I didn't see in the article how many of those that dropped out were treatment naïve, perhaps I overlooked it? I suspect those more ill, and tx experienced have greater incentive to be fully compliant and complete tx. I can understand where the dropout rate would be higher for those on interferon/Riba with Sovaldi. Some are physically unable to complete tx.
Malcolm when you say; "There may be an emerging perception that HCV is easy to treat, so, no worries if it doesn't work this time," I suspect my doc may have had this perception when the S/O first became available. I asked about taking the riba in the regimen and was told it wasn't necessary and that "we can always retreat"....a BIG IF the insurance companies will pay for it again? The outcomes and statistics of relatively small clinical studies no doubt, also played a role in the decision not to prescribe riba with the S/O. I hope that in time, and with larger patient samples, practitioners will have a better understanding of how to individualize tx for patients based upon diagnosis and medical history.
Physicians need to remind all patients, that compliance is not optional. Doc's should be sure to note in charts, when a patient has dropped out of treatment for reasons other than medical necessity. With the prices of these meds, non-compliance for frivolous reasons should come with serious penalty.
Perhaps patients could sign a contract that if they drop out for frivolous reasons they would have to be responsible for paying the cost of the meds? This would get people's attention.
Edit, thanks Malcolm for all the great information and knowledge you share with us. It is truly appreciated.
-- Edited by Groupergetter on Friday 10th of October 2014 03:26:47 PM
mallani said
Oct 10, 2014
Hi all,
The drop-out rates are not surprising. When you look at the figures, it is >10% when Sovaldi is used with Peg and Riba, >9% when used with Riba and 5% if just Sovaldi and Olysio are used.
We all know Peg and Riba are the pits. As a 48-weeker, it's easy to say 'man-up, it's only for 12 weeks'. We need to know why patients are discontinuing- is it from severe Sx or some more mundane reason?
Obviously, patient selection is part of the reason. Patients who did Trials were strongly motivated to clear their disease. Previous treatment failures would also have strong motivation, and this is reflected in the fact that discontinuation was almost twice as common in Tx-naives. Perhaps more emphasis should be placed on patient education about the dire consequences of HCV.
The prescribing doctors are probably at fault. Proper informed consent has never been satisfactory in HCV treatment. The common side effects of HCV drugs should be explained as well as possible remedies. It seems that assessing liver status properly is becoming forgotten. There is no doubt that patients with severe liver damage have more side effects.
There may be an emerging perception that HCV is easy to treat, so, no worries if it doesn't work this time.
With Sovaldi/ Ledipasvir, one pill a day for 12 weeks with no side effects should be manageable. I hope so. Cheers.
wmlj1960 said
Oct 10, 2014
Isiscat2011 wrote:
wmlj1960 wrote:
That irritates me almost as much as the pharmaceutical company pricing the medicine so out of reach for so many. JMO
Try not to be too mad at the patients.
We need to continue to support and educate each other.
When I'm honest with myself, I can substitute my lack of willingness to quit drinking alcohol when my liver was not so badly damaged to the new treatment naive / minimally affected patients lack of willingness to go through the discomforts, inconveniences and major Sx's in some cases that Tx can dish out. I was not dedicated to HCV recovery until I was forced into the hospital via pain, so I have no right to judge anyone for doing as I did. And you are right about lack of medical staff to work with patients on anything close to an individual level in order to prepare them for Tx as well as be available for help during Tx. That's a big issue where I am being treated! If it were not for the help and understanding I've found on this forum, I would have had a much harder time dealing with Tx. I try to pay it forward by watching for new member post and making an attempt to make them feel welcome.
Tig56 wrote:
I also wonder if providing the inter treatment viral load results (showing UND) are counter productive in some cases?
Tig
It certainly may be a factor in a treatment naive or un-informed patient to slack up on Tx adherence/compliance after seeing this UND result, not realizing that UND happens quickly with the new DAA's, but SVR is the result of completing Tx as instructed - and anything less than this is not advised.
Dzdayscomin wrote:.I wish they could see where this disease landed me and what I go thru each day, to give them a greater appreciation of how fortunate they truly are.
Me too Duane. I truly only see one good thing I possibly received from living the alcoholic - drug addict life. And that is to be an example of what the negative results of that lifestyle are so the younger crowd, who are trying to live through the obstacles that I lived through will want to change. But I also have to remember that I was shown countless examples on my way through it but that didn't even slow me down. BUT, the seed was planted so when I made the decision to change, I knew right where some good support and a lot of the answers were right from the start.
One thing I did notice was the S/O regimine had the smallest aggregate drop out rate, which would tell me a couple things, either it was the easiest to tolerate, or the patients prescribed the off lable use were the sickest and the tx meant more to them to prevent any urge to drop out of tx.
Probably both. The S/O is more tolerable and the stakes are higher for the sicker patients. The sicker patients were often tx experienced so they would tend to have more realistic expectations going in as well. To a tx naive person headaches, rashes, nausea, depression, (all common side effects) would naturally be more alarming.
Also, we have seen a few people here hospitalized or seen at emergency rooms during all oral tx, so side effects can be serious for some. I simply don't believe it is all in their heads.
Dzdayscomin said
Oct 9, 2014
My thinking is that it's not the sovaldi that is causing the drop out rate, but rather it's the assisting drugs(riba, peg interferon etc), having done the S/O combo I really can't see what would cause people to drop out..... it just does not have the sx alone to cause this.
Unless it is those patients that have very little symptoms of the disease and the fatigue makes them say "geez i felt better before taking tx" and don't have regard for the long term effect of not ridding themselves of HCV.....living for today syndrome I'll call it.
Either way it's very disappointing to hear that these life saving drugs are wasted, it just breaks my heart for those that really need them and would never think of abusing the opportunity to get well......I wish they could see where this disease landed me and what I go thru each day, to give them a greater appreciation of how fortunate they truly are.
One thing I did notice was the S/O regimine had the smallest aggregate drop out rate, which would tell me a couple things, either it was the easiest to tolerate, or the patients prescribed the off lable use were the sickest and the tx meant more to them to prevent any urge to drop out of tx.
I'm not Mr analytical so if i mis spoke on my understanding of this forgive me.
Duane
Isiscat2011 said
Oct 9, 2014
wmlj1960 wrote:
That irritates me almost as much as the pharmaceutical company pricing the medicine so out of reach for so many. JMO
Try not to be too mad at the patients. That lets Pharma off the hook for downplaying side effects and turning the tx into a scarce resource by overpricing, payers off the hook for being stingy about paying for tx, and the government off the hook for not allocating sufficient resources to deal with the HCV problem. That is what they all want. We need to continue to support and educate each other.
Tig said
Oct 9, 2014
That is very surprising and disappointing! I'm curious if the reports of 8 week success rates in some of the articles that are out there, have any impact on these figures? I also wonder if providing the inter treatment viral load results (showing UND) are counter productive in some cases? Good grief, that's almost 1 in 10....
Tig
Isiscat2011 said
Oct 9, 2014
This is the CVS study and I think the numbers are legit. Higher discontinuation "real world" rates are a given. The study authors concluded that tx naive patients had significantly greater discontinuation rates and that makes sense to me. Some of these patients were also on Interferon or Riba although many were not.
The study also concluded that better patient counseling and monitoring are needed and I agree. It could be that some patients don't take tx seriously enough--they are not paying for it themselves--and it could be that they are not sufficiently educated about HCV, cost issues, and especially side effects. They expect minimal to no interruption or changes in their daily lives during tx. That just isn't the way it turns out for everyone, however.
When tx problems do arise the medical professionals who are administering tx are not always sufficiently trained or lack adequate time to deal with the problems. Increased discontinuation rates are to be expected when patients are simply handed a prescription and left to their own devices which happens too often with HCV tx. That is why forums like this are sought out by so many. Patients need information and support and they are not getting enough of it from the medical community.
It isn't the medical community's "fault" but rather the problem is a lack of adequate resources. This problem will continue until more resources are allocated to manage HCV tx. We are in new territory here. Treating millions of people for an infectious disease creates many challenges. And, there will always be some irresponsible people--regardless of how well they are treated and monitored--fewer however I believe if they are properly educated on the realities of tx and well monitored during tx.
Most studies have an agenda and this one is fairly clear (cost containment via improved patient vetting) if you read the concluding remarks. That agenda doesn't mean the study is without value, however.
wmlj1960 said
Oct 9, 2014
I got the link to THIS article from the Hepatitis Central news letter:
Over 8 percent of hepatitis C patients taking Sovaldi (sofosbuvir; Gilead) are failing to complete their full, 12-week course of drug therapy, a dropout rate roughly four times that observed in clinical trials.
They are wrong about "incurring health care costs of $28,000 or $56,000" (unless for some reason they mean 1 month or 2 months?) so hopefully they are wrong about dropout rates because a rate 4 times higher than that observed in trials seems like some patients are quitting as a result of the first little inconvenience. I know some participants have legit medical issues related to Sovaldi treatment, but based on my 12 of 24 weeks experience so far, and that of most people that have commented about Sov Sx's, I suspect some of those early dropouts are due to lack of desire to be cured. And that waist expensive medicine that could have been used to save somebody's life who's priority is doing what it takes in order to live HCV free. That irritates me almost as much as the pharmaceutical company pricing the medicine so out of reach for so many. JMO
More information on that study is available via .pdf veiwable or downloadable file HERE
Hi Greg,
Here's the link. Cheers.
http://cvshealth.com/sites/default/files/hepatitisCutilization.pdf
I didn't see in the article how many of those that dropped out were treatment naïve, perhaps I overlooked it? I suspect those more ill, and tx experienced have greater incentive to be fully compliant and complete tx. I can understand where the dropout rate would be higher for those on interferon/Riba with Sovaldi. Some are physically unable to complete tx.
Malcolm when you say; "There may be an emerging perception that HCV is easy to treat, so, no worries if it doesn't work this time," I suspect my doc may have had this perception when the S/O first became available. I asked about taking the riba in the regimen and was told it wasn't necessary and that "we can always retreat"....a BIG IF the insurance companies will pay for it again? The outcomes and statistics of relatively small clinical studies no doubt, also played a role in the decision not to prescribe riba with the S/O. I hope that in time, and with larger patient samples, practitioners will have a better understanding of how to individualize tx for patients based upon diagnosis and medical history.
Physicians need to remind all patients, that compliance is not optional. Doc's should be sure to note in charts, when a patient has dropped out of treatment for reasons other than medical necessity. With the prices of these meds, non-compliance for frivolous reasons should come with serious penalty.
Perhaps patients could sign a contract that if they drop out for frivolous reasons they would have to be responsible for paying the cost of the meds? This would get people's attention.
Edit, thanks Malcolm for all the great information and knowledge you share with us. It is truly appreciated.
-- Edited by Groupergetter on Friday 10th of October 2014 03:26:47 PM
Hi all,
The drop-out rates are not surprising. When you look at the figures, it is >10% when Sovaldi is used with Peg and Riba, >9% when used with Riba and 5% if just Sovaldi and Olysio are used.
We all know Peg and Riba are the pits. As a 48-weeker, it's easy to say 'man-up, it's only for 12 weeks'. We need to know why patients are discontinuing- is it from severe Sx or some more mundane reason?
Obviously, patient selection is part of the reason. Patients who did Trials were strongly motivated to clear their disease. Previous treatment failures would also have strong motivation, and this is reflected in the fact that discontinuation was almost twice as common in Tx-naives. Perhaps more emphasis should be placed on patient education about the dire consequences of HCV.
The prescribing doctors are probably at fault. Proper informed consent has never been satisfactory in HCV treatment. The common side effects of HCV drugs should be explained as well as possible remedies. It seems that assessing liver status properly is becoming forgotten. There is no doubt that patients with severe liver damage have more side effects.
There may be an emerging perception that HCV is easy to treat, so, no worries if it doesn't work this time.
With Sovaldi/ Ledipasvir, one pill a day for 12 weeks with no side effects should be manageable. I hope so. Cheers.
When I'm honest with myself, I can substitute my lack of willingness to quit drinking alcohol when my liver was not so badly damaged to the new treatment naive / minimally affected patients lack of willingness to go through the discomforts, inconveniences and major Sx's in some cases that Tx can dish out. I was not dedicated to HCV recovery until I was forced into the hospital via pain, so I have no right to judge anyone for doing as I did. And you are right about lack of medical staff to work with patients on anything close to an individual level in order to prepare them for Tx as well as be available for help during Tx. That's a big issue where I am being treated! If it were not for the help and understanding I've found on this forum, I would have had a much harder time dealing with Tx. I try to pay it forward by watching for new member post and making an attempt to make them feel welcome.
It certainly may be a factor in a treatment naive or un-informed patient to slack up on Tx adherence/compliance after seeing this UND result, not realizing that UND happens quickly with the new DAA's, but SVR is the result of completing Tx as instructed - and anything less than this is not advised.
Me too Duane. I truly only see one good thing I possibly received from living the alcoholic - drug addict life. And that is to be an example of what the negative results of that lifestyle are so the younger crowd, who are trying to live through the obstacles that I lived through will want to change. But I also have to remember that I was shown countless examples on my way through it but that didn't even slow me down. BUT, the seed was planted so when I made the decision to change, I knew right where some good support and a lot of the answers were right from the start.
Probably both. The S/O is more tolerable and the stakes are higher for the sicker patients. The sicker patients were often tx experienced so they would tend to have more realistic expectations going in as well. To a tx naive person headaches, rashes, nausea, depression, (all common side effects) would naturally be more alarming.
Also, we have seen a few people here hospitalized or seen at emergency rooms during all oral tx, so side effects can be serious for some. I simply don't believe it is all in their heads.
My thinking is that it's not the sovaldi that is causing the drop out rate, but rather it's the assisting drugs(riba, peg interferon etc), having done the S/O combo I really can't see what would cause people to drop out..... it just does not have the sx alone to cause this.
Unless it is those patients that have very little symptoms of the disease and the fatigue makes them say "geez i felt better before taking tx" and don't have regard for the long term effect of not ridding themselves of HCV.....living for today syndrome I'll call it.
Either way it's very disappointing to hear that these life saving drugs are wasted, it just breaks my heart for those that really need them and would never think of abusing the opportunity to get well......I wish they could see where this disease landed me and what I go thru each day, to give them a greater appreciation of how fortunate they truly are.
One thing I did notice was the S/O regimine had the smallest aggregate drop out rate, which would tell me a couple things, either it was the easiest to tolerate, or the patients prescribed the off lable use were the sickest and the tx meant more to them to prevent any urge to drop out of tx.
I'm not Mr analytical so if i mis spoke on my understanding of this forgive me.
Duane
Try not to be too mad at the patients. That lets Pharma off the hook for downplaying side effects and turning the tx into a scarce resource by overpricing, payers off the hook for being stingy about paying for tx, and the government off the hook for not allocating sufficient resources to deal with the HCV problem. That is what they all want. We need to continue to support and educate each other.
That is very surprising and disappointing! I'm curious if the reports of 8 week success rates in some of the articles that are out there, have any impact on these figures? I also wonder if providing the inter treatment viral load results (showing UND) are counter productive in some cases? Good grief, that's almost 1 in 10....
Tig
This is the CVS study and I think the numbers are legit. Higher discontinuation "real world" rates are a given. The study authors concluded that tx naive patients had significantly greater discontinuation rates and that makes sense to me. Some of these patients were also on Interferon or Riba although many were not.
The study also concluded that better patient counseling and monitoring are needed and I agree. It could be that some patients don't take tx seriously enough--they are not paying for it themselves--and it could be that they are not sufficiently educated about HCV, cost issues, and especially side effects. They expect minimal to no interruption or changes in their daily lives during tx. That just isn't the way it turns out for everyone, however.
When tx problems do arise the medical professionals who are administering tx are not always sufficiently trained or lack adequate time to deal with the problems. Increased discontinuation rates are to be expected when patients are simply handed a prescription and left to their own devices which happens too often with HCV tx. That is why forums like this are sought out by so many. Patients need information and support and they are not getting enough of it from the medical community.
It isn't the medical community's "fault" but rather the problem is a lack of adequate resources. This problem will continue until more resources are allocated to manage HCV tx. We are in new territory here. Treating millions of people for an infectious disease creates many challenges. And, there will always be some irresponsible people--regardless of how well they are treated and monitored--fewer however I believe if they are properly educated on the realities of tx and well monitored during tx.
Most studies have an agenda and this one is fairly clear (cost containment via improved patient vetting) if you read the concluding remarks. That agenda doesn't mean the study is without value, however.
I got the link to THIS article from the Hepatitis Central news letter:
They are wrong about "incurring health care costs of $28,000 or $56,000" (unless for some reason they mean 1 month or 2 months?) so hopefully they are wrong about dropout rates because a rate 4 times higher than that observed in trials seems like some patients are quitting as a result of the first little inconvenience. I know some participants have legit medical issues related to Sovaldi treatment, but based on my 12 of 24 weeks experience so far, and that of most people that have commented about Sov Sx's, I suspect some of those early dropouts are due to lack of desire to be cured. And that waist expensive medicine that could have been used to save somebody's life who's priority is doing what it takes in order to live HCV free. That irritates me almost as much as the pharmaceutical company pricing the medicine so out of reach for so many. JMO
More information on that study is available via .pdf veiwable or downloadable file HERE