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FDA Panel endorses Boceprevir for Hepatitis C-voted today
FDA Panel Endorses Boceprevir for Hepatitis C
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: April 27, 2011
SILVER SPRING, Md. -- An FDA advisory committee has voted unanimously to recommend approval of the investigational drug boceprevir (Victrelis), in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.
The agency's Antiviral Drugs Advisory Committee voted 18-0 Wednesday that boceprevir, made by Merck, appears to be a safe and effective new option to treat a disease that affects between three and four million people in U.S.
The panel was expected to endorse the drug -- and the FDA is expected to approve it -- since clinical trials showed that in the difficult-to-treat genotype 1 patients boceprevir yielded sustained virological response rates as high as 67%.
In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.
The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during the panel's two-day meeting this week. The other is telaprevir -- slated for review on Thursday -- which exhibited even higher sustained response rates than boceprevir.
If the FDA approves the two new drugs as expected, they would be the first HCV protease inhibitors to reach market and are thought to represent a major advance in therapy for genotype 1 hepatitis C.
Until now, treatment has relied on boosting the immune system, rather than attacking the virus directly.
Panelist Lawrence Friedman, MD, chair of the Department of Medicine at Newton-Wellesley Hospital in Newton, Mass., said when he first started seeing HCV patients, there was no treatment at all.
"To go to 60% or 70% [sustained response] really seems like a dream come true," he said. "I think this is a major advance, so I'm very enthusiastic about this drug."
Both boceprevir and telaprevir have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.
On Wednesday, the panel discussed Merck's trial data, which suggest that adding boceprevir to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates among certain subsets of patients.
For instance, in one of the trials, in patients who had never been treated for HCV, 40% of the control group receiving the conventional regimen had a sustained response versus about 70% of patients with boceprevir added.
Analyzing data of patients with previous partial or unsustained responses to the standard regimen showed that 21% achieved a sustained response with a second round of the same treatment, whereas approximately 60% did when that second round included boceprevir.
The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on how well a patient was responding to treatment after eight and 24 weeks.
Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.
But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated.
Panelists also discussed the hematologic side effects associated with boceprevir -- including anemia, neutropenia, and thrombocytopenia -- all of which were more common in patients treated with boceprevir -- but they were ultimately convinced that anemia is a manageable side effect during treatment with boceprevir and is reversible after the drug is stopped.
The FDA is expected to make decisions on both boceprevir and telaprevir in May and physicians who treat HCV patients are eagerly awaiting approval. The anticipation has led some doctors to postpone treatment until the drugs are available, according to Donald Gardenier, DNP, of Mount Sinai School of Medicine in New York City.
The delays are based on the expectation that "the new treatments will be both more effective and administered over shorter courses," Gardenier said in an email to MedPage Today.
For most patients, the delay will have "little or no downside," he said.
"Chronic hepatitis C progresses slowly and the goal of treatment is to prevent the long-term consequences, so a delay of a few months is not significant for most patients," Gardenier said.
In some cases, such as where liver disease is advanced, doctors would go ahead with standard treatment, he added, "although that happens less frequently as the availability of the new medications comes closer."
Once the drug is approved, it still has to be made and shipped and insurers need to agree to pay for it, he noted. Currently, experts are expecting to see the drug in the clinic by late summer or early fall.
"In the meantime, we are actively planning for handling what we anticipate will be a corresponding increase in patient volume," Gardenier said.
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: April 27, 2011
SILVER SPRING, Md. -- An FDA advisory committee has voted unanimously to recommend approval of the investigational drug boceprevir (Victrelis), in combination with peginterferon and ribavirin, to treat hepatitis C genotype 1.
The agency's Antiviral Drugs Advisory Committee voted 18-0 Wednesday that boceprevir, made by Merck, appears to be a safe and effective new option to treat a disease that affects between three and four million people in U.S.
The panel was expected to endorse the drug -- and the FDA is expected to approve it -- since clinical trials showed that in the difficult-to-treat genotype 1 patients boceprevir yielded sustained virological response rates as high as 67%.
In contrast, the rate for patients getting the standard regimen of pegylated interferon injections and ribavirin pills was about 40%.
The drug is one of two hepatitis C virus (HCV) protease inhibitors that will be reviewed during the panel's two-day meeting this week. The other is telaprevir -- slated for review on Thursday -- which exhibited even higher sustained response rates than boceprevir.
If the FDA approves the two new drugs as expected, they would be the first HCV protease inhibitors to reach market and are thought to represent a major advance in therapy for genotype 1 hepatitis C.
Until now, treatment has relied on boosting the immune system, rather than attacking the virus directly.
Panelist Lawrence Friedman, MD, chair of the Department of Medicine at Newton-Wellesley Hospital in Newton, Mass., said when he first started seeing HCV patients, there was no treatment at all.
"To go to 60% or 70% [sustained response] really seems like a dream come true," he said. "I think this is a major advance, so I'm very enthusiastic about this drug."
Both boceprevir and telaprevir have attracted major buzz among physicians and patients on the basis of excellent-looking clinical trial results, most recently from two of boceprevir's pivotal studies published in the New England Journal of Medicine last month.
On Wednesday, the panel discussed Merck's trial data, which suggest that adding boceprevir to the standard peginterferon-ribavirin combination doubles or triples the sustained viral response rates among certain subsets of patients.
For instance, in one of the trials, in patients who had never been treated for HCV, 40% of the control group receiving the conventional regimen had a sustained response versus about 70% of patients with boceprevir added.
Analyzing data of patients with previous partial or unsustained responses to the standard regimen showed that 21% achieved a sustained response with a second round of the same treatment, whereas approximately 60% did when that second round included boceprevir.
The core treatment regimen with boceprevir tested in the trials included a four-week lead-in period with peginterferon and ribavirin with boceprevir then added for 44 weeks. But some of the trials also included a regimen in which the duration of boceprevir treatment could be extended based on how well a patient was responding to treatment after eight and 24 weeks.
Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.
But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated.
Panelists also discussed the hematologic side effects associated with boceprevir -- including anemia, neutropenia, and thrombocytopenia -- all of which were more common in patients treated with boceprevir -- but they were ultimately convinced that anemia is a manageable side effect during treatment with boceprevir and is reversible after the drug is stopped.
The FDA is expected to make decisions on both boceprevir and telaprevir in May and physicians who treat HCV patients are eagerly awaiting approval. The anticipation has led some doctors to postpone treatment until the drugs are available, according to Donald Gardenier, DNP, of Mount Sinai School of Medicine in New York City.
The delays are based on the expectation that "the new treatments will be both more effective and administered over shorter courses," Gardenier said in an email to MedPage Today.
For most patients, the delay will have "little or no downside," he said.
"Chronic hepatitis C progresses slowly and the goal of treatment is to prevent the long-term consequences, so a delay of a few months is not significant for most patients," Gardenier said.
In some cases, such as where liver disease is advanced, doctors would go ahead with standard treatment, he added, "although that happens less frequently as the availability of the new medications comes closer."
Once the drug is approved, it still has to be made and shipped and insurers need to agree to pay for it, he noted. Currently, experts are expecting to see the drug in the clinic by late summer or early fall.
"In the meantime, we are actively planning for handling what we anticipate will be a corresponding increase in patient volume," Gardenier said.
Your doctor can order the test from LabCorp.
http://people.chgv.lsrc.duke.edu/~dg48//sva/L8464-0710-Service-Announcement-FINAL.pdf
Last year's service announcement only includes the rs12979860 site on the interleukin 28B (IL28B) gene, but there are two others nearby, the rs8099917 and rs12980275, which have been proven to have relevance to geno 1s.
http://www.natap.org/2011/HCV/021611_02.htm
I do agree with Proactive that each new drug (and each new genetic test) adds exponentially to the complexity of tx.
At least most docs know to do a 4 week PCR now. We're sloooowly climbing out of the Dark Ages.
http://people.chgv.lsrc.duke.edu/~dg48//sva/L8464-0710-Service-Announcement-FINAL.pdf
Last year's service announcement only includes the rs12979860 site on the interleukin 28B (IL28B) gene, but there are two others nearby, the rs8099917 and rs12980275, which have been proven to have relevance to geno 1s.
http://www.natap.org/2011/HCV/021611_02.htm
I do agree with Proactive that each new drug (and each new genetic test) adds exponentially to the complexity of tx.
At least most docs know to do a 4 week PCR now. We're sloooowly climbing out of the Dark Ages.
Some time ago, both my Gastro and Hepatologist said at the very worst, if you don't clear with whatever treatment you're on, you will be buying time until something else comes along. Thinking along those lines is hopeful in the worst case scenario. One thing to remember, is that thankfully, this is a slow moving disease. Time could very well be on the side of even new drug non-responders...
Let's face it, the race is now on and new clinical trials are in motion even as everyone is excited about these two new drugs. As the Stones said, "time is on my side". Let's hope so...
Magnum
Let's face it, the race is now on and new clinical trials are in motion even as everyone is excited about these two new drugs. As the Stones said, "time is on my side". Let's hope so...
Magnum
susan - great news to be sure. Thanks for the post.
desrt - how exactly does one get the IL28B test? Is it possible to have it covered by medical insurance?
desrt - how exactly does one get the IL28B test? Is it possible to have it covered by medical insurance?
"Yes, the addition of a third drug to SOC is going to make tx decisions even moe complicated for both patients and doctors, but hasn't a huge complaint always been that we have cookie-cutter, one-size-fits-all tx ? "
I think based on presentations and recommendations over the past 2 years a more response guided approach has been accepted as the norm as opposed to the tx cookie-cutter SOC.
"We should all just shut up and eat our cookies." Not sure what you mean here. If cookies are 200mg ribavirin, I ate about 4000 of them, during my response guided 72 week journey..
Just another example of the hep doc having as much importance to TX success as the drugs in some cases.
Adding one more additional drug to the mix, exponentially changes the variables.
I think based on presentations and recommendations over the past 2 years a more response guided approach has been accepted as the norm as opposed to the tx cookie-cutter SOC.
"We should all just shut up and eat our cookies." Not sure what you mean here. If cookies are 200mg ribavirin, I ate about 4000 of them, during my response guided 72 week journey..
Just another example of the hep doc having as much importance to TX success as the drugs in some cases.
Adding one more additional drug to the mix, exponentially changes the variables.
IFN based tx seems to have a huge range of possible, *individual* responses - from some geno 2s and 3s who SVR with 12 weeks of tx to others who never clear. There also seems to be a huge range of post-tx sx, making a minimal use of tx drugs desirable.
I've watched for the last 8 years while millions have been poured into the 'PI race' while very little (comparitively) has been spent on things like the IL28B test,, that would actually guide physicians in how to use these drugs. Yes, the addition of a third drug to SOC is going to make tx decisions even moe complicated for both patients and doctors, but hasn't a huge complaint always been that we have cookie-cutter, one-size-fits-all tx ?
This panel's objection isn't just to tx-extension for this particular drug, they have 'concern' about this "type of "response-guided therapy,"". We should all just shut up and eat our cookies.
Double Gackkk!
I've watched for the last 8 years while millions have been poured into the 'PI race' while very little (comparitively) has been spent on things like the IL28B test,, that would actually guide physicians in how to use these drugs. Yes, the addition of a third drug to SOC is going to make tx decisions even moe complicated for both patients and doctors, but hasn't a huge complaint always been that we have cookie-cutter, one-size-fits-all tx ?
This panel's objection isn't just to tx-extension for this particular drug, they have 'concern' about this "type of "response-guided therapy,"". We should all just shut up and eat our cookies.
Double Gackkk!
This is good news for you, Susan - and for others who might not be suited to Telaprevir. Good to have options and it looks good for Telaprevir approval to see that Boceprevir was approved unanimously. I hope this raises your prospects and gives you a bit more hope for good things to come. Thanks for the post.
Trish
Trish
"But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated"
I confess, I haven't been following the details closely. Has there been a written explanation as to how the response will guide therapy? (aside from helper drug intervention)
The panel's statement does make sense to me and underscores the importance of finding a hepatologist who is up to date and current in their knowledge of using the boc...Which obviously not many will have the knowledge of experience,to begin with..Even though the trials are over, it looks like there is still a long learning curve ahead of the docotrs.
I confess, I haven't been following the details closely. Has there been a written explanation as to how the response will guide therapy? (aside from helper drug intervention)
The panel's statement does make sense to me and underscores the importance of finding a hepatologist who is up to date and current in their knowledge of using the boc...Which obviously not many will have the knowledge of experience,to begin with..Even though the trials are over, it looks like there is still a long learning curve ahead of the docotrs.
"Merck would like the drug's label to allow longer treatment for patients with detectable HCV RNA at eight weeks but who achieve a full virologic response at 24 weeks, as some data suggested that such a regimen improves the sustained response rate.
But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated."
Always good to know that the people who make these types of life and death decisions for us are, apparently, easily confused simpletons.
Ackkk!
But the panel expressed concern over that type of "response-guided therapy," in part because it would make HCV treatment even more complicated."
Always good to know that the people who make these types of life and death decisions for us are, apparently, easily confused simpletons.
Ackkk!
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