medical trial using the drug nitazoxanide

Hi everyone, I do not suffer with Hep C, but am going to take part in a medical trial involving the drug nitazoxanide 2700mg, is anyone familiar with this drug and is it safe???? I'm just doing a bit of research before I go ahead with the trial, would appreciate any info....thanks

[Diane12855]

You will get answers to this later. Things tend to slow down over the weekend.

Sorry but I don't know anything about this stuff.

Diane

[ClippedWings]

I used Alinia when I was undergoing treatment for Hep C.  Didn't work for me but I didn't suffer any side effects other than a truly bizzare neon-yellow-green looking urine.  Tough to describe, but you'll know exactly what I'm talking about if it happens to you.  I think it might have been something in the dye (the pills were a bright yellow) but have no real idea.

[Bali05]

that`s got to be the new time release version

[GSDgirl]

There are other forums for people whe DON"'T have hep C,  Maybe one of them will give you an answer

[foofighter]

Is it a Phase 1 trial Aphrodite? Search using Alinia, as CW mentioned and you will find additional posts.

GSDgirl, many times trials begin with healthy volunteers.

[orleans]

I used it for 10 months during tx with very minor sx (stool stuff, 'nough said!) It has been approved for infants 1 year and older. My understanding is that it has been used long term with aids sufferers w/out probs. What kind of trial are you doing?

[Trish77]

Nitazoxanide, or Alinia, is a drug that is already used on-market for treatment of diarrhea.  It just so happens that they found it also has some effect on eliminating the Hep C virus.  Therefore, it's already a drug that's out there in the market and being used by people.  There should be lots of information out there, here is at least something to start you off.

http://www.nlm.nih.gov/medlineplus/druginfo/meds/a603017.html

Thanks for the healthy volunteers who start the trials off.  

[stef2011]

we are using it for hbv too, check hbv community alinia or nitazoxanide posts.the effect on hbv is by far much more potent than on hcv but for marketing reasons it was choosen to start hcv trials first (too many drugs already on hbv market but they only suppress replication without any virus eradication, alinia has a high percentage of eradication in antivirals/interferon combos).

the drug is very very safe and in hbv community we have a group using 1.5-2g daily every 6-8hr to mimic the slow release version, the responce of 1g daily is very very weak because blood half life of drug is only 7hrs.
the only sides we have found  are on stomach healthy bacteria since it acts also like an antibiotic so use of probiotics can be helpful to prevent these very mild sides.we are using lactobacillus reuteri since there are trials of alinia+reuteri on decompensated cirrhosis (end stage liver disease) for hepatic Encephalopathy

the slow release version should allow to reach the 2,7g daily dose without effects on stomach bacteria but most of us have already no sides at 2g every 6hr using probiotics

please let us know about any side since some of us could even bear more than 2g but since this is the maximum dose for continuous use on aids patients we didn t try higher dose, i have seen short trials using even 4g daily but just for 2-3 weeks

if you are not aware alinia boosts immune system  response to viruses and active on bacteria and viruses, in vitro even stomach cancers cells.the main activity studied is hbv-hcv and flu virus too at low dose so you might even avoid flu during the trial

[eureka254]

As I understand it, Nitazoxanide is generally prescribed for treatment of certain protozoan infections of the GI tract, was incidentally found to have benefit in fighting hepatitis, and in recent years has been used in hepatitis c treatment.  

My husband has been taking 500mg twice a day for two years now as part of his hep c treatment, and besides very mild diarrhea the first day or two, it has not appeared to have any significant side effects (besides rendering his urine a fluorescent-neon shade of lime-yellow).

Are you in a trial for hep B? I'm curious as I've heard it's been found to have possible benefits for hep b patients.  Good luck on your trial participation! ~eureka

[willing]

yeah,  the day-glo pee is one of the few cheerful notes on these gloomy days. However, I noticed it tends to only happen about 5 hours after the last pill. So I bought one of those nifty pill guillotines and am now splitting my daily 1g into 4 250s,

Seems that along with the known anti-viral effect, NTZ also has enhances induction of interferon-stimulated genes. From AASLD abstract 1878 "Augmentation of Interferon signaling pathway by Nitazoxanide: A novel therapeutic strategy for Relapsers to Peg-interferon and Ribavirin therapy.

" Results: We found a dose-dependent NTZ direct suppression of HCV replication in vitro when compared to untreated cells (p LT 0.002) and a synergistic antiviral effect with IFN, compared to IFN alone (p LT 0.01) and NTZ alone (p LT 0.003). Pre-treatment of NTZ for 3 days prior to IFN treatment resulted in the maximal suppression of HCV replication in vitro (p LT 0.001). NTZ treatment of PBMCs, ex vivo, resulted in a direct induction (fold change) of IFIGs in PBMCs of relapsers (2.6 ± 0.9, p LT0.01) and SVRs (3.1 ± 1.1, p LT0.003), but not in null responders (0.6 ± 0.3; p GT 0.05). NTZ treatment also augmented IFN–mediated IFIG induction seen in PBMCs from relapsers (4.6 ± 1.2, p LT 0.002) and SVRs (5.1 ± 1.3, p LT 0.001), but not in null responders (1.5 ± 0.9, p GT 0.3) when compared to IFN alone, although relapsers and SVR had no differences in IFIG induction when treated with IFN alone. "

[Bali05]

so you took the pill cutter out and are doing 4 x 250mg NTZ.
check out page #25 if you have not seen it yet
Stefano made me aware of it.

https://docs.google.com/leaf?id=0B_yFgxI8KNcRODEwMTJmNzgtYWMyYS00MDBjLTg3YTEtZTQ5ODQ5ODM5NWYw&hl=en

I am thinking of going to 3 x 500mg . Let`s if my GP will up my rx
How is your predosing coming along ?

[willing]

thanks for the link - I looked at  Keeffe's DART'09 slides before but it's much more relevant now that I'm taking the stuff. That slide 25 is pretty interesting - increase ntz dose by a factor of 2.7 and trough concentration shoots up by a factor of 11. However that alone doesn't say whether the increase in circulating ntz is doing any good. Slide 28 gives a partial answer - but it's frustrating their control is placebo - not the  standard 2X500mg dose.

At the moment I'm having a hard time staying afloat so am not looking to increase dosage of anything but I figured the evidence from both peg vs plain ifn and the requirement for very regular dosing in all PI studies point towards the importance of steady continuous pressure on viral replication. So I bough myself one of those jumbo luxorama pill boxes and am spreading all my meds (rbv, ntz and ifn ) into smaller more frequent doses (not sure how much good this does, but it can't hurt).

Results so far are OK. I'm coming up on 3rd shot. Decline from predose was only 0.26, disappointing, but in line with what Keeffe shows on slide 14. However synergy with ifn looks good : first phase decline (base to 48h) was 1.5. At that point decline slowed, exactly as predicted by the Neumann differential equations, but 1st week drop still finished at 2.06 which would seem to put me in team blue. This is encouraging since I'm expecting a legal tangle with my insco over off-label PI rx.

Meanwhile however  I'm running out of oxygen in a big way. Trouble breathing at night and can't stay vertical for more than 4-5 hours. Hgb decline was 15 to 12 from the predose and tomorrow I'll see  the additional impact from 2w of ifn . If below 11, I'll probably back off from the 19mg/kg  to 17. Gotta stay alive after all. And I wanted to pass along a big thanks for sharing the details of your rbv dosing - I hadn't considered going above 17 until you posted.

[nygirl7]

Do you mean you don't have HepC or you dont suffer any effects of the hepC?

[Bali05]

just spoke to my pharmacist. you might have noticed that Alinia has a yellow coating.
Tablets are usually coated so they pass thru the stomach to dissolve in the small intestine.
By cutting Alinia tab you are changing the way it was meant for your body to absorp it.
I would not do that.

You are having a steep drop in HgB prior to INF and that should be great for viral response.
Of course such a big drop leaves you out of breath until your body adjusts.

What was your last viral load ?

You are doing great ! Keep us posted with your next PCR

b

[Bali05]

I stand corrected apparently Alinia tab is not PH dependend and can be cut.
Spoke to a better pharmacist this time , going to call Romark as well

Cheers
b

[willing]

thanks for the warning Bali.  I looked through the Romark patent application for their controlled-release formulation:
http://www.wipo.int/pctdb/en/wo.jsp?IA=US2010024000
and, if I understood it (doubtful) it seems the time-release effect is due entirely  to packaging. It seems absorption anywhere along the GI tract should be fine for what we take it for (for the anti-protozoan effect that may not be true). However destroying the coating may affect the time-release effect. I've ceased and desisted while mulling this over (also my attempts at diving my ifn shot yielded something of a mess and a dramatic slowing of my VL drop so that's also history). I really feel for that gal whose Dr. wanted her to split her shot seven ways.

How are things going? you should be coming out of the valley of the 30s and into view of the Single Digit Mountains?  

[Bali05]

starting the 30s this week......
how close are you to UND ?

[willing]

With the 30s under way the   3/4 mark comes into view - yay! It does seem tx is the perfect antidote for that doesn't-time-pass-much-more-quickly-as we age effect..

As of end of w3 I was at 3.45, about half way to UND given a 7.04 start pre-everything. Have been following it pretty closely and results looked good other than a very flat w2-w3 decline of only 0.36. Blaming that on unsuccessful dose splitting until I find a better reason. Tomorrow starts w5.

[merryBe]

I took Alinia for a year or more with no ill effects other than a couple days of some gastro stuff at the beginning, after that it was smooth ailing...of course, it didn't end up helping me to get free of this disease, but perhaps in combination with all the other stuff (PI's Soc etc.) it will.

I'd definitely take it again, although I guess some folks have more gastro stuff with it, for me it was minor. Everything I've read on it seems to indicate it is one of the safer drugs...it also caused no increase in my liver enzymes, thank goodness..
mb

[Cory255]

A few research studies did seem to indicate that Alinia improved SVR rates for Geno 1's.  I'm considering purchasing it online from one of several suppliers before my next round of TX.          

Cory