Sovaldi and Olysi

[GP7852]

Is the Sovaldi and Olysi combo still too early to know if there have been relapses from this combo after clearing

[GP7852]

Thank you hector,I love a story with a happy ending and null response after 12 weeks for 100% is definitely a happy ending
                                        Glen

[HectorSF]

Relapse is how people fail the Sovaldi and Olysio treatment assuming they complete the treatment. There are no breakthroughs or people that don't become undetectable as with previous interferon based treatments.

COSMOS - Study Design

COSMOS is a phase IIa, randomized, open-label study investigating the safety and efficacy of simeprevir in combination with sofosbuvir, with and without ribavirin, for either 12 or 24 weeks. The study enrolled HCV genotype 1 patients who were prior null responders to treatment with interferon and ribavirin with METAVIR F0-F2 scores (cohort 1, n=80), or treatment-naïve patients and prior null responders with METAVIR F3-F4 scores (cohort 2, n=87).

Final sustained virologic response 12 weeks after the end of treatment (SVR12) data from cohort 1 in previous null responder patients with METAVIR scores F0-F2 were presented, along with sustained virologic response 4 weeks after the end of treatment (SVR4) data from the 12 week arms of cohort 2 in treatment-naïve and previous null-responder patients with METAVIR scores F3-F4. The METAVIR score is used to quantify the degree of inflammation and fibrosis of the liver. Liver fibrosis is scored on a four-point scale.

In cohort 1, 77 percent of the patients had genotype 1a (GT1a) subtype with 50 percent of those having baseline Q80K polymorphism. Seventy percent had IL28B CT genotype, 24 percent had IL28B TT genotype and 59 percent had METAVIR score F2.

In cohort 2, 78 percent of patients had GT1a subtype with 40 percent of those having baseline Q80K polymorphism. Fifty-six percent had IL28B CT genotype, 23 percent had IL28B TT genotype, 47 percent had METAVIR score F4 (cirrhosis) and 54 percent were prior null responders.

"COSMOS – Efficacy Summary

In cohort 1, the SVR12 rate was 93 percent in genotype 1 null-responder patients with METAVIR scores of F0-F2 treated with simeprevir and sofosbuvir for either 12 or 24 weeks.

In an interim analysis of cohort 2, the SVR4 rate was 100 percent in both genotype 1 treatment-naive patients and prior null-responder patients with METAVIR scores of F3-F4 treated with simeprevir and sofosbuvir for 12 weeks.

In a pooled analysis of the 12-week treatment arms in cohorts 1 and 2, SVR4 was achieved among patients treated with simeprevir and sofosbuvir with or without ribavirin, in 96 percent of patients with IL28B non-CC genotype, 91 and 100 percent of patients with a METAVIR score of F4, respectively, and 95 percent of prior null responders.

All patients who completed treatment were HCV RNA undetectable at end of treatment and there were no viral breakthroughs in either cohort 1 or 2. The COSMOS study interim results show no benefit from adding ribavirin to simeprevir and sofosbuvir in this difficult to treat groups of hepatitis C patients and that 12 week treatment may confer similar clinical benefit to 24 week treatment."

Efficacy results with 150 mg simeprevir (SMV) and 400 mg sofosbuvir (SOF) once daily with or without ribavirin (RBV). Intent-to-treat (ITT) population.

Cohort 1:Prior null-responder HCV patients with METAVIR scores F0-F2
SMV / SOF 12-week SVR 93 % (13/14)
*17% (4/24) non-virologic failure

Cohort 2: Treatment naive and prior null-responder and treatment-naïve HCV patients with METAVIR scores F3-F4
* SMV / SOF Null response 12-week 100% (7/7)

* SVR4 data was only available for 12-week arms at time of interim analysis cut-off


Hector