pages 8 through 12

Kramer, It looks like you are a stockholder of Gilead's. I did not see anywhere in that report they are curing hepatitis C using their sofosbuvir with 5885 with out using the toxic drugs ribavirin or interferon. I don't care if the call it Peg this or that as long as they have any name remotely resembling interferon..........its interferon

What was shown is the only way genotype 2 & 3 had results is with ribavirin and the poor genotype 1's had to have both toxic drugs interferon and ribavirin.

No not a stock holder at Gilead, just watching the ship get closer and closer.
If you missed page 9 I copy paste for your convenience.
No mention of Interferon.
You are invited to ignore my posts in the future unless you have something positive to add. I don't need your negative energy as HCV on my plate is more than enough for me thank you.

Sofosbuvir Phase 3 Program: GT 1,4,5 and 6
SOF 400 mg QD +
PEG 180 g/week +
RBV 500 or 600 mg BID
Study Weeks
study commenced June 2012, fully enrolled early August 2012
NEUTRINO:
Treatment-nave patients, multicenter, open-label study
Primary objective:
Determine efficacy of 12 weeks of treatment with
Sofosbuvir+PEG+RBV as measured by SVR12
Evaluate the safety and tolerability
9
Overall SVR12 90%
(89% in GT-1 (n=292); 97% in GT-4, 5 or 6 (n=35)

Sorry I pasted the wrong page.
I redirect your attention to page 11 and 12
FDC refers to Fixed Dose Combination

ION-1 Sofosbuvir/Ledipasvir Phase 3 FDC Study
Interim analysis (SVR4 of the 12 week arms) after 200 patients
(50/arm)
200 patient vanguard cohort fully enrolled
SOF 400 mg + LDV
90 mg FDC
SOF 400 mg +LDV 90 mg FDC SVR12
SOF 400 mg + LDV
90 mg FDC/RBV
SOF 400 mg + LDV 90 mg FDC/RBV SVR12
n=200/arm
GT1 Treatment
Nave Patients
12 weeks 24 weeks
SVR12
SVR12
11ION-2 Sofosbuvir/Ledipasvir Phase 3 FDC Study
Primary Endpoint:
Determine antiviral efficacy of combination treatment with SOF/LDV FDC
RBV as measured by the proportion of patients with sustained viral
response 12 weeks after discontinuation of therapy (SVR 12)
Screening patients
SOF 400 mg + LDV 90 mg FDC SVR12

Gilead Provides Update on Hepatitis C Development Programs
-- Sustained Virologic Response Achieved with Oral Regimen of Sofosbuvir, GS-5885 and Ribavirin in 9/9 Null Responder Genotype 1 Hepatitis C Patients --

-- Second Phase 3 Study Evaluating Fixed-dose Combination of Sofosbuvir and GS-5885 to Begin Later this Month --

Gilead is currently evaluating a once-daily fixed-dose combination tablet containing sofosbuvir and GS-5885 in several Phase 2 and 3 trials. The studies evaluate sofosbuvir/GS-5885 with and without RBV among a range of genotype 1 HCV patient populations.

ION-1: This Phase 3 trial was initiated in October 2012 and is evaluating sofosbuvir/GS-5885 with and without RBV for 12 or 24 weeks among treatment-nave genotype 1 patients. Pending a review of results from the two 12-week arms (n=50/arm) of an initial enrollment of 200 patients, ION-1 will continue to recruit patients and assess sofosbuvir/GS-5885 in a total of 800 individuals.
ION-2: Gilead today announced that a second Phase 3 study for sofosbuvir/GS-5885, ION-2, is expected to begin screening patients in January 2013. This study will evaluate the fixed-dose combination, with RBV for 12 weeks and with and without RBV for 24 weeks of therapy among 400 treatment-experienced genotype 1 HCV patients. Participants in this study will have failed past therapy with regimens containing IFN or IFN plus a protease inhibitor.
LONESTAR: Gilead also announced that enrollment is now underway for a new Phase 2 study of sofosbuvir/GS-5885 for 12 weeks and of sofosbuvir/GS-5885 with and without RBV for 8 weeks among genotype 1 treatment-nave patients. Two additional arms in this trial will evaluate sofosbuvir/GS-5885 with and without RBV for 12 weeks among treatment-experienced genotype 1 patients who had previously received a protease inhibitor-containing regimen. This study, which will enroll 100 patients, is the first trial to evaluate the combination of sofosbuvir and
GS-5885 for only eight weeks of treatment.

http://www.gilead.com/pr_1771657

Thank you Kramer, Sorry , I just want a cure for all of us without the toxcity of two of worse drugs in exisitance, ribavirin and interferon. I feel so bad for the many that have gone through these "treatments" and have failed just to go onto stronger more toxic treatments. I have genotype 1a.

Interferon is the enemy. Ribavirin, while no picnic is doable.
Not sure where you feel we are asked to "just to go onto stronger more toxic treatments."
Sofosbuvir and Ledipasvir are well tolerated with high compliance in the trials. Treatment duration is 12 weeks, not 48 as in the past.

What I meant was, it seems that people try a treatment and fail and then they seem to go onto triple or quad treatments. Ribavairin maybe doable but it is still toxic. It's side effects are bad. I'll go for a treatment without the FEAR and BAD (interfearon and ribadvirin). I do understanding that the sofosbuvir and Ledipasiv (5885) are being tolerated well, but I want to see how Hepccat makes out without the riBADvirin.

You must have the luxury of time on your side. That is enviable. Best to wait for what you are comfortable with then and I wish you luck.

http://www.aafp.org/afp/2005/0815/p655.html

Ribavirin causes birth defects, fetal demise, serious hemolytic anemias, and worsening of cardiac disease. It also may be carcinogenic. Patients should be carefully counseled about the risks of these medications and monitored closely during treatment
Ribavirin can cause a hemolytic anemia. The traditional approach to hematologic toxicity has been reducing the dose of the offending antiviral; however, lower doses also may reduce treatment efficacy.
Elevations of bilirubin usually are an indication of hemolysis caused by the ribavirin and usually are concomitant with drops in the hematocrit. Between 1 and 2 percent of patients will develop thyroid abnormalities severe enough to require clinical interventions, so thyroid-stimulating hormone levels should be checked periodically while the patient is on treatment. Triglycerides can be elevated and can cause pancreatitis.

Posttreatment Issues
Side effects of the medications may linger for some weeks after they are discontinued, and in some cases may be permanent, so monitoring is important even after successful completion of a course of treatment.

Well im in day 10 of that trial.. Im geno type 1A and im on the 12 week sofosbuvir with 5885 I have done the interferon with the pegas and Rib and i didnt not et any results..Lowered my viral load but went back up when i got off. But im thankful to try this and i look forward to trying to help other people in the future.. So with that said good luck to everyone..

Wow mdudley for your first post ever you sure jump in! Hmmmm my sense tells me it's time to move on here. Ta ta ;-)

But before I go best of luck on your trial ofl69ers!

Well ,I have done riba and interferon and a year later riba,interferon and bociipervier got close too clearing but after 7.5 months I threw the towel in,well my body told me I had too and the doc said I should have stopped at 3 months,but with my stubborn arse attitude at the time I persisted.
Should have listened to my doc and stopped.
Sorry ,long story short,when australia finally get gilead,my doc recommends I do add riba,so that my chances are much greater.
Even after all I have been through with treatments I will use riba again ,with out hesitating.
Better getting riba into me then this virus,well thats my 2 cents anyway.
Cheers
Les.

I think that it's pretty obvious that you have a chip on your shoulder towards anyone that is only sharing information in a positive manner which for whatever reason you don't agree with... Especially if Interferon or Riba is even mentioned in any post!

We're not the enemy Maliesz!!! HCV is!!! And you wonder why you're not getting enough signatures (I already signed a while ago)???

Maybe being less negative and showing more solidarity is something that could help you instead of shooting at the messenger... Whoever that may be in any given post.

So drink a gallon or two of "Frosty" and the phuck out!!!
You want to represent??? Well you're doing one heck of a job so far!!!

Henry