Hep c back - 12 weeks out- sovaldi

[LA618]

Hello- my husband is cirrhotic, age 53. He has geno 2 hep c and was initially SVR after treatment with ribovirin and sovaldi.  Unfortunately, his last test came back positive again.  I have been scouring the web to get educated on other treatment options. I just don't know what is out there.  I was hoping that someone might have some info for me.

[budstim]

I know little about this disease, Im getting tested next week for possable expossure.  I will pray tonight for neg results for myself and your husband full recovery.  Stay strong, God answers prayers in impossible situations.  Good luck

[dragonars]

I too relasped on sol/rib 12 weeks tx last year g2b As of now there is no other tx for g2. Currently I'm doing 24 week of the same sol/rib hopefully 24 weeks will kill the bugs for good.  This my third tx relasped on reg peg/rib. G2 is supposed to be the easiest to tx apparently my body hasn't got that news letter. Peace

[jules2551]

Hi LA...just wanted to say I am sorry about your hubby's relapse.  Been there, done that, hated it!  

Just curious as to when your hubby actually tested positive for a viral load after his treatment?

Also the GS-5816 (Gilead) is in phase 3 of their trials.  



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Gilead Announces Phase 2 Data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for the Treatment of Chronic Hepatitis C


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-- Once-Daily Combination Achieves High SVR12 Rates Across Multiple HCV Genotypes --

BOSTON--(BUSINESS WIRE)--Nov. 11, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced data from three Phase 2 open-label studies evaluating the safety and efficacy of an investigational all-oral pan-genotypic regimen containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® by the U.S. Food and Drug Administration in December 2013, and the investigational NS5A inhibitor GS-5816 for the treatment of chronic hepatitis C virus (HCV) infection. These data are being presented this week at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting® 2014) in Boston.

All three studies evaluated SOF 400 mg plus GS-5816 25 or 100 mg, with and without ribavirin (RBV), for eight or 12 weeks. Rates of sustained virologic response (SVR12) ranged from 88 percent to 100 percent among those receiving SOF plus GS-5816 100 mg for 12 weeks – the regimen selected for Phase 3 studies. Patients who achieve SVR12 are considered cured of HCV infection.

“There continues to be a need for simple, interferon- and ribavirin-free treatment regimens that are effective for all hepatitis C patients, regardless of genotype,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences. “These data demonstrate the high efficacy and tolerability of sofosbuvir plus GS-5816 among patients with varying genotypes and disease progression and we look forward to providing Phase 3 data on the combination across all six genotypes.”

The first study, GS-US-342-0109 (Oral #197), evaluated 12 weeks of SOF plus GS-5816 with and without RBV in treatment-experienced genotype 1 and 3 patients with and without cirrhosis. The genotype 1 patients had all failed a prior treatment course that included a protease inhibitor. The number and proportion of patients achieving SVR12 are summarized in the table below.

    

SVR12 Rates Among Treatment-Experienced Patients in Study GS-US-342-0109
  
Regimen        GT1
without cirrhosis        GT1
with cirrhosis        GT3
without cirrhosis        GT3
with cirrhosis  
SOF+GS-5816 100 mg    100% (n=20/20)    100% (n=7/7)    100% (n=27/27)    88% (n=23/26)  
SOF+GS-5816 100 mg +RBV    100% (n=18/18)    90% (n=9/10)    100% (n=26/26)    
96% (n=25/26)
  
                

The second study, ELECTRON 2 (Oral #79), evaluated the same combination of SOF plus GS-5816, with and without RBV, for eight weeks in non-cirrhotic, treatment-naïve genotype 3 patients. Patients receiving SOF with GS-5816 100 mg achieved SVR12 rates of 100 percent (n=26/26) with RBV and 96 percent (n=26/27) without RBV.

The third study, GS-US-342-0102, evaluated SOF plus GS-5816, with and without RBV, among non-cirrhotic treatment-naïve patients. The results of Part A of the study evaluating 12 weeks of therapy were presented at the 49th Annual Meeting of the European Association for the Study of the Liver (The International Liver Congress 2014) in April 2014.

The results of Part B, presented at the Liver Meeting this week (Oral #80), evaluated eight weeks of SOF plus GS-5816, with and without RBV, in patients with genotype 1 or 2 HCV infection. Among genotype 1 patients receiving SOF plus GS-5816 100 mg, SVR12 rates were 81 percent (n=25/31) and 90 percent (n=26/29), with and without RBV, respectively. Genotype 2 patients achieved SVR12 rates of 88 percent (n=23/26) with RBV and 88 percent (n=23/26) without RBV.

SOF plus GS-5816 was well tolerated in over 800 patients with HCV infection evaluated in these three studies. There was a low incidence of serious adverse effects and few discontinuations due to adverse events. The most frequently reported adverse events (>10%) were fatigue, headache, nausea and insomnia. The most frequently observed hematologic abnormality was hemoglobin decrease in the RBV-containing treatment groups.

GS-5816 is an investigational product and its safety and efficacy have not been established.

Additional information about these studies can be found at www.clinicaltrials.gov

sorry about the chart go to www.gilead.com and click on press releases.  This is also from the phase 2 trial.  Waiting on phase 3 results.

jules

[Dee1956]

You guys are the best, the way your surround people with love and caring is just unbelievable.
Thank you so much for being here.  It really makes a difference.  To the original poster and all the people who don't post but read here every day
Take Care, Dee

[AWorriedMom]

A friend of mine was at a conference tonight and asked what was availble for geno 2 relapsers or non-responders. He was told that some docs would retreat for 24 weeks. And some would wait for a new drug that Gilead has in trial called GS-5816 (at least that is number he thinks it is). The point is, your hubby shouldn't have to wait too long for something new to come along.

Wishing you the best.

[hepcandme]

I am so sorry to hear about your husband's relapse

It's just so difficult to fight so hard for something, to become undetected, only to find out later that the virus has returned

But MMorgan is spot on. There are new breakthroughs every day and someday Hep C will be something for the history books

Here's a link to a website that talks about new treatments and other many issues that affect Heppers:

http://www.hcvadvocate.org

And, this forum is a great place to pose questions and share your journey. These people are very knowledgable - in fact, more than many doctors I have met, about Hep C issues because they have conducted lots of research and are quite simply, very caring individuals

Good luck to you and your husband!

[Mmorgan854]

hey, I also treated with same meds an same genotype..I asked doctor what was plan 2 in case it didn't work.  He said nothing was available BUT that was last summer an everyone's right about new meds coming out fast.  I think 2 meds have hit the market since then, Harvoni an something else I believe. Don't give up.  I had a failure decades ago, but can tell you one thing I've noticed, treatment has come sooo far an I've seen lots of people being cured, so don't give up..keep positive an think " hubby will be Hep C free soon. Take care.  Mary

[sue4hula]

II don't know what future treatments are coming for geno 2s, but I'm sure things are in the pipeline.  Never give up hope!

Most of all, I want to say how sorry I am to hear about the treatment failing your husband (and you by extension).  It's a crummy feeling.  Give yourselves time to recover and regroup.  

I am starting number 4 of treatment regimes.  The treatments have evolved and come sooner and work better every year.  I believe that our time IS coming! HOPE is the word!

Be well.
Susan

[AWorriedMom]

Unfortunately the HCV guidelines do not say anything about geno 2 patients with your hubby's profile. They do say that extending to 16 weeks for cirrhotics may be a good idea. I don't know if after relapse he can treat again for a longer time. There will be new drugs coming out soon that very well may be successful for him. Have you talked with his doc about any of this?

[Dee1956]

I found this: I wish there was something else.  

http://www.hepatitisc.uw.edu/go/treatment-infection/treatment-genotype-2/core-concept/all

[Dee1956]

I am so sorry to hear this news.  It is awful to relapse.  I know I felt terrible when I relapsed.  I had to wait 3 years and treat again.  The same will happen for your husband.
I am sure others will be along soon but I will go take a look to see what is advised
Take Care, Dee

[AWorriedMom]

I'm sorry to hear about your husband's relapse. Can yu tell us how long he treated for?