Hep C Discussion Forum

I guess I'm cool enough LOL.....I had to wait till EOT for my 1st VL test, it would have been nice to know if it were working, but I guess if I had found out at 4 weeks I wasn't UND and then waited 8 more weeks to find out I was, well I think I would have been more worried during that 2 month period than just thinking positive that it was working, plus you only got one report bad or good to deal with at the end, other than a 12 week after tx test for SVR.

But If you are paying I don't see why any Dr. wouldn't do the blood draws you want done, it's not like you are asking for some invasive procedure, and if I'm paying and can afford it who are they to say no to any blood testing.

The only reason they didn't test me they said was because everybody in their group that has taken the S/O combo has been UND as early as 2-4 weeks so they didn't feel it was a reasonable use of health care $'s.

What I would like to see is a test at 11 weeks so that if for what ever reason if an additional 4 weeks could be added prior to a lapse in treatment it would be best INO, that way you'd have time to get the test result back and the order in for the script if needed........but the way things move that may have to be at 9-10 weeks???

Duane

Tig-

You wrote:

Quest uses the COBAS (R) AmpliPrep/COBAS (R) TaqMan (R) HCV Test Kit (Roche Molecular Systems, Inc.). It states it detects plasma viral nucleic acid levels to 10 IU/ml with a LLOD of 7.1 IU/ml.

Labcorp says it also uses the Taqman, but that the range of sensitivity is 15 - 100mil IU/mL. Weird.

Whether Quest is better than Labcorp, I really don't have an impression on that. I would be more concerned on cost if it were coming out of pocket. They are both good and qualified laboratories and I would have faith in the qualifications of either.

Okay, that makes sense.

I've seen these tests run anywhere from $900 to $1800 per test

Yikes!

so I would confirm prices well ahead of time.

I sure will.

You should also ask your doctor if you can get his/her office price for the test. It is often far less than your cash price will be. 

Unfortunately the MD who wrote the prescription, and who applied for me to Gilead and Janssen for patient assistance, didn't seem interested in monitoring the therapy. He brushed off VL tests like they weren't necessary.

I don't know why limiting VL's would put MD's out of business though. My doc didn't make any profits off of the testing procedure. It was simply another test added to the list of routines that were done throughout my care. 

It's different if you're going through a private MD, where you're paying for office visits every time there's a lab test. Shortened Tx times and less lab work are taking Tx out of the hands of MDs.

Mike

Hi Mike,

Quest uses the COBAS (R) AmpliPrep/COBAS (R) TaqMan (R) HCV Test Kit (Roche Molecular Systems, Inc.).

It states it detects plasma viral nucleic acid levels to 10 IU/ml with a LLOD of 7.1 IU/ml. Whether Quest is better than Labcorp, I really don't have an impression on that. I would be more concerned on cost if it were coming out of pocket. They are both good and qualified laboratories and I would have faith in the qualifications of either. The costs of the tests have been dropping. Use to be the Qualitative were more sensitive but they only provided a positive or negative result. The new Quantatative testing, such as the Quest test, returns a LLOD of 7 IU/ml and that's plenty low enough for me. I've seen these tests run anywhere from $900 to $1800 per test, so I would confirm prices well ahead of time. You should also ask your doctor if you can get his/her office price for the test. It is often far less than your cash price will be. 

I don't know why limiting VL's would put MD's out of business though. My doc didn't make any profits off of the testing procedure. It was simply another test added to the list of routines that were done throughout my care. 

Tig

Tig-

You wrote

Even though not needed, it is certainly nice to see evidence of proper drug action at the half way mark.

Who has the cool to wait 12 weeks to find out if the meds worked? I'd be a basket case.

I don't think you'll find many doctors that wouldn't agree to order the test, but you may get some friction from your insurance carrier.

Probably. But as I don't have insurance and will be paying for the tests myself, I can do what I think is right.

I believe once they see how effective these medications are, they may only authorize pre and post treatment VL's due to the expense.

There will be a lot of opposition to that, I think. It puts the MDs out of business.

I had all of my VL's done by Quest and the VA.

Is Quest better than Labcorp? Do you happen to know which quantitative PCR Quest uses?

Mike

Mike,

Yes, that would be my preference if given a choice. That would cover every base, including the 6th week morale booster. Even though not needed, it is certainly nice to see evidence of proper drug action at the half way mark. I don't think you'll find many doctors that wouldn't agree to order the test, but you may get some friction from your insurance carrier. The older SOC's had us going in every two to four weeks in some cases for these tests, so it may not even be questioned by insurance at this stage. I believe once they see how effective these medications are, they may only authorize pre and post treatment VL's due to the expense. I had all of my VL's done by Quest and the VA. Whenever Quest did the tests, they always pre approved it with BCBS. So I didn't have many problems with coverage, except the one time they failed to do it and don't you know, that was the time BCBS threw a fit and didn't want to pay for it! I'm still dancing with them over that expense, lol! 

Tig

Mike,

The CBC is a complete blood count test and the CMP is a comprehensive metabolic panel to measure liver and kidney function. And yes, I definitely need to work out the details for post. VL testing schedules.

I have seen many folks on this forum who haven't been UND at four weeks and at least one that was UND at week four and still relapsed. Relapse is still very much a reality but at least this gives your liver a major break from the inflammation. I'm still hoping the 92% success rate is in everyone's favor as SVR results are still rolling in on this new option. 

The big reason I'm optimistic is I'm still working fires on this tx and that's huge as I'm committed to providing for my family. It's a win win regardless for me!

Rob-

Why would two post-Tx VLs be necessary? Is it still possible for the virus to reappear, if it was undetectable at 12 weeks post-Tx?

If the 24-week post-Tx is unnecessary, why do it? Like you say, it will just keep you in a state of nerves.

Coupla questions about other blood tests:

- Is an LFT included in a CBC?

- What is a CMP?

Glad to hear that your are feeling okay.

Mike

Mike,

You're right- the tests are expensive, even with insurance (for me anyway). So yes, my doc is still going off of a VL test done in March (3 Million) and this was pre Tx. Now that I've started Tx, the plan is to do a VL test at six weeks (per my request), and another at EOT (12 weeks). After Tx I'm not sure what's next for VL testing? I would guess maybe two more. One at 12 weeks post Tx and another at 24 weeks to see if SVR has occurred. That's going to be a very difficult time for me mentally I already know. Ha ha

Additionally, I'm scheduled to do plenty of blood work to see how I'm doing otherwise (LFT's). I have a CBC at two weeks and then a CBC and CMP at a month and so on throughout the three months.

One week down and I feel awesome! The first couple of days were rough but all sfx have disappeared. I'm feeling so blessed to have this opportunity!

Best,

Rob

Hi, Rob. Thanks for your post.

So you are doing three, one before starting, one at week 6, and one at week 12, is that right?

What about follow-up VLs at 3 and 6 months post-Tx, to make sure there's no re-emergence of the virus?

I'm not so put off by the cost of the tests, more by not knowing what's happening to me. They are expensive, though, and since I'm paying out of pocket I'd like to figure out the best plan.

This is all predicated on my even being able to find somewhere to do the tests.

Mike

Hi Mike,

I would certainly expect to have a pre tx VL test done for a baseline, that's a given. I don't know of anyone starting tx that doesn't have a current VL on record. That's an insurance requirement to obtain approval. As was mentioned, this combination is a real virus killer and extremely effective at it's job. The standard VL protocol has been a pre tx baseline and then an EOT and an EOT +12. Some will even do an EOT +24 but I think that's from the old school way of thinking. When I finished tx, the standard was to have the VL done every 4 weeks from start to finish and then the EOT, EOT +12 and +24. Now they consider EOT +12 as the SVR qualifier. Relapse after EOT+12 is less than .5% (<1/2%). Those are very good rates of success. There is something to say about having these tests done during tx strictly for a morale booster, but it's proving unnecessary. If I were to want a test during tx, to keep my spirits up, it would be at the 6th week of tx. I've seen too many tests come back detected at week 4, so it may be asking an awful lot to expect a UND that early, even though they happen regularly. But if you jump the gun and get one too early and it's still detected, you haven't done anything but give yourself something to be disappointed over and then you'll want another  and another until it comes back UND. Don't second guess the effectiveness of this combination. It's a very good protocol and will work, just give it the time required to do it's job, then test. You'll be fine! Good luck, keep your chin up!!

Tig

Other than you are a 1b and I WAS 1a ...............I don't think you need that many VL tests unless it's just a feel good thing....... the stuff flat out works!

I mean if you get one at 4 weeks ur probably already UND so then just wait till a couple weeks post tx and test again, then 12 weeks ptx and Like someone told me if you relapse it happens rather soon after stopping tx.

Now i'm not the expert here and the 1a 1b may make all the difference.

I knew it was working , I felt it, it showed up in the LFT's  and btw you should have those done for sure on regular basis thru tx.

Think positive you have never had a better chance with the least amount of sx to clear this!

JMO but I admit I really wanted to know if and how fast it worked to clear it! They just said no!

Hi Mike,

Unfortunately a testing protocol for Sov/Oly hasn't been established. What we're seeing more and more often are physicians waiting until the end of treatment (EOT) and EOT +12 to do the viral load testing. As there isn't a futility rule established for this combination, and the fact that it is a relatively short treatment course, may be the justification for it. The old SOC's (standard treatments) used to do them at week 4, 8, 12 and EOT. Insurance carriers have a big say in it due to cost and necessity. So far there hasn't been a lot of input from them on this with Sov/Oly. It has everything to do I believe with the rates of success these drugs offer and the cost of a single VL can be in excess of $1000.00.

Tig