Sofosbvir vs Simeprivir

[48weeks]

Over the years since 1990 I twice failed interferon+ribiviran and then last month found out at my 6 month EOT that I relapsed from a 48 week Teleprevir+Int+Rib treatment. I'm trying to get more info on these two treatments to decide which would be more effective for Genotype 1a, I don't know the status of my liver because I haven't gotten a biopsy in 8 years. I am getting a biopsy next month. I've heard lots of people talk about the effectiveness of Sofosbvir, but have not heard as many personal reports on Simeprivir. Is there anyone out there treatment experienced that has been through a Simeprivir trial and what was your experience?

Thanks

[48weeks]

Well you've all sort of confirmed my suspicions. I have been thinking that my chances are best with Sos+Led+Rib. Not sure why my hepatologist seems so high on Simeprevir. Thanks, now for the endless wait

[Cheesegrater]

Trials for sofosbuvir/ledi/riba are wrapping up and in these trials are those who failed previous (telaprevir-incevik/boceprevir) with peg-ifn-riba.

Very high rates of SVR so far even in those who were null responders or failed protease inhibitor/Peg-riba.

I would wait for a SOF/NS5A with or without Riba treatment if I had GT 1a and failed previous PI/Peg/riba as the development of viral resistance/breakthrough  seems to be far less with SOF than PI for GT 1a, your chances would be better.

[ppmguy]

         hmmmmm!!   insurance will not likely approve sofo for you, since you are tx exp.   and while you can most likely get any of the three PIs available, how can drs test for ressisstance to PIs.
barry

[pooh55811]

Just to add to what Can-do posted, Simeprevir is more effective in people without the Q80K polymorphism and less effective in people with the Q80K polymorphism. So one would want to get tested for that polymorphism before making a decision on treatment.

OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C

"Janssen Therapeutics, Division of Janssen Products, LP (Janssen), announced today the U.S. Food and Drug Administration (FDA) has approved OLYSIO™ (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.  .....

Given the complexity of the condition, OLYSIO™ was studied in a number of different patient populations, including individuals who have relapsed or failed to respond to previous treatments," said Douglas Dieterich, M.D., Professor of Medicine in the Division of Liver Diseases, Mount Sinai School of Medicine, and OLYSIO™ clinical trial investigator. "The FDA approval of OLYSIO™ is an important milestone for people living with chronic hepatitis C as it means that patients have a new treatment option with the potential to cure this challenging disease."   .....

The efficacy of OLYSIO™ in combination with peginterferon and ribavirin is greatly decreased in patients who have genotype 1a Q80K. Please talk to your doctor about testing for genotype 1a Q80K and using a different therapy when genotype 1a Q80K is present. It is not known if OLYSIO™ is safe and effective in children under 18 years of age.

The New Drug Application (NDA) filed by Janssen Research & Development, LLC, for OLYSIO™ was based in part on efficacy and safety results from three pivotal Phase 3 studies – QUEST-1 and QUEST-2 in treatment-naive patients and PROMISE in patients who have relapsed after prior interferon-based treatment – as well as data from the Phase 2b ASPIRE study in prior non-responder patients. Each of the studies evaluated OLYSIO™ dosed once daily in combination with pegylated interferon and ribavirin versus treatment with placebo plus pegylated interferon and ribavirin.

Results from a pooled analysis of QUEST-1 and QUEST-2 demonstrated that 80 percent of treatment-naive patients in the group receiving OLYSIO™ achieved sustained virologic response 12 weeks after the end of treatment (SVR12), compared with 50 percent of patients in the placebo groups. In PROMISE, 79 percent of prior-relapser patients in the simeprevir group of the study achieved SVR12 compared with 37 percent of patients in the placebo group. Results from ASPIRE demonstrated that use of OLYSIO™ led to sustained virologic response 24 weeks after the end of treatment (SVR24) in 65 percent of prior partial-responder patients and 53 percent of prior-null responder patients compared with 9 percent and 19 percent of prior partial- and null-responder patients in the placebo groups, respectively.

In the QUEST-1 and QUEST-2 studies, among genotype 1a treatment-naive 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 placebo arm, 52 percent of patients with the Q80K polymorphism achieved SVR12. 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. In the placebo arm, 30 percent of patients with the Q80K polymorphism achieved SVR12.     ..... "

Read more here: http://www.sacbee.com/2013/11/22/5938464/olysio-simeprevir-receives-fda.html#storylink=cpy

[can-do-man]

Sense Simeprevir is another PI with about the same results as the other 2 I'm not sure a doctor would even recommend a prior failure even attempt it. Besides that it seems to be interferon just doesn't work for you. If it was me and I needed to treat right away I would ask about going off label and treat all oral using both of them, Sofo and simeprevir.

If you do decide to treat again find out your IL28b type as it seems to play a huge factor with Simeprevir

"Patients enrolled in QUEST-1 and QUEST-2 were stratified by HCV genotype 1 subtype and IL28B genotype. In QUEST-1, SVR12 rates among patients treated with simeprevir with IL28B genotype variations were 94 percent for the CC allele, 76 percent for the CT allele, and 65 percent for the TT allele. In QUEST-2, SVR12 rates among patients treated with simeprevir with IL28B genotype variations were 96 percent for the CC allele, 80 percent for the CT allele, and 58 percent for the TT allele. Among patients with METAVIR scores F3 and F4, 70 percent of patients treated with simeprevir in QUEST-1 and 66 percent of patients treated with simeprevir in QUEST-2 achieved SVR12. Among patients with METAVIR scores F0 to F2, 83 percent of patients treated with simeprevir in QUEST-1 and 85 percent of patients treated with simeprevir in QUEST-2 achieved SVR12. The METAVIR score is used to quantify the degree of inflammation and fibrosis of the liver and patients are scored on a four-point scale.

"Patient response rates to hepatitis C therapy can be variable, depending on factors such as viral genotype and subtype, and liver fibrosis. Patients with genotype 1a, IL28B genotype TT and METAVIR scores of F3 and F4 can be particularly challenging to cure," said Maria Beumont, M.D., medical leader for simeprevir, Janssen. "Janssen is committed to advancing hepatitis C therapy for even the most difficult-to-cure patients."

Good luck