If I am reading this correct he is hoping to be able to go off-label and treat with both Simeprevir and Sofosbuvir together? It is worth a shot as the results of both of these together have had great results across the line.......... Good luck
That would be great getting treated off label, if that's your case. What geno type are you?
I see you're a 1b, missed that the fist time. It will be interesting to hear what the names of the 2 meds are next time you have a chance to ask.
There are many different health insurance plans. The only way to know if your own health insurance plan with cover the treatment drugs and what your co-pay will be is the call them and ask where they are in the process of approving coverage of the drugs. Of course first you have to know what the drugs are that your doctor is proposing to treat you with.
A few corrections:
The new hepatitis C treatments that have now be approved by the FDA require the use of both injectable Peg-interferon and oral Ribavirin in addition to Sovaldi/Sofosbuvir or Olysio/Simeprevir in order to work at this time. These drugs are expected to not require peg-interferon and possibly ribavirin in the future but this is a transition period now. The only all oral treatment (Gilead's) that doesn't use injectable peg-interferon is for genotypes 2 and 3 ONLY.
Just so you don't have unrealistic expectations, there is no new or old treatment for hepatitis C that has an SVR rate of 90% for persons with genotype 1 and cirrhosis.
In Gilead's NEUTRINO study seventeen percent of patients had compensated cirrhosis and 89 percent were infected with genotype 1.
The treatment requires Sovaldi 400 mg once daily in combination with RBV (1,000 or 1,200 mg/day based on patient's weight) and peg-IFN (180 g/week). The SRV rate in "treatment naive" patients with cirrhosis in this study had a SVR rate of 80%. A huge improvement over the 14% SVR rate when using only Peg-interferon + Ribavirin alone which is all we had only a few years ago!
SVR12 Rates in Treatment-Naïve Patients with HCV Genotype 1 Infection (Pooled Data QUEST 1 and QUEST 2) in those with stage 3 and stage 4 (cirrhosis) were 68%.
Best of luck with your treatment.
YES can-do-man that is exactly what he wants to do. He said there is no way I should ever go on Riba or Interferon again due to the bad sides. He travels the globe attending the seminars on all new developments and feels really confident that this will be a success for me and many more.
Fingers crossed that they will go for it and kudos to your doctor for giving it a shot... It has been done before with other Hep C drugs. Really wishing you the very best as treatment for you at this time is very important... Again, good luck.
AASLD Meeting 11/06/13
COSMOS: Simeprevir plus sofosbuvir elicits sustained viral response
WASHINGTON – Results from a planned interim analysis show that using a combination of simeprevir and sofosbuvir as hepatitis C therapy achieved slightly higher sustained viral response in HCV genotype 1–infected patients at 4 and 12 weeks post treatment, suggesting that it may not be necessary to add in ribavirin.
That’s according to lead author Dr. Ira M. Jacobson, medical director of the Center for the Study of Hepatitis C at the Weill Cornell Medical College, New York, who spoke at the annual meeting of the American Association for the Study of Liver Diseases.
Dr. Jacobson presented results from the four-arm, two-cohort, phase IIa COSMOS (Combination of Simeprevir and Sofosbuvir in HCV Genotype 1–Infected Patients) study. He reported on the final sustained viral response (SVR)12 for both arms of cohort 1 and the interim SVR4 for the 12-week arms of cohort 2. The two cohorts were enrolled simultaneously.
Patients were randomized to simeprevir 150 mg once daily plus sofosbuvir 400 mg once daily either with or without ribavirin for 12 or 24 weeks. Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir. Sofosbuvir is an investigational nucleotide inhibitor developed by Gilead Sciences.
Cohort 1, with 80 patients, had a METAVIR score of F0-F2 and had previously not responded to pegylated interferon plus ribavirin.
METAVIR is an algorithm for establishing degree of fibrosis, with 0 being no fibrosis and 4 being cirrhosis. There were four arms of cohort 1: 24 patients received the triple drug regimen for 24 weeks, 15 received simeprevir plus sofosbuvir for 24 weeks, 27 received the triple therapy for 12 weeks, and 14 were given simeprevir plus sofosbuvir for 12 weeks.
* Cohort 2, with 87 patients, consisted of treatment-naive or prior null responders and those with a METAVIR score of F3-F4. In the four arms studied, 30 received triple therapy for 24 weeks, 16 received simeprevir plus sofosbuvir for 24 weeks, 27 got triple therapy for 12 weeks, and 14 received simeprevir plus sofosbuvir for 12 weeks. There was an even split in each arm between treatment-naive and null responders.
At the planned interim analysis, all patients in both cohorts had completed 12 weeks of therapy. In cohort 1, all patients – with the exception of three in the first arm and one in the second arm – had completed 24 weeks of therapy.
* All cohort 2 patients were continuing on study drugs, with the exception of two patients who discontinued triple therapy and one who stopped taking the combination of simeprevir plus sofosbuvir.
In cohort 1, 96% of those who took triple drug therapy for 12 weeks achieved an SVR12, compared with 93% of those on the dual-drug regimen. The SVR12 in those who received 24 weeks of therapy was 79% for triple therapy and 93% for dual therapy.
* For cohort 2, the SVR4 for dual therapy was 100% after 12 weeks of treatment, compared with 96% for the triple therapy. All treatment-naive patients achieved an SVR4 while taking either triple or dual therapy. All prior null responders taking dual therapy also achieved an SVR4, while only 93% of those on the triple therapy achieved an SVR4.
When looked at by HCV GT1 subtype, the results show that patients with the Q80K polymorphism did not fare as well. In cohort 1, 89% of patients with that polymorphism achieved an SVR12, compared with 100% of those with GT1a or 1b without Q80K. In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K.
The most common adverse events were fatigue, headache, and nausea. Adverse events occurred in 70% of patients in the 12-week treatment group and 90% in the 24-week group. Three patients had a serious adverse event.
This is why I am hoping GramyA's doctor is able to pull this off, at her stage she needs to treat and all oral is her best shot...
You are so right kind Sir! The last attempt about killed me (as so many others can attest to the same) My Dr. feels so confident that this plan will be successful for me, I so want to believe him. My body is now finally feeling normal after almost a year out of treatment and feeling good so to think of dealing with any amount of sides again is unpleasant to say the least. I do however feel like it might very well be one of my last hopes in achieving SVR and making it to a ripe older age. I will be sure to let everyone know if the insurance approves the drugs and how it goes as I travel that road again.
Thanks to all of you for your time to respond to my posting! Blessings to one and all!
I wonder if any rich rock n rollers that can afford the $170,000 plus Dr and lab fees might try this off label combo. Of course as Hector pointed out the Q80K polymorphism test will help decide.
Good to see you back and still helping people! :)
I have an appt. with my gastro doctor on Jan. 2 to see if I can get started on the all-oral Sovaldi (sofosbuvir) + ribavirin 12-week regimen (I'm genotype 2, treatment-naive). I have BlueCross Federal. If approved, I'll share the news with the forum.
Fingers crossed for all of us who have been waiting for this new drug!
Treatment naive genotype 2s had a SRV rate of 95% is the FISSION study,
SOVALDI + RBV for 12 weeks.
Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System. The assay had a lower limit of quantification (LLOQ) of 25 IU per mL. Sustained virologic response (SVR) was the primary endpoint which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment.
FISSION was a randomized, open-label, active-controlled trial that evaluated 12 weeks of treatment with SOVALDI and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 2 and 3 HCV. The ribavirin doses used in the SOVALDI + ribavirin and peginterferon alfa 2a + ribavirin arms were weight-based 1000-1200 mg per day and 800 mg per day regardless of weight, respectively. Subjects were randomized in a 1:1 ratio and stratified by cirrhosis (presence vs. absence), HCV genotype (2 vs. 3) and baseline HCV RNA level (<6 log10IU/mL vs. ≥6 log10IU/mL). Subjects with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio.
The most common adverse events (≥ 20%) for SOVALDI + ribavirin combination therapy were fatigue and headache.
I did this treatment for 48 weeks having cirrhosis and liver cancer and found the side effects minimal in comparison to peg-interferon and ribavirin treatment. I had headaches on and off for a few weeks and then fatigue increased over the 48 weeks although I never became anemic. It is very easy to take, 2 pills in the morning one at night.The recommended dose of SOVALDI is one 400 mg tablet, taken orally, once daily with or without food. The dose of ribavirin is weight-based (<165 = 1000 mg and ≥165 = 1200 mg). The daily dose of ribavirin is administered orally in two divided doses With food.
For someone treatment naive with genotype 2 chronic hep C this treatment seems to be what we would all could only dream of a few years ago.
Good luck with your treatment.
Thanks for the info! Don't know if my insurance will pay for it or not.
I hope you're feeling a lot better. I'm glad to see you posting again!
with or without polymorphism 91 % is still great . I highly doubt insurance will pay for sofosbuvir & simprevir , off label , your looking at $ 150 000 usd if you have the funds go for it if not you need to wait until end of 2014 for gilead and abbvie , next treatments will be cheaper as gilead will have competition .One reason of the high price of sofosbuvir is so people do not go off label , if it was say for example like $ 70 000 for the simeprevir sofosbuvir combined many people would do it now even without insurance assistance , I know I would .
In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K.
Express Scripts Pushes Price Competition for Gilead Drug
By Drew Armstrong Dec 10, 2013 4:07 PM ET- Bloomberg
The biggest U.S. drug benefits manager plans to start a price war over a new generation of hepatitis C treatments that will cost $1,000 a pill, in a bid to drive down spending on the medicines.
Express Scripts Holding Co. (ESRX) will pit Gilead Sciences Inc. against AbbVie Inc. (ABBV) and other drugmakers when the new treatments come to market next year or early in 2015. The new hepatitis C pills are projected to be among the biggest pharmaceutical sellers ever. While Gilead’s once-a-day drug may be the easiest to use, Express Scripts might block the pill from reimbursement if the competitors accept lower pricing.
Pharmacy benefit managers like Express Scripts control the list of covered drugs, or formularies, that get reimbursed or are subject to lower co-payments for patients. The companies force drugmakers to compete in an effort to gain discounts in return for making it on to their list, or for having lower co-pays to drive patients to the drugs.
excerpts above - link to full story below
What wrong with this scenario? have dr. prescribe the Sofosbuvir + interf. + riba through insurance and get a prescription for simprevir (cheaper than sofo from what i read on this forum) and pay out of pocket at pharmacy for it? Could this be done?
Sofosbuvir + interf. + riba prescribed for naïve not for treatment experienced so I do not think they would pay for retreatment
I think this is correct , I really hope I am wrong , does any body know ?
If I am wrong that is a great idea
Sofosbuvir + interf. + riba with simeprevir would be a great combo
HealthStat Rx: Curing Hepatitis C (HCV) With Confidence
ATLANTA --(Business Wire)-- December 12, 2013
One of the nation's leading medication therapy management companies, HealthStat Rx, announces today it offers Sovaldi™ from Gilead Sciences and Olysio™ from Janssen Therapeutics, to treat chronic hepatitis C virus (HCV) infection in adults.
HealthStat Rx's national customer base includes hospitals, clinics, healthcare networks, home health care providers and patients with chronic disease. Healthtat Rx partners with patients and providers to drive superior outcomes.
Full article - http://it.tmcnet.com/news/2013/12/12/7591534.htm
FYI If your provider uses HealthStat Rx it may help. But only your insurance company can provide coverage information.
I spoke to a hepatologist and he said that you could get on insurance
sofosbuvir & interferon & ribavirin under you insurance then pay out of pocket for simeprevir about $ 65 000 usd , sounds like a great deal
with this combo you have a great chance to succeed and really $ 65000 out of pocket is not a lot of money for your health
$65.000 is a fortune if you don't have it.
Yeah. You can't *get* $65,000 if you don't have it. I agree.
That is an interesting article. It is entirely possible that maybe now in the 2013/2014 time frame, we're approaching the development of the perfect cocktail to combat the dragon, yet don't be surprised if the insurance giants and the chemical giants force some kind of competition that winds up getting tied up in court for months/years.
Lab corp offers a new test to check for the Q80K polymorphism called the HCV Geno Sure drug resistant NS3/4 test. Don't know the cost though.