blood testing frequency

[Dayna]

My GI has me on Harvoni 12 week treatment.  Been on it 3  weeks. He said he does not require any more blood draws until I am done with the treatment for an additional 12 weeks, finding out the end results after I am done with it for 12 more weeks.  I've read so many posts of testing done as soon as 4 weeks, etc. to check viral loads. Does this length of a waiting period sound peculiar? Also, though I had a biopsy 10 years ago and was non responder on 11 months of interferon/ribavirin. He only  required an ultrasound prior to Harvoni treatment.  I haven't received any numbers pertaining to my levels, which I know I can obtain but now seeing all the information everyone else here has received, I am beginning to wonder if my GI is slacking on me.  What is your opinion on this?

[Lynn K]

Well no matter what your viral load shows it won't change your treatment. Some have tested low positive at 4 weeks and it worried them basically needlessly because 4 week results mean little and from what I have read almost everyone clears on treatment so I reality I guess there is not much benefit to be had by testing for viral load but it is reassuring for the patient to see if not undetected at least a significant drop in viral load.

Good luck on tx

[Dayna]

So true.  And I know each GI has their own protocol.  I maybe a little sensitive because my first GI Doctor had an undesirable attitude.  He wants to meet with me after 8 weeks and I have plenty of questions for him now whereas initially I didn't know really what to ask.  Thanks Lynn.

[dragonslayer]

Dayna, my doctor was the same way.. The Harvoni regimen doesnt call for response-guided-treatment the way earlier protocols did.  It is uncommon for doctors using Harvoni to change treatment duration as a result of on-treatment bloodwork.. And, because the only test that matters is the one done 12 wks post treatment, many have simply dispensed with on treatment testing. 

[Dayna]

Hi dragonslayer, I see what you are saying.  Thanks.  Today is day 25. Nearly 1/3 the way there!  Have received good info and encouragement here. Glad I found you all!

[morning_glory]

I read this article, it may be helpful...

MONITORING PATIENTS WHO ARE STARTING HEPATITIS C TREATMENT, ARE ON TREATMENT, OR HAVE COMPLETED THERAPY

http://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have

MG

[Dayna]

Morning Glory, Thanks! That's excellent info.

[apache]

Thanks for the link.
One question:   there's a very odd exception in the list of recommended tests at that URL:

Recommended assessments prior to starting antiviral therapy.

Assessment of potential drug-drug interactions with concomitant medications is recommended prior to starting antiviral therapy.

The following laboratory tests are recommended within 12 weeks prior to starting antiviral therapy:

    Complete blood count (CBC); international normalized ratio (INR)

    Hepatic function panel (albumin, total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase levels)

    Thyroid-stimulating hormone (TSH) if IFN is used

    Calculated glomerular filtration rate (GFR)

The following laboratory testing is recommended at any time prior to starting antiviral therapy:

    HCV genotype and subtype

    Quantitative HCV viral load, except in the circumstance that a quantitative viral load will influence duration of therapy

I would have thought that a quantitative HCV viral load would be especially recommended (and not contraindicated) in the circumstance that a quant. VL will influence duration of therapy.

In particular, with Harvoni they recommend 12 weeks if VL > 6 million.  So one would think the starting VL would be important to know.    Am I missing something here?

[Dayna]

Hi Apache, My GI assigned the 12 week treatment to prior to VL test because I was non responder to interferon in 2004, which in hind sight seems odd as well.  He did do blood work up after our initial consultation though... After I received the meds with specs and saw the SVR percentages of 1b 12 wk 87% & 24 wk 100% that's when I got curious about treatment duration. (Of course I'm 1b.)

[morning_glory]

Dayna - You're welcome! 

apache wrote - "I would have thought that a quantitative HCV viral load would be especially recommended (and not contraindicated) in the circumstance that a quant. VL will influence duration of therapy.
In particular, with Harvoni they recommend 12 weeks if VL > 6 million.  So one would think the starting VL would be important to know. Am I missing something here?"

Good question. I have read this statement several times. I don't quite understand it either. Maybe someone else here has a better "understanding" of this. (Lately, my brain doesn't want to work for me - ugh!)

My GI appointment last week was canceled, because of snow. It was suppose to be a follow-up on my Harvoni treatment - Ha, I'm not even on it yet. The next available appointment isn't until Apr. 1st. 

I am considering going to my PCP & asking him to run my blood work, per the recommendations in the article. I will bring a copy of the article for him to read. Especially, since my GI doc didn't do blood work in Nov 2014 when I saw him. HE was the one wanting to put me on Harvoni. I really didn't understand why he didn't order the BW. So the last blood work I had was back in August 2014, ordered by my PCP.

My PCP is one of those docs that likes to learn from his patients, as well as, teach them. Great guy, very caring. (Hope he stays that way.)

I talked with Support Path this week, it looks like they have all they papers they need to move forward, in approving Harvoni for me. My case is now going to the next step - 'Application to be reviewed' department.

*** To all my friends on this forum - I know we are all in this together & the support we give each other is beyond words. Many of us have no one else who we can relate to, or even talk to, about what we are going through. A big THANK YOU to each one of you! ***

Blessings,
MG

[Mike]

Hi Danya,

A lot has changed since the days of Interferon-based treatments, including response-guided-treatment and blood work requirements.

Since you were previously treated and did not clear the virus, and since you don't have cirrhosis, the protocol for Harvoni is 12 weeks (regardless of your viral load at the beginning of tx).

Knowing this, there would be no clinical reason for wk 4 VL, as the results would not change the treatment protocol you are currently on (in fact, it would only serve as a treatment cost-driver).

The 12 week end of treatment (EOT) and the 12 week post treatment (to establish SVR12) are the ones that count.

Best wishes, Mike

[Dayna]

Thanks Mike, I didn't do any research prior to this time around because it all came up so quickly.  So I'm learning a lot from these posts! My mid treatment appointment is in a week, so I can dig into other questions.
Just started my 5th week. Side effects minimizing quite a bit now too.  Still finding lots of water & eating right helps a great deal.

[motor]

   Reading this thread made me think the treatment protocol of where I'm being treated might be useful info. I sure hope so.  Anyway, I tagged it "the gold standard for hepC care" and hope you will have a look.

[Bituman]

Knowing this, there would be no clinical reason for wk 4 VL, as the results would not change the treatment protocol you are currently on (in fact, it would only serve as a treatment cost-driver).

The 12 week end of treatment (EOT) and the 12 week post treatment (to establish SVR12) are the ones that count.

Best wishes, Mike

Mike I just had an interesting development re: testing protocol.  Doctor's office just called and said as a consequence of my 4 week results, they want me to have 6 week testing.  For reference, right before treatment I was about 3.6 million VL, then 59 at two weeks, then last week 4 week results were "<15".  Even though this was not quite as good as "undetected" I was still pretty thrilled with the result.  On the other hand, the phone call asking me to come in at 6 weeks seemed a little foreboding.   

As I lay awake last night wondering about this, it occured to me that the professionals are still making up a lot of the protocol as they go along.  Or perhaps my doctor has a specific opinion re: those of us who remain detected at 4 weeks.  I then realized that so far, that phone call created the only treatment-related side effect I've has thus far.  So I decided to go back to sleep. 

Bob

[Mike]

Hi Bob,

You always want to follow the advice of your doctor.

My physician did a week 4 VL, wk 12 VL and an SVR12. If the wk 4 VL was still positive for HCV, nothing would have changed. We would have continued treatment through wk 12, followed by a VL. If the VL was still positive at EOT, there would be no need for an SVR test, as I would have failed treatment.

In the clinical trials for Sovaldi and Harvoni, a week 4 VL was included to gauge how fast the medication was killing off the virus to determine if there was a correlation with a SVR12. Initially, it was thought that if the virus was still present at week 4, a decision could be made to stop treatment as it wasn't working.

This has since been debunked, and there is no correlation between a low level of virus at the week 4 treatment mark and an SVR12.

The only possible exception would be if the individual did not experience a significant log drop after 4 weeks of treatment. For example, if a patient started treatment with 2 million VL, and 4 weeks in to treatment the VL was measured at 350,000 -  that would be a problem - and the treatment protocol would be significantly modified or  discontinued.

I would be interested in why your doctor wants a week 6, 8 and 12 VL. If you find out, let us know.

Best wishes, Mike

[Bituman]

You always want to follow the advice of your doctor.

I would be interested in why your doctor wants a week 6, 8 and 12 VL. If you find out, let us know.

Best wishes, Mike

Agree on following my doctor's advice.  I trust him implicitly.  The only change to to the original testing plan is the addition of the 6-week series (8- and 12-week were always in the plan).  I will find out about that end of next week.  But I wonder whether he is just trying to gain perspective on time dependency of test results.  In my job I deal with construction materials testing.  In order to understand what trends in test results signify, I need to look at a lot of data.  This is what I think my doctor is doing by ordering the 6-week tests.  Or maybe he thinks I'm going down in flames with respect to SVR and wants to confirm!  Probably not.  But I think we are all expecting more structure in a process that is not yet well established. 

Bob

[Mike]

Hi Bob,

I think you're right: there needs to be more structure in the process - not only for the patients but also the medical professionals..

This will occur in the near future, as the first large group of patients will have completed treatment with Harvoni and a  plethora of new information will be available to study, assimilate and further develop the HCV tx process.

This data should start pouring in around April and May, as a large, real world group of patients will have reached the SVR12 threshold.

Best wishes, Mike

In an

[Bituman]

This will occur in the near future, as the first large group of patients will have completed treatment with Harvoni and a  plethora of new information will be available to study, assimilate and further develop the HCV tx process

This right here!  I think you really nailed it.  It will be very interesting to see how/if treatment protocol changes as a result of early experience.  Exciting times in the liver disease business!

Bob

[davidsconfused]

I had my four week tests (I thought) last week.  I had the blood tests,  then later in the week saw my doctor.  I found out that the blood test was just to monitor health and not VL.

They don't do VL testing during treatment as they said it's meaningless. Pretty much every body comes back undetectable with a very few with very low count,  which worries these people and the treatment isn't going to change anyway. We will get checked at eot,  12 & 24 weeks.

I did learn that my liver ensimes had been in the 140s for both before I started and now both are in the normal range.

[motor]

I was originally scheduled for 12wks Harvoni, but they changed it to 8wks.  It's my understanding that they will extend treatment to 12 wks, if 4wk VL is not UND.
   Please see my Gold Standard thread for details.
   @Davidsconfused and Bituman, would you mind creating your signature?  It really helps me to understand your comments.  Or if you don't want to, would you tell me why?  I notice many don't.
   

[Bituman]

   @Davidsconfused and Bituman, would you mind creating your signature?  It really helps me to understand your comments.  Or if you don't want to, would you tell me why?  I notice many don't.
 

I would rather have my affirmation in my signature.  But if you are interested in stats, see here: 

http://forums.hepmag.com/index.php?topic=2196.0

Bob