Gilead study question-gs9190, gs9256 & SOC

[sherritaylor12]

When I posted an update on me and hubby, frijole asked if the study had been scraped, researchmonkey replied that only Tegobuvir (GS9190) had been pulled because of the bad interaction with Interferon.  I have been searching for information on this (no one has mentioned it at the study clinic) and can't find anything, could you please tell me where you got your info?  Maybe that is why hubby had such BAD side effects.
Thanks,
Sherri  

[OdinLovesLife]

Thanks for posting the info Sherri.  It is really helpful for everybody to know what is going on with the research drugs. Best wishes for your husband.

[researchmonkey326]

Hubby must have dropped out a few weeks before they pulled the drug.  I was 23 weeks in but don't know yet if I had the PI's or placebos.  I know your husband took as much of it as he could.  I remember that he had problems from the very beginning with the the meds so the fact that he made it 23 weeks is commendable.  I hope that you get some good news with his vl results and I hope he is feeling better.

[curiouslady1]

Thank you for your participation in this trial.  It doesnt always turn out as planned but your husband is to be commended for volunteering and doing the best he could to tolerate it.  With my personality, I don't think I would have the ability to go through a trial unless it was open label although I probably would have tried a blinded study if that was all there was. I am truly amazed at what people go through to defeat the dragon.  

[sherritaylor12]

Thanks to you both for the information.  This is very interesting because they tell him now since he quit the study drugs one wk early (wk 23)  he is not in compliance and not eligible for the all oral study.  Yet they won't tell us if he received the PI's or the plecebo.  Very confusing.  he retested for vl and we are waiting for new results.

[HectorSF]

For data about changes you can always go to the drug manufacturer's  website.
http://www.gilead.com/

"Gilead Amends Study Design for Ongoing Hepatitis C Clinical Trials That Include GS 9190, Pegylated Interferon and Ribavirin, and Another Direct-Acting Antiviral Agent
Change Does Not Affect Ongoing "All Oral" Clinical Trials Evaluating Multiple Direct-Acting Antivirals in Combination

FOSTER CITY, Calif., Sep 04, 2011 (BUSINESS WIRE) --

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that, in consultation with the U.S. Food and Drug Administration (FDA), the company will amend the design of ongoing clinical trials to discontinue dosing of GS 9190 in hepatitis C-infected patients who are receiving that compound in combination with pegylated interferon and ribavirin, and another direct-acting antiviral agent.

This decision follows reports of two serious adverse events in patients enrolled in two separate studies who were receiving a four-drug regimen of GS 9190, an investigational HCV NS5B polymerase inhibitor; pegylated interferon and ribavirin; and one of two protease inhibitors (GS 9451 in one study and GS 9256 in the second study). Patient safety is Gilead's top priority, and the company will therefore immediately halt the dosing of GS 9190 in patients receiving this combination of medications.

Pegylated interferon in combination with ribavirin is currently part of the standard of care treatment for patients with chronic hepatitis C. Because of the side effects that can be associated with interferon, Gilead is working to develop multiple oral antivirals that, when used in combination, may be able to reduce or eliminate the need for interferon.

Gilead does not anticipate any impact on the timelines for or goals of its planned and ongoing clinical studies evaluating an "all oral" regimen for the treatment of chronic hepatitis C. Studies that include GS 9190 but do not include pegylated interferon will continue as planned. Similarly, studies that include the combination of GS 9451 (an investigational protease inhibitor), GS 5885 (an investigational NS5A) and pegylated interferon and ribavirin will continue. "

Good luck.
Hector

[CoWriter]

"Gilead Sciences Inc. discontinued dosing of a four-drug HCV regimen consisting of tegobuvir (GS 9190), ribavirin, pegylated interferon and either GS 9451 or GS 9256. Gilead said the regimen led to two serious adverse events in two separate studies. The company did not say how many trials would be affected but added that the timelines of the studies will remain unchanged. Dosing regimens that include GS 9190 but not interferon will continue as planned."

http://www.bioportfolio.com/news/article/792023/Gilead-Amends-Gs-9190-Dosing-After-Ae.html