Infergen - Better data

I'm considering Infergen and Riba as my next move (see below post below "Viral Breakthrough - Now What?").

The best data I've read about Infergen is a study of 137 nonresponders to PEG-INF alfa 2b + RBV.  All had a less than 2-log reduction at 12 weeks on this tx.  

They were retreated with Infergen 15mcg daily for 12 weeks then 15 mcg TIW for 36 weeks (in combination with 1000-1200 mg RBV).  

At beginning of Infergen/RBV tx:
1.) All were type 1's
2.) 32% African-American
3.) 72% HCV RNA >850,000 IU
4.) 29% cirrhosis
5.) Average fibrosis stage = 3.79 (on Ishak scale)
6.) Most were male
7.) Average age 49

37% of the nonresponders from the above study achieved SVR.

My personal stats seem better, which is my question.  I'm Caucasian, Stage 1 mild inflammation, low BMI.  Additionally I experienced nearly a 3-log reduction on PEG/RBV.

Does anyone have more granular data and statistics?  I'm looking for information about "what if" I don't start out cirrhotic, African-American, and did have a 3-log drop on Peg/RBV.

Also any information about Infergen sides would be appreciate.  This study states that 71% of patients preferred daily Infergen/RBV to PEG/RBV.  

I've been able to manage PEG-INF but with Infergen will I be walking around puking and not able to work?

[giddyup]

I'm on 15msg of infergen plus 1000 of ribba daily.My doc feels this is the best shot at svr.I did not get a 2 log drop on pegysus.
The study I'm in includes about 500 people. Half will get 9 mcg and the other 15 mcg.
My doctor feels that if you have less factors of poor response then in the study you mentioned, then the odds should improve!

The first 2 wks of sides are tough. now at week 20 it's not as bad. Alot like peg but peg gnawed away at me a little more.Let me know if you have other ?.good luck with your decision.

giddyup

[giddyup]

I'm a genotype 1a ,stage 4 (develping cirrohsis), male ,240 pds.

On pegysus my viral load of 2.2 million dropped to 100k at week 14.

On daily infergen the viral load dropped to 100k at wk 4.

It dropped to 20,000 at week 12.

My next test is at wk 24.

[miked]

Giddyup.  Thanks.

What's your stats?  1 a/b, age, VL, etc.  Also have you had a PCR since the beginning of Infergen tx?  

[TnHepGuy_]

Here are some pages with info on Infergen:

<a href="http://www.hivandhepatitis.com/hep_c/hepc_news_inter.html#infergen">As Monotherapy</a>

<a href="http://www.hivandhepatitis.com/hep_c/hepc_news_alter.html#act">Plus Actimune</a>

<a href="http://www.hivandhepatitis.com/hep_c/hepc_news_alter.html#weight">Plus Ribavirin</a>


TnHepGuy

[giddyup]

Sorry, the above post was to you not Magnum.

[miked]

Thanks for the info.  One last question.....how bad is bad for the first couple of weeks of Infergen?  Were you able to work?

[DoubleDose]

Many of the more HCV experienced docs will prescribe dosages that may not be entirely in-line with FDA standards, because in special cases they know it is necessary to adjust dosages according to unique history, and to the response.  I was able to do a 15 mcg. Infergen 2 times per day for two weeks only because I had a highly knowledgable doc, who knew a difficult case when he saw one!

The clinical trials are another thing entirely.  They are very regimented, restricted, and generally allow little or no flexibility whatsoever.  Having a personal treating physician, and doing a customized regimen is the best route for those who have proven to be 'difficult' responders.  Good luck on your next tx!!!!  You CAN clear this virus, and your past history indicates that you probably just need more horsepower!  Also do not forget the max. doses of Riba, which are very important in assuring the best chance at permanent eradication.  Get your doc prepared to do lots of Procrit if and when necessary.

I actually think the daily Infergen may be as easy to tolerate as the three times per week program...too much up and down with the 3X, and too much time for viral rebound in between.
Just my opinions of course.

DoubleDose

[miked]

At a high dose induction and continued high dosage my instincts tell me I will go undectable.  You and others have said that the doseage I'm on now with PEGIntron is sub-optimal.

It's good to hear that you were able to work through the duration of tx in Infergen.

How do these docs prescribe dosages higher than FDA and/or clinical trials allow? The DIRECT trial is either 15 mcg or 9mcg daily or nothing (with option to roll into tx after 6 months).

Thanks for the feedback.

[DoubleDose]

As I have discussed in previous posts, I did 15 mcg. Infergen daily, for about 5 months, and had no real problems.  I ran my business the entire time, and even did a minor aerobic workout at the gym from time to time.  As the Riba induced anemia got worse, I dropped the workouts, and eventually stopped the tx, even though I was undetected throughout the last 5 months.  If only they had used Procrit during tx six years ago, I probably would not have had to do a second round of tx.  

I don't thinks my sx on Infergen were worse than my high-dose Peg-Intron experiences for 18 months.  Again, I was able to work, except for the first two weeks, during which I was taking TWO shots per DAY of the 15 mcg. Infergen.  I cleared at the end of week #2 !!!!!  We did a PCR to see how effective the dosage was, and it was 'undetected'!

I think the key is to do an adequate dosage  (15 mcg. in your case)  and keep it at that level throughout tx!  This may mean DAILY Infergen for the duration, which is not the regimen your doctor is recommending.  I believe that reducing the frequency is often what causes either breakthrough or relapse for previous partial responders.  See how you feel after a few months of daily 15 mcg. and see if you doc will let you run it out on a daily basis, if you are handling the tx.

Of course all of this is predicated on your getting to undetected before week 24, and preferably before week 12 or so.
If it takes close to 24 weeks, then I am sure you are aware that extended dosing (18 months) will be your best bet...by FAR more effective than just going 48 weeks...

Keep us posted.

DoubleDose

[DonL]

Thanks all for the info. My question is relapsers. Infergen seems to be good for non-responders, but what about relapsers? I was undetectable at 12, 24, 48, so I respond well, but it seems to come back once I stop the meds.

[TnHepGuy_]

Here is a post by 'ificu1st' from lower thread regarding Infergen/Consensus:


C12 ificu1st
(12-Jan-05)  . I can't believe I finally found a site that hits home. I am a non-responder and the VA is starting me on the consensus interferon. Are the side effects as bad as the peg? I had a really rough time with the treatment the first time. A shot everyday? bejeezus. Another year? More of the same? It has been a year and a half since I finished treatment and my viral load is rising rapidly. Is all this worth it? I am so confused....Any comments?

[whoaisme]

Thanks for the infergen information. I talked to the doctor today and the chances of clearing on infergen are 43% and the chances of svr are 37% leaving a very low relapse rate on this study.

[whoaisme]

My husband Giddyup says: "I forgot to mention that I am 40 years old. I think you can do anything you want to do on infergen that you can do on pegylated."

[ificu1st]

great comments.  My biggest fear is that I will have to give up my job and quit school.  I am 45 years old and feel crunched for time.  I was diagnosed 4 years ago and so far am doing everything I am supposed to do but I am getting weary.  The consensus tx scares me because I had such a hard time with the peg.  I guess it all scares me.  I had to quit my last job because of fatigue, headaches, and depression, and that was before tx.
Would like to hear more input on the side effects of consensus if anyone has some.  
Thanks
TY