Aa
A
A
A
Close
Hepatitis C Community
13.4k Members
Avatar universal

Sofosbuvir/Sovaldi Approved


Sofosbuvir/Sovaldi just approved by the FDA shortly after Stock market close Friday

http://finance.yahoo.com/news/u-food-drug-administration-approves-211900093.html


U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C

– Sovaldi Approved for Use in Genotypes 1, 2, 3 or 4 –

– High Cure Rates (SVR12) and Shortened, 12-Week Course of Therapy for Many Patients –

– First Ever Oral Treatment Regimen for Genotypes 2 or 3 –

– First Regimen for Patients Awaiting Liver Transplantation to Prevent HCV Recurrence –
43 Responses
4896357 tn?1360674504
Is this used with PegInterferon? Is it approved for use in prior non-responders to triple therapy?
Avatar universal
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.

willy
Avatar universal
Great News

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
excerpt-----
......
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:


Avatar universal
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
Avatar universal
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.
6786733 tn?1384799349
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:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm
Have an Answer?
Top Hepatitis Answerers
317787 tn?1473362051
DC
683231 tn?1467326617
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Here’s how your baby’s growing in your body each week.
These common ADD/ADHD myths could already be hurting your child
This article will tell you more about strength training at home, giving you some options that require little to no equipment.
In You Can Prevent a Stroke, Dr. Joshua Yamamoto and Dr. Kristin Thomas help us understand what we can do to prevent a stroke.
Smoking substitute may not provide such a healthy swap, after all.