Alinia monotherapy for type 4

[Bali05]

Hi everybody ,

just newly joining the dragon fighting club.
Had IBS starting in Jan09 saw 5 docs until doc #6
gave me the news last month. Have discomfort
burning sometimes stabbing  in the liver region, sleep problems.
Take herbs ,changed to organic high antioxidant diet (fruits/veggies)
symptoms got better especially sleep , burning or awareness feeling comes and goes.
Her is my profile:
- geno type 4a,c
- VL 38,466 I.U./ml
- ALT 65  (<40)
- G-GTP 60 (7-51)
All other lab work incl. ferritin in normal range.
My doc thinks I have this for a long time ago (maybe 20 years)

Being type 4 I am heavily considering giving Alinia monotherapy a shot
(Gastroentereology March 2009 article)
and eventually following it with standard treatment.

Anybody in this forum that is type 4 and has experiences with Alina ?

Is there a fibroscan available in NYC or close by ?

[moe28]

live in nyc, I'm in your shose with type for, went through 10 month interfron than relapsed, and recently i stoped another interfron course combined with incevick after 6 month. after testing pos. considering alinia but fear the side effects of interfron and ribbvarin

[Bali05]

did not get your personal email can you please resend.

thank you evangelin

[evangelin]

He did have diarreah for a few months at the beginning but it finally got better.  He took Immodium a few times and that helped.  He didn't have any other symptoms that couldn't be blamed on the Interferon and Ribavirin.  He has cirrhosis so I would have been scared to death if he'd had yellowing of the eyes!  
I sent you a personal email message.
Ev

[Bali05]

you are right about the resitance so far not being a problem . The pharmacist at Romark
told me that the reason for this is that Alinia does not attack the HCV virus
but works by strengthening the healthy liver cell against the Virus.

Did your husband have any sides from long term Alinia like yellowing of eyes or
diarreah ?

[evangelin]

I believe I have read that there aren't any resistance problems with Alinia so the only risk of trying it would be the expense involved.  Ask the Pharmacist at Romark to be sure, but I know I have read somewhere that it doesn't build up resistance so you could still try it later with Interferon and Ribavirin if necessary. My husband has been on it for over a year along with the interferon and ribavirin.  He has geno 1 and has been a nonresponder twice in the past.  His response was still not very good but it was much better with the Alinia than it was without.  Without it he didn't even get a 2 log drop by 12 weeks.
Best wishes,
Ev

[Bali05]

you are right , just like that not very good odds but odds without significant side effects as monotherapy.
If it does not work and you are type 4 you still can profit by using it as a lead-in phase for standard treatment . SVR 24 weeks post treatment : with Alinia 79% without 50%
_________________________________________________________________
In this issue of Gastroenterology March 09, Rossignol et al5 present the results of a randomized, controlled trial evaluating the efficacy of NTZ in combination with peginterferon and ribavirin. Patients with genotype 4 from 2 Egyptian centers were randomized to receive NTZ monotherapy for 12 weeks followed by either peginterferon plus NTZ (dual therapy) or peginterferon plus ribavirin plus NTZ (triple therapy) for an additional 36 weeks; a control arm received standard dosing of peginterferon and ribavirin for 48 weeks. Rapid virologic response (RVR; undetectable HCV RNA at week 4 of combination therapy) was observed in 38% of the standard of care group, 54% of the dual therapy group, and 64% of the triple therapy group. Complete early virologic response (undetectable HCV RNA at 12 weeks of combination therapy) occurred in 70%, 68%, and 86%, respectively, and the SVR rates at 24 weeks posttreatment were 50%, 61%, and 79%. RVR and SVR rates were significantly higher in patients receiving triple therapy compared with the standard of care. Adverse events were equal among treatment groups except for more anemia noted with ribavirin use. The authors conclude that NTZ with peginterferon and ribavirin increases RVR and SVR rates compared with standard therapy without increasing adverse events.

[Marcia2202]

I think that the conclusion explains it

CONCLUSION: Nitazoxanide monotherapy is safe and effective in achieving sustained virological response in a modest number of patients with chronic hepatitis C genotype 4, particularly in patients with low baseline serum HCV RNA levels.

a modest number of patients.... that doesn't sound like very good odds to me

[Bali05]

Why do you think is this a waste of time ?
_____________________________________________________________________

Clinical trial: randomized, double-blind, placebo-controlled study of nitazoxanide monotherapy for the treatment of patients with chronic hepatitis C genotype 4.
Rossignol JF, Kabil SM, El-Gohary Y, Elfert A, Keeffe EB.
The Romark Institute for Medical Research, Tampa, FL, and Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.

BACKGROUND: Nitazoxanide, licensed in the US for treatment of Cryptosporidium parvum and Giardia lamblia, inhibits hepatitis C virus replication in replicon systems. AIM: To evaluate the safety and efficacy of nitazoxanide monotherapy for the treatment of chronic hepatitis C. METHODS: This multicentre, randomized, double-blind, placebo-controlled study randomized 50 adult patients with chronic hepatitis C genotype 4 at three centres in Egypt to nitazoxanide 500 mg tablet or placebo twice daily for 24 weeks. Patients were followed up every 4 weeks during treatment and for 24 weeks after therapy. RESULTS: Seven of 23 patients (30.4%) in the nitazoxanide group achieved undetectable serum HCV RNA compared to 0 of 24 in the placebo group during therapy (P = 0.004). Each of the seven responders had baseline HCV RNA levels < or =400 000 IU/mL. Six of the seven virological responders were followed up for 24 weeks after the end of treatment, and four patients (17.4% of 23 treated) had a sustained virological response. Adverse events were similar in the nitazoxanide and placebo groups.

CONCLUSION: Nitazoxanide monotherapy is safe and effective in achieving sustained virological response in a modest number of patients with chronic hepatitis C genotype 4, particularly in patients with low baseline serum HCV RNA levels.
____________________________________________________________________

[FloridaMouse]

I just got back from Shands at the University of Florida research and teaching hospital.  I am a 2 time relapser and discussed with them the possibility of using Alinia.  I was advised that they have recentlly decided that it does not work.  I believe this was at a conference in Copenhagen.

Mouse

[Bali05]

Genotype for 4 is not huge only 3%.There is no major interest in it like it is for 1 which is 70% of HCV infected in US.
Have you read the article about it in Gastroenetreology March 2009
or in PubMed about monotherapy ?
All of this pretains to type 4 and since the results were so strong there is now ongoing
the same trial in NYC for genotype 1
Do not think you will ever see a trial for type 4
in USA nobody interested in paying for it.Also  the big fanfare is on Telepravir again for type 1 (with more sides)
I spoke with a pharamacist at Romark about all this and he agrees that especially with low baseline viral load there is a chance of clearing the virus being type 4.

Here are some points that speak for Alinia for type 4

- no significant side effects ( same as placebo group in monotrial)
- does not make HCV virus resistant because it works by helping  the
  healthy liver cell combat the virus not by trying to attack HCV directly like Peg.
- once you do it you are still considered treatment naive for standard
- even if it has no effect alone it enhences standard treatment if you choose to follow
  with SVR up to 79% in 36wks not 48 like for standard alone.
- 23 % chance of clearing with monotherapy maybe better when starting with very   low  VL

The real question with all these treatments is how safe is it long term?
Considering all the other drugs and there safety issues I would say Alinia
has been prescribed to millions even kids of short term and has been
prescribed to HIV + people for long term with no major sides.

Why not give something a shot that can work with little to no side effects
see where it leads and than you can still follow with standard treatment

Is there a fibroscan in NYC ?

[gauf]

No, It must be used as an adjunct to standard care.  Don't waste the time or expense.

[nygirl7]

I don't think anybody would advise you to do an Alinia monotherapy in hopes of clearing the virus completely.  A few people here did it with standard combo treatment but as a therapy of it's own.......not even for a geno 4. I know there was a lot of study about it but if it had worked it would be HUGE news by now as it's been a few years.