16 week sov/rib trial ends monday

[TIMBOY67]

Hi , Finishing 16 week sov/rib trial this monday , side effects hasn't been to bad at all , just felt a bit aggitated at times
& quick tempered , i've been und since week 2 , this is second attempt at tx , tried int/rib in 2011 had to stop after 12 weeks non resp , so hopefully God willing I'll stay und till 12 weeks after tx & get s.v.r. .. I've also managed to work through tx .Three teenage kids weren't aware of hepc or tx , so looking forward to being there for wife & kids a bit more, & not being so ingested with tx .

P.S. good luck to any fellow sufferrers who are thinking of starting or are about to start tx  


45 yr male ,non chirrotic , diagnosed 2011, Geno 3 , infected 22yrs i.v. user , int / rib non res 2011 , v.l. 3.2 mill ,

[heart_in_the_keyes]

Okay....thank you for the information.  That was very clear and informative on many levels.  Thank you.  

[pooh55811]

If he was Undetected at 16 weeks of treatment that just means he is Undetected. It does not mean he is SVR. SVR is if he is still UND at 24 weeks post end of treatment (24 weeks after the end of treatment).

The thing with Sofosbuvir and Ribavirin treatment in Genotype 3 patients is that people do go UND early on in treatment. However, what they found in the studies is that people who treat for 16 weeks as opposed to 24 weeks have a much greater chance for relapse.

In the Fusion study, those Genotype 3 patients who received 16 weeks of treatment had an overall SVR rate of 63% (and previous non-responders had an SVR rate of 53%).

In the Valence study those with Genotype 3 who received 24 weeks of treatment had an overall SVR rate of 84% (77% for treatment experienced). That is a huge difference in SVR rates.

In addition, once it became clear that Genotype 3 patients had much higher SVR rates with 24 weeks of treatment, the original Valence Study design was changed and they put all remaining Geno 3 participants into the 24 week treatment regimen.

"The VALENCE trial evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis. The original trial design was a 4 to 1 randomization to SOVALDI + ribavirin for 12 weeks or placebo. Based on emerging data, this trial was unblinded and all genotype 2 HCV-infected subjects continued the original planned treatment and received SOVALDI + ribavirin for 12 weeks, and duration of treatment with SOVALDI + ribavirin in genotype 3 HCV-infected subjects was extended to 24 weeks. Eleven genotype 3 subjects had already completed SOVALDI + ribavirin for 12 weeks at the time of the amendment."

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/ucm377920.htm

[heart_in_the_keyes]

Pooh...if he was showing SVR at 16 weeks would there really be a reason for him to continue with the drugs for another 8 weeks...that's another $64,000 in drugs...don't know how he is paying but if he has to do copay it could be any where from $3,000 to $14,000 a month.  

I am geno 1 and they have already told me that I am going 24 weeks even though what I read is 12...

Do you think it's based on the individual rather than the guidelines? This is a real question.  Start on the Sovaldi/Riba on Saturday.  

[JimmyMose]

TIMBOY67  Good luck hope SVR 12 weeks post tx
was this your trial?  
http://www.clinicaltrials.gov/ct2/show/NCT01962441

FYI to those with HCV GT1 & GT3 in India
New trial to start soon but wonder why 16 weeks for GT3 is still one of the arms?

http://www.clinicaltrials.gov/ct2/show/NCT02074514

Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
This study is not yet open for participant recruitment.
First received: February 26, 2014  Phase 3
Arms
Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.

[cheflady]

Just wanted to say hi and wish you all the very best,ialso wish you the ultimate goal of SVR. best wishes Jules

[pooh55811]

I realize you are in a trial, but I am wondering why there is a trial with 16 weeks of Sofosbuvir and Ribavirin when it has already been shown that Genotype 3 has a much better SVR rate when the length of treatment is 24 weeks. The SVR rates were not that good with 16 weeks of treatment but were considerably improved when the treatment was for 24 weeks.

The SVR rates with 16 weeks of treatment were in the low 60 percents. The SVR rates with 24 weeks of treatment were 84% (overall).

Scroll down to the Valence study in this link.

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/ucm377920.htm

Again, I know you are in a trial, but it may be worth it to ask about this factor and find out why you are being treated for 16 weeks when it has already been proven that 24 weeks offers much higher SVR rates.  Also, is there a rollover plan or something in place if you do not attain SVR.

Regardless, I do hope you attain SVR and I wish you the very best of luck.