Start treatment and have surgery

[Faithdove]

My husband is seeing doc next week to hopefully start treatment with the newly approved Sofo with RBV and INF. he has issues with his shoulder and thinks he can get surgery for that while starting this treatment. I do not know yet if his doc will prescribe this regimen and even if his insurance will cover it. (Express scripts). From all I have read, for his Hep C genotype 1a, he is going to have to get the INF regardless. Sooooo.....what do you all think. I am so worried about him, when he had is liver biopsy it said he was at a 3/4 ?? Not sure what that means.he has a lot of sensitivity in the area of his liver, and to me, has also appears to have fluid buildup. He looks 8 months pregnant to me, and the way his stomach bulges, i can't believe it is just fat. If it were you would you attempt shoulder surgery while on treatment. When he had his other shoulder done a few years ago, it was a living hell....please please ....tell me what you think. I can't stand to see him in all this pain. He also has much fatigue and sleepless nights and joint pain in general, I try to watch how much Advil he takes, because I know that is not good for the liver.

[Faithdove]

I wanted to let you know I am thinking of you and tell you I really admire you! Ten times of various treatments, wow, you are a very strong person an I know you will beat this. From all of the reading I have been doing, the goal of many pharm companies is to get a drug regimen without INF and RBV. It is going to happen and you will be free of this disease. God Bless you and thank you for sharing your strength and know that you are an inspiration. Hugs.

[Faithdove]

I wish I could help you with the math, but it has me very confused! Too skinny! What the heck is that about, well good for you losing weight regardless, that is better for your health overall. I am still wondering if your health insurance goes through a speciality pharmacy like CVS Caremark? Genotype 2, okay, so what I just posted won't help. Are you on a general clinical trial list so they will call you for any trial with Genotype 2? That is good if that is the case, the 100 mile trip is not, but they must reimburse you for something if you participate?? I don't know, but for sure all questions you may want to ask. Thank you, I hope and pray my hubby gets through this, after his horrific accident early last year, it has been too much for him and for me! But we will all keep moving forward and get through this one road block after the other!!!!!

[Faithdove]

Here's another clinical trial!!

Here is another Phase 3 for subjects with Subjects With Compensated Cirrhosis

A Study of an Investigational Treatment Regimen of Daclatasvir(DCV)+Asunaprevir(ASV)+BMS-791325 in a Fixed Dose Combination(the Triple Regimen)With or Without Ribavirin(RBV)for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
ClinicalTrials Identifier: NCT01973049
Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.
Status Recruiting
Start date 2013-12
Last follow-up date 2014-12 (Anticipated)
Primary completion date 2014-10 (Anticipated)
Criteria
Inclusion Criteria:

•  Subjects chronically infected with HCV genotype 1
•  Subjects with compensated cirrhosis
•  HCV RNA ≥ 10,000 IU/mL at screening
•  Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV Direct Acting Antivirals (DAA) (protease, polymerase inhibitor, etc.)
•  Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the DCV/ASV/BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of nonstructural protein 5B (NS5B) polymerase, inhibitors of cyclophilin, or inhibitors of microRNA.

Exclusion Criteria:

•  Subjects without cirrhosis
•  Liver or any other organ transplant
•  Current or known history of cancer within 5 years prior to screening
•  Documented or suspected hepatocellular carcinoma(HCC)
•  Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

http://www.clinicaltrials.gov/ct2/show/NCT01973049?term=bms-791325
scroll down link and click to Show 49 Study Locations

[WyoSue]

When the time comes for me to start treatment (hopefully in a or two), I'll certainly look into the Sovaldi coupon program. And I'm very interested in hearing from other members of the group who start treatment with Sovaldi and how much it costs them.
Thanks, FaithDove, for the clinical trial info. I don't qualify for that one because I have Genotype 2. I live about 100 miles from a hepatology center that conducts clinical trials. I'm on their list and they called me several weeks ago about a trial they were recruiting for. Unfortunately, they said I was too skinny. Just a couple years ago, my doc told me to lose weight so I got busy and lost 15 lbs. Darn it.
I sure hope all goes well with your husband's treatment and Sovaldi works for him. Keep us posted....

[WyoSue]

Sovaldi costs $1000 per pill. A 12-week treatment regimen is 84 pills which will cost $84,000. My co-pay for a Tier 5 non-preferred specialty drug is 30%. Unless, I'm doing the math wrong, that comes to $25,200, right?

[susan400]

I am going to having a problem with affordability on the insurance for the Sovaldi (have to take the Infer./Riba w/it according to my doctor), because of the fact that my primary insurance is a medicare HMO and they don't add new FDA approved drugs to the formulary for at the very least 6 mon. and even then, it's not a guarantee.  The person on my insurance's cust. service explained that they don't even review newly FDA approved drugs until 6 mon. and that the review process can take some time and that not all drugs will make it to the formulary.  If it makes it to the formulary it will be at at Tier 4 or 5.  Interferon and Ribavirin would probably be on there, but again, at a Tier 4 or 5.  My husband's company has prescription drug coverage on me as well, but since I'm not ready to start my 11 or is it 12th treatment until the springtime, I haven't asked them if they plan on adding the Sovaldi. I hope that they do.  Before I do my next treatment I'm probably going to need another biopsy because by the springtime (June) I'll be at 4 yrs since the last one. While I don't particularly like Interferon and Ribavirin.., I know I can handle them because I've already done them SO MANY times.., unfortnately, so far w/o responding.  As far as a clinical trial goes, not of the trials will take me anymore because I've been exposed to Telaprevir, way on back in 2007 when it was in trials and I was in Prove-3. I was randomized into the no Riba group and even though I had a huge viral load drop in the first 10 days, it rebounded back up by like day 11-14 (most like due to lack of the Ribavirin).  Since most of the clinical trial sites won't accept someone who was exposed to a protease inhibitor w/o having all 3 drugs..., I'm left with waiting for FDA approved drugs (now that's Sovaldi, Interferon/Riba).  As far as a fatty liver (my last sono) showed that I've just not developed mild steatosis (fatty liver).  However, one does not have to be fat, does not have to be diabetic, does not have to have elevated triglycerides, or insulin resistent,.., to have a fatty liver.  I am a thin/normal weight woman, no cholesterol or blood sugar issues whatsoever.But, I have had Hep C for 30 yrs.  Susan400