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Sofosbuvir (GS-7977), GS-5885 and Ribavirin
AASLD-100 Percent Sustained Virologic Response Rate (SVR4) Interferon-Free Regimen of Sofosbuvir (GS-7977), GS-5885 and Ribavirin in Treatment-Naïve Geno 1 Hepatitis C Infected Patients
Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) for an Interferon-Free Regimen of Sofosbuvir (GS-7977), GS-5885 and Ribavirin in Treatment-Na ïve Genotype 1 Hepatitis C Infected Patients
- Phase 3 Study with a Fixed-Dose Combination Tablet of Sofosbuvir and GS-5885 Now Underway
BOSTON--(BUSINESS WIRE)--
Nov. 10, 2012-- Gilead Sciences (Nasdaq: GILD) today announced interim data from the ongoing Phase 2 ELECTRON study examining a 12-week course of therapy with the investigational nucleotide sofosbuvir (formerly referred to as GS-7977), the NS5A inhibitor GS-5885 and ribavirin in patients with genotype 1 chronic hepatitis C virus (HCV) infection. Among treatment-naïve patients receiving this combination, 100 percent (n=25/25) remained HCV RNA undetectable four weeks after completing therapy (SVR4). These data will be presented on Tuesday, November 13th at the 63rd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2012) in Boston.
“These results indicate that adding GS-5885 to sofosbuvir-based regimens may enhance SVR rates, potentially offering HCV genotype 1 infected patients a convenient 12-week course of oral therapy,” said ProfessorEdward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON study. “Along with other data from the ELECTRON study, these results add to the growing body of evidence supporting the potential for effective sofosbuvir-based all-oral regimens.”
Gilead recently initiated the first Phase 3 trial (ION-I) evaluating a fixed-dose combination of sofosbuvir and GS-5885 in treatment-naïve genotype 1 patients. This four-arm study is evaluating the fixed-dose combination with and without ribavirin for 12-and 24-week durations in 800 patients, 20 percent of whom have evidence of cirrhosis.
Preliminary data from a subset of an ongoing cohort in the ELECTRON study in which nine genotype 1 previous null responders were treated with sofosbuvir, GS-5885 and ribavirin for 12 weeks also will be presented on Tuesday. Thus far, three of the nine patients have reached the four-week post-treatment time point and all three remain HCV negative.
Both sofosbuvir in combination with ribavirin and sofosbuvir in combination with GS-5885 and ribavirin were well tolerated in the ELECTRON study. In the sofosbuvir combined with GS-5885 and ribavirin groups, there was one discontinuation due to an adverse event unrelated to study drugs. Despite stopping therapy at week 8, this patient also achieved SVR4.
The most common adverse events were headache, fatigue, upper respiratory tract infection and nausea. The most common clinically significant grade 3/4 laboratory abnormality was a hemoglobin reduction.
Additional Safety Data for GS-5885
In a poster presentation at The Liver Meeting on Sunday, November 11th, investigators will report combined safety data for more than 1,000 patients who have received at least one dose of GS-5885, in combination with other HCV medicines, in six ongoing Phase 2 clinical trials. In this analysis, 616 patients received a 30 mg dose and 423 patients received the 90 mg dose of GS-5885, which is being assessed in Phase 3 research. More than 700 patients completed at least 12 weeks of treatment with GS-5885. Approximately 70 percent of patients were treatment-naïve and 70 percent had HCV genotype 1a infection.
Researchers concluded that GS-5885 is safe and well tolerated. No laboratory abnormalities or other safety signal of concern has been observed in the GS-5885 development program.
Sofosbuvir and GS-5885 are investigational products and their safety and efficacy have not yet been established.
hector
Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) for an Interferon-Free Regimen of Sofosbuvir (GS-7977), GS-5885 and Ribavirin in Treatment-Na ïve Genotype 1 Hepatitis C Infected Patients
- Phase 3 Study with a Fixed-Dose Combination Tablet of Sofosbuvir and GS-5885 Now Underway
BOSTON--(BUSINESS WIRE)--
Nov. 10, 2012-- Gilead Sciences (Nasdaq: GILD) today announced interim data from the ongoing Phase 2 ELECTRON study examining a 12-week course of therapy with the investigational nucleotide sofosbuvir (formerly referred to as GS-7977), the NS5A inhibitor GS-5885 and ribavirin in patients with genotype 1 chronic hepatitis C virus (HCV) infection. Among treatment-naïve patients receiving this combination, 100 percent (n=25/25) remained HCV RNA undetectable four weeks after completing therapy (SVR4). These data will be presented on Tuesday, November 13th at the 63rd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2012) in Boston.
“These results indicate that adding GS-5885 to sofosbuvir-based regimens may enhance SVR rates, potentially offering HCV genotype 1 infected patients a convenient 12-week course of oral therapy,” said ProfessorEdward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON study. “Along with other data from the ELECTRON study, these results add to the growing body of evidence supporting the potential for effective sofosbuvir-based all-oral regimens.”
Gilead recently initiated the first Phase 3 trial (ION-I) evaluating a fixed-dose combination of sofosbuvir and GS-5885 in treatment-naïve genotype 1 patients. This four-arm study is evaluating the fixed-dose combination with and without ribavirin for 12-and 24-week durations in 800 patients, 20 percent of whom have evidence of cirrhosis.
Preliminary data from a subset of an ongoing cohort in the ELECTRON study in which nine genotype 1 previous null responders were treated with sofosbuvir, GS-5885 and ribavirin for 12 weeks also will be presented on Tuesday. Thus far, three of the nine patients have reached the four-week post-treatment time point and all three remain HCV negative.
Both sofosbuvir in combination with ribavirin and sofosbuvir in combination with GS-5885 and ribavirin were well tolerated in the ELECTRON study. In the sofosbuvir combined with GS-5885 and ribavirin groups, there was one discontinuation due to an adverse event unrelated to study drugs. Despite stopping therapy at week 8, this patient also achieved SVR4.
The most common adverse events were headache, fatigue, upper respiratory tract infection and nausea. The most common clinically significant grade 3/4 laboratory abnormality was a hemoglobin reduction.
Additional Safety Data for GS-5885
In a poster presentation at The Liver Meeting on Sunday, November 11th, investigators will report combined safety data for more than 1,000 patients who have received at least one dose of GS-5885, in combination with other HCV medicines, in six ongoing Phase 2 clinical trials. In this analysis, 616 patients received a 30 mg dose and 423 patients received the 90 mg dose of GS-5885, which is being assessed in Phase 3 research. More than 700 patients completed at least 12 weeks of treatment with GS-5885. Approximately 70 percent of patients were treatment-naïve and 70 percent had HCV genotype 1a infection.
Researchers concluded that GS-5885 is safe and well tolerated. No laboratory abnormalities or other safety signal of concern has been observed in the GS-5885 development program.
Sofosbuvir and GS-5885 are investigational products and their safety and efficacy have not yet been established.
hector
Have you checked with Virginia Mason in Seattle? They participate in quite a few trials there. I used Dr. Siddique and Dr. Kowdley, which I highly recommend as well.
I am under trials for Sofosbuvir 400mg/G-5885 90mg, 1 week after trials viral load was down to under 25 from over 400K. 2nd week "NEGATIVE". Waiting for 3rd week results. Gen Type 1, first time treatment. No side effects. Hope this helps.
http://www.clinicaltrials.gov/ct2/show/study/NCT01466790?term=7977+TMC&rank=1&show_locs=Y#locn
Scroll down and look at Cohort 2, which I believe is starting to screen now. Does this help or not?
Scroll down and look at Cohort 2, which I believe is starting to screen now. Does this help or not?
This is such great news, thanks for sharing this article.
The times they are a'changin...
The times they are a'changin...
Gene53, as you know, my hubby is in the same situation as you, G1, previous partial responder to SOC, failed triple tx (viral breakthrough), and Cirrhosis. His liver is still compensated, and we too are watching for a trial that would be beneficial for him or new treatments. I have seen some trials for Cirrhotics who are G2, Cirrhotics with portal hypertension, and of course the great trial that HectorSF is in for pre-transplant Cirrhotics. I haven't seen any for compensated Cirrhotic G1s, at least not in our are (Seattle), as yet. Hang in there. You guys are probably next to be in trials.
Advocate1955
Advocate1955
Sofosbuvir (GS-7977), GS-5885 + or - Ribavirin (we have to wait for trial data so show if the addition of ribavirin is needed).
Assuming future trials are successful, Gilead expects the regimen to be filed for regulatory approval in 2014 (NDA), and launched in 2015.
Hope this helps.
hector
Assuming future trials are successful, Gilead expects the regimen to be filed for regulatory approval in 2014 (NDA), and launched in 2015.
Hope this helps.
hector
Hector:
Thanks for posting. This is great news to anyone in an area where trials will be held.
gene: Nobody can say for certain when the FDA will approve the new meds. Some are predicting as early as 2014.
However, after hearing predictions for the triple treatment that took much longer than thought, I wouldn't bet on it.
It'd be safer to simply say probably within the next 4 years, hopefully sooner than later.
Thanks for posting. This is great news to anyone in an area where trials will be held.
gene: Nobody can say for certain when the FDA will approve the new meds. Some are predicting as early as 2014.
However, after hearing predictions for the triple treatment that took much longer than thought, I wouldn't bet on it.
It'd be safer to simply say probably within the next 4 years, hopefully sooner than later.
I'm almost positive you're already aware of these options, but on the 0.1% chance you aren't...
Do you check Quintiles regularly, and are you signed up with KU Med's Clinical Research Center, in case something comes up? I know that KU Med keeps a database of people who would like to be contacted if a matching clinical trial is started there:
http://www.kumc.edu/crc.html
(Forgive me for posting what is *probably* already obvious to you.)
Do you check Quintiles regularly, and are you signed up with KU Med's Clinical Research Center, in case something comes up? I know that KU Med keeps a database of people who would like to be contacted if a matching clinical trial is started there:
http://www.kumc.edu/crc.html
(Forgive me for posting what is *probably* already obvious to you.)
Thanks for posting this Hector. Any ideas when this will be available to the public? I'm still looking for trials in my KC area but so far all I hear is wait a year or 2 and at stage 4 cirrhosis the sooner the better...
At least its a step in the right direction
Take Care and Good Luck to you
At least its a step in the right direction
Take Care and Good Luck to you
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