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In need of advice- no health insurance- mom newly diagnosed- Clinical Trials??
Hi- today is my first day here. So many questions. My mom was recently diagnosed - geno 1, stage 3 fibrosis. She is 64 and only known risk factor was a blood transfusion she had as an infant- if that's where she got this she's had it all her life and not known.
I am wondering if someone can tell me the name of this study that is being talked about in this thread by Renee, Willy, and many others. I THINK I've found it on clinical trials and it says they are recruiting some in our area- the study number i see is NCT01701401 - is that the one everyone is talking about??What is the best way to try to get into a study- tell her doctor or email the contact person listed with that study on the clinical trials sight?
. We are beyond frightened and confused- she got a phone call from her doctor explaining the stage 3 biopsy results and recommending the triple therapy with incivek. A quick phone call though was not enough time for her to come up with questions and understand what we are getting into here. In addition to being so scared about the side effects she has NO health insurance. My second question is..Has anyone here gotten through treatment without any health insurance??She is supposed to meet with the nurse at the gastro/hepatologist's office to discuss charity care and drug company assistance for the actual drugs but it seems like with all the side effects and health problems it could cause (possible need for Procrit, etc...) it might be disastrous for her to undertake the triple therapy tx with no insurance. maybe she should wait till next year when she gets on medicare? Does medicare pay for these drugs?? I feel so lost and have no idea who to ask. I am thinking this study would be the way to go- no interferon or incivek side effects and it all appears to be paid for. She feels absolutely fine- should she wait for a study or the new sofosbuvir to actually come out, or at least wait till she's 65 and on medicare before undertaking treatment? Any answers/ thoughts would be so very appreciated.thanks
I am wondering if someone can tell me the name of this study that is being talked about in this thread by Renee, Willy, and many others. I THINK I've found it on clinical trials and it says they are recruiting some in our area- the study number i see is NCT01701401 - is that the one everyone is talking about??What is the best way to try to get into a study- tell her doctor or email the contact person listed with that study on the clinical trials sight?
. We are beyond frightened and confused- she got a phone call from her doctor explaining the stage 3 biopsy results and recommending the triple therapy with incivek. A quick phone call though was not enough time for her to come up with questions and understand what we are getting into here. In addition to being so scared about the side effects she has NO health insurance. My second question is..Has anyone here gotten through treatment without any health insurance??She is supposed to meet with the nurse at the gastro/hepatologist's office to discuss charity care and drug company assistance for the actual drugs but it seems like with all the side effects and health problems it could cause (possible need for Procrit, etc...) it might be disastrous for her to undertake the triple therapy tx with no insurance. maybe she should wait till next year when she gets on medicare? Does medicare pay for these drugs?? I feel so lost and have no idea who to ask. I am thinking this study would be the way to go- no interferon or incivek side effects and it all appears to be paid for. She feels absolutely fine- should she wait for a study or the new sofosbuvir to actually come out, or at least wait till she's 65 and on medicare before undertaking treatment? Any answers/ thoughts would be so very appreciated.thanks
Best Answer
I did my whole treatment (triple w/Incivek) with no health insurance. I started out at a free clinic where I got diagnosed, was referred to a county hospital for biopsy, and treated through the hospital's hep C program. I think most cities have these types of clinics for the poor or uninsured. My Incivek was supplied by Vertex through their patient assistance program. My PegIntron and Ribavirin was supplied by the manufacturers at no cost and was obtained by the hospital for me. All tests, exams, visits, etc., were at no cost to me because I was low income. I think a trial covers all costs for patients too. I was stage 3 and chose to treat instead of waiting. I don't know anything about Medicare. I'd say a trial or a county clinic might be her best bet.
Welcome to the forum. I am sorry that your mom has Hepatitis C and is having these problems. I won't go into the study question because others who know more about the studies can respond to that. I will try to adress some of your other questions.
"My second question is..Has anyone here gotten through treatment without any health insurance??"
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Yes, people have. Most large medical centers, especially university affiliated medical centers, give free care and/or financial assistance to those who need it. I do not know where your mom lives but there should be a university affiliated medical center within driving distance. Contact that facility and ask for their social services department and/or their financial assistance department, tell them your situation, and ask them if your mom can get free or sliding scale medical assistance. If her income is low enough, she will probably get everything free.
"She is supposed to meet with the nurse at the gastro/hepatologist's office to discuss charity care and drug company assistance for the actual drugs but it seems like with all the side effects and health problems it could cause (possible need for Procrit, etc...) it might be disastrous for her to undertake the triple therapy tx with no insurance."
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She should still meet with the nurse and see what they will offer. Have a list of questions to ask the nurse in terms of assistance with all of the medical problems, not just the Hep C meds, but everything that could come up.
"maybe she should wait till next year when she gets on medicare? Does medicare pay for these drugs??"
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If your mother gets Medicare Parts A and B then Medicare, generally speaking, will cover 80% of costs such as hospitalizations, lab, X-rays, tests, office visits, etc. (Be sure the doctor accepts Medicare assignment (agrees to what Medicare will pay). Your mom gets Medicare Part A free but she will have to pay for Medicare Part B. It is about $100 a month, but she must get it. It is deducted from her Soc. Sec. check. She will need to get what is called a Medi-gap insurance also. This is insurance that covers what Medicare does not cover (that 20%). She should shop around and find a good plan that picks up the part of the bill that Medicare does not cover. Neither Medicare Part A or Part B pays for prescriptions. Therefore, she also needs to buy Medicare Part D insurance, which is the prescription drug insurance for people on Medicare. She will need to shop around for this type of insurance also. But she needs to buy it. If she does not buy Medicare Part D prescription drug coverage when she first signs up for Medicare (actually I think there is a 6 month grace period) then every month that she waits before she buys it, she will get penalized. In other words, as an example, If she signs up for Medicare in 2014, but does not buy the Medicare Part D in 2014, then, if she buys it in 2015 or 2016, she will pay more every month for Medicare Part D than if she had bought it in 2014. Anyway, this is a long explanation, but you can see that just waiting for Medicare is not a magic bullet. Medicare is complicated and they do not pay for everything. She will still need that Medi-gap insurance as well as Part D.
Now, another thing about waiting. Your mother is 64 and she has Stage 3 fibrosis. Liver fibrosis tends to pick up speed as we age. At 64 she is probably progressing faster than she was 20 years ago. Also, there are only 5 stages.
The fibrosis score is assigned a number from 0-4:
0 = no scarring
1 = minimal scarring
2 = scarring has occurred and extends outside
the areas in the liver that contains blood vessels
3=bridging fibrosis is spreading and
connecting to other areas that contain fibrosis
4=cirrhosis or advanced scarring of the liver
In addition, your mom could have Stage 3 in the part of the liver they biopsied, but she could have Stage 4 in another part that was not biopsied.
Stage 4 is cirrhosis. Your mother should definitely treat before she progresses to cirrhosis. One does not want to wait around to treat and develop cirrhosis while waiting. It is more difficult to treat people when they are cirrhotic (they tend to have more complications) and the cure rate is considerably lower in cirrhotics than it is in people who do not have cirrhosis. So she should treat sooner rather than later.
Please come often to the forum and ask as many questions as you wish. Hopefully we can help you and your mother.
Wishing the best for you and your mother.
"My second question is..Has anyone here gotten through treatment without any health insurance??"
----------------------
Yes, people have. Most large medical centers, especially university affiliated medical centers, give free care and/or financial assistance to those who need it. I do not know where your mom lives but there should be a university affiliated medical center within driving distance. Contact that facility and ask for their social services department and/or their financial assistance department, tell them your situation, and ask them if your mom can get free or sliding scale medical assistance. If her income is low enough, she will probably get everything free.
"She is supposed to meet with the nurse at the gastro/hepatologist's office to discuss charity care and drug company assistance for the actual drugs but it seems like with all the side effects and health problems it could cause (possible need for Procrit, etc...) it might be disastrous for her to undertake the triple therapy tx with no insurance."
-----------------------------------------
She should still meet with the nurse and see what they will offer. Have a list of questions to ask the nurse in terms of assistance with all of the medical problems, not just the Hep C meds, but everything that could come up.
"maybe she should wait till next year when she gets on medicare? Does medicare pay for these drugs??"
-------------------------------------------------
If your mother gets Medicare Parts A and B then Medicare, generally speaking, will cover 80% of costs such as hospitalizations, lab, X-rays, tests, office visits, etc. (Be sure the doctor accepts Medicare assignment (agrees to what Medicare will pay). Your mom gets Medicare Part A free but she will have to pay for Medicare Part B. It is about $100 a month, but she must get it. It is deducted from her Soc. Sec. check. She will need to get what is called a Medi-gap insurance also. This is insurance that covers what Medicare does not cover (that 20%). She should shop around and find a good plan that picks up the part of the bill that Medicare does not cover. Neither Medicare Part A or Part B pays for prescriptions. Therefore, she also needs to buy Medicare Part D insurance, which is the prescription drug insurance for people on Medicare. She will need to shop around for this type of insurance also. But she needs to buy it. If she does not buy Medicare Part D prescription drug coverage when she first signs up for Medicare (actually I think there is a 6 month grace period) then every month that she waits before she buys it, she will get penalized. In other words, as an example, If she signs up for Medicare in 2014, but does not buy the Medicare Part D in 2014, then, if she buys it in 2015 or 2016, she will pay more every month for Medicare Part D than if she had bought it in 2014. Anyway, this is a long explanation, but you can see that just waiting for Medicare is not a magic bullet. Medicare is complicated and they do not pay for everything. She will still need that Medi-gap insurance as well as Part D.
Now, another thing about waiting. Your mother is 64 and she has Stage 3 fibrosis. Liver fibrosis tends to pick up speed as we age. At 64 she is probably progressing faster than she was 20 years ago. Also, there are only 5 stages.
The fibrosis score is assigned a number from 0-4:
0 = no scarring
1 = minimal scarring
2 = scarring has occurred and extends outside
the areas in the liver that contains blood vessels
3=bridging fibrosis is spreading and
connecting to other areas that contain fibrosis
4=cirrhosis or advanced scarring of the liver
In addition, your mom could have Stage 3 in the part of the liver they biopsied, but she could have Stage 4 in another part that was not biopsied.
Stage 4 is cirrhosis. Your mother should definitely treat before she progresses to cirrhosis. One does not want to wait around to treat and develop cirrhosis while waiting. It is more difficult to treat people when they are cirrhotic (they tend to have more complications) and the cure rate is considerably lower in cirrhotics than it is in people who do not have cirrhosis. So she should treat sooner rather than later.
Please come often to the forum and ask as many questions as you wish. Hopefully we can help you and your mother.
Wishing the best for you and your mother.
I am very impressed how you picked up that treating with the currently available protease inhibitors comes with the potential for side effects. Not having the resources to treat them can be very scary and could have an effect on treatment adherence.
The only think I can think off offhand is why her doctor recommended Incivek (Telaprevir) as opposed to Victrelis (Boceprevir). Vicrelis comes with its share of sides but they are different than the Incivek sides. If waiting is not an option and a trial does not come up then I would ask.
The only think I can think off offhand is why her doctor recommended Incivek (Telaprevir) as opposed to Victrelis (Boceprevir). Vicrelis comes with its share of sides but they are different than the Incivek sides. If waiting is not an option and a trial does not come up then I would ask.
Wow, thanks so much everyone for taking the time and writing me- I've already learned a great deal from your comments and have a better idea of what to ask the doc now (if we can manage to get an actual appt to discuss results and treatment- so far it was just a phone call!)
Pooh, can't tell you how much I appreciate you taking the time to give me all that info- I actually think I understand Medicare now somewhat!
And most importantly you explained what was not explained to us by the doctor that stage 4 WAS cirrhosis. He told us that in 5-10 years it COULD progress to cirrhosis and he recommends to treat. Do you hear of anyone who just stays at stage 3 at it never really progresses to cirrhosis?
And most importantly you explained what was not explained to us by the doctor that stage 4 WAS cirrhosis. He told us that in 5-10 years it COULD progress to cirrhosis and he recommends to treat. Do you hear of anyone who just stays at stage 3 at it never really progresses to cirrhosis?
Thanks- it is good to hear that it can be done if need be without insurance. If you don't mind me asking how did you do with the treatment? Were there meds you needed as a result of side effects and were they paid for? I keep thinking what if she became anemic and needed Procrit - would the clinic pay for that too I'm wondering. Also, I am new to this site and tapped the screen in the wrong place I think and the REPORT icon came up next to your post!! I really hope I didn't report your post lol! If so I'm so sorry- I didn't mean to!
Thanks for the info on the 2 different PI's..I didn't realize there were even two choices and I tried my best to research the two kinds. To me it seems , but i have only started research so I'm not sure, that the incivek can cause an awful rash and diarrhea issues, but the other one is more likely to cause anemia? The incivek looked to be slightly more effective but maybe the other one was somewhat better tolerated despite the anemia risk??
Unfortunately I'm worried that my mom won't have much of a choice on this and a lot of things with this treatment with the no insurance issue. Wondering if the 11 months until medicare kicks in when she turns 65 is too long to wait.
Unfortunately I'm worried that my mom won't have much of a choice on this and a lot of things with this treatment with the no insurance issue. Wondering if the 11 months until medicare kicks in when she turns 65 is too long to wait.
No problem on the report button--I've done it myself. I treated for 24 weeks and was Und. at weeks 4, 12, and 24. I'll know in Sept. if I attain SVR. I didn't need any rescue meds but if I did, they would have been provided to me at no cost. I paid for some prescriptions for rash and itching but they were cheap. I would rather have had health insurance but I picked a good time to be unemployed and broke. I feel my care was excellent.
It's great that you've already learned so much about things like Procrit and you'll be a great advocate for your mother. You can look at my labs by clicking on my name and going to the photos section in my profile. It does take some time to get things in motion, so if you're considering the clinic/county route I'd try to get an appt. or walk your mother in soon. You can always go another route if you change your mind later.
It's great that you've already learned so much about things like Procrit and you'll be a great advocate for your mother. You can look at my labs by clicking on my name and going to the photos section in my profile. It does take some time to get things in motion, so if you're considering the clinic/county route I'd try to get an appt. or walk your mother in soon. You can always go another route if you change your mind later.
"He told us that in 5-10 years it COULD progress to cirrhosis "
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That is possible (that it would take that long), but it is not something I would want to take my chances on. We have people on the forum who have progressed from Stage 1-2 fibrosis to cirrhosis in only 2-3 years. Liver fibrosis is not linear. No one knows how fast anyone is going to progress, but at stage 3, it is urgent to treat sooner rather than later.
The other thing is, just because she had Stage 3 fibrosis in the biopsied part of her liver does not mean it is Stage 3 all over the liver. She could already have Stage 4 fibrosis (cirrhosis) in part of the liver that was n ot biopsied.
"Do you hear of anyone who just stays at stage 3 at it never really progresses to cirrhosis? "
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I suppose that is possible, but I don't know of anyone. Liver fibrosis picks up speed as we age. That we do know. There are other things to consider too. The longer she waits, the more likely she will develop cirrhosis. Also, her chances of getting liver cancer increase the longer she waits. Plus, the earlier one treats the better chance one has of the damage regressing (liver function and histology improving). In addition, at age 64, other health problems could start to arise and some of these health problems may preclude her from doing treatment. There are many people who cannot treat because they developed a health problem that excludes them from treating. She would want to treat before developing any of these problems. In addition, treatment can be a lot harder on cirrhotics, and the SVR rate is lower in cirrhotics. If you ask any cirrhotic, pretty much all of them will say to treat now, before becoming cirrhotic.
We have a lot of cirrhotics on the forum. Many of them had tried treatment in the past when it was just Interferon and Ribavirin and the treatment did not work for them. Some had tried treatment 3,4 ,5 ,6 or more times. When the new Protease Inhibitors came on the market (Incivek and Victrellis) in June/July 2011, many of these cirrhotics were ready and waiting to treat with the new drugs. This group of people who started triple med treatment in the summer and fall of 2011 have now finished treatment and many of them have attained Sustained Viroglogic Response (cure). Some did not and some are waiting for transplants. It is in your mother's best interest to treat as soon as possible.
I realize you need to get the financial part figured out. But there are ways to get the care. If you tell us which state your mother is in, someone may have information to help you out.
As far as the meds go, the Incivek can cause more rash issues and more anal rectal problems. But you take the Incivek for only 3 months and then you are done with the Incivek. You have to continue the Interferon and Riba for either 24 or 48 weeks total depending on certain factors. The Victrellis has more issues with anemia than the Incivek and you have to take the Victrellis longer, either 24 weeks or longer depending on certain factors. They both have somewhat comparable results in terms of SVR.
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That is possible (that it would take that long), but it is not something I would want to take my chances on. We have people on the forum who have progressed from Stage 1-2 fibrosis to cirrhosis in only 2-3 years. Liver fibrosis is not linear. No one knows how fast anyone is going to progress, but at stage 3, it is urgent to treat sooner rather than later.
The other thing is, just because she had Stage 3 fibrosis in the biopsied part of her liver does not mean it is Stage 3 all over the liver. She could already have Stage 4 fibrosis (cirrhosis) in part of the liver that was n ot biopsied.
"Do you hear of anyone who just stays at stage 3 at it never really progresses to cirrhosis? "
--------------------------------
I suppose that is possible, but I don't know of anyone. Liver fibrosis picks up speed as we age. That we do know. There are other things to consider too. The longer she waits, the more likely she will develop cirrhosis. Also, her chances of getting liver cancer increase the longer she waits. Plus, the earlier one treats the better chance one has of the damage regressing (liver function and histology improving). In addition, at age 64, other health problems could start to arise and some of these health problems may preclude her from doing treatment. There are many people who cannot treat because they developed a health problem that excludes them from treating. She would want to treat before developing any of these problems. In addition, treatment can be a lot harder on cirrhotics, and the SVR rate is lower in cirrhotics. If you ask any cirrhotic, pretty much all of them will say to treat now, before becoming cirrhotic.
We have a lot of cirrhotics on the forum. Many of them had tried treatment in the past when it was just Interferon and Ribavirin and the treatment did not work for them. Some had tried treatment 3,4 ,5 ,6 or more times. When the new Protease Inhibitors came on the market (Incivek and Victrellis) in June/July 2011, many of these cirrhotics were ready and waiting to treat with the new drugs. This group of people who started triple med treatment in the summer and fall of 2011 have now finished treatment and many of them have attained Sustained Viroglogic Response (cure). Some did not and some are waiting for transplants. It is in your mother's best interest to treat as soon as possible.
I realize you need to get the financial part figured out. But there are ways to get the care. If you tell us which state your mother is in, someone may have information to help you out.
As far as the meds go, the Incivek can cause more rash issues and more anal rectal problems. But you take the Incivek for only 3 months and then you are done with the Incivek. You have to continue the Interferon and Riba for either 24 or 48 weeks total depending on certain factors. The Victrellis has more issues with anemia than the Incivek and you have to take the Victrellis longer, either 24 weeks or longer depending on certain factors. They both have somewhat comparable results in terms of SVR.
1-(800) GILEAD-5 ( 800-445-3235 ) between 8:00 a.m. and 5:00 p.m. Pacific Time.
Renee, Willy and I are in the Gilead trial. There are also others on clinicaltrials.gov.
Renee, Willy and I are in the Gilead trial. There are also others on clinicaltrials.gov.
i'm so sorry that your mom has hep c. i went through a clinical trial with scripp's research in san diego. i had the best care and my study nurse was fantastic. i reached SVR last november 2012. so i got cured and i was paid for my participation. i had no health insurance at the time. good luck to your mom. p.s. i was 62 at the time. belle
Thanks everyone for your input. I never in a million years realized all that people with Hep C had to go through. My thoughts and prayers are with everyone and good luck in September,Reid..I hope you find out you beat it!
Pooh, We are in southern NJ, close to Philly. When she first got diagnosed last month we made an appt with a gastro/hepatology practice here in south jersey that is also affiliated with jefferson hospital's hepatology dept in Philly . We asked as many questions as we could think of but we didn't even know what her staging was and if treatment was going to be necessary - I figured we would ask more questions at the appt where we learned the results. I am shocked that there WAS no follow up appt- he just called her on the phone and told results and recommended treatment and told her she would be coming in soon to meet with a woman about the financial side. We have so many questions and concerns yet, just getting familiarized with all this. When we called back yesterday and asked to meet with the doc again we were told August was the soonest she could get in! Is this normal?? Also there are about 10 other docs in this practice but they told her she could only meet with her one doc. Does this sound right?I thought if she needed someone she could see anyone. I'm so concerned about this availability issue and also having to ask the doc to call back so we can try to have a phone discussion on speaker or something so I can be present plus u never know when they are going to call. I'm wondering if this is because she is on charity care...she's not even getting free visits just paying a reduced rate.
Unbelievable...She always had health insurance and lost it last year due to job loss- she only had 2 yrs to get through uninsured until medicare and we got this diagnosis by accident !
I keep mentioning the Procrit because I try to think of everything that can possibly go wrong ahead of time. (Thats either a blessing or a curse I guess..i think curse)God forbid we get the treatment itself paid for but then she becomes anemic and needs Procrit during the treatment to save her life, and they just hand us a script for it and we're on our own- that med alone is thousands of dollars. Also, is it possible if u become anemic to remain anemic after treatment has ended? Has anyone heard of this?
Also I was surprised that the doc only said it would be 6 months of treatment. I mean, I'm thrilled for her that it wasn't the 48 weeks but so much of what I read seemed to say that depending on the level of damage, genotype and length of time of infection, and patient age the harder to treat cases would be the 48 weeks - . She is geno 1, at stage 3 , has possibly had this since infancy (blood transfusion)... Does the 24 weeks sound right to everyone? Do docs sometimes tell u 24 then change it to 48 along the way??
So sorry for this long post ! Thank u so much everyone!
Pooh, We are in southern NJ, close to Philly. When she first got diagnosed last month we made an appt with a gastro/hepatology practice here in south jersey that is also affiliated with jefferson hospital's hepatology dept in Philly . We asked as many questions as we could think of but we didn't even know what her staging was and if treatment was going to be necessary - I figured we would ask more questions at the appt where we learned the results. I am shocked that there WAS no follow up appt- he just called her on the phone and told results and recommended treatment and told her she would be coming in soon to meet with a woman about the financial side. We have so many questions and concerns yet, just getting familiarized with all this. When we called back yesterday and asked to meet with the doc again we were told August was the soonest she could get in! Is this normal?? Also there are about 10 other docs in this practice but they told her she could only meet with her one doc. Does this sound right?I thought if she needed someone she could see anyone. I'm so concerned about this availability issue and also having to ask the doc to call back so we can try to have a phone discussion on speaker or something so I can be present plus u never know when they are going to call. I'm wondering if this is because she is on charity care...she's not even getting free visits just paying a reduced rate.
Unbelievable...She always had health insurance and lost it last year due to job loss- she only had 2 yrs to get through uninsured until medicare and we got this diagnosis by accident !
I keep mentioning the Procrit because I try to think of everything that can possibly go wrong ahead of time. (Thats either a blessing or a curse I guess..i think curse)God forbid we get the treatment itself paid for but then she becomes anemic and needs Procrit during the treatment to save her life, and they just hand us a script for it and we're on our own- that med alone is thousands of dollars. Also, is it possible if u become anemic to remain anemic after treatment has ended? Has anyone heard of this?
Also I was surprised that the doc only said it would be 6 months of treatment. I mean, I'm thrilled for her that it wasn't the 48 weeks but so much of what I read seemed to say that depending on the level of damage, genotype and length of time of infection, and patient age the harder to treat cases would be the 48 weeks - . She is geno 1, at stage 3 , has possibly had this since infancy (blood transfusion)... Does the 24 weeks sound right to everyone? Do docs sometimes tell u 24 then change it to 48 along the way??
So sorry for this long post ! Thank u so much everyone!
Thanks so much! My mom was just wondering yesterday if we couldn't just call Gilead directly. Is the study that the three of you are in still recruiting..? I saw one on clinical trials.gov that seemed to be sofosbuvir/5885 with and without ribo that was still recruiting. Is that the one you are in?
Also, is getting in to such a study pretty much a long shot do you think? Either way we will at least try.
And BEST OF LUCK to you on the outcome!
Also, is getting in to such a study pretty much a long shot do you think? Either way we will at least try.
And BEST OF LUCK to you on the outcome!
Thanks Belle, that's so great and encouraging to hear that you were able to get through it, get cured, and without insurance too! Do u mind me asking what the study meds were and how u got the ball rolling on getting into it?
Welcome to the world of Hepatitis C. Pooh has provided you will excellent information along with everyone else. By your post it looks like you are catching on very fast. Your mother is very lucky she has you in her corner.
This can be a fight to understand, get into treatment and getting your doctor to call you back. When you figure out that last one...I would love to know how you accomplished that feat. FYI - it doesn't have anything to do with having insurance or not. With your help and determination... you can get
your mother where she needs to be.....in treatment for Hepatitis C and the
sooner the better.
This can be a fight to understand, get into treatment and getting your doctor to call you back. When you figure out that last one...I would love to know how you accomplished that feat. FYI - it doesn't have anything to do with having insurance or not. With your help and determination... you can get
your mother where she needs to be.....in treatment for Hepatitis C and the
sooner the better.
As far as 24 vs. 48 weeks, for type 1's, I think it's based on response to treatment and whether a person is cirrhotic or not. If cirrhotic, 48 weeks is the standard treatment. If not cirrhotic, 24 weeks of treatment is done as long as a person is undetected at 4 weeks. If the virus is detected at 4 weeks, treatment is extended to 48 weeks. If a viral load is shown at 12 weeks, I think treatment is discontinued. This is how it was explained to me by my NP (nurse practitioner) and I'm pretty sure this is how I've read people talk about it on the forum.
Our more technically savvy members may give you more info. on this but that's my understanding of how it works.
Our more technically savvy members may give you more info. on this but that's my understanding of how it works.
Incivek protocol/treatment duration/futility rules/PCR testing
2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration.
Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.
2.7.2 Duration of Treatment—Previously Treated Subjects
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
Treatment Futility Rules: All Patients
HCV-RNA Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin
Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.
http://pi.vrtx.com/files/uspi_telaprevir.pdf .
2.7.1 Duration of Treatment in Treatment-Naive Subjects
In subjects who have had no previous treatment for HCV (treatment-naive), treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
HCV-RNA levels should be monitored at Weeks 4 and 12 to determine treatment duration.
Treatment with telaprevir should be discontinued in subjects who do not have an adequate viral response during treatment.
2.7.2 Duration of Treatment—Previously Treated Subjects
In subjects who have had previous treatment for HCV, treatment with telaprevir must be initiated in combination with Peg-IFN and RBV and administered for 12 weeks. Subjects who had a partial response to previous treatment (partial responders) or minimal response
(null responders) to Peg-IFN plus RBV receive an additional 36 weeks of Peg-IFN and RBV treatment alone for a total treatment duration of 48 weeks.
In subjects who had relapse after previous treatment to Peg-IFN plus RBV, a responseguided regimen is recommended.
• Subjects with undetectable HCV RNA at Weeks 4 and 12 of telaprevir-based treatment receive an additional 12 weeks of Peg-IFN and RBV alone for a total treatment duration of 24 weeks
• Subjects with detectable HCV RNA at either Weeks 4 or 12 of telaprevir-based treatment receive an additional 36 weeks of Peg-IFN and RBV alone for a total treatment duration of 48 weeks
Telaprevir must be dosed with Peg-IFN and RBV to prevent treatment failure.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM252562.pdf
Treatment Futility Rules: All Patients
HCV-RNA Week 4 or Week 12: Greater than 1000 IU/mL Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks)
Week 24: Detectable Discontinue peginterferon alfa and ribavirin
Laboratory Tests
HCV-RNA levels should be monitored at weeks 4 and 12 and as clinically indicated. Use of a sensitive real-time RT-PCR assay for monitoring HCV-RNA levels during treatment is recommended. The assay should have a lower limit of HCV-RNA quantification equal to or less than 25 IU/mL and a limit of HCV-RNA detection of approximately 10-15 IU/mL. For the purpose of assessing response-guided therapy eligibility, an “undetectable” HCV-RNA result is required; a confirmed “detectable but below limit of quantification” HCV-RNA result should not be considered equivalent to an “undetectable” HCVRNA result.
http://pi.vrtx.com/files/uspi_telaprevir.pdf .
Victrelis/Peginterferon alfa/Ribavirin Combination Therapy: Patients Without Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and Ribavirin Therapy
•Initiate therapy with peginterferon alfa and ribavirin for 4 weeks (Treatment Weeks 1–4).
•Add Victrelis 800 mg (four 200-mg capsules) orally three times daily (every 7 to 9 hours) to peginterferon alfa and ribavirin regimen after 4 weeks of treatment. Based on the patient's HCV-RNA levels at Treatment Week (TW) 8, TW12 and TW24, use the following guidelines to determine duration of treatment (see Table 1).
Table 1
Previously Untreated Patients
ASSESSMENT (HCV-RNA Results) At Treatment Week 8-Not Detected and At Treatment Week 24 Not Detected
RECOMMENDATION
Complete three-medicine regimen at TW28.
ASSESSMENT (HCV-RNA Results) At Treatment Week 8-Detected and At Treatment Week 24 Not Detected
RECOMMENDATION
1.Continue all three medicines and finish through TW36; and then
2.Administer peginterferon alfa and ribavirin and finish through TW48.
TREATMENT FUTILITY
If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW12, then discontinue three-medicine regimen.
If the patient has confirmed, detectable HCV-RNA at TW24, then discontinue three-medicine regimen."Not Detected" refers to HCV-RNA assay results reported as "Target Not Detected" or "HCV-RNA Not Detected". In clinical trials, HCV-RNA in plasma was measured using a Roche COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. See Warnings and Precautions (5.6) for a description of HCV-RNA assay recommendations.
http://www.drugs.com/pro/victrelis.html
Also cirrhotics are recommended to do 48 wks with either incivek or victrelis.
•Initiate therapy with peginterferon alfa and ribavirin for 4 weeks (Treatment Weeks 1–4).
•Add Victrelis 800 mg (four 200-mg capsules) orally three times daily (every 7 to 9 hours) to peginterferon alfa and ribavirin regimen after 4 weeks of treatment. Based on the patient's HCV-RNA levels at Treatment Week (TW) 8, TW12 and TW24, use the following guidelines to determine duration of treatment (see Table 1).
Table 1
Previously Untreated Patients
ASSESSMENT (HCV-RNA Results) At Treatment Week 8-Not Detected and At Treatment Week 24 Not Detected
RECOMMENDATION
Complete three-medicine regimen at TW28.
ASSESSMENT (HCV-RNA Results) At Treatment Week 8-Detected and At Treatment Week 24 Not Detected
RECOMMENDATION
1.Continue all three medicines and finish through TW36; and then
2.Administer peginterferon alfa and ribavirin and finish through TW48.
TREATMENT FUTILITY
If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW12, then discontinue three-medicine regimen.
If the patient has confirmed, detectable HCV-RNA at TW24, then discontinue three-medicine regimen."Not Detected" refers to HCV-RNA assay results reported as "Target Not Detected" or "HCV-RNA Not Detected". In clinical trials, HCV-RNA in plasma was measured using a Roche COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. See Warnings and Precautions (5.6) for a description of HCV-RNA assay recommendations.
http://www.drugs.com/pro/victrelis.html
Also cirrhotics are recommended to do 48 wks with either incivek or victrelis.
hi there. i answered an ad that was in our local entertainment magazine. i called the scripp's research and ucsd medical center. they interviewed me over the phone and was accepted for both. i chose the scripp's one because it was closer to home. as of now i still don't know what study group i was in. they won't disclose that until the rest of the people in it are finished. my study nurse said that i was probably in group 1 because of my numbers on my lab work. it was a gilead study. group 1 was peg/riba, gs-9451 and tegobuvir. whatever i got worked for me. that's all that counts. good luck to your mom. let me know if you have any other questions. i'd be happy to help out. best wishes. belle
They are currently still recruting treatment Naive, not treatment experienced. Also new study 8 and 12 week Naive geno 1 was announced 03May but I have not seen this one posted on clinical trials. I started with Gilead. Abbot, Merck. Bristol Myers are also doing PI trials no interferon.
From what I read of your posts you are looking in the right places. Give Gilead a call.
Also from the trial number you list the contact email listed is:
Contact: Kili Fujiwara, RN, BSN
337-***@****
From what I read of your posts you are looking in the right places. Give Gilead a call.
Also from the trial number you list the contact email listed is:
Contact: Kili Fujiwara, RN, BSN
337-***@****
Hi Tina,
Please pursue the clinical trials avenue. Stay on them, call a least once a week or so. Email the coordinator. Get all medical records fax, sent or walked in. I seriously doubt that given your mothers age that she could tolerate Triple therapy. Let alone INF would be hard enough. She should treat soon. But please check all options and be informed before jumping into something. I am sorry there will be lots on this forum that will disagree with me, but triple therapy is long, side effects can be very horrific, It is poison. Deadly. Perhaps that is why there have been reports of it possibly being pulled off the market. Abbott, Gilead, BMS have trials ongoing. I am sure you could find a fit on clinicaltrials.gov
If nothing else as long as she is living liver healthy, no alcohol etc. These new orals are being reviewed for approval by the end of this year. Hitting the market by 2015.
That is my opinion. Oh and by the way I am currently in an Abbott trial for 12 weeks with orals no INF and was UD at 14 days. I am 56 y/o a bit younger than your mom but not much and I would not even consider tx with triple therapy........
Please pursue the clinical trials avenue. Stay on them, call a least once a week or so. Email the coordinator. Get all medical records fax, sent or walked in. I seriously doubt that given your mothers age that she could tolerate Triple therapy. Let alone INF would be hard enough. She should treat soon. But please check all options and be informed before jumping into something. I am sorry there will be lots on this forum that will disagree with me, but triple therapy is long, side effects can be very horrific, It is poison. Deadly. Perhaps that is why there have been reports of it possibly being pulled off the market. Abbott, Gilead, BMS have trials ongoing. I am sure you could find a fit on clinicaltrials.gov
If nothing else as long as she is living liver healthy, no alcohol etc. These new orals are being reviewed for approval by the end of this year. Hitting the market by 2015.
That is my opinion. Oh and by the way I am currently in an Abbott trial for 12 weeks with orals no INF and was UD at 14 days. I am 56 y/o a bit younger than your mom but not much and I would not even consider tx with triple therapy........
"I seriously doubt that given your mothers age that she could tolerate Triple therapy."
There have been many here treated with triple treatment at 64 and older, I am curious if you can post a link to this statement as I have never heard this before........
."Perhaps that is why there have been reports of it possibly being pulled off the market."
As was stated in this thread one should never wait until you become cirrhotic to treat as their odds are much lower, there is plenty of links to back up lower SVR's with cirrhosis.........
"I would not even consider tx with triple therapy"
Sure as heck beats ESLD don't you think???
There have been many here treated with triple treatment at 64 and older, I am curious if you can post a link to this statement as I have never heard this before........
."Perhaps that is why there have been reports of it possibly being pulled off the market."
As was stated in this thread one should never wait until you become cirrhotic to treat as their odds are much lower, there is plenty of links to back up lower SVR's with cirrhosis.........
"I would not even consider tx with triple therapy"
Sure as heck beats ESLD don't you think???
I chose triple over ESLD. Tolerated it pretty well for a old 60s something granny.
Happy to be here : )
Happy to be here : )
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give you lists of trials and how to access them. The "discoverHepC.com" site
just appeared on Television. They are looking for participants. It might
be in your area. Also, it sounds like your mother has been referred to a doctor and I would see what kind of assistance she can obtain. You might be surprised at the assistance now being offered. I don't know about the Medicare and I'm sure someone on the forum as that knowledge to confirm if it would be covered or not.
Best to you and your mother