Abby Trail versus Cosmo (Solvadi Olysio)

[milliehepc]

My Insurance approved the Cosmo regimen - Solvadi and Olysio.  However, today my Dr.  told me today that the test came back that determines if the Solvadi and Olysio were right for me.  Turns out I am geno 1A and that gives a 80% cure rate.  He said, I have a chance to be resistant to the S/O combo or the S...not sure...if one or both..

He thinks I should wait for the new Abby trial (don't know a thing about it) that would require a 4 day hospital stay.  (Not clear why one would have to stay in the hospital yet). They will do a Fibroscan to see what has transpired since the 2011 Biopsy where I was a 2/3.  

My recent scan did not show any huge changes from last May.  Mild Elevation.  Everything looking "good" no enlarge spleen asiste and stuff like that....I am also treatment naive.

He thinks I should consider this trail and/or wait for the better meds that gives me a higher cure rate than 80%.  

If you have ANY information on this trail - ABBY please let me know...

Thanks to all on this site that have guided me since 2011 - Hector who is my virtual doctor...and all.

Millie

[milliehepc]

Thank you very much Pamelajean and hrsepwrguy.  Really appreciate the information and will research your links and read it carefully.

I don't know why - he just said for my case its 80%.  He thinks this other regimen (AbbVie) will work better for me.  It requires a 4 days stay in a hospital!  I need to find out why that would be and will post it as soon as I get more information.

United Health had approved the meds (O&S) and I got a co-pay from Patient Access Network up to $7,000 for the co-pay.  So - I suppose I still have that option but I am waiting for his advice.  My Dr. is the Director of Hepatology...at NYU School of Medicine....so I hope he has it right.

The AbbVie would be a Trail -everything would be covered free.  I will have another appointment with him in 2 weeks.  Also, he is going to do a Fibroscan - sort of to update the condition since my 2011 (Stage 2/3) biopsy.  Have had the virus since I was 26 (my best estimate) and I am currently 65!  

Again, thank you for taking the time to advice me.

[hrsepwrguy]

AbbVie Oral Regimen Cures Nearly All GT1 Hepatitis C, Phase 3 Trials Now Done

AbbVie announced this week that it has completed Phase 3 clinical trials of its interferon-free regimen containing 3 direct-acting antivirals, with or without ribavirin, for the treatment of chronic hepatitis C. Across all studies, between 90% and 100% of participants achieved sustained virological response, usually with 12 weeks of therapy, including hard-to-treat patient groups such as people with HCV subtype 1a and liver cirrhosis.

AbbVie previously announced findings from the SAPPHIRE-I and SAPPHIRE-II trials, which both produced 96% overall sustained response rates at 12 weeks post-treatment (SVR12) using a 4-drug regimen consisting of the HCV protease inhibitor ABT-450, the NS5A inhibitor ABT-267, the non-nucleoside polymerase inhibitor ABT-333, and ribavirin

Since then, the PEARL-II, -III, and -IV trials have shown that a 3-drug regimen without ribavirin for 12 weeks cures 99%-100% of patients with HCV subtype 1b, but adding ribavirin is more effective for those with harder-to-treat subtype 1a. The TURQUOISE-II study showed that the quadruple regimen for 12 or 24 weeks cures most people with compensated liver cirrhosis.

AbbVie plans to submit data from these trials to the U.S. Food and Drug Administration in the second quarter of 2014, putting the designated "breakthrough therapy" on track for approval by the end of the year.

http://hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4507-abbvie-all-oral-regimen-cures-nearly-all-gt1-hepatitis-c-phase-3-trials-now-complete

[hrsepwrguy]

(Reuters) - AbbVie Inc's all-oral hepatitis C therapy cured 96 percent of difficult-to-treat patients in a late-stage clinical trial after 12 weeks, keeping the company well placed in a highly competitive race to deliver new treatments for the serious liver disease.

http://www.reuters.com/article/2013/12/10/us-abbvie-study-hepatitisc-idUSBRE9B90KL20131210

AbbVie’s trial for an unnamed multidrug therapy is in the last of three stages typically required for U.S. approval and is moving quickly, Scott Brun, the company’s head of drug development, told investors today at a conference in New York. Gilead is seeking to bring its own multidrug regimen with its therapies sofosbuvir and ledipasvir to market next year.

“We’ve got a very good shot at being first,” Brun said at the conference hosted by Goldman Sachs Group Inc. “It is a very tight race.”

http://www.bloomberg.com/news/2013-06-13/abbvie-says-it-can-be-first-with-new-hepatitis-c-drugs.html

[Pamelajean1]

Forgot to add....was just researching the Abby trials this morning and it appears that Gilead will be FDA approved with their combo pill of Sovaldi/Ledi before theirs. Gilead has submitted to FDA and are poised to be approved in the fall of this year.

Depending on the condition of your liver that might be a consideration. If not, I would suggest you take the above recommendation to your doc for him to review....it's all moving so fast sometimes we know things our doc does not. :)

[Pamelajean1]

I'm curious as to where he's getting the 80%. I'm 1a, cirrhotic and Q80K positive...the Q80K does decrease success rate some but not to 80%.

The American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society-USA (IAS-USA) this week announced the first new hepatitis C treatment guidelines that include next-generation direct-acting antiviral agents recently approved by the FDA. The guidance is available on a new website, HCVguidelines.org, that will enable frequent updates to reflect emerging data.

"It is important to keep in mind that FDA only will approve drugs that have gone through rigorous testing," said IAS-USA panel co-chair Michael Saag from the University of Alabama at Birmingham. "We cannot run a Phase 3 trial on every possible [drug] combination or every possible patient population. The website allows experts in the field to look at the emerging data and craft what we feel the evidence supports, [which] may fall short of what is specifically in an FDA-approved package insert."

"For genotype 1 patients who cannot take interferon, the panel recommends sofosbuvir plus the HCV protease inhibitor simeprevir (Olysio), with or without ribavirin, again for 12 weeks. This off-label regimen has not been through full Phase 3 testing, but performed very well in the Phase 2 COSMOS trial.
An alternative for this group is sofosbuvir plus ribavirin for 24 weeks, though the panel noted that it is not as effective as sofosbuvir plus simeprevir, especially for patients with liver cirrhosis."

"For patients infected with genotype 1a HCV, baseline resistance testing for the Q80K polymorphism may be considered. However, in contrast to using simeprevir to treat a genotype 1a HCV patient with PEG/RBV when the mutation markedly alters the probability of an SVR, the finding of the Q80K polymorphism does not preclude treatment with simeprevir and sofosbuvir, because the SVR rate was high in patients with genotype 1a/Q80K infection (SVR12 rate for cohort 1 was 86% [24 of 28 patients]; SVR4 rate for cohort 2 was 90% [10 of 11 patients]). To date, virologic failure has not been observed in patients in either cohort infected with HCV genotype 1b and with HCV genotype 1a in the absence of the Q80K polymorphism. Thus Q80K testing can be considered but is not strongly recommended."