Aa
OLYSIO( PI s) VS DECLASTASVIR OR LEDIPASVIR
I read that Declatasvir and Ledipasvir (direct-acting antiviral) is a much safer and has less side effects compared to Olysio(PIs) but they did not get into details. Does anyone here know why?
Not only are the trials cure rates of the Abbvie triple-therapy extremely high, but I think I read somewhere that Abbvie is going to undercut Gilead on price, by a lot. May have to wait for Jan., 2015, though.
Thanks for the info and the site cite (did I just make a pun? Maybe my brain is getting better : -) ). That is good, and interesting info on the AbbVie product.
M: Interesting about theSVR on the AbbVie combo.
Pat
M: Interesting about theSVR on the AbbVie combo.
Pat
FYI, a former contributor to this forum, whose name I can't recall, was cured in a trial of Abbvie's new triple-therapy after four earlier therapies failed her. She had cirrhosis.
Results from the PEARL-I study of people with HCV genotype 4, reported at the EASL International Liver Congress in April, showed that ABT-450/ritonavir plus ombitasvir, used alone or with ribavirin, cured 91% and 100% of previously untreated patients, respectively (dasabuvir is not effective against this genotype).
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4681-ddw-2014-abbvie-interferon-free-regimen-cures-more-than-90-of-hepatitis-c-patients
http://www.hivandhepatitis.com/hcv-treatment/experimental-hcv-drugs/4681-ddw-2014-abbvie-interferon-free-regimen-cures-more-than-90-of-hepatitis-c-patients
GT 1
AbbVie completes phase 3 trial programme of hepatitis therapy
US drug maker AbbVie has completed its phase 3 clinical programme and released results of four additional studies designed to evaluate its investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
The results are from the PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II studies, which are part of the six phase 3 registrational studies being carried out by AbbVie to treat genotype 1 (GT1) hepatitis C virus (HCV) infection using a regimen containing Enanta Pharmaceuticals' lead protease inhibitor ABT-450.
Around 2,308 patients from more than 25 countries around the world have participated in the six phase 3 trials.
According to the company, the results of these studies show high sustained virologic response rates 12 weeks post-treatment (SVR12) and tolerability in the GT1 patients.
ABT-450 is part of AbbVie's investigational three direct-acting antiviral regimen that consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed twice daily.
The studies were carried out with and without ribavirin, while the combination of the three different mechanisms of action in this regimen interrupts the HCV replication process with the goal of optimising SVR rates across different patient populations.
The PEARL-II study is designed to assess the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with and without ribavirin in non-cirrhotic, GT1b HCV-infected, treatment-experienced adult patients.
A total of 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis were included in the trial, of which 91 were randomised to the regimen without ribavirin for 12 weeks, and 88 were randomised to the regimen plus ribavirin for 12 weeks.
In the ribavirin-free arm, 100% (n=91/91) of patients achieved SVR12, while 97% (n=85/88) achieved SVR12 in the ribavirin-containing arm.
The PEARL-III study included a total of 419 GT1b treatment-naïve patients with no evidence of liver cirrhosis, out of which 209 were randomised to the regimen without ribavirin for 12 weeks, and 210 were randomised to the regimen plus ribavirin for 12 weeks.
After 12 weeks of treatment, 99% of patients receiving the regimen without ribavirin (n=207/209) and 99% of them receiving the regimen plus ribavirin (n=209/210) achieved SVR12.
PEARL-IV is a global, multi-centre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with AbbVie's regimen with and without ribavirin in non-cirrhotic, GT1a HCV-infected, treatment-naive adult patients.
A total of 305 GT1a treatment-naive patients with no evidence of liver cirrhosis were included in the PEARL-IV study, of which 205 patients were randomised to the regimen without ribavirin for 12 weeks, and 100 patients randomised to the regimen with ribavirin for 12 weeks.
After 12 weeks of treatment, 90% of patients receiving the regimen without ribavirin (n=185/205) and 97% receiving the regimen with ribavirin (n=97/100) achieved SVR12.
TURQUOISE-II is the first phase 3 study completed in GT1 cirrhotic patients investigating an all-oral, interferon-free regimen.
The trial evaluated the efficacy and safety of 12 or 24 weeks of treatment with AbbVie's regimen with ribavirin in cirrhotic, GT1a and GT1b HCV-infected, treatment-naive and treatment-experienced adult patients.
The study included 380 GT1a and GT1b, treatment-naive and treatment-experienced patients with compensated cirrhosis: 208 patients randomised to the regimen with ribavirin for 12 weeks and 172 patients randomised to the regimen with ribavirin for 24 weeks.
After the 12-week treatment, 92% of patients (n=191/208) achieved SVR12 and following 24 weeks of treatment, 96% of patients (n=165/172) achieved SVR12.
Most commonly reported adverse events in PEARL-II and PEARL-III studies were fatigue and headache, while fatigue, headache and nausea were the most commonly reported adverse events in PEARL-IV and TURQUOISE-II trials.
ABT-450, which was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens, is currently being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of HCV.
AbbVie, which previously secured breakthrough therapy designation from the US FDA for its regimen with and without ribavirin for HCV GT1, is now on track to start major regulatory submissions early in the second quarter of 2014.
http://www.drugdevelopment-technology.com/news/newsabbvie-completes-phase-iii-trial-programme-for-treatment-of-hepatitis-c-genotype-1-4170150
AbbVie completes phase 3 trial programme of hepatitis therapy
US drug maker AbbVie has completed its phase 3 clinical programme and released results of four additional studies designed to evaluate its investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
The results are from the PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II studies, which are part of the six phase 3 registrational studies being carried out by AbbVie to treat genotype 1 (GT1) hepatitis C virus (HCV) infection using a regimen containing Enanta Pharmaceuticals' lead protease inhibitor ABT-450.
Around 2,308 patients from more than 25 countries around the world have participated in the six phase 3 trials.
According to the company, the results of these studies show high sustained virologic response rates 12 weeks post-treatment (SVR12) and tolerability in the GT1 patients.
ABT-450 is part of AbbVie's investigational three direct-acting antiviral regimen that consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed twice daily.
The studies were carried out with and without ribavirin, while the combination of the three different mechanisms of action in this regimen interrupts the HCV replication process with the goal of optimising SVR rates across different patient populations.
The PEARL-II study is designed to assess the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with and without ribavirin in non-cirrhotic, GT1b HCV-infected, treatment-experienced adult patients.
A total of 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis were included in the trial, of which 91 were randomised to the regimen without ribavirin for 12 weeks, and 88 were randomised to the regimen plus ribavirin for 12 weeks.
In the ribavirin-free arm, 100% (n=91/91) of patients achieved SVR12, while 97% (n=85/88) achieved SVR12 in the ribavirin-containing arm.
The PEARL-III study included a total of 419 GT1b treatment-naïve patients with no evidence of liver cirrhosis, out of which 209 were randomised to the regimen without ribavirin for 12 weeks, and 210 were randomised to the regimen plus ribavirin for 12 weeks.
After 12 weeks of treatment, 99% of patients receiving the regimen without ribavirin (n=207/209) and 99% of them receiving the regimen plus ribavirin (n=209/210) achieved SVR12.
PEARL-IV is a global, multi-centre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with AbbVie's regimen with and without ribavirin in non-cirrhotic, GT1a HCV-infected, treatment-naive adult patients.
A total of 305 GT1a treatment-naive patients with no evidence of liver cirrhosis were included in the PEARL-IV study, of which 205 patients were randomised to the regimen without ribavirin for 12 weeks, and 100 patients randomised to the regimen with ribavirin for 12 weeks.
After 12 weeks of treatment, 90% of patients receiving the regimen without ribavirin (n=185/205) and 97% receiving the regimen with ribavirin (n=97/100) achieved SVR12.
TURQUOISE-II is the first phase 3 study completed in GT1 cirrhotic patients investigating an all-oral, interferon-free regimen.
The trial evaluated the efficacy and safety of 12 or 24 weeks of treatment with AbbVie's regimen with ribavirin in cirrhotic, GT1a and GT1b HCV-infected, treatment-naive and treatment-experienced adult patients.
The study included 380 GT1a and GT1b, treatment-naive and treatment-experienced patients with compensated cirrhosis: 208 patients randomised to the regimen with ribavirin for 12 weeks and 172 patients randomised to the regimen with ribavirin for 24 weeks.
After the 12-week treatment, 92% of patients (n=191/208) achieved SVR12 and following 24 weeks of treatment, 96% of patients (n=165/172) achieved SVR12.
Most commonly reported adverse events in PEARL-II and PEARL-III studies were fatigue and headache, while fatigue, headache and nausea were the most commonly reported adverse events in PEARL-IV and TURQUOISE-II trials.
ABT-450, which was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens, is currently being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of HCV.
AbbVie, which previously secured breakthrough therapy designation from the US FDA for its regimen with and without ribavirin for HCV GT1, is now on track to start major regulatory submissions early in the second quarter of 2014.
http://www.drugdevelopment-technology.com/news/newsabbvie-completes-phase-iii-trial-programme-for-treatment-of-hepatitis-c-genotype-1-4170150
K: Thanks for the AbbVie info. Sounds like they are literally going to give Gilead a 'run for their money'. Did your friend say which genotype thry were aiming at or if this is supposed to be an across Gt treatment? Pat
I talked to an insider with AbbVie and she said Jan 1 they will unveil their "2 in one" pill. It will be S/L combo if I heard her right. It will be much cheaper than Gilead drugs. This is the one that might do it for those who have dual genotypes.
Follow the link, you have to sign up but it's free, this site will answer many of your questions better than I can
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Keeping%20Up/Interactive%20Virtual%20Presentation/IVP.aspx
http://www.clinicaloptions.com/Hepatitis/Treatment%20Updates/HCV%20Keeping%20Up/Interactive%20Virtual%20Presentation/IVP.aspx
Just read on FierceBioTech that the new Sol/Led combo will be marketed as brand name HARVONI.
The Combo, under that name has just been recommendet to the European Commision for approval.
I believe Daclatasvir/Sovaldi was approbed for us in the EU either last month or earlier this month.
I didn't see anything about when AbbVie's combo will be up for consideration.
New weapons for our on-goin war with the dragon! : -)
The Combo, under that name has just been recommendet to the European Commision for approval.
I believe Daclatasvir/Sovaldi was approbed for us in the EU either last month or earlier this month.
I didn't see anything about when AbbVie's combo will be up for consideration.
New weapons for our on-goin war with the dragon! : -)
Fred: I cannot give you a knowledgeable explanation, but, basically, MY understanding is that they are both DDAs but by different companies. Gilead started out working with BMS (Sol/Dacla), but after some trials, which showed good results, decided to go their own road and do their own NS5A (profit driven? better idea? I don't know). Anyway, they Ledisprevir/Sovaldi combo is the result. trials mostly aimed at Gt 1 but I have seen references to using with other Gts, (i believe Hector, can-do-man, or Hrsepwr quoted the stats on this). This one is up for Approval as a combo on Oct 10th.
BMS comtinued working working w/their NS5A using the Sovaldi. When the Daclatisvir is approved this combo will be off label but , since most of these studies were on Gt3s, I am really interested in this on, in case my Sol/Riba current Tx doesn't work. Daclatasvir is up for approval sometime in Nov.
AbbVie is also working on their version which I have read on one of the financial sites should be up for consideration in Dec.
BMS comtinued working working w/their NS5A using the Sovaldi. When the Daclatisvir is approved this combo will be off label but , since most of these studies were on Gt3s, I am really interested in this on, in case my Sol/Riba current Tx doesn't work. Daclatasvir is up for approval sometime in Nov.
AbbVie is also working on their version which I have read on one of the financial sites should be up for consideration in Dec.
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