Sofosbuvir Is approved!!

[Mike1A84]

This weekend there was great news!!Sofosbuvir was  approved!Now just waiting to get a hold of a good G.I in my area.(Not to fond of my current one)Does anyone know the svr rates if you previously failed treatment?I did riba+Pegasus+Incevek in 2012 Virus recurred after 1 month post tx.Also does anyone know the process of getting into the patient assistant programs for this new treatment?All that Im reading on it im confident in beating this virus.All info including recommendations about good G.I's in my area of Monterey or California in general would be great thanks!!

[ceanothus]

Regarding doctors in your area: I live just a little north of you and I love my hepatologist at Stanford, Gabriel Garcia. It would be a bit of a drive for you, but not too bad. I'd guess about 75 min travel time as long as you avoided rush hours. I've seen him since about 1989 and have been through three full rounds of tx and various other serious medical (liver and other GI) issues with him and have always been happy with my care. If your treatment goes smoothly it won't require going in to see him in person very often, as he does stay on top of the blood tests and is readily accessible via webmail. If you get your blood draws done at Stanford the results come back faster than most labs and they are quickly posted on your private Stanford web account so you have easy access to them yourself. The blood draws can be done either at the normal blood draw clinic (with normal clinic hours), or you can use the hospital blood draw that services the ER, which means you can really avoid traffic hassles by going in on weekends, holidays or in the middle of the night. Dr. Garcia usually posts a brief message regarding each set of blood tests, especially if there is any indication of trouble brewing, and you can always post questions for him, which he answers pretty quickly. I think its worth the extra drive to get such excellent care!

[Mike1A84]

Thanks for the information everyone!!Im pulling for each and everyone of you.We will beat this!!!!!!!

[Diamando6]

I think that there was three groups in this trial. One of them included previously treated patients, who didnt acheved SVR.

[48weeks]

I also failed twice with Int+Rib in 90's, and I relapsed after 48weeks of triple therapy with Incivek in 2012. I am a GT 1a and hoping for something soon. Intially I was hoping either Olysio or Sovaldi would be available for us, but after reading and re-reading, I still don't have a clear picture of whether or not it includes us.  I'm getting another liver biopsy in Jan and seeing my Hepatologist in February and hopefully by then some of the dust settles and the smoke clears. Good luck guys

[Diamando6]

Hello Mike. I am geno 1 too. I was diagnosed with hep c back in 2007. Went through a therapy with Pegasys& Riba, for 24 months, and failed to achieve SVR.  Then, I was again treated from May 2011 with triple therapy Telap&Riba&Interf. Have been negative after three months (while taking Telaprevir), but made a breakethrough at the end of therapy.,
For us difficult to treat patients, new medication is a only option so far. I hope that in my country this pill, will come soon, and medical research program will again allow, and give us a chance to live longer, and with greater chances of succsess! God help us, we are not so bad!

[klonny55]

Hi Mike,

Are you genotype 1? Before approval the understanding was that sofosbuvir/sovaldi would be prescribed only for those genotyope 1s previously untreated. I cannot find any mention of that in the FDA prescribing guidelines:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm377920.htm

So it appears those genotype 1s who have previously failed treatment may be eligible for the 12 week sovaldi/peg/rib treatment after all. Can anyone else confirm that I am reading this correctly?

There is also an unexpected mention of genotype 1s "ineligible" to receive interferon may take the sovaldi/ribavirin dual therapy for 24 weeks. SVR results for different patient groups participating in clinical trials are included in tables in the above link.

Also Gilead has patient assistance programs in place. This is taken from the Gilead web site:

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:

Access to dedicated case managers to help patients and their providers with insurance-related needs, including identifying alternative coverage options such as federally-insured programs (e.g., Medicaid, Medicare) and health exchanges.

Education and support, including a 24/7 nursing support service line and the ability to schedule an onsite visit from a clinical educator.

The Sovaldi Co-pay Coupon Program, which provides co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than $5 per co-pay. Co-pay assistance can also be applied toward deductibles and co-insurance obligations.

Gilead will provide support to the Patient Access Network (PAN) Foundation, an independent non-profit organization that provides assistance for eligible federally-insured and privately-insured patients who need help covering out-of-pocket medication costs.

The Support Path Patient Assistance Program will provide Sovaldi at no charge for eligible patients with no other insurance options.
Information about how to apply for any of these forms of assistance can be found at www.MySupportPath.com or by calling 1-855-7MyPath (1-855-769-7284) between 9 a.m. - 8 p.m. EST.

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.AnozrNW4.dpuf