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962490 tn?1406841002

Pricing for Olyiso

Hi,

I currently have Hepatitis C genome type 1A which I have had for a long time. I heard that Olysio (simeprevir) can cure Hepatitis in a person like me. So I what I want to know is: Is this actually true, and, if so, what is the cost of the treatment?

Thanks.
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962490 tn?1406841002
Thanks for the information. As a naive HCV person it is what I was looking for.
Helpful - 0
962490 tn?1406841002
Thanks for the information. As a naive HCV person it is what I was looking for.
Helpful - 0
962490 tn?1406841002
Thanks for the information. As a naive HCV person it is what I was looking for.
Helpful - 0
962490 tn?1406841002
Thanks for the information. As a naive HCV person it is what I was looking for.
Helpful - 0
Avatar universal
Just for clarity...this is a summary from the Final Phase of Cosmos. Note that Cohort 21 is F3/F4 and Cohort 12 is F0/F2....

Final Phase 2 Data from the Interferon-free COSMOS Study
Cohort 21
Final results from cohort 2 of the Phase 2 COSMOS study* found that overall, 94 percent of genotype 1 treatment-naïve and prior null-responder HCV patients, with advanced liver fibrosis (METAVIR F3 or F4 scores) treated with simeprevir in combination with sofosbuvir, with or without RBV, for either 12 or 24 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). In patients treated with simeprevir and sofosbuvir alone, 93 percent and 100 percent of patients achieved SVR12 after 12 weeks and 24 weeks of treatment, respectively. The addition of RBV did not improve SVR rates; 93 percent of patients treated with the ribavirin-containing regimen achieved SVR12 after both 12 weeks and 24 weeks of treatment. Among HCV genotype 1a patients without Q80K, overall 97 percent of patients achieved SVR12 after 12 or 24 weeks of treatment regardless of treatment regimen, respectively. All patients with HCV genotype 1b achieved SVR12, regardless of treatment regimen or duration.

Among patients with baseline characteristics typically considered more difficult to treat, overall 98 percent of patients with the IL28B CT genotype, 95 percent of patients with the IL28B TT genotype, 95 percent of patients with METAVIR F4 scores, and 96 percent of genotype 1a patients with the Q80K polymorphism at baseline achieved SVR12. The most common adverse events reported during the study were fatigue, headache and nausea.

*Excluding non-virologic failures

Cohort 12
An analysis of data from cohort 1 of the COSMOS study* demonstrated that overall 97 percent and 96 percent of genotype 1 HCV patients with METAVIR F0-F1 scores and F2 scores, respectively, treated with simeprevir and sofosbuvir alone achieved SVR12 after both 12 and 24 weeks of treatment. In patients treated with the ribavirin-containing regimen, 100 percent achieved SVR12 after 12 weeks and 24 weeks of treatment, respectively.

Among HCV genotype 1a patients with Q80K, 83 percent and 100 percent of patients treated with simeprevir and sofosbuvir alone achieved SVR12 after 12 or 24 weeks of treatment, respectively, compared to 89 percent of patients treated with simeprevir and sofosbuvir in combination with ribavirin. All patients with HCV genotype 1b achieved SVR12, regardless of treatment regimen or duration. Among patients with baseline characteristics typically considered more difficult to treat, overall 100 percent of patients with the IL28B CT genotype, 83 percent of patients with the IL28B TT genotype, and 100 percent of patients with IL28B CC genotype achieved SVR12. All patients without the Q80K polymorphism achieved SVR12, regardless of treatment regimen or duration. Adverse events (AEs) were mostly Grade 1/2 (77.5%); no serious AEs were reported, two patients discontinued treatment due to AEs.3

“The efficacy seen with the combination of simeprevir and sofosbuvir is very promising, especially considering the inclusion of patients with more advanced liver fibrosis in Cohort 2,” said Dr. Eric Lawitz, M.D., simeprevir clinical trial investigator, CEO at The Texas Liver Institute and Alamo Medical Research and Clinical Professor of Medicine at University of Texas Health Science Center. “I look forward to seeing the combination of simeprevir and sofosbuvir further evaluated in the recently initiated Phase 3 OPTIMIST trial.”
Helpful - 0
446474 tn?1446347682
Actually Olysio standard treatment, using peg-interferon + ribavirin for 48 weeks is not recommended or used by anyone I have heard of. There are much more effective treatments with less side effects currently available and better ones at the end of this year and early next year.

Very poor results for GT 1a treatment naive people (the easiest patients to treat)...
"In the QUEST-1 and QUEST-2 studies, among genotype 1a treatment-naïve patients receiving OLYSIO who had the Q80K polymorphism (a naturally occurring variation in the HCV NS3/4A protease enzyme), 58 percent achieved SVR12 versus 84 percent of patients without the Q80K polymorphism. In the PROMISE study, among prior-relapser patients with the Q80K polymorphism who received OLYSIO, 47 percent achieved SVR12 versus 78 percent of patients without the polymorphism. "

Compared to
genotype 1a using SOVALDI + Peg-IFN alfa + RBV 12 weeks
SVR = 92% (206/225)

Olysio is commonly used with Sovaldi although its use is currently off-label and there may be insurance issues for some folks. Olysio's manufacturer has applied for FDA approval of the combination.

Since you are genotype 1a Olysio based treatment works poorly in patients with genotype 1a the Q80K polymorphism. About 50% of 1as. As FlyingLyn said the recommend treatments for 1a people are...

Sofosbuvir (Sovaldi), Peg-Interferon + ribavirin for 12 weeks
Sovaldi has high cure rates in genotype 1as.
or
Sofosbuvir (Sovaldi) + Simeprevir (Olysio) + Ribavirin 12 weeks
The addition of ribavirin helps to overcome the poorer response in 1a using Olysio.

Better yet wait until the end of the year...

ION-1 GT 1 treatment-naïve (including 15.7 percent (136/865) with cirrhosis)

SOF/LDV   12 weeks 97.7% (209/214)
SOF/LDV + RBV 12 weeks 97.2% (211/217)

ION-2 GT 1 treatment-experienced (including 20.0 percent (88/440) with cirrhosis)

SOF/LDV    12 weeks 93.6% (102/109)
SOF/LDV+RBV    12 weeks 96.4% (107/111)

ION-3   GT 1 treatment-naïve
SOF/LDV          8 weeks 94.0% (202/215)
SOF/LDV + RBV 8 weeks 93.1% (201/216)
SOF/LDV         12 weeks 95.4% (206/216)

So the total retail cost for 3 months of treatment. Of course no one pays this. That is why we have health insurance.
84,000.00 (Sovaldi)
66,360.00 (Olysio)
minimal (ribavirin)
= about $150,000.00

Good luck with your treatment.
Hector
Helpful - 0
683231 tn?1467323017
Forgot to mention the Cosmos study used the medicines Sovaldi and Olysio with and without ribavirin but without any interferon
Helpful - 0
683231 tn?1467323017
Hi

There are a couple of different treatment plans depending on your previous treatment history, the condition of you liver (cirrhosis or no cirrhosis), and especially your Genotype.

The recommended treatment for Genotype 1a per the AASLD (American Association for the Study of Liver Disease)

Summary of Recommendations for Patients Who are Initiating Therapy
for HCV Infection or Who Experienced Relapse after Prior PEG/RBV Therapy
http://www.hcvguidelines.org/sites/default/files/full_report.pdf

Genotype 1 interferon eligible Sofosbuvir (Sovaldi), Peg Interferon (injections once a week)/ ribivirin (5 to 6 pills a day) for 12 weeks

Genotype 1 interferon ineligible Sofosbuvir (Sovaldi) + Simeprevir (Olysio) +/- Ribavirin 12 weeks

Of course the decision to treat and what treatment is between you and your doctor.

The effectiveness data from the Cosmos clinical trials for Cohort 1 (F0-F2 Fibrosis scores) and Cohort 2 (F3-F4 Cirrhosis scores) varies depending of your status between 79% to 100% SVR 12 (cure)

The cost of treatment will depend on your insurance coverage and if you can get assistance from the pharamcutical companies to off set the cost.

here are their web sites:

http://www.olysio.com/hcp/affordability

http://www.mysupportpath.com/

The drugs in the US cost without any assistance for the 12 week treatment of 1 pill a day of each
Sovaldi cost is $ 84,000.00 and Olysio is $ 66,360.00

I have insurance and all I had to pay was $30 dollars a month or $90 total.

Others here have gotten the meds with medicare I think. There are ways to get the medicine which others here have more info than I because for me that was not an issue.

I hope this has helped you and I would ask do you know the severity of your liver damage and hopefully you are under the care of a hepatologist (liver specialist) or at least a gastroenterologist familiar with treating hepatitis c.

Additionally there is a newer treatment hopefully to be approved this fall by the FDA a single pill combo of Sovaldi with Ledipasvir which is proving to be even more effective than Sovaldi and Olysio.

Good Luck
Lynn
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