for sofosbuvir trial

[chirag0019]

(for female : 60 year)
inj. pegasys 180 mg for (24 week)
cap. ribavarin 200 mg for (24 week)
i have almost treated this medicine.but not a fair result
now doctore suggest above treatment repeat for 48 weeks.
but doctor not sure for good result above treatment.

(So please help me about Tab. SOFOSBUVIR clinical trial places or information.)
note: sofosbuvir not available in market.

[cebach50]

Pharma and the doctors are so full of it. You do not need the Int, or Riv pills. Sofosbuvis along with Daclatasvir , and you won't need Interferon or Ribavirin. The complete study I read was that the 2 of these drugs knocked the virus 100% out of the body. The study that was done to some of his patients was done without Interferon or Ribavirin. Both Interferon and Ribavirin were origanally suppose to aid in the recovery of Polio. When they finally found out that these drugs wern't going to aid in a cure for Polio, they went onto another vaccine, which we use today. Well all of that stock pile of those drugs, Interferon, and Ribavirin, which are said to have a 50 year shelf life, they wern't just going to throw away. There was well over 2 million vials, and twice as many pills. Billion of Pharma money. So they started using the Interferon and Ribavirin on Hep C patients. They are actually the same disease. How do I know that? My VA primary care doctor told me they were, and all about the Interferon, and Ribavirin roller coaster, I have went through the 48 week combo theropy, 2 Pegintron treatments, and 1 pegasis treatment. Pegisis took me from 33 million V load , down to 700,000 in 6 weeks. At that point the side affects got way worse. So i quit. I quit because I started using small amounts of Medical Marijuana and showed up positive on a drug test for THC. I was using the Marijuana from the minute I started Pegisis. It got me through the first 6 weeks, and then Igot knocked out of the program. They said the Marijuana was slowing down the process. Well tuff chit. I had just about no side affects from the pills and injections. That is the reason I was still going stong . I would have made 48 weeks. These 2 new drugs are the ticket for us. Please help me make it more away to the public, and especially the Hep C community.

[ActingBrandNew]

"Is it true that we will still have to take Riba and INf with it?"

Since you are a Genotype 3 then it will just be Riba+Sofosbuvir

Gilead's GS 7977 (Sofosbuvir)

Gilead are developing a new drug for the treatment of hepatitis C that may be taken without Interferon. This would mean an all oral (in the form of pills) treatment that would be taken with Ribavirin. The drug is a polymerase inhibitor and its development name is GS – 7977.

As with all drugs it will have to go through rigorous research and safety procedures before it is licensed but if it is successful we are hoping to see availability of this drug possibly in 2014.

Sofosbuvir (GS-7977) Plus Ribavirin for Genotypes 2 and 3

Press release: 27.12.12

POSITRON Demonstrates Efficacy of a 12-Week All-Oral Regimen of Sofosbuvir Plus Ribavirin for Chronic Hepatitis C Patients who are Unable or Unwilling to Take Interferon

Gilead Sciences today announced topline results from the Phase 3 POSITRON study examining a 12-week course of once-daily sofosbuvir plus ribavirin (RBV) in patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who are not candidates to take interferon (IFN). The study found that 78 percent of patients (n=161/207) remained HCV RNA undetectable 12 weeks after completing therapy (SVR12). The safety profile of sofosbuvir was similar to that observed in previous studies, and there were few treatment discontinuations due to adverse events.

POSITRON is the first of three Phase 3 studies to be completed that are evaluating sofosbuvir therapy in HCV genotype 2 or 3 infected patient populations.

http://www.hepctrust.org.uk/Treatment/Potential+New+Drugs/Drugs+that+target+the+virus/Gilead+GS+7977+%28Sofosbuvir%29

[mythoughts]

Hi guys,

I haven't posted for a while so I'm looking for updates on 7977. Is it true that we will still have to take Riba and INf with it? That the 90+% cure rate is down to 50-90%? Wow.

I am 38yr olf female, geno3 450,000 Vl, co-infected with HBv, -20 VL. Liver emzymes wetn from low 40's to low 20;'s after i started a probiotic, cut glutne from my diet (I was allergic) and started taking effential fatty acids daily. Literally, those were my only changes and my emzymes that were always low 40's for years dropped to low 20's and stayed there. I have no fibrosis per Fibrosure and ultrasound looked normal.

On the one hand, I want to treat with 7977 b/c as a 3, my chances look good. BUT, I've been told that the HCv is the dominant virus, and is suppressing the HCV b/c I don't have any HBV antibodies. My doctor recommends taking duoble dose INF with 7977 for a year to have a whole 30% chance of clearing the HCv. Without it, even if I clear the C the B will flare up most likely.

For now, I'm healthy despite infection for likely 20yrs. If you were me, would you treat with just 7977 when you can, 7977 with a year in INF or keep waiting? The choice is hard. I don't qualify for ANY trials due to the co-infection (I've tried), even though the HCV is -20 which is considered undetectable per the VL tests, as long as I am angiten + they won't treat me in any trials for HCv.


What would YOU do?

Thanks guys.

[ActingBrandNew]

I am a genotype 3 as well and finished SOC a month ago. I see you are in India. Below i am posting a link for the clinical trials registry in India. Type in key word HCV or Hepatitis C for trial search and many will come up.  Ive posted a few links to trials. It seems most of the good ones are for genotype 1 however I would recommend contacting the recruiters anyways because they may have information regarding an up and coming trial for a genotype 3.

I see all the info you put above but I did not see an IL28B Genotype. I recommend your mother get the test done. If she is an IL28b TT genotype then I wouldn't even consider treating for 48 weeks but if she is a CC or CT and there are no other options she may want to consider doing the 48. She should definitely look into the trials though.

"note: sofosbuvir not available in market. "

Sofosbuvir isnt even on the market here in the U.S. yet.

I posted many links and am not sure what trials are active or even if they apply to your mother but its worth a look for you. Worst case scenario you have the contact info to many recruiters.

Best of luck

___________________________________________________________

http://ctri.nic.in/Clinicaltrials/advancesearchmain.php



http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=409&EncHid=&userName=HCV

http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2369&EncHid=&userName=HCV

http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2368&EncHid=&userName=HCV

http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2549&EncHid=&userName=HCV

http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2623&EncHid=&userName=HCV

http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=3845&EncHid=&userName=HCV

http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5660&EncHid=&userName=HCV

[chirag0019]

NAME: PURIBEN K PATEL                  AGE/SEX:   60/FEMALE

 12th APRIL 2012 Test is done HCV (+VE)

 30TH APRIL 2012 1)   HCV VIRAL LOAD *42500
                 2)*GENOTYPE 3

 15TH MAY 2012:        TREATMENT PROTOCOL STARTED
Inj. Pegasys 180 mcg 1 per every week for 24 weeks
        Cap. Ribavarin 200 mg 2-0-3 for 24 weeks

• After 4th week of treatment 12th JUNE 2012 – VIRAL LOAD *52

• After 12th week of treatment 26Th AUG 2012 – VIRAL LOAD *BELOW 15

• After 24th week of treatment 29Th OCT 2012 – VIRAL LOAD *BELOW 15

• After 24th week of treatment 29Th OCT 2012 – **NOT DETECTED


 26TH APRIL 2013 (after 6 month of treatment) AGAIN TEST IS DONE

RESULT: - VIRAL LOAD *1,06,000

I have two doctors suggestion.
---->One doctor told repeat this Treatment again 48 weeks.But my mother is not acceptable for this treatment.
---->Second doctor was told---> not better result in this treatments and not acceptable this dose of patient of
                                              this age.If you are collect medicine SOFOSBUVIR and treat this patient than
                                               we hope better result.
Dear all,
Please help of this Case.

[chirag0019]

Thank you Sir For interested in my case.

I Live In INDIA and this disease on my mother.
He is 60 years old.
Not biopsy of liver.
complete treatment of 24 week of viral load is below 15 and virus not detected,
But after treatment of six month report is viral load 106000.
-->So, if available Tab. SOFOSBUVIR than may be chance of recover of this disease.

[pooh55811]

I think if we had a little more information it may help us respond better to your questions.

You said you are Genotype 3.

Where do you live? In the USA or another country? If in the USA, which state?

Did you have a liver biopsy and what stage of liver fibrosis do you have?

What was the result of your 24 weeks of treatment with Interferon and Ribavirin? Did you ever become Undetectable? Did you finish treatment? Did you relapse after completing treatment?

There are others on the forum who are Genotype 3 and hopefully some of them will respond. Also, there are people with Genotype 3 who are in trials and hopefully they will also respond. Having more information about you will help people to respond better.

[chirag0019]

HCV Genotype 3

[HectorSF]

TUESDAY, APRIL 23, 2013

Data from Phase 3 Studies of Gilead’s Sofosbuvir for Hepatitis C
To Be Presented at 48th Annual EASL Meeting; Findings Published Online Today in The New England Journal of Medicine

AMSTERDAM--(BUSINESS WIRE)--Apr. 23, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that detailed results from four Phase 3 clinical trials (NEUTRINO, FISSION, POSITRON and FUSION) evaluating sofosbuvir, the company’s investigational once-daily nucleotide NS5B inhibitor for the treatment of chronic hepatitis C virus (HCV) infection, will be presented this week in oral sessions at the 48th Annual Meeting of the European Association for the Study of the Liver (International Liver Congress 2013) in Amsterdam, The Netherlands. In addition, detailed results from the four clinical studies have also been published online in two papers, ahead of print, in The New England Journal of Medicine (NEJM).
  
In the four trials, sofosbuvir was administered to nearly 1,000 patients with chronic HCV infection as part of an all-oral 12-week or 16-week treatment regimen in combination with ribavirin (RBV) in genotypes 2 and 3, or with RBV and pegylated interferon (peg-IFN) for 12 weeks in genotypes 1, 4, 5 and 6. Overall SVR12 rates (sustained viral response 12 weeks after completing therapy) from 50 to 90 percent were observed. Patients who achieve SVR12 are considered cured of their HCV infection.
A description of the four Phase 3 studies and SVR12 results are summarized in the table below. Detailed results from the Phase 3 studies of sofosbuvir are available at www.nejm.org/online-first.

Sofosbuvir Phase 3 Studies
Study    Population    Treatment groups    SVR12 Rates

NEUTRINO    Genotype 1/4/5/6 treatment-naïve    Sofosbuvir + RBV + Peg-IFN for 12 weeks    90% (295/327)

FISSION    Genotype 2/3 treatment-naïve    Sofosbuvir + RBV for 12 weeks or    67% (107/253)
   Peg-IFN + RBV for 24 weeks    67% (162/243)

POSITRON Genotype 2/3, IFN intolerant, ineligible or unwilling Sofosbuvir + RBV for 12 weeks or 78% (161/207)
   Placebo for 12 weeks    0% (0/71)

FUSION Genotype 2/3 treatment-experienced Sofosbuvir + RBV for 12 weeks or 50% (50/100)
   Sofosbuvir + RBV for 16 weeks    73% (69/95)

“There remains an urgent unmet medical need for individuals diagnosed with chronic hepatitis C infection,” commented Ira Jacobson, MD, Chief of the Division of Gastroenterology and Hepatology, Vincent Astor Distinguished Professor of Medicine, The Joan Sanford I. Weill Medical College of Cornell University, Attending Physician, New York-Presbyterian Hospital Cornell Campus. “The breadth of data from the Phase 3 program evaluating sofosbuvir will help physicians understand how to treat the disease in the future across various HCV genotypes and patient populations.”

“In these particular studies, sofosbuvir-based HCV therapy demonstrated high efficacy rates and a favorable safety profile while reducing the need for interferon injections to 12 weeks, or eliminating interferon completely from the regimen,” said Eric Lawitz, MD, President and Medical Director, The Texas Liver Institute, University of Texas Health Science Center, San Antonio. “Based on these findings, sofosbuvir, once approved, has the potential to play an important role in addressing the global hepatitis C epidemic.”

The NS5b region of the HCV viral genome for all patients who relapsed was sequenced and no S282T mutations were observed by population or deep sequencing (1 percent cutoff). There was no change in susceptibility to sofosbuvir or RBV observed by phenotypic analyses.

With the exception of one patient in FISSION who was non-compliant, relapse accounted for all virologic failures. Adverse events were generally mild and included fatigue, nausea, headache, insomnia, pruritis, anemia and dizziness. Less than 2 percent of patients in the sofosbuvir treatment groups discontinued due to adverse events.

On April 8, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sofosbuvir for the treatment of HCV infection. The data submitted in the NDA support the use of sofosbuvir and RBV as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and peg-IFN for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union, in the second quarter of 2013. The European Medicines Agency (EMA) has accepted Gilead’s request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest. Accelerated assessment could shorten the EMA’s review time of sofosbuvir by two months. Granting of accelerated assessment does not guarantee a positive opinion from the CHMP or approval by the European Commission.

About Sofosbuvir
Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B protein, which plays an essential role in HCV replication. Sofosbuvir is a direct-acting agent, meaning that it interferes directly with the HCV life cycle by suppressing viral replication. Sofosbuvir is intended to become a cornerstone of interferon-free, all-oral treatment regimens for HCV that achieve higher cure rates more rapidly and with fewer side effects than current therapeutic options. Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.

[HectorSF]

What genotype are you? 1, 2 or 3?


Hector