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Author Topic: 8 weeks of harvoni then 2 weeks later doctor wants me to take another 4 weeks!  (Read 16735 times)

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Offline tortuga

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I finished an 8 week course of Harvoni on December 8. That was what the prescription was for. 2 weeks later I find out that the doctor wants me to continue for another 4 weeks. I called the specialty pharmacy and Gilead Sciences to find out any information from them about a 2 week gap in doses. They said they had no information and Gilead said they never did that type of testing. I was undetected at 5 weeks. Any one ever hear of this. Need advice as it makes me nervous. I can't get any information from the doctors office.

Offline Lynn K

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 What was your pre-treatment viral load?  Did you ever treat in the past and do you have any liver damage specifically do you have cirrhosis?  If you never treated before and do not have liver damage and your viral load was below 6 million  the recommended treatment regime is eight weeks  so your odds of being cured with only treating for eight weeks is very good.

Were you not detected at EOT?

Beyond that the only way to know what your doctor is thinking is to speak with your doctors office.
« Last Edit: December 22, 2016, 09:27:24 pm by Lynn K »
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline tortuga

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  • Posts: 7
My numbers were good pre treatment. My viral load was 700,000 and I am genotype 1b and treatment naive. Mild fibrosis F2. I'm happy with the current results however, the stopping and then starting 2 1/2 weeks later confuses me. I talked to the doctors office and was told that the doctor wanted me to take another 4 week course. This practice is not patient friendly. I was to be tested at 12 weeks after my last dose. All my pre treatment research said no stopping and starting. I have all my information from my HMO and I believe that the doctor wanted me to do an extra 4 weeks and his office did not submit the request in a timely matter. They have vague answers to my questions. My last dose was 8 Dec. and the request was submitted to the HMO on 6 Dec. and approved on 19 Dec. Will it hurt me to start again and will it help me to start again? I have no advocate at this practice. I just want to be done and move along and never have to deal with them any longer. Thanks for responding!

Offline Lynn K

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Surprised you insurance approved treatment for anything longer than 8 weeks as that is the protocol for a patient like you.

Additional treatment will cause you no more issues than the first 8 weeks. Just to add I am not a medical professional of any kind. As to your questions:

"Will it hurt me to start again" likely no

"will it help me to start again?" As far as your odds of cure this comes from the ION 3 clinical trial results for treatment naive without cirrhosis:

Genotype 1b
8 weeks of treatment arm SVR was 98% (42/43)
12 weeks of treatment arm SVR was 98% (43/44)

See page 30
https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf

I have no idea why your doctor wants to add additional weeks but again I am not a doctor.
« Last Edit: December 23, 2016, 12:21:11 am by Lynn K »
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline andrew j

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I feel uncomfortable about this.
This is NOT how these drugs are normally prescribed - and you sure as hell don't want anything to go wrong.

It sounds, as you say, as if the Dr. wanted to prescribe more, but didn't submit the paperwork in time.

Either get a second opinion - or approach a patient advocate - or both.

Try to get in contact with Lucinda Porter.
She is one of the global moderators here (lporterrn).

(Lynn - Do you know how to contact her?).
« Last Edit: December 23, 2016, 04:04:01 am by andrew j »

Offline Lynn K

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Well you can go to her profile and send her a PM

But really per the prescribing information sheet for Harvoni the standard treatment for someone who is treatment naive, low viral load, and no cirrhosis is 8 weeks. Also genotype 1b has a higher cure rate than genotype 1a. So basically 8 weeks is the recommended treatment regime as far as I am aware from what I have read. I doesn't get much better than 98% odds of cure.
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline andrew j

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Yes.

DON"T TAKE ANYTHING UNLESS AND UNTIL YOU KNOW IT"S SAFE!

That's my opinion.

« Last Edit: December 23, 2016, 04:14:25 am by andrew j »

Offline Lynn K

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I just think he needs to contact his doctor for his questions all we can do is guess and quote data we surely can't second guess a medical professional
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline andrew j

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I agree.

I've just never heard of such a thing happening.

If it was me, I'd be questioning this decision again, and / or getting a second opinion - whatever I had to do to get it.

« Last Edit: December 23, 2016, 05:44:50 am by andrew j »

Offline tortuga

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I agree that I should talk to the dr. However, I can't get an appointment to see him until February. I have to talk to his nurse and that is a chore. I call and leave voice mails and my calls are not returned. I call again and same. The test results I have shared I got from the testing lab. I took the comprehensive panel blood test at 4 weeks bur no RNA testing. I called and left a message about checking my viral load and I got a message that the doctor does not test for that until 12 weeks after my last dose. I reminded them that I was only taking an 8 week course. So, I received via USPS a document from the drs office to take to the lab for the RNA test. To this day the drs office has not shared these results with me. I went to the lab and got copies. I don't trust this nurse as I believe she could be the one who is not keeping up. I plan on sending a registered letter to the doctor himself to express my concerns.  I spoke to Briova and Gilead Sciences and both said they are against this decision to start again after over 2 weeks. But, they both said they recommend that I do as the doctor advises. That is there policy. Briova called the doctors office on my behalf and instructed them to call me and tell me what is going on. I am still waiting for that call. This whole thing is just crazy. I am starting to feel anxious about this situation.

Offline Lynn K

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Well like I said the 8 weeks should be sufficient. Taking 4 additional weeks should not physically harm you if you have not reacted so far which most people don't have much problems although some had problems they attribute to treatment. But if you haven't had any problems 4 additional weeks won't change that.

Taking the additional treatment would not change your probability of being cured either with or without taking the additional meds.

I am not able to guess your doctors reasons so sorry for you difficulty in contacting them for answers. But if it were me I guess it would come down to going with what I have done already as it should work or taking the extra weeks just in case I need the (albeit late) extra boost of treatment to improve my odds even a tiny percentage.

You already have spoken to the experts at your pharmacy and Gilead. We only have opinions and are not experts. The only way to know why your doctor has made this decision is to speak with him. I hope you can break through his walls and ask what the heck is going on with this. If you want you can message Lucinda directly but not sure if she will say anything much different than the other experts.

Good luck
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline tortuga

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Thanks for all the help! Part of my research before taking the Harvoni was reading many of the posts from you folks. I found it very informative and  helpful. I am more willing to accept the opinions of people in your circumstances as people who have "been there". As to my case through the 8 weeks I had no side effects. I felt no different than before taking it. So, it will either help me or not but should not harm me. After reading my posts I think I may have been needing to vent. Thanks for listening! I appreciate it from all of you.....

Offline Lynn K

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Happy Holidays and best of luck!  :)
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline andrew j

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Hi Tortuga,

How are you? - and where are things at with you?

Offline tortuga

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Hi Andrew,
I'm in the same position as I earlier reported. I decided to take the extra 3rd week of Harvoni even though I have the over 2 week gap in doses. I started on the 24th so I am 3 days into it. I figured that if I don't and things go south it will be my fault for not following the instructions. So, I will take it and finish the course. I know that I will never get any answers from the nurse who is my contact person. I asked more questions and left her a voice mail message. She returned the message and left me the most unusual answer. It was this rambling disconnected missive that did not answer any of my questions. This is the strangest medical situation I have ever encountered. Thanks for asking and happy thoughts to you and yours for the new year.

Offline andrew j

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I wondered if this might have happened.

Without the information you need in order to make an 'informed decision', and in the absence of a second opinion - you have effectively been put in a position of having to self-medicate ... of having to gamble with your life.

In a situation like this - it is not enough to simply fall back on the default setting and blindly 'Trust Dr. - he knows best'.
Clearly, he doesn't know best.
Or he doesn't know what he's doing. Or his nurse doesn't know what she's doing. Or their processes have gone to hell.
Or something?!

Taking meds like this contrary to manufacturers instructions is UNSAFE (i.e. it might be safe, but it might equally not be).
It's outrageous, IMO.
You have done everything you can to try to get them to simply tell you what in the hell is going on!!

Please do get a second opinion ASAP, or contact Lucinda (as above), or a patient advocate ... or someone else who might know.
(Timing's crap, I know).

I live in New Zealand - so it's difficult for me to advise you on specifically who you might contact.
I have even contacted the liver unit / hepatology dept. of a public hospital here before to ask an important question. I got lucky - and was able to talk to a specialist walking past!
You know - use your imagination!

I don't mean to frighten you, mate - but this is quite literally unchartered territory.
I think you know that?
« Last Edit: December 27, 2016, 01:49:38 am by andrew j »

Offline tortuga

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I agree with all you say. Everyone that I have talked to says the same thing. Contact your doctor. Easier said than done. I can't get a face to face meeting with the doctor until late Feb. or early March. I will be long done by then. Plus we go away for part of the winter and won't return until late March. The nurse says things to me like..."doctor is aware that patient has not taken his medicine for 2 weeks". She makes it sound like I forgot to take the doses and this is my fault. This is how she sounds, I am always referred to in the 3rd person. However, I have all of this documented via voicemails and all my back and forth with my insurance company. I spoke again with a rep from Gilead Sciences and she told me that starting again after the gap will not hurt me. Might not help me either but won't hurt. This doctor has to know what is going on as he was contacted by Briova Pharmacy that supplies the meds and by Gilead Sciences who made it. Both told him that I called them for advice and information and that I  have concerns. Whether this info made it to him directly I don't know but I asked the nurse to have him call me and she said he does not do that. I have a question that keeps popping into my head and seems like a touchy subject but I always wonder if the doctor receives compensation for prescribing this medicine. I have never asked anyone but I still wonder. I will finish out the 28 days and go on. My 5 week RNA test showed that I was undetected so I will celebrate that. You are correct about uncharted territory, all I spoke with said they had never heard of this before. Being first is not always a good thing.
Take Care.....

Offline Lynn K

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Hi Andrew

Really many people took Harvoni for up to 24 weeks. So I don't believe he is in danger by taking the additional weeks. Taking Harvoni for 12 weeks is certainly not uncharted territory. My only thought is if there would be any point in the additional time because of his break in treatment. Would there be an improvement in efficacy?

While course less is best which is one reason why other than the cost of the meds that they allow people who qualify to treat for only 8 weeks. Many here who were only prescribed 8 weeks actually tried to take medication for the 12 weeks as the 8 week regime was only listed as patients who meet certain criteria "May be considered for" 8 weeks of treatment.

So while the situation is hardly optimal taking harvoni for the standard length of treatment of 12 weeks rather than the shortened regimen of 8 weeks I don't believe would be particularly more dangerous.
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline andrew j

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After - however long it is - ten days? - your [8 week] treatment was over.
You can't just decide to make more meds available again (because your practice hasn't got it's sh*t together enough to get another 4 weeks worth in time - if that's what you think is best for the patient).

Anyway - we're here now, so I guess you'll have to just keep taking them until you can get a more definitive answer.

I asked a friend in Australia (who has a comprehensive network - and who was as dumbfounded by this as I am) - and he thought, as Lynn does, that you probably won't do yourself any harm.

(This looks like negligence to me - or medical malpractice - or whatever they call it in the U.S.?!).




Offline Lynn K

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I guess my big question is why did he prescribe 8 weeks let it runout and belatedly decide after you were already at 2 weeks complete to order 4 weeks more treatment. If he wanted to treat you for 12 weeks what happened here? Really sounds like your doctor dropped the ball. If you need to see a liver specialist in the future I think I would find a new doctor going forwards. I don't see a liver doctor now just the nurse at the liver speciality center but they are specifically trained in liver disease and the doctor reviewes my case file. I either leave messages or I can post questions on a web site called my chart. They generally get back in a day or 2 when I ask about getting set up for my regular 6 month and annual testing.

Sucks not having some way to communicate when you have questions.
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline andrew j

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Yes - that sort of thing!

... I was thinking that, too:
If you can't connect with a Dr. or specialist - then a medical centre with knowledge of - or expertise in, liver disease.
(... Or a website like the one you suggest, Lynn).

There isn't much of that sort of thing here - just a couple of nurses attached to medical centres, with comprehensive knowledge of Hep C / liver disease etc.

(Something that can help, I've found - is to state openly how worried or upset you are.
This will often spark-up people in the health sector - who are usually pretty caring and concerned when it comes down to it.).


Offline Lynn K

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MyChart is used by many doctors to communicate with patients. The medical group of Multicare of which the Swedish Hospital is a part of uses MyChart. My lab results are posted to my secure account on MyChart. It also allows me to send messages for questions, scheduling appointments, or to request prescription refills. There are other web utilities for this purpose. Quite handy really at least in my experience. 

Because I have advanced liver disease I go to the Swedish Liver center once a year and have lab testing, ultrasounds every 6 months and upper endoscopies annually. My results are reported to the Swedish Liver Center.
« Last Edit: December 26, 2016, 08:48:45 pm by Lynn K »
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline tortuga

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The doctor originally made the treatment for 12 weeks. My health care provider peer reviewed my data and authorized 8 weeks. I spoke to the nurse before I started treatment to make sure they knew my prescription had been changed to 8 weeks. They said of course they did. On another occasion I questioned their timing of my blood work as it indicated that they still thought I was taking 12 weeks. I corrected them again. So, 8 weeks go by and I stop. 2 weeks later I get a letter from my health care provider that I have been authorized to take another 4 weeks. The request was sent on 6 December and my last dose was 8 December. No one will explain why. I can continue to try and hold their feet to the fire for an explanation or confession but that is never going to happen. I don't know these people as I am a patient for the treatment only. Also, I won't ever be a patient there ever again. My primary care doctor has what is called "patient portal" and is the same as "my chart". All my information is right there. I did not call my primary provider for assistance for this matter because he will tell me to talk to the gastro doctor to resolve any issues. In a couple of weeks this will all be over and I can move on. If any problems occur in the future there are remedies. I'm a 68 year old male in very good to excellent health. This is my only issue and I have never had any problems. I picked it up in the 1970s and it was discovered in the early 1990s through routine blood tests. I lived my life as if I did not have the virus and never thought about getting sick. My primary doctor recommended this treatment to be done with it forever.

Offline Lynn K

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Hope it works for you with all this going on it should have likely worked with just the 8 weeks

 
« Last Edit: December 27, 2016, 12:44:48 am by Lynn K »
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline andrew j

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  • Posts: 477
Yes.

Here in N.Z., in situations like this, one can complain to the office of the 'Health and Disability Commissioner'.
This office will investigate when things go wrong in the health sector - not so much to apportion blame, or punish healthcare providers, as to raise awareness and improve performance.

... Sounds like mistakes and / or procedural errors in your case?
Certainly, you should have been kept much better informed!

You sound pragmatic and upbeat, which is great!

Here's hoping that things just smooth along nicely for you; that maybe you get some therapeutic benefit from this, and that - yes - you can just move on happily with your life!
« Last Edit: December 27, 2016, 01:22:45 am by andrew j »

Offline maudib1492

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Guys I need help translating my hep c lab results I just finished a regimen of harvoni

Offline Lynn K

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Hi maudib

What are your results and have you called your doctors office?

If you just finished the result you are looking for is the 12 weeks after treatment has ended and a HCV RNA viral load test result of not detected
« Last Edit: January 04, 2017, 01:26:08 pm by Lynn K »
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline gnatcatcher

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Welcome, maudib1492. Do you have before-treatment and end-of-treatment results you can compare? Your ALT and AST are probably much lower now. Likewise, the HCV RNA viral load result is probably much lower. It is usually presented two ways:
1. as a regular number
2. as the logarithm of that regular number (easier for doctors to compare tests)

The HCV RNA viral load result will never say zero, because the test cannot count lower than a certain number, typically 15 but at certain facilities 12. Your result may show "<15" or "<12" somewhere, just to tell you it can detect but not count amounts smaller than that.

If UNDETECTED or NOT DETECTED appears, that's terrific news (although, as Lynn says, the test taken 12 weeks after treatment ends is the one that matters). If the result is DETECTED but <15 or <12, that's excellent news. There are people here who were DETECTED at the end of treatment or even some weeks afterward who nevertheless were UNDETECTED when they took the test 12 weeks after treatment ended. If the result amount is considerably higher than 15, your doctor will explain your next steps to getting cured.

Hope this helps.

Gnatty
« Last Edit: January 04, 2017, 05:15:57 pm by gnatcatcher »
9/29/71 transfusions
HCV genotype 1a
7/09/15-9/30/15 Harvoni

Before treatment:
Viral Load 9,490,582
FibroScan 19.5 kPa [F4]
ALT 262
AST 217
ALP 183

Most recent:
VL still UNDETECTED (SVR 102)
FibroScan 7.6 kPa [F1-2]
ALT 15
AST 20
ALP 85

 


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