Is this used with PegInterferon? Is it approved for use in prior non-responders to triple therapy?
I have not had time to read the prescribing info yet Carl.
Yes, for all geno 1's it is to be used w/ interferon......
.....However there seems to be a backdoor for "interferon ineligible" to treat w/ just Sovaldi and RBV.
In addition...... the trials originally submitted were for TX naives..... but I *believe* that the eligible group has now been expanded to CHC G-1 patients (which I infer is both naives and TX experienced).
So I presently see no wording in the article that suggests excluding TX experienced/past failures.
Got to get back to work. There will be a lot more written and explained in the days to come.
U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C - See more at: http://www.gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c#sthash.YbRxElBW.dpuf
The Wholesaler Acquisition Cost (WAC) of a 28-tablet bottle of Sovaldi in the United States is $28,000.
U.S. Patient Assistance Program
Gilead is committed to ensuring that people with hepatitis C can access Sovaldi and has launched Support Path™ (www.MySupportPath.com) to provide assistance to patients who are uninsured, underinsured or who need financial assistance to pay for the medicine. The program consists of an integrated offering of support services for patients and providers, including:
Hey...will watch this for more info....as most of you know I am Geno 1, Stage 4 ESLD w/HVC load of 1 mil. plus, 0% of viable liver, at moderate level, and am on transplant list but MELD keeps going between 10 - 13....
my hepatologist is starting me on new two drug trial that was to be approved by Dec 8th by FDA....has no riba...no interferon...since I have adverse reactions to them and was a non-responder....also, was a non-responder on 4 different trials.
So keep the info coming...if I find out anything I will let you all know. Thanks
Daughter just said to me that my hepatologist said no interferon....that he didn't say anything about the riba.....uuuuww.....hate the riba.....rashes and loss of hair.....think positive....maybe it will have reverse effect this time or no adverse effect at all. Just want to clear HCV before I have a TP.
Geno 1a will still require interferon/riba, but the entire tx course is only 12 weeks vs 48. I don't know about prior non-responder's, but according to the text: "...Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation..."
Here's a link to the FDA's entire press release: