had undetectable levels of the virus. That compared with 52 percent who took only the standard treatments

"Although the latest results are preliminary, they are exciting and confirm findings from initial studies," said Dr. John McHutchison, a Duke University professor who led the new study.

Despite its potency, 9 percent of patients taking VX-950 dropped out of the ongoing trial due to side effects, including rash, gastrointestinal disorders and anemia -- compared with 3 percent taking the standard dual therapy.

Serious adverse events were seen in 3 percent of those taking the Vertex drug, compared with 1 percent taking just interferon and ribavirin.

"The efficacy and safety data were both a little less than expected," Prudential Equity Group analyst Jason Zhang said. But Zhang added that he continues to believe VX-950 has potential to become the new standard of care for the life-threatening liver disease.

While side effects were more pronounced among patients taking VX-950, McHutchison said they should be weighed against the far-worse risks of continued hepatitis C infection. He said the virus causes cirrhosis in about 20 percent of people infected for 20 years or longer. And its damage is the leading reason for liver transplants.

The latest trial involves 250 patients infected with the most common, but hardest-to-treat, genotype 1 form of hepatitis C, who received the Vertex pill for 12 weeks. None had previously received any drugs to eliminate the virus, which infects an estimated 4 million Americans.

The U.S. study, one of three sizable mid-stage trials either planned or already in progress, is assessing how well patients respond to the Vertex drug within 24 weeks after completing treatment. Patients were divided into four treatment groups.
Three groups received the Vertex drug for 12 weeks in combination with the gold standard of therapy -- long-acting interferon and antiviral drug ribavirin. Another group received only interferon and ribavirin, plus a placebo.

Among 74 patients given VX-950 for whom data were available after 12 weeks, 88 percent had undetectable levels of the virus. That compared with 52 percent of those in the group that received only interferon and ribavirin.

"In effect, almost 90 percent of patients had undetectable virus after the first 12 weeks of triple therapy in this trial," McHutchison said

He said patients from one arm of the trial whose virus was undetectable after four weeks of treatment and continued to be undetectable after 12 weeks may elect to stop taking all medicines, but continue to be followed.

Others will continue to take interferon and ribavirin alone for either an additional 12 or 36 weeks, but receive no additional VX-950.

"If the virus remains undetectable 24 weeks after treatment is stopped, you are considered to have cleared the virus," McHutchison said, a main reason the 12 weeks of data now in hand are considered only preliminary.

With interferon and ribavirin alone, only half of patients typically clear the virus after a full year of treatment. And the dual therapy -- rival forms of which are sold by Schering-Plough Corp.
and Roche Holding AG can cause severe flu-like symptoms as well as depression.

Although the Vertex medicine by itself has been shown to wipe out more than 99.99 percent of virus in the bloodstream, it is not a stand-alone cure because the virus rebounds.

© Reuters 2006. All Rights Reserved.

I obviously have some concerns and alot of questions but really just want to get on with the drug trials and get it over and done with. I see I will probably have to take both the interferon and the ribavirin again but it looks like it may only be for 12 weeks instead of the 48 or maybe 12 weeks with the trio and then I can drop the ribavirin when they stop the VX-950. Maybe it will be enough to keep the virus away. I was undectable from 12 weeks on last time and still relapsed when the treatment was done so my hope is that the combo of the three drugs for 12 weeks and then the interferon for the rest of 48 weeks will be enough the kill the beast.

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