In November, Achillion announced that combining ACH-3102, a drug targeting the same protein as Gilead Sciences' ledipasvir, when dosed alongside Sovaldi for eight weeks successfully cleared the disease in 100% of the genotype 1 patients studied. That prompted Achillion to launch a study to evaluate treatment over a shorter six week period.
In late December, Achillion reported interim results from that six week study suggesting that matching up ACH-3102 with Sovaldi was equally effective in the shorter period. In February, Achillion released the full results from that six week trial, which showed that 100% of genotype 1 patients were indeed disease-free 12 weeks following treatment ending.
Now with success in both an eight week and a six week study, the company is launching another study that will evaluate the combination's efficacy over an even shorter four week treatment duration.
pamelajean said
Feb 17, 2015
mallani wrote:
Hi Susan,
Achillion have been a bit slow. ACH-3102 was fast-tracked by the FDA in May 2012, but only in the last few months have we seen some Phase 2 results.
OK, 100% SVR sounds good for both 8 weeks and 6 weeks of ACH-3102/Sovaldi. With only 12 Rx-naive patients in each study, it's hard to get excited. They call ACH-3102 pan-genomic, but I haven't seen any trials of genotypes other than 1.
They rave about their new drug, ACH-3422 which is supposed to be 7 times as potent as Sovaldi. Why haven't they coformulated ACH-3102 and ACH-3422 into a single pill, and maybe even add Sovaprevir?
I look forward to the Phase 3 trials, and to see how cirrhotics fare.
I worry about short treatment times, particularly if they will continue to use Sovaldi. Supervisuses resistant to Sovaldi is a real concern. Cheers.
Interesting that ACH-3102 was fast tracked in 2012. Thanks for that... http://hepatitiscnewdrugs.blogspot.com/2015/02/achillion-gilead-drug-****tail-cures.html
"The achievement of 100% SVR12 after six weeks of treatment with a dual NS5A-nucleotide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports our belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration," commented Dr. David Apelian, Executive Vice President of Clinical Development and Chief Medical Officer at Achillion. "We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sovaprevir, for treatment naïve genotype 1 HCV patients. In parallel, we plan on exploring sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir as part of our global development program."
-- Edited by pamelajean on Tuesday 17th of February 2015 03:33:01 PM
-- Edited by pamelajean on Tuesday 17th of February 2015 03:33:42 PM
-- Edited by pamelajean on Tuesday 17th of February 2015 04:10:45 PM
suziq said
Feb 17, 2015
Thanks Mallani for the clarification. Press info often does not release the whole story.
Merck (my clinical trial) found that shorter time really cut their success rate in clinical trials last year. Recently read somewhere that the FDA has cut their Breakthrough Status. Also read they have purchased another company in their quest for a better combo, so they are forging ahead with their Hep C program. My trial had great success, but Merck apparently didn't extend that combo into a much larger Phase 3 trial. They don't release a lot of information--very few press releases--so not sure how they are doing. I did 18 weeks with riba a year and half ago. Still SVR at tests EOT + 9 months last October. Next check in April.
SuziQ
-- Edited by suziq on Tuesday 17th of February 2015 03:54:34 PM
Tig said
Feb 16, 2015
Hi Roey,
Will you do us a favor please? Would you repost your last message to the Harvoni Train thread? I would move it but can't move an individual post. You will get more attention to your question and issue. This is the HCV News section. (You need to investigate the available Payment Assistance programs. We can talk about that at that time.) Thanks for your understanding!
Tig
mallani said
Feb 16, 2015
Hi Susan,
Achillion have been a bit slow. ACH-3102 was fast-tracked by the FDA in May 2012, but only in the last few months have we seen some Phase 2 results.
OK, 100% SVR sounds good for both 8 weeks and 6 weeks of ACH-3102/Sovaldi. With only 12 Rx-naive patients in each study, it's hard to get excited. They call ACH-3102 pan-genomic, but I haven't seen any trials of genotypes other than 1.
They rave about their new drug, ACH-3422 which is supposed to be 7 times as potent as Sovaldi. Why haven't they coformulated ACH-3102 and ACH-3422 into a single pill, and maybe even add Sovaprevir?
I look forward to the Phase 3 trials, and to see how cirrhotics fare.
I worry about short treatment times, particularly if they will continue to use Sovaldi. Supervisuses resistant to Sovaldi is a real concern. Cheers.
Roey said
Feb 16, 2015
Another day another freakin prob. I went to the paharmacy and he told me I had to pay 32,000.00 for the 2nd month if Harvoni. I can't believe I have to start making phone calls all over again. Just disgusted with our Health system. It's quite unbelievable that I'm in the middle of treatment and there is no funds out there to help pay for Harvoni.
suziq said
Feb 16, 2015
I was too old to wait when I did my clinical trial, plus I had cirrhosis by then. But, if I were in early stages and younger, I might have considered waiting for something as good as this appears. I really believe that there will be better and shorter treatments in the relatively near future. I realize this is an investor site, but Motley Fool has been following Hep C treatments as an investment for a while . This is the most exciting news from them so far !!! A little investment money might have been nice, BUT, my SVR is definitely a wonderful benefit.
May all join me in SVR as the drug companies continue researching this newest group of drugs.
-- Edited by suziq on Monday 16th of February 2015 05:15:05 PM
Tig said
Feb 16, 2015
Hi Susan,
Nice to hear from you again! I trust everything is going well? I sure hope so!
This is some very promising information, thanks for sharing it. I see where they mentioned Incivek was an injectable only, That hopefully was an oversight in editing! That protocol was a difficult one, injecting it 2-3 times a day would've driven too many away! It would be a boom for Achillion Pharm! I can see Gilead's bean counters and scientists working overtime to head this off at the pass. Wouldn't it be nice if they could just work together? Let's pray for that day to come soon...
Tig
Fireman Rob said
Feb 16, 2015
Hi Suzi,
Thanks for posting this. I've been watching this for a while and it looks very promising, considering it successfully gets through the trials stage.
Eraticate HCV! Love it!!
-Rob
suziq said
Feb 16, 2015
Could This Be The Biggest Advance in Hepatitis C since Gilead Sciences' Sovaldi?
Tiny biotech stock Achillion Pharmaceuticals (NASDAQ: ACHN) reported what could be pretty big news for hepatitis C patients this week. The clinical stage biotechnology company released data showing that combining its ACH-3102 with Gilead Sciences' (NASDAQ: GILD) Sovaldi achieved 100% cure rates in as little as six weeks of treatment. The success of that combination is prompting Achillion to launch a study of the two drugs over an even shorter 4-week dosing period. If that study pans out, it could be the biggest advance in hepatitis C treatment since Sovaldi won approval in 2013.
Source: Achillion Pharmaceuticals
Blockbuster breakthrough A decade ago, hepatitis C patients were treated with a combination of the drugs peg-interferon and ribavirin, which was dosed over 48 weeks, cured just 50% of patients, and came with a host of side effects. In 2011, treatment took a huge step forward when the FDA approved Vertex Pharmaceuticals' Incivek, a therapy that cured 80% of patients over a 24 week time period.
However, Incivek was still far from a perfect drug. It was injected, rather than taken as a pill. Additionally, Incivek was still dosed alongside the pesky and side effect-causing peg interferon and ribavirin mashup, a fact that hampered adherence rates.
As a result, the approval of Gilead Sciences' oral Sovaldi for the treatment of hepatitis C has arguably been the biggest leap forward in treatment for the disease. Sovaldi's once-daily oral dosing, 12-week treatment regimen, and 90% plus cure rates made a functional hepatitis C cure available to the vast majority of patients for the first time. Importantly, it did so while removing the need to dose peg interferon simultaneously in many patients. As a result, Sovaldi became the fastest drug to ever reach billion dollar blockbuster status, and the only drug to achieve $10 billion in sales during its first year on the market.
Improving adherence rates Although Sovaldi was a breakthrough for patients, considerable room remains to improve hepatitis C treatment. Sovaldi still requires the dosing of ribavirin in many patients, and a 12-week treatment course still creates obstacles that can impact patient adherence rates, which in turn can significantly increase costs and reduce efficacy.
To address some of that problem, Gilead Sciences won approval of a single dose combination tablet of Sovaldi and ledipasvir, sold as Harvoni, in October of 2014. Harvoni casts aside peg interferon and ribavirin for the vast majority of patients, offers cure rates in the high 90% range, and can be dosed over as little as an 8-week period for roughly 45% of genotype 1 patients.
Removing the need to dose peg interferon and ribavirin, and shortening treatment periods by a third, means that Harvoni is a big improvement over Sovaldi in type 1 patients. But an even better solution could be coming from Achillion Pharmaceuticals.
Source: Achillion Pharmaceuticals
Shorter durations With current treatments cure rates at the mid to high 90% levels, the next major advance in treatment could be delivering similarly effective treatments with far fewer doses.
A number of companies, including Gilead Sciences and Merck & Company,are developing shorter-duration treatments for hepatitis C, but it's Achillion that has reported the steadiest stream of recent success.
In November, Achillion announced that combining ACH-3102, a drug targeting the same protein as Gilead Sciences' ledipasvir, when dosed alongside Sovaldi for eight weeks successfully cleared the disease in 100% of the genotype 1 patients studied. That prompted Achillion to launch a study to evaluate treatment over a shorter six week period.
In late December, Achillion reported interim results from that six week study suggesting that matching up ACH-3102 with Sovaldi was equally effective in the shorter period. In February, Achillion released the full results from that six week trial, which showed that 100% of genotype 1 patients were indeed disease-free 12 weeks following treatment ending.
Now with success in both an eight week and a six week study, the company is launching another study that will evaluate the combination's efficacy over an even shorter four week treatment duration.
Looking ahead Currently, Harvoni's eight week regimen is only available to genotype 1 patients who have a viral load that is below 6 million IU/ml. That means that the majority of patients are still being dosed with 12 weeks of Harvoni, and that there could be a compelling argument made that a shorter therapy could win over a significant share of the hepatitis C drug market; particularly given that Achillion's trial included patients with viral loads above that 6 million IU/ml level.
A six week therapy may or may not be a big enough differentiator to encourage the eventual use of Achillion's drug over other therapies. However, a four week regimen would clearly be a major advance, and that could mean that investors would be wise to keep an eye on this company over the coming months.
This coming blockbuster will make every biotech jealous The best biotech investors consistently reap gigantic profits by recognizing true potential earlier and more accurately than anyone else. Let me cut right to the chase. There is a product in development that could revolutionize not just how we treat a common chronic illness, but potentially the entire health industry. Analysts are already licking their chops at the sales potential. If you hope to outsmart Wall Street and realize multi-bagger returns you will need to get in early -- check out The Motley Fools new free report on the dream-team responsible for this game-changing blockbuster. CLICK HERE NOW.
Wow just saw this
In November, Achillion announced that combining ACH-3102, a drug targeting the same protein as Gilead Sciences' ledipasvir, when dosed alongside Sovaldi for eight weeks successfully cleared the disease in 100% of the genotype 1 patients studied. That prompted Achillion to launch a study to evaluate treatment over a shorter six week period.
In late December, Achillion reported interim results from that six week study suggesting that matching up ACH-3102 with Sovaldi was equally effective in the shorter period. In February, Achillion released the full results from that six week trial, which showed that 100% of genotype 1 patients were indeed disease-free 12 weeks following treatment ending.
Now with success in both an eight week and a six week study, the company is launching another study that will evaluate the combination's efficacy over an even shorter four week treatment duration.
Interesting that ACH-3102 was fast tracked in 2012. Thanks for that... http://hepatitiscnewdrugs.blogspot.com/2015/02/achillion-gilead-drug-****tail-cures.html
"The achievement of 100% SVR12 after six weeks of treatment with a dual NS5A-nucleotide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports our belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration," commented Dr. David Apelian, Executive Vice President of Clinical Development and Chief Medical Officer at Achillion. "We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sovaprevir, for treatment naïve genotype 1 HCV patients. In parallel, we plan on exploring sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir as part of our global development program."
-- Edited by pamelajean on Tuesday 17th of February 2015 03:33:01 PM
-- Edited by pamelajean on Tuesday 17th of February 2015 03:33:42 PM
-- Edited by pamelajean on Tuesday 17th of February 2015 04:10:45 PM
Thanks Mallani for the clarification. Press info often does not release the whole story.
Merck (my clinical trial) found that shorter time really cut their success rate in clinical trials last year. Recently read somewhere that the FDA has cut their Breakthrough Status. Also read they have purchased another company in their quest for a better combo, so they are forging ahead with their Hep C program. My trial had great success, but Merck apparently didn't extend that combo into a much larger Phase 3 trial. They don't release a lot of information--very few press releases--so not sure how they are doing. I did 18 weeks with riba a year and half ago. Still SVR at tests EOT + 9 months last October. Next check in April.
SuziQ
-- Edited by suziq on Tuesday 17th of February 2015 03:54:34 PM
Hi Roey,
Will you do us a favor please? Would you repost your last message to the Harvoni Train thread? I would move it but can't move an individual post. You will get more attention to your question and issue. This is the HCV News section. (You need to investigate the available Payment Assistance programs. We can talk about that at that time.) Thanks for your understanding!
Tig
Hi Susan,
Achillion have been a bit slow. ACH-3102 was fast-tracked by the FDA in May 2012, but only in the last few months have we seen some Phase 2 results.
OK, 100% SVR sounds good for both 8 weeks and 6 weeks of ACH-3102/Sovaldi. With only 12 Rx-naive patients in each study, it's hard to get excited. They call ACH-3102 pan-genomic, but I haven't seen any trials of genotypes other than 1.
They rave about their new drug, ACH-3422 which is supposed to be 7 times as potent as Sovaldi. Why haven't they coformulated ACH-3102 and ACH-3422 into a single pill, and maybe even add Sovaprevir?
I look forward to the Phase 3 trials, and to see how cirrhotics fare.
I worry about short treatment times, particularly if they will continue to use Sovaldi. Supervisuses resistant to Sovaldi is a real concern. Cheers.
Another day another freakin prob. I went to the paharmacy and he told me I had to pay 32,000.00 for the 2nd month if Harvoni. I can't believe I have to start making phone calls all over again. Just disgusted with our Health system. It's quite unbelievable that I'm in the middle of treatment and there is no funds out there to help pay for Harvoni.
I was too old to wait when I did my clinical trial, plus I had cirrhosis by then. But, if I were in early stages and younger, I might have considered waiting for something as good as this appears. I really believe that there will be better and shorter treatments in the relatively near future. I realize this is an investor site, but Motley Fool has been following Hep C treatments as an investment for a while . This is the most exciting news from them so far !!! A little investment money might have been nice, BUT, my SVR is definitely a wonderful benefit.
May all join me in SVR as the drug companies continue researching this newest group of drugs.
-- Edited by suziq on Monday 16th of February 2015 05:15:05 PM
Hi Susan,
Nice to hear from you again! I trust everything is going well? I sure hope so!
This is some very promising information, thanks for sharing it. I see where they mentioned Incivek was an injectable only, That hopefully was an oversight in editing! That protocol was a difficult one, injecting it 2-3 times a day would've driven too many away! It would be a boom for Achillion Pharm! I can see Gilead's bean counters and scientists working overtime to head this off at the pass. Wouldn't it be nice if they could just work together? Let's pray for that day to come soon...
Tig
Hi Suzi,
Thanks for posting this. I've been watching this for a while and it looks very promising, considering it successfully gets through the trials stage.
Eraticate HCV! Love it!!
-Rob
Could This Be The Biggest Advance in Hepatitis C since Gilead Sciences' Sovaldi?
By Todd Campbell | More Articles
February 16, 2015 | Comments (1)
Tiny biotech stock Achillion Pharmaceuticals (NASDAQ: ACHN ) reported what could be pretty big news for hepatitis C patients this week. The clinical stage biotechnology company released data showing that combining its ACH-3102 with Gilead Sciences' (NASDAQ: GILD ) Sovaldi achieved 100% cure rates in as little as six weeks of treatment. The success of that combination is prompting Achillion to launch a study of the two drugs over an even shorter 4-week dosing period. If that study pans out, it could be the biggest advance in hepatitis C treatment since Sovaldi won approval in 2013.
Source: Achillion Pharmaceuticals
Blockbuster breakthrough
A decade ago, hepatitis C patients were treated with a combination of the drugs peg-interferon and ribavirin, which was dosed over 48 weeks, cured just 50% of patients, and came with a host of side effects. In 2011, treatment took a huge step forward when the FDA approved Vertex Pharmaceuticals' Incivek, a therapy that cured 80% of patients over a 24 week time period.
However, Incivek was still far from a perfect drug. It was injected, rather than taken as a pill. Additionally, Incivek was still dosed alongside the pesky and side effect-causing peg interferon and ribavirin mashup, a fact that hampered adherence rates.
As a result, the approval of Gilead Sciences' oral Sovaldi for the treatment of hepatitis C has arguably been the biggest leap forward in treatment for the disease. Sovaldi's once-daily oral dosing, 12-week treatment regimen, and 90% plus cure rates made a functional hepatitis C cure available to the vast majority of patients for the first time. Importantly, it did so while removing the need to dose peg interferon simultaneously in many patients. As a result, Sovaldi became the fastest drug to ever reach billion dollar blockbuster status, and the only drug to achieve $10 billion in sales during its first year on the market.
Improving adherence rates
Although Sovaldi was a breakthrough for patients, considerable room remains to improve hepatitis C treatment. Sovaldi still requires the dosing of ribavirin in many patients, and a 12-week treatment course still creates obstacles that can impact patient adherence rates, which in turn can significantly increase costs and reduce efficacy.
To address some of that problem, Gilead Sciences won approval of a single dose combination tablet of Sovaldi and ledipasvir, sold as Harvoni, in October of 2014. Harvoni casts aside peg interferon and ribavirin for the vast majority of patients, offers cure rates in the high 90% range, and can be dosed over as little as an 8-week period for roughly 45% of genotype 1 patients.
Removing the need to dose peg interferon and ribavirin, and shortening treatment periods by a third, means that Harvoni is a big improvement over Sovaldi in type 1 patients. But an even better solution could be coming from Achillion Pharmaceuticals.
Source: Achillion Pharmaceuticals
Shorter durations
With current treatments cure rates at the mid to high 90% levels, the next major advance in treatment could be delivering similarly effective treatments with far fewer doses.
A number of companies, including Gilead Sciences and Merck & Company, are developing shorter-duration treatments for hepatitis C, but it's Achillion that has reported the steadiest stream of recent success.
In November, Achillion announced that combining ACH-3102, a drug targeting the same protein as Gilead Sciences' ledipasvir, when dosed alongside Sovaldi for eight weeks successfully cleared the disease in 100% of the genotype 1 patients studied. That prompted Achillion to launch a study to evaluate treatment over a shorter six week period.
In late December, Achillion reported interim results from that six week study suggesting that matching up ACH-3102 with Sovaldi was equally effective in the shorter period. In February, Achillion released the full results from that six week trial, which showed that 100% of genotype 1 patients were indeed disease-free 12 weeks following treatment ending.
Now with success in both an eight week and a six week study, the company is launching another study that will evaluate the combination's efficacy over an even shorter four week treatment duration.
Looking ahead
Currently, Harvoni's eight week regimen is only available to genotype 1 patients who have a viral load that is below 6 million IU/ml. That means that the majority of patients are still being dosed with 12 weeks of Harvoni, and that there could be a compelling argument made that a shorter therapy could win over a significant share of the hepatitis C drug market; particularly given that Achillion's trial included patients with viral loads above that 6 million IU/ml level.
A six week therapy may or may not be a big enough differentiator to encourage the eventual use of Achillion's drug over other therapies. However, a four week regimen would clearly be a major advance, and that could mean that investors would be wise to keep an eye on this company over the coming months.
This coming blockbuster will make every biotech jealous
The best biotech investors consistently reap gigantic profits by recognizing true potential earlier and more accurately than anyone else. Let me cut right to the chase. There is a product in development that could revolutionize not just how we treat a common chronic illness, but potentially the entire health industry. Analysts are already licking their chops at the sales potential. If you hope to outsmart Wall Street and realize multi-bagger returns you will need to get in early -- check out The Motley Fools new free report on the dream-team responsible for this game-changing blockbuster. CLICK HERE NOW.