Dropping out of Tx at 8 weeks...

[Virusbuster]

I just got my 7th week VL result: 2.6 million. Given that I started with 13.7 million, a 0.72 drop. Well below the 1 log that I had agreed with my doc as a stopcriterion. Hence, I stop, right here, right now. It was a horrible 8 weeks, and I can only say I'm happy the result is black or white (albeit black in this case) and not grey.

Hopefully, I'll be me old self again soon. And even more hopefully, my liver will last until the new meds come out.

Thank you guys for all the support you have given me the past weeks. I'll try to reciprocate.

VB

[newleaf09]

I beleive that general guidelines are to look for a 2 log drop at 12 weeks and then decide.  Are you sure you want to jump out?

[Virusbuster]

Yes, I am. Even if I would manage to reach 2 log at 12 weeks (which would mean quite an improvement from the current rate of suppression), my chance of SVR would only be 5%. That's not worth a 72 week treatement with the new drugs on the horizon, IMHO.

[GreatBird]

Sorry to hear that you had to quit, but think you made the right decision.

I'm in the boceprevir trial and I made little headway with viral drop in the first four weeks that was SOC only. As soon as I got the blue pills (boceprevir/placebo) my VL dropped to almost nothing (less than 25 but detectible which was--as I recall--over a 4 log drop for me).

I'm still in the midst of the trial. I cannot predict my outcome. But, based on what happened to me in just the first two weeks with the PIs, I think they are the way to go. Perhaps by the time they become generally available, they will predose everyone with SOC and based on their response will decide whether or not to add PIs. I dunno. You sound like an excellent candidate for them based on my own experience.

Have a good trip!

[portann]

Sounds like a smart decision and presumably one your medical team also wanted.

Co-infection is more complicated to treat, so if I were in your situation, I'd definitely wait for the PI's to increase my SVR chances and possibly reduce my tx time.

And now you get to take that pre-planned vacation. Will you be up to it?

[jmjm530]

Implementing a pre-determined earlier stop rule is a very intelligent approach that I wish more people would consider, just as many consider extending treatment given the same or differing scenarios.

That said, I assume you probably do not have significant liver damage and have ruled out controllable factors such as proper dosing, compliance, etc. A couple of newer factors to look into are Insulin Reistance and Hemoglobin drop from baseline. Has your doc ruled out IR and do you know what your pre-tx hemoglobin was and what it was on treatment including now?

[RCM829]

I'll assume that your quoted 5% chance of SVR is because you are co-infected and that this number is accurate and clinically documented, right?
If this figure IS correct, I sincerely applaud you for making an extremely difficult decision with an admirable degree of certainty.
You seem self-directed and confident, and that will serve you well always.
Have a wonderful trip and keep in touch with us, O.K.?
My very best to you....

[jdwithhcv]

I think you did the right thing.  There is little point in putting yourself through this horror without much hope for success.  When you are ready for another try, perhaps the new drugs will be ready for you.  

Meanwhile, have a wonderful time on your vacation.  I hope you are feeling well enough to thoroughly enjoy yourself.  Please let us know how you are keeping.

All the best,
jd

[Virusbuster]

Thanks GB, I am eagerly awaiting the new drugs. I'm ready for a new fight anytime!

[Virusbuster]

I had a fierce debate to convince my doc to do this. She had preferred to continue up to 12 weeks. However, she did see the logic of my reasoning and agreed, I have to give her that.

I will make the best of my vacation, I assure you that. However, my WBC has fallen through the bottom, so I do hope I won't get sick.

[Virusbuster]

" assume you probably do not have significant liver damage and have ruled out controllable factors such as proper dosing, compliance, etc."

I do have a moderate stage 3 fibrosis, so it's not an easy idea to have to wait perhaps two years for the new meds. My dosing was fine (riba 1000 mg @ 68 kg)

"A couple of newer factors to look into are Insulin Reistance and Hemoglobin drop from baseline. Has your doc ruled out IR and do you know what your pre-tx hemoglobin was and what it was on treatment including now?"

My doc hasn't ruled out IR. I just brought up the subject, and we'll look into that. However, my glucose values (check my tracker) didn't worry my doc, esp. not since I had eaten when I got tested. I know what my HG was pre-Tx (14.7) and is now (10.9). I'm very easily out of breath now.

[Virusbuster]

"l assume that your quoted 5% chance of SVR is because you are co-infected and that this number is accurate and clinically documented, right?"

Indeed. In fact, that information was part of the protocol that I received prior to treatment.

"If this figure IS correct, I sincerely applaud you for making an extremely difficult decision with an admirable degree of certainty. You seem self-directed and confident, and that will serve you well always."

I take that as a really nice compliment. Thank you, I feel flattered!

[RCM829]

Just curious...what are your WBC and Absolute Neutrophils? I'm trying to get a read on what levels are bothersome to people. My understanding is that you multiply them and if you are between 300 and 500, you considered low and if you fall under 300, you need rescue meds ASAP.

[Virusbuster]

My WBC have dropped from 5000 down to 2300. I understood that below 3000 it becomes tricky.

I don't know about neutrophils, I only have the complete WBC and my CD4 cells.

[jmjm530]

Is the 5% figure with 48 or 72 weeks? Do you have any study back up? I thought the 72 week figure (assuming UND by week 24) was pretty decent although did not look at any co-infected studies. As you know, fibrosis progression is greater if you're co-infected so personally, given you're a stage 3,  I'd think twice about stopping now unless you can verify those figures. Ploughing on until week 12 might make some sense as your doc suggests.

[jmjm530]

this suggests 17% SVR (not 5%) assuming two-log drop at week 12

http://www.hcvadvocate.org/news/newsLetter/2009/advocate0309.html#1

[jmjm530]

http://www.hivandhepatitis.com/hep_c/news/2009/042109_a.html

Also, a newer study suggests that tx possibly can reduce fibrosis rregression even if no svr

[Trinity4]

Sorry you did not have the viral load drop you were looking for.  I barely got a one long drop at 6 wks and still had not cleared at 12 wks but did sometime around 14 wks.  You would have a greater challenge with co-infection though.  Hgb went from 12.6 to 11.2 in 3 wks but never went much below that and it's back up to 11.5 - 12 after 57 wks.  WBC started low and continued on a downward trend until Neupogen was prescribed.
I agree it was the right decision to stop and you can plan new strategies now.  

Best of Luck to you,
Trinity  

[jmjm530]

this suggests sijmilar svr rates for coinfected (40%) geno 1's
http://www.hivandhepatitis.com/hiv_hcv_co_inf/2007/101907_a.html

I'd really think twice about stopping  before week 12 given: (1) coinfectrion: (3) stage 3:

[portann]

VB had no 'proper' biopsy, as I believe he said.

[jmjm530]

Not sure if that's good or bad news. Anyway, Fibroscan said stage 3 and coinfected individuals progress faster.

[Virusbuster]

"Is the 5% figure with 48 or 72 weeks?"

72 weeks for genotype 1, co-infected with HIV.

"Do you have any study back up?"

The < 5% chance if at 12 weeks there's a < 2 log drop comes straight from my treatement protocol. It refers to the Apricot Trial of HIV-HCV co-infection, abstract at CROI 2003. Even though I haven't seen the publication with my own eyes, a < 5% SVR chance seems to me like a reasonable threshold to give up treatment..

"As you know, fibrosis progression is greater if you're co-infected so personally, given you're a stage 3,  I'd think twice about stopping now unless you can verify those figures. Ploughing on until week 12 might make some sense as your doc suggests."

I have no doubt about the protocol used. I think it's pretty standard, actually. Also, I don't have faith that when it takes 7 weeks to achieve a 0.7 log drop, in the remaining 5 weeks it will suddenly drop way below 2 logs. Note, just making it to 2 log isn't good enough. I'm not willing to put myself through 60 more weeks for a 5% chance of SVR. It should drop more than 2 log. And I just don't see that happening.

I know my liver isn't into that good a state. It will be monitored closely in the time to come. Hopefully, the fact that my HIV is now UND will make the detoriation less. But for now, it's the end if this battle of my little private war. And I'm gonna enjoy my vacation as much as I can.

[jmjm530]

Virusbuster: Also, I don't have faith that when it takes 7 weeks to achieve a 0.7 log drop, in the remaining 5 weeks it will suddenly drop way below 2 logs.

Trinity: I barely got a one long drop at 6 wks and still had not cleared at 12 wks but did sometime around 14 wks.
----------------------

Trinity had a similar response to yours and did clear around week 14, so maybe giving it another 3-4 weeks is a reasonable choice as your doctor probably argued -- that is if you're willing to accept a 30% chance of SVR with 72 weeks of total treatment, assuming you follow Trinity's pattern.  In your shoes I probably would, but of course I'm not.

-- Jim

[Trinity4]

VB's viral load was a lot higher than mine starting out.  He was 13,000,000 and I was 1,300,000.  He only had a .23 log drop at 4 wks and I had a little over a 1 log at 6 wks.  My biggest drop occurred between 6 wks and 14 - 15 wks but a big factor here is he is co-infected and his doctors advised him the HIV drugs can reduce the effectiveness of the HCV drugs.  

[jmjm530]

Yes, but the SVR rates are similar with co-infected, so not sure that advisement is correct. Also, very high viral load and high have same results. I do hear you that it isn't apples and apples but only suggesting he wait until week 12 to see if a two-log drop can be achieved. It's only a few more weeks. Have a feeling you would wait :)

-- Jim