FDA Approves Sovaldi Olysio combo

[flyinlynn]

Sov/Oly is no longer off label with 24 weeks recommended for patients with cirrhosis

http://www.aidsmeds.com/articles/Olysio_Sovaldi_approval_1667_26373.shtml

On November 5, the U.S. Food and Drug Administration granted approval of Olysio (simeprevir) and Sovaldi (sofosbuvir) to be used in combination for the treatment of genotype 1 of hepatitis C virus (HCV), Bloomberg News reports. Janssen’s NS3/4A protease inhibitor Olysio and Gilead Sciences’ nucleotide analog NS5B polymerase inhibitor Sovaldi were each approved at the end of 2013 and since then have often been prescribed together. (Although Sovaldi in combination with interferon and ribavirin has dominated the market.) But because Olysio and Sovaldi had not been approved as a combination therapy, clinicians have had to prescribe them off label. This approval removes that technicality and also allows Janssen to market the combination.

The FDA recommends 12 weeks of Olysio-Sovaldi for people without cirrhosis and 24 weeks of the combination therapy for those with cirrhosis.

Already on the  Olysio full prescribing Information but I did not see the change to the Sovaldi Information Sheet

https://www.olysio.com/shared/product/olysio/prescribing-information.pdf

-----------------------DOSAGE AND ADMINISTRATION-----------------------
• One 150 mg capsule taken once daily with food. (2.1)
• OLYSIO should be administered in combination with other antiviral
drugs for the treatment of CHC infection.
• Recommended treatment duration (2.1):
• OLYSIO with peginterferon alfa and ribavirin: 12 weeks, followed
by 12 or 36 additional weeks of peginterferon alfa and ribavirin
depending on prior response status.
• OLYSIO with sofosbuvir:
o Treatment-naïve or treatment-experienced without cirrhosis:
12 weeks

[Kanarstead]

More "real world" results here. 1211 patients.

http://www.natap.org/2014/AASLD/AASLD_09.htm

[Pamelajean1]

Real world results with S/O were just released....

http://www.ajmc.com/conferences/AASLD2014/The-Real-World-Experience-With-Simprevir-and-Sofosbuvir-Based-Regimens-in-Hep-C-Treatment

[Dee1956]

Hi Lynn, thank you for sharing this, it is really good news to hear.
I am sure others will be happy hear as well
Take Care
Dee

[flyinlynn]

And I was in the 6/7 or 85% group with cirrhosis.

That's the thing about clincal trials and why the results do not precisely extrapolate out when you treat 4 million patients

[can-do-man]

From flyinlynn link.

"Ninety-five percent (20 out of 21 participants) of those with METAVIR fibrosis scores of F0 to F3 who took 12 weeks of Olysio-Sovaldi achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Eighty-six percent (6/7) of all participants who had cirrhosis and took the combination therapy for 12 weeks achieved an SVR12, and 100 percent (10/10) of those with cirrhosis who were treated for 24 weeks were cured.

Across the board, 93 percent (26/28) of participants cured after taking 12 weeks of treatment and 97 percent (30/21) achieved an SVR12 after 24 weeks of treatment.
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This is what makes me shake my head, look at the numbers. 20 out of 21 people? Really? If you had got lucky with the right people with the old SOC treatment you could have had these numbers but in reality only around 38% with SOC were cured...