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Gilead's HCV combination has better efficacy than AbbVie's

Anonymous

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AbbVie may have been first to release phase 3 data for an all-oral hepatitis treatment for genotype 1 patients, but Gilead Sciences now has the lead for the most phase 3 data. It might even have the best data. Maybe.

The biotech passed AbbVie in the data count, releasing results from three different phase 3 clinical trials today. The trials combined sofosbuvir, which was recently approved as Sovaldi, and a new drug ledipasvir, with and without a generic called ribavirin.

In one trial, dubbed ION-1, 97.7% of patients who had never been treated before were clear of virus 12 weeks after finishing a 12-week course of the two medications; essentially, they were cured. Adding ribavirin didn't help any -- the cure rate was actually slightly lower at 97.2% -- possibly due to patients dropping out because of unwanted side effects of ribavirin.

In AbbVie's first phase 3 trial, 96% of genotype 1 patients were cured with its five-drug cocktail. While lower than Gilead's 97.7%, it's not clear how comparable the number is. AbbVie released the breakdown of genotype 1a, which is harder to treat, and genotype 1b patients with cure rates of 95% and 98%, respectively. If Gilead enrolled a lot of genotype 1b patients, it's 97.7% cure rate could be artificially inflated.

In a second trial, Gilead enrolled patients whohad failed a previous treatment, producing a 93.6% cure rate for the two-drug combination, and a 96.4% cure rate when ribavirin was added for the 12 weeks. That's close to AbbVie's second phase 3 trial where 96% of treatment-experienced patients were cured, although it's even more dangerous to compare those two.

Not only do we still have the issue of the breakdown for genotype 1a/1b, but how the patients responded to the previous treatment -- null responders versus partial responders -- and this should predict how hard they are to treat. AbbVie said about 49% of the patients in the trial were prior null responders, while Gilead didn't release the breakdown. Complicating matters more, Gilead's patients previously failed the best regimen currently available, which includes a protease inhibitor -- either Vertex Pharmaceuticals' (NASDAQ: VRTX ) Incivek or Merck's (NYSE: MRK ) Victrelis -- while AbbVie's trial doesn't mention that the patients had to fail the first-generation oral medications from Vertex or Merck.

Unlike AbbVie, Gilead also tested its drug combo for 24 weeks, which appears to have paid off. A solid 99.1% of treatment-experienced patients were cured regardless of whether ribavirin was added to the treatment. Gilead is also testing the combo for 24 weeks in treatment-naive patients, but the results aren't available yet.

In a third trial, Gilead gambled in the other direction, testing the drug combination for just eight weeks. With cure rates dropping to 93.1% to 94% with and without ribavirin respectively, it doesn't look like the shorter course of treatment will get adopted widely. Of course, we could just be looking at a tough-to-treat population, because the control group that was treated for 12 weeks had a cure rate of 95.4%, lower than the 97.7% seen in the first trial mentioned above.

Based on what we know now, it appears Gilead's combination has better efficacy than AbbVie's, but probably not enough to make that much of a difference in which drug is prescribed. Doctors' choice will likely come down to convenience, pricing, and side effects. With fewer pills required, Gilead appears to have AbbVie beat on convenience, but the latter two are still undecided. What we can say for certain is the all-oral combinations are so much better than Vertex's and Merck's drugs, that their use will disappear during the comin
 




The other problem is we didn't include cirrhotics in our trials - they are in the last of the 6 phase 3 studies. I read where Gilead's combo had cirrhotics included in their trial so our 96% may be artificially high since it was all earlier stage patients?
 








You conclusion is not solid.

<1> Gilead did not sub-classify their enrolled patients in their trial. A slightly difference in the numbers of genotype 1a/b could result in a different percentage of cure rates.

<2> The cure rates between Abbvie and Gilead are so close. There is hardly to say any statistical significance between these two groups of numbers for the drugs unless these two groups drugs are tested at the same time in a same group of patients, which are divided into at least three subgroups (Abbvie’s, Gilead’s, and controls) in a double blinded clinical trials.

<3> The results from Gilead and Abbvie indicate that the mechanism works by targeting HCV using these cocktails, but hardly to tell which cocktail is better.

<4> The above three points show that there is no significant difference in efficacy between Abbvie’s and Gilead’s cocktail.

<5> The most important things for patients to accept the drug is its efficacy, price, and side effect. The convenience shall be the low priority for most patients since they know it is a serious disease and they need to take a great care of it, not mention that Abbvie shall be sure to improve its pills to make it more convenient to patients in the future,

Conclusion: Abbvie’s cocktail could still be better than Gilead’s.
 




You conclusion is not solid.

<1> Gilead did not sub-classify their enrolled patients in their trial. A slightly difference in the numbers of genotype 1a/b could result in a different percentage of cure rates.

<2> The cure rates between Abbvie and Gilead are so close. There is hardly to say any statistical significance between these two groups of numbers for the drugs unless these two groups drugs are tested at the same time in a same group of patients, which are divided into at least three subgroups (Abbvie’s, Gilead’s, and controls) in a double blinded clinical trials.

<3> The results from Gilead and Abbvie indicate that the mechanism works by targeting HCV using these cocktails, but hardly to tell which cocktail is better.

<4> The above three points show that there is no significant difference in efficacy between Abbvie’s and Gilead’s cocktail.

<5> The most important things for patients to accept the drug is its efficacy, price, and side effect. The convenience shall be the low priority for most patients since they know it is a serious disease and they need to take a great care of it, not mention that Abbvie shall be sure to improve its pills to make it more convenient to patients in the future,

Conclusion: Abbvie’s cocktail could still be better than Gilead’s.



^^^^^^kool aid alert^^^^^^^^^^^^
 








You conclusion is not solid.

<1> Gilead did not sub-classify their enrolled patients in their trial. A slightly difference in the numbers of genotype 1a/b could result in a different percentage of cure rates.

<2> The cure rates between Abbvie and Gilead are so close. There is hardly to say any statistical significance between these two groups of numbers for the drugs unless these two groups drugs are tested at the same time in a same group of patients, which are divided into at least three subgroups (Abbvie’s, Gilead’s, and controls) in a double blinded clinical trials.

<3> The results from Gilead and Abbvie indicate that the mechanism works by targeting HCV using these cocktails, but hardly to tell which cocktail is better.

<4> The above three points show that there is no significant difference in efficacy between Abbvie’s and Gilead’s cocktail.

<5> The most important things for patients to accept the drug is its efficacy, price, and side effect. The convenience shall be the low priority for most patients since they know it is a serious disease and they need to take a great care of it, not mention that Abbvie shall be sure to improve its pills to make it more convenient to patients in the future,

Conclusion: Abbvie’s cocktail could still be better than Gilead’s.

Hardest to treat group is those with cirrhosis. Abbvie studies with 96% SVR had zero patients with cirrhosis. Gilead studies with 96% SVR had around 20% patients with cirrhosis. No significant difference only if you ignore this.

When a patient fails the Abbvie regimen they have PI, NS5A and NN resistance. When a patient fails the Gilead regimen they have zero resistance. Hard to tell which cocktail is better only if you ignore this.

It takes 3 drugs plus ritonavir plus ribavirin to get to a high SVR with the Abbvie regimen. It take 2 drugs with no ritonavir and no ribavirin to get to a high SVR with the Gilead regimen. Hard to tell which cocktail is better only if you ignore this.
 




Hardest to treat group is those with cirrhosis. Abbvie studies with 96% SVR had zero patients with cirrhosis. Gilead studies with 96% SVR had around 20% patients with cirrhosis. No significant difference only if you ignore this.

When a patient fails the Abbvie regimen they have PI, NS5A and NN resistance. When a patient fails the Gilead regimen they have zero resistance. Hard to tell which cocktail is better only if you ignore this.

It takes 3 drugs plus ritonavir plus ribavirin to get to a high SVR with the Abbvie regimen. It take 2 drugs with no ritonavir and no ribavirin to get to a high SVR with the Gilead regimen. Hard to tell which cocktail is better only if you ignore this.

Long list of drug interactions with the Abbvie regimen. Short list of drug interactions with the Gilead regimen. Hard to tell which cocktail is better only if you ignore this.
 




Long list of drug interactions with the Abbvie regimen. Short list of drug interactions with the Gilead regimen. Hard to tell which cocktail is better only if you ignore this.

1 pill a day with Gilead regimen. 6 pills a day, with 2 of them once a day, and 4 of them twice a day. Hard to tell which cocktail is better only if you ignore this.
 




Hardest to treat group is those with cirrhosis. Abbvie studies with 96% SVR had zero patients with cirrhosis. Gilead studies with 96% SVR had around 20% patients with cirrhosis. No significant difference only if you ignore this.

When a patient fails the Abbvie regimen they have PI, NS5A and NN resistance. When a patient fails the Gilead regimen they have zero resistance. Hard to tell which cocktail is better only if you ignore this.

It takes 3 drugs plus ritonavir plus ribavirin to get to a high SVR with the Abbvie regimen. It take 2 drugs with no ritonavir and no ribavirin to get to a high SVR with the Gilead regimen. Hard to tell which cocktail is better only if you ignore this.

<1> The definition for the success of the drug on HCV is svr12-rates. It is irrelevant to the patients with or without cirrhosis, not to mention that Gilead did not show any comparative analysis in patients with/without the pathological stage of the disease.

Conclusion: you can ignore Gilead’s group to include cirrhosis.

<2> Gilead’s data did not indicate a “ZERO” resistance for those patients who had a failed treatment, suggesting that the mechanism behind these failed patients remains unclear. However, Abbvie regiment give a clue for their resistance, and open the window for future more effective drug development for this very fragmental number of patients.

Conclusion: Gilead needs work more on those failed patients.

<3> Again, the most important things to market a drug for treating HCV is related to its efficacy, price, and side-effect, while the numbers of pills to be taken is less priority if the cocktail can effectively eliminate the virus and achieve high SVR.

Conclusion: the difference can only be told by the market.

<4> The concern for multiple drug interactions in pharmacology is taken on for their side effect. It is irrelevant to a short or long list of drugs being taken. If the side-effect for Gilead’s cocktail is not better than Abbvie’s, why care about the length of the list?

<5> Quote from the Forward-Looking Statement at Gilead’s Press Release on Dec 18, 2013: “Additional clinical studies of sofosbuvir and the SOF/LDV fixed-dose combination, including results from the 24-week arms of ION-1, may not produce favorable results.” Suggesting all results need to be verified by incoming independent research and/or clinical studies.
 




Hardest to treat group is those with cirrhosis. Abbvie studies with 96% SVR had zero patients with cirrhosis. Gilead studies with 96% SVR had around 20% patients with cirrhosis. No significant difference only if you ignore this.

When a patient fails the Abbvie regimen they have PI, NS5A and NN resistance. When a patient fails the Gilead regimen they have zero resistance. Hard to tell which cocktail is better only if you ignore this.

It takes 3 drugs plus ritonavir plus ribavirin to get to a high SVR with the Abbvie regimen. It take 2 drugs with no ritonavir and no ribavirin to get to a high SVR with the Gilead regimen. Hard to tell which cocktail is better only if you ignore this.

<1> The definition for the success of the drug on HCV is svr12-rates. It is irrelevant to the patients with or without cirrhosis, not to mention that Gilead did not show any comparative analysis in patients with/without the pathological stage of the disease.

Conclusion: you can ignore Gilead’s group to include cirrhosis.

<2> Gilead’s data did not indicate a “ZERO” resistance for those patients who had a failed treatment, suggesting that the mechanism behind these failed patients remains unclear. However, Abbvie regiment give a clue for their resistance, and open the window for future more effective drug development for this very fragmental number of patients.

Conclusion: Gilead needs work more on those failed patients.

<3> Again, the most important things to market a drug for treating HCV is related to its efficacy, price, and side-effect, while the numbers of pills to be taken is less priority if the cocktail can effectively eliminate the virus and achieve high SVR.

Conclusion: the difference can only be told by the market.

<4> The concern for multiple drug interactions in pharmacology is taken on for their side effect. It is irrelevant to a short or long list of drugs being taken. If the side-effect for Gilead’s cocktail is not better than Abbvie’s, why care about the length of the list?

<5> Quote from the Forward-Looking Statement at Gilead’s Press Release on Dec 18, 2013: “Additional clinical studies of sofosbuvir and the SOF/LDV fixed-dose combination, including results from the 24-week arms of ION-1, may not produce favorable results.” Suggesting all results need to be verified by incoming independent research and/or clinical studies.
 




Dude, patients with cirrhosis have a 10-20% lower rate of SVR with most treatments for HCV (peg and riba, peg, riba and Incivek) - saying this doesn't matter shows the ignorance of Abbott people - keep believing this, and please say this to anybody who treats hepatitis C - it will do wonders for your cred!

yeah - no resistance compared to resistance to protease, NS5A and non-nuc is really bad. Much better to have resistant to almost every drug class when someone fails. Come on Anthony - you can't be that dumb!

if this is the level of intelligence we can expect after you train all the sales people, it doesn't matter the difference between the 2 regimens. Abbott sales people will be the laughingstock of the hep C world!
 




I am betting this is an Abbvie DM tryin to convince themselves that they stand a chance.

And you are either lying to yourself or have no HCV experience. Compliance has always been a concern when treating HCV. HCV patients are notoriously irresponsible ex addicts.

And Gilead has what Abbvie is hoping for. Just three years earlier. Rotanovir is a mess, and proves the cocktail is weak. Keep in mind, HCV patients usually have a laundry list of additional drugs they take, all of which will be effected by rot.

It is as if you are arguing that Abbvie wouldn't want a one pill a day that is equally efficacious, with less d to d, no RIBA and no rot. And that's funny.

Abbvie is in trouble it's that simple.
 




I am betting this is an Abbvie DM tryin to convince themselves that they stand a chance.

And you are either lying to yourself or have no HCV experience. Compliance has always been a concern when treating HCV. HCV patients are notoriously irresponsible ex addicts.

And Gilead has what Abbvie is hoping for. Just three years earlier. Rotanovir is a mess, and proves the cocktail is weak. Keep in mind, HCV patients usually have a laundry list of additional drugs they take, all of which will be effected by rot.

It is as if you are arguing that Abbvie wouldn't want a one pill a day that is equally efficacious, with less d to d, no RIBA and no rot. And that's funny.

Abbvie is in trouble it's that simple.

:)
 




Dude, patients with cirrhosis have a 10-20% lower rate of SVR with most treatments for HCV (peg and riba, peg, riba and Incivek) - saying this doesn't matter shows the ignorance of Abbott people - keep believing this, and please say this to anybody who treats hepatitis C - it will do wonders for your cred!

yeah - no resistance compared to resistance to protease, NS5A and non-nuc is really bad. Much better to have resistant to almost every drug class when someone fails. Come on Anthony - you can't be that dumb!

if this is the level of intelligence we can expect after you train all the sales people, it doesn't matter the difference between the 2 regimens. Abbott sales people will be the laughingstock of the hep C world!

Common, my friend, you certainly need to update your scientific knowledge on how to compare different data sets. If those “most treatment” worked very well on HCV, it would have been unnecessary for Abbvie to invent its HCV cocktail, or for you to support Gilead’s.

How do you define “no resistance” in those patients who failed with Gilead’s regimens? How do you explain why those HCV patients fail with Gilead’s regimens? Make sure your smart can figure it out first before showing your smiling face.

The coordinated negative campaign only exposes those laughable “intelligence”.
 




Dude, patients with cirrhosis have a 10-20% lower rate of SVR with most treatments for HCV (peg and riba, peg, riba and Incivek) - saying this doesn't matter shows the ignorance of Abbott people - keep believing this, and please say this to anybody who treats hepatitis C - it will do wonders for your cred!

yeah - no resistance compared to resistance to protease, NS5A and non-nuc is really bad. Much better to have resistant to almost every drug class when someone fails. Come on Anthony - you can't be that dumb!

if this is the level of intelligence we can expect after you train all the sales people, it doesn't matter the difference between the 2 regimens. Abbott sales people will be the laughingstock of the hep C world!

WAIT...This sound like me!!! But, I did not write this. "yeah - no resistance compared to resistance to protease, NS5A and non-nuc is really bad." Ohh yes, I say this all the time!!!

"Come on Anthony - you can't be that dumb! " I say this too all the time!!!

Ok, who wrote this? Are you me? No you are not! But Dam you are smart!!!
 




WAIT...This sound like me!!! But, I did not write this. "yeah - no resistance compared to resistance to protease, NS5A and non-nuc is really bad." Ohh yes, I say this all the time!!!

"Come on Anthony - you can't be that dumb! " I say this too all the time!!!

Ok, who wrote this? Are you me? No you are not! But Dam you are smart!!!

Just do not forget one thing though - Gilead has a little Patent Problem that they need to clear up - or did you forget!?!?
 




WAIT...This sound like me!!! But, I did not write this. "yeah - no resistance compared to resistance to protease, NS5A and non-nuc is really bad." Ohh yes, I say this all the time!!!

"Come on Anthony - you can't be that dumb! " I say this too all the time!!!

Ok, who wrote this? Are you me? No you are not! But Dam you are smart!!!

Who is Anthony? the Dude?
 








WAIT...This sound like me!!! But, I did not write this. "yeah - no resistance compared to resistance to protease, NS5A and non-nuc is really bad." Ohh yes, I say this all the time!!!

"Come on Anthony - you can't be that dumb! " I say this too all the time!!!

Ok, who wrote this? Are you me? No you are not! But Dam you are smart!!!

It is confusing who wrote this, while the purpose for the argument is to help those Abbvie Reps to continue having their confidence on Abbvie’s HCV regimen. Sounds I am from Abbvie, right?