cautiously optimistic with Alinia

[viaduk]

I just received my recent bloodwork, and it seems that the Alinia approach is doing something.  My PCR results  are:

pre tx:                                    2,300,000
2 weeks alinia                         1,800,000
5 wks alinia  and 1 1/2 wks riba:  400,000

I  continued the riba for a total of 3 weeks and just took my first pegasys shot tonight. This is the lowest that my VL has been since my previous tx, so I'm taking it as a good sign and keeping my fingers crossed for an RVR, no  dose reduction, and ultimately SVR.  Thank you all for your help and support (especially Willing who posted the studies that convinced me to get off the bench and into the batter's box).

[spectda]

Good luck with your treatment. I hope it continues to go well. what genotype are you?
-Dave

[Trinity4]

Curious if the alinia has caused loose bowels with you?  I'm thinking of using it before starting tx again but not sure I want to deal with that.

Trinity

[Bali05]

I am on Alinia and predosed Riba as well.
Keep doing the PCRs !!!  I included a wk2
Also check your hemoglobin you might be able
to up your Riba dose without crashing your HgB.
I did that and  it requires frequent checking of  HgB.

Another thing when you get closer to UND run the LabCorp NGI QuantaSure PCR <2 IU !!

Now kick some viral a**

b

[Bali05]

I have taken Alinia soon a year with no sx other than more yellow urine
and very slight yellowing of eyes . If your gut has a weak flora to begin with
Alinia might do that. Generally at 500mg BID Alinia is very well tolerated. Take Probiotics if you are
worried. There is a guy on this forum using Alinia for Hep B and they have upped it to 1500mg
or even 2000mg /day

[sunshines76]

I sincerely wish you the best luck with Alinia and riba. Yet, I can't imagine that your doctor would find these PCRs significant - your vl did not decrease that much, actually, if you look in logs. I had this type of variations in my vl even before I started tx. One month it was 375,000, then 175,000, another - 1,000,060, and then it would go down again. Keep watching your vl closely, perhaps if it continues to go down slowly but surely (without any spikes going up again), that could be a sign of hope.
Good luck!

[Trinity4]

2,300,000 to 400,000 is a .76 log drop.

Not that significant in the big scheme of things but a drop none the less.

I started treatment with a viral load of 1,300,000 IU/mL.  3 month post 72 wk tx PCR 132.700 IU/mL

1 year post tx 400,140 IU/mL.  No big spike in the viral load but what is important is how the immune system works with the interferon and ribavirin.  In my opinion if I were to treat with SOC again I would expect to see the same results.

[Trinity4]

Forgot to say thanks for the heads up on the Alinia.  Hope your treatment is going well.

Trinity

[willing]

cautious optimism is well-warranted -  congratulations! A 0.76 log drop before the ifn hits is a promising sign. More importantly, you are now thoroughly marinated in both rbv and ntz, both of which demonstrably improve ifn effectiveness so you're getting optimal yield from the ifn. What mg/kg rbv dose did you settle on?  I'm a bit further behind you on the same trail. Yesterday got a call from pharmacy OK'ing the rbv rx, but need  approval for the ifn. Still no word on whether they'll cover the alinia. How many weeks of ntz are you doing ? I'm planning to stop at w12. Also looking for a good supplier of silipide.  

[Bali05]

what makes you stop NTZ @wk12 ?

[Bali05]

do you take Alinia with Riba or apart ?

[viaduk]

Thank you all for the words of encouragement.  Sorry for the delay in responding, but I forgot how much fun interferon is and spent most of yesterday in bed. Today is better!

Spectda: my genotype is 1a

Trinity:  I did have some stomach issues at first, but that resolved in a few days.  I do take lactulose for HE, so loose bowel movements are "normal"  for me these days

Bali:  I do remember that you are taking alinia.  Thanks for the advice.  I am taking the alinia and riba pretty much at the same time, one during the meal and the other when I'm done eating. I also take fish oil  or flax seed oil with the meal.

Willing:  I am taking 1200 of riba and plan to continue with the alinia for the full course of treatment.  My hepatologist is friendly with Dr. Keefe, and they discussed this plan prior to me starting.  Why do you plan to stop alinia at week 12?  I don't remember you saying that during the earlier posts.  I wish you luck with the insurance approval.

[Bali05]

I was taking Riba + Alinia a few hrs apart but I grew tired of it since both require food . This a particularly a pain when travelling abroad with 6 hr time difference. I found myself taking Riba
at midnight and Peg at 4:00 am to stay on schedule.

Anyway to anyone taking Alinia with SOC the Romark trials were designed by taking Alinia and Riba
at the SAME time with food. So apparently there are no known absorption issues.

Viaduk :
When are you planning your next PCR and which  Lab/PCR are you doing ?

[viaduk]

As you suggested earlier, I will have my first PCR at the end of week 2 at Labcorp (wouldn't it be nice...) I think it's called quantasure and goes down to either  <2 or <5.  The PA wrote the script for heptimax, but that is Quest and my insurance insists on labcorp.  I think that they are both TMA.

[Bali05]

LabCorp:
HCV NGI QuantaSure  Test#:   140639 !
Assay Range:  2 IU/ml - 2Mill IU/ml

Quest TMA only to 5 IU and is known for false positves.

I just got a new requistion myself , the NGI Quantasure is the most
sensitive and reliable PCR out there !

Remember you want to be as UND as you possibly can so get UND with the Quantasure < 2 IU.
                      

[willing]

viaduk: It's reassuring to know Lady Interferon hasn't lost her ability to knock a guy flat off his feet; I hope you're recovering from her charms.

bali: my main reasons for adding alinia to week 12 are (a)  adherence to the Basu et al protocol reported at the last AASLD
http://download.journals.elsevierhealth.com/pdfs/journals/0016-5085/PIIS0016508510609882.pdf
(b) safety (c) cost - still not sure whether ins will cover it

[Bali05]

Assuming Alinia works as an Inf inducer than why stop it at wk12 ?
the Basu study results included predose/high riba

why do you have safety concerns when Alinia has proven to be very safe ?

i never asked my insurance , i am sure they would have turned it down because
it is expensive and not SOC. I just got a script and went to pharmacy, BINGO !
don`t ask , don`t tell sort of thing.

[orleans]

Hey, I used Alinia and was concerned about it being covered. Was planning on buying it on the net for cheap if I had to.  When I talked to my Hepa. Dr he said it would be no problem and  bowed up a bit when I mentioned my doubts. He said "I"M THE DR. and all I have to have is a reasonable case that it could be helpful.There is enough evidence to warrant it's use."  This was back in Aug. 08 when all we had were the Egyptian trails to go by. He put in the request and there was no hesitation from the insurers (BCBS of GA.)  My policy ***** too! I am self employed and have a $10,000 deductable on care and a $1000 on drugs.  jerry  ps UND @ 2 weeks, dropped the riba at 24 wks, stopped inf/ alinia at 36wks, UND @ 12 wks post, never did the 6 month post PCR

[willing]

definitely planning on both pre-dose and  high/riba.  Will start at 17mg/kg and adjust as needed.  NTZ seems generally, but not universally, well-tolerated. CS had a devil of a time with it. If there are no problems will re-evaluate at w12. Going to pharmacy with the rx is easy - what I was worried about was whether at checkout they would ask for the full cost ($1400) or the insco copay($40). Life is good - they covered it. Took 1st pill and no allergy evident. Dr. also agreed, in principle, to  additional testing. Since not sure whether PI will/won't overlap am curious about measuring 1st/2nd phase decline and so would like tests at (0, 12, 24, 48, 72)h and (7, 14, 21, 28)d after 1st ifn. No need for any of these to be high-sensitivity but he may still balk at that much testing. Backup plan is to draw my own and keep at -80.

[Bali05]

congrats to the ntz approval , still remember how it felt a year ago
when i got my first script.
yes CS had a bad time with it but that is a rarity.

What is your tx plan at this point ?

[viaduk]

Congratulations on the alinia approval!  Welcome aboard.

[willing]

Thanks -  not quite "on the road again" but getting close. Major obstacle with my tx planning at the moment is getting a few tons of 3/4"" gravel delivered and driving to Fresno in search of a 1500 gallon septic tank (don't ask). But as far as tx, I'm planning to stick pretty close to the Basu protocol. Only twists will be the 1600 SAMe and probably dividing my weekly pegasys dose into twice weekly shots. Am still holding out dim hopes of access to IV-SIL (the iv-infusion milk-thistle product) but it's not looking likely.

[CoWriter]

The diarrhea started at week 8 and nothing worked to make it stop....immodium, lomotil, probiotics.  He tried restarting it later and the same thing happened.  

It's supposed to prevent relapse....so it makes no sense stopping it at week 12.

Are you taking probiotics?

Co

[willing]

Co:
>It's supposed to prevent relapse....so it makes no sense stopping it at week 12.

as far as I know, the only documented evidence for NTZ's hcv-suppressive mechanism is enhanced  activation (phosphorylation) of eif2A and PKR:
http://www.ncbi.nlm.nih.gov/pubmed/19664635

So,  not unlike the SAMe/Stat1 story,  the effect is to keep two key molecules in busy-bee mode but, unlike STAT1, on the ifn effector rather than ifn signaling side. How/why would this  mechanism be limited to relapse? Also note that in the Basu study relapse rate was 0% with 12w NTZ,  though whether that was due to the high dose rbv or ntz is not clear.

all: looks like the AASLD abstracts are  available on 10/1 as promised - get'em while they're there..

Bali:check out the text for abstract 828 (Activity of Telaprevir Monotherapy or in Combination with Peginterferon-alfa-2a and Ribavirin in Treatment-naïve Genotype 4 Hepatitis-C Patients: Final Results of Study C210 ). They claim "TVR in combination with PR had greater activity against HCV G4 than PR alone," though the SVR rates don't seem to support this. Still, it may be worth thinking about adding tvr at the tail end of your tx if it's out by then.

[Bali05]

thanks,
I am very aware of C210 even before I started tx.
I would not add it to the tail end nor would I use it if it were available right now.
According to my famous hepatologist @ wk12 meeting my odds for SVR are 80% WORSE CASE !!!
Since there is no 100% , I am very happy with my results and I would not change
a thing.
Tela can create resistant strains. I would only use it if I had no other option and my odds for SVR were very low.
I would have to relapse first to go down that path .