Aa
Aa
A
A
A
Close
Avatar universal

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
Best Answer
2059648 tn?1439766665
Go to "DiscoverHepC.com" or call 1-877-309-5705.  "ClinicalTrials.gov" can
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
36 Responses
Sort by: Helpful Oldest Newest
Avatar universal
I am very sorry that you feel ganged up on.
It is a very touchy subject but thankfully in a few years this controversy will be history with the new drugs making there way in.

I would advise anyone in this situation to find a top Hepatologist and go with what s/he advises.

All the best to you.
Helpful - 0
1815939 tn?1377991799
Just to clarify, I am pretty sure Can-do means:

"Which is worse, Triple Therapy, or dying of ESLD."

Since thousands of people die from ESLD  EVERY year, and only a handful  have died from treatment related complications (over the years), I think most of us can see that treatment is a lot safer than advancing to ESLD.
Helpful - 0
Avatar universal
One more thing, you say, "but triple therapy is long, side effects can be very horrific, It is poison. Deadly."

Which is worse dying from ESLD or triple therapy?
Helpful - 0
Avatar universal
I am sorry you feel like your being bashed when your the one who said "We are all entitled to our opinons."... There is many here that have treated at 64 and older... As for reports of either Inc or Vic being pulled from the market, well it would have to be the FDA that would do that so all one needs to do is read there and they say nothing about pulling either one.......... And called a liar??? Where?

No your upset because others have opinions different from yours.
Helpful - 0
5359548 tn?1366988604
To all,

I don't appreciate being bashed this way. My words have been twisted in a knot by all. I never said anything different than you all said. I only elaborated on the subject of 3x Nor did I give false info. Incivik and rash 2 deaths, there was a news cast with implications of pull back.
I never said she should wait, merely to not jump into 3x treat.  My God you act as though I am saying she has years to wait.      Maybe I worded things wrong or don't have the same opinions as the little click on here. But your opinions are not the gold standard. I am a member of 3 others forums and never have I seen anyone treated the you people have me. I  don't take it well being called a liar.....I won't be back here.....
  
Helpful - 0
Avatar universal
I have to agree with the others on this post about treating sooner than later!! Stage 3 is nothing to wait around and tap your nails on the coffee table to see when the new drugs are available. You might not have any nails left! My Dr told me we should start treatment yesterday instead of today. So he made his point very clear. You dont want to become cirrhotic and make life more difficult.

So wherever you came up with stage 3 is a healthy liver?  You should do more reading about Hep C.  BTW, 40 wks with triple, vic, am UND!
Helpful - 0
Avatar universal
Opinions are fine here, posting false info is not... Good luck to you
Helpful - 0
1815939 tn?1377991799
Correction to above post:

I stated: "I did treatment for 48 months and I did very well. "

I meant to state:  "I did treatment for 48 weeks and I did very well."

(Thanks, to my forum friend who pointed that out to me.)
Helpful - 0
1815939 tn?1377991799
"I seriously doubt that given your mothers age that she could tolerate Triple therapy. "
------------------------------------------

Her mother is 64. She is not 94. I am 67 (I was 65 years and 10 months when I started treatment of Interferon, Ribavirin, and Incivek). I did treatment for 48 months and I did very well. I am now SVR and feeling better than I have in 20 years. Of course I had some side effects with treatment, but nothing that would have ever made me think of stopping treatment. I would do triple med treatment again if necessary. (I know you cannot do it twice. I am just making the point that I would go through it again if I had to.) There are many, many on the forum who are in their 60s, even some in their 70s, who have successfully treated with Triple Med Treatment. We did treatment and most of us attained SVR. Plus, we are doing fine post treatment.

At 67, I am now out working in the garden, doing some landscaping, construction a walkway, doing major deep cleaning and redecorating in the house, hiking, walking, volunteering at several organizations, up and about on my feet all day long every day of the week, and feeling as good as I felt when I was in my forties (except my knees are not quite as good). I never get tired now and I am full of tons of energy and pep. Like I said, I feel better than I have felt in 20 years.

My point is, 64 is not too old to treat, and treatment is a heck of a lot better than getting a bunch of serious extrahepatic manifestations and/or ESLD. At Stage 3 one does not want to wait. One wants to treat before one gets Cirrhosis (at which point the SVR rates decrease considerably and one increases one's chance for developing Hepatocellular Carcinoma).

I have heard nothing about Incivek being taken off the market and I think that rumor is an unfounded rumor.
Helpful - 0
2059648 tn?1439766665
I think what is missing here is that you can advance from stage 3 to 4 and
develop additional health problems with age.  Having Cirrhosis comes with
additional health issues too.  I'm no expert on this subject by far....but I have learned that ESLD should be avoided at all costs.  I treated at stage 2 and didn't hesitate.  Not everyone has a horrible outcome to treating with triple.
People having problems with treatment post for help.  There are 1000s who
didn't need to post for help.  Yes - triple treatment isn't easy.  But waiting is not always an option and in my opinion (which we all should be able to express) at stage 3 - your pushing the envelope waiting for better treatments.
I made it though triple with little problems and benefited from reading the do
and not do....like the posts in this thread.  I treated my Hepatitis C with Incivek, Interferon and Ribavirin.....beats advancing to cirrhosis and having to deal with that in addition to having Hepatitis C.  Not everyone has the choice to wait for treatment or even search out trials.  Stage 3 is past the recommended stage to treat.  You should not wait past stage 2 to get treatment.  I now don't have a threat of advancing to cirrhosis, don't  worry about Hepatitis C anymore and have triple treatment to thank for that. Happy
I chose to treat and not wait for something better to come along. That is my opinion.





  
Helpful - 0
5359548 tn?1366988604
I forgot the doctor that recommended it could be more harm than benefit for my husband to tx with triple therapy was also Everson
Helpful - 0
5359548 tn?1366988604
May I point out that this is a forum. We are all entitled to our opinons.   'That is my Opinion"                                                                          Mine may not reflect those of others, nor yours mine.  
Now let me point out that my opinions are based on facts.
Yes I do know that there have been people successfully over 64 treated. Here is the first link, It should be used cautiously......please refer to page 3, http://pi.vrtx.com/files/canadapm_telaprevir_en.pdf
This second link is in regards to the "Sure as heck beats ESLD don't you think???"   My husband died from ESLD doctors considered giving it to him while he was still compensated barely. They agreed it would do more harm then benefits. Note the article state may boost .....with serious side effects a risk .
http://www.hepmag.com/articles/victrelis_incivek_cirrhosis_2501_22291.shtml
Sorry I could not find the link to the article that it could be pulled off the market. This one is over a year old.....

http://www.bostonglobe.com/business/2012/12/20/vertex-adds-black-box-warning-label-after-least-two-deaths-from-hepatitis-drug-combination-using-its-incivek-treatment/07QQFrYwdrB2I3JwNqHrxK/story.html

First of all I never said someone should wait to treat HCV.  I would not recommend to anyone to jump into such a treatment as this. She should be informed of the possible options available. If a person is leading a liver healthy life and is St 3.....it is quite possible to wait for newer drugs to be on the market. As you state cirrohotics successfully treat with incivik. Then even if this lady was to go to stage 4 she would still be able to treat with much gentler drugs once approved. The newer drugs are being tested much more on cirrohotics than incivik (if you like I can send that link as well)With better results and less side effects if any.   Come on really is this being debated.....SOC works and does not in many cases and we all know that INF is poison and those that could tx without it would and should.  
I am sorry if you disagree. I do not make flippant remarks where someone's life is concerned. I do my homework. I read. I ask my doc a lot of questions. Since that doc is Dr.G Everson I trust what he tells me.
Helpful - 0
2059648 tn?1439766665
I chose triple over ESLD.  Tolerated it pretty well for a old 60s something granny.  

Happy to be here : )
Helpful - 0
Avatar universal
"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???
Helpful - 0
5359548 tn?1366988604
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........
Helpful - 0
180992 tn?1383374057
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-***@****


  
Helpful - 0
1652596 tn?1342011626
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
Helpful - 0
1747881 tn?1546175878
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.

Helpful - 0
1747881 tn?1546175878
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 .
Helpful - 0
3159077 tn?1356031131
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.
Helpful - 0
2059648 tn?1439766665
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.  



Helpful - 0
Avatar universal
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?
Helpful - 0
Avatar universal
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!
Helpful - 0
Avatar universal
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!
Helpful - 0
2
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.