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Pegasys vs Peg-Intron

AASLD: HCV Outcomes Found Equivalent With Pegylated Interferons and Ribavirin

"BOSTON, Nov. 4 -- The pegylated interferons alpha-2a (Pegasys) and alpha-2b (PegIntron) are comparably effective and safe in combination with ribavirin (Rebetol) for hepatitis C viral infection, reported investigators here.
Action Points

    * Explain to patients who ask that this study found pegylated interferon in combination with weight-based dosing of ribavirin is effective at controlling or clearing hepatitis C viral infections.

    * Explain that untreated HCV infections can lead to fibrosis, cirrhosis, liver failure and the need for transplant.

    * This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

Although there are no results from head-to-head trials pitting the two pegylagted interferons against each other in combination with ribavirin, a retrospective review showed them similar in efficacy in all patients with HCV infections, reported Ihab Hammoud, M.D., of the Henry Ford Hospital in Detroit, and colleagues.

There were also no significant differences in outcomes or in safety parameters among patients with HCV genotype 1, including those with a high viral load, the investigators reported at the American Association for the Study of Liver Diseases meeting.

The authors looked at all treatment naïve patients with HCV treated with a pegylated interferon and weight-based dose ribavirin at their center from 2001 through 2005. Patients with HCV and HIV or HBV co-infection and those who were on dialysis were excluded from the analysis.

"This was a relatively difficult to treat population," said Dr. Hammoud in an interview. "We had 40% African-American patients, 74% of patients had genotype 1 and 60% had a high viral load, but still we found no real differences between pegylated interferon alpha-2a or pegylated interferon alpha-2b when given with ribavirin with weight-based dosing."

Patients with the more treatment-refractory HCV genotype 1 received peginterferon 2a or 2b and weight-based dose ribavirin for 48 weeks. Patients with HCV genotype 2 or 3 received treatment for either 24 or 48 weeks.

The patients were evaluated for sustained viral responses at 24 weeks with polymerase chain reaction testing for HCV RNA.

A total of 259 patients were included in the analysis, 212 them receiving peginterferon alfa-2b and ribavirin and 47 given peginterferon alfa-2a with ribavirin.

There were no significant differences between the groups in gender, percentage of African-American patients, frequency of HCV genotype, HCV genotype with high viral load, percentage of patients weighing more than 105 kg (231 pounds) or ribavirin dosing.

In addition, on-treatment dose reductions of either peginterferon or ribavirin were similar for the two groups, at 8% for patients on peginterferon-2b and 2% for those on peginterferon-2a (P=NS).

The overall sustained viral response among patients in the 2b group was 38%, and in the 2a groups was 40% (P=NS). Among the patients with genotype 1, the sustained viral response was 23% for patients on 2b, and 26% for patients on 2a (P=NS).

Among patients with genotype 1 and a high viral load, the sustained viral response was 20% for patients on 2b, and 30% for patients on 2a (P=NS), and for those genotype 1 patients who weighed more than 105 kg, the SVR rates were nearly identical, at 20.7% and 20%, respectively (P=NS).

Safety parameters were also similar between the groups, Dr. Hammoud said.

He noted that the study was neither randomized nor controlled, and that the number of patients treated with peginterferon-2b was greater than that of patients treated with peginterfron-2a. The randomized IDEAL trial, conducted by Schering-Plough, maker of PegIntron, compared the two drugs head-to-head. Results are expected later this year or early in 2008."

What struck me was that there was no difference in patients weighing 230+ pounds. I only recently conceded that overweight patients would do better with Peg-Intron than with Pegasys but this study seems to suggest that is not the case. What's your take Jim - am I missing something here?

Mike
15 Responses
223152 tn?1346981971
I think the reason there was no difference between Pegysys and Peg-Intron for patients over 230 is because they did not use weight- based dosing.  My assumption here is that the Peg_intron patients just took the standard dose.  Maybe I am wrong.

Thanks for posting this.
Kathy
Avatar universal
""This was a relatively difficult to treat population," said Dr. Hammoud in an interview. "We had 40% African-American patients, 74% of patients had genotype 1 and 60% had a high viral load, but still we found no real differences between pegylated interferon alpha-2a or pegylated interferon alpha-2b when given with ribavirin with weight-based dosing."

It seems that weight based ribavirin was at play - unless I am confused again.

How have you been lately? I hope your happy and healthy. Mike
Avatar universal
I only recently conceded that overweight patients would do better with Peg-Intron than with Pegasys but this study seems to suggest that is not the case. What's your take Jim - am I missing something here?
---------------------------------------------------
Maybe you conceded too soon. LOL.

But seriously,  as you probably know, many of the top docs seem to have their 'favorite' pegs -- with various reasons, including the one I was given -- none of which were supported by trials and so admitted by the doctors. In my case, I was actually told I might do better on Pegasys, because I was on the lighter side (176 pre-tx) and not sure lighter folks are broken down in this particular study. It also seems intuitive (to me at least) that a 100 pound woman taking 180 peg might do better than a 230 lb man taking 180 peg per week -- given, for example, the double-dose studies, etc. Other than that, really have no other thoughts but thanks for posting.

-- Jim
Avatar universal
It may sound intuitive but my experience is that intuition isn't always correct. When you and I were discussing this a few months ago I did find support for the proposition that Peg-Intron was a better choice for overweight (obese patients) but this seems to contradict that. The only thing that sticks out here is that a significant majority of patients were treated with 2b - 212 while only 47were treated with 2a. If you discount that Pegasys looks as good or better all the way around. The authors also said that the dose reduction between the 2 groups was not significant but 2% vs 8% seems so to me.
Mike
Avatar universal
We'd probably have to look at full-text of both studies to resolve this, and even then, not unusual for studies to differ in conclusions. Perhaps I used the wrong word "intutitive" because I was really basing my view somewhat on the double-dose studies which suggest better results with more peg. I also think 2% and 8% seem significant, but again that might be explained more in the full-text.

-- Jim
Avatar universal
Dr. Cecil seems to think the Pegasus has less side effects. He was the one who convinced me to treat. But I only found out that he preferred Pegasus after I had already started with Peg-Intron because it's weight based. I lost 17 lbs. and was able to cut out one Riba capsule toward the end of tx when I was getting really tired of it all.
Avatar universal
my doc,robert levine, at upstate medical-affiliated w syracuse univ. was just begining a study comparing peg&pegasys when i trx'd.....i was not part of this and he prefers peg-intron.....i am not impressed with svr rates from either arm of this study!...we here seem to be experiencing much higher sucess rates,yes?
Avatar universal
My treatment doctor prefers Pegasys (he runs Pegasys trials) and one of my primary consulting docs prefers Peg Intron (he runs Peg Intron trials). I also sense some bias in attitudes on the new PI's with those involved in the trials being more optimistic toward a particular PI and those not involved being less optimistic and perhaps more optimistic toward a PI they are trialing. The 'human nature' factor is always there, be it a doctor or not. Just some early Thursday morning musings :)
Avatar universal
My experience was that Pegasys was by far and away easier to tolerate than was Peg-Intron and I took a bigger dose of ribavirin with Pegasys than I did with Peg-Intron. I treated with Peg-Intron on my second try and I cleared late probably around week 24. I knew that I shouldn't stop at week 53 but I was so beat up I just threw in the towel and prayed. I relapsed is less than 3 weeks and started on Pegasys 5 weeks later. I treated for 73 weeks with full dose ribavirin (1000 mg) whereas I had been treating previously with 800 mg. I could have gone more than 73 weeks because it was so much easier on me. I simply felt that I had treated long enough so I stopped but not because I felt so badly like I did with Peg-Intron. That just my experience but I have spoken with a lot of people who treated with both and feel the same way. Mike
Avatar universal
Not at all saying your theories are wrong regarding insufficient riba dosing as being the primary factor for your first two relapses -- but have you considered that re-treatment itself (i.e. more interferon piled on intereferon piled on more interferon) could have made the difference?

In other words, that the first attempt(s) more or less started the process that the last attempt finally finished off? I've had this thought for some time now, regarding re-treatment in general, based not only on anecdotal stories here, but on a couple of the short-course trials for geno 2's, where the re-treatment groups did unexpectedly well. I'm referring to relapsers here, not to non-responders.

In re-treatment scenarios, credit is often given to the last protocol (the one that worked) but maybe it's more complicated than that. Just some more musings.

-- Jim
Avatar universal
I have considered that possibility but I seriously doubt that was the deciding issue. For one thing, when I stopped my second try at 53 weeks I was undetectable <5 IU/ml. Within 3 weeks my VL was 8.65 million IU/ml and the highest VL I had  previously was 2.75 million IU/ml. Though this might not be considered as significant it does seem to imply that replication was not significantly controlled. I also treated the fist time with 3x weekly doses of 3 MU regular interferon for 52 weeks with 600 mg ribavirin and never cleared. I think it was either the ribavirin or the extended treatment or both. I don't think the kinetics of Pegasys played but the side effect profile did make it possible to extend so in that context the 2a may have played a role too. Mike
223152 tn?1346981971
Thanks for pointing out that the study did use weight based Peg-Intron.  That really gives me pause too.  It makes me wonder whether induction therapy (doubling the interferon to start) is helpful.

Thanks for asking about me.  I am fine.  Talked to the surgeon yesterday about upping my biopsy to next month instead of waiting until next April which is the month before I see the hepatologist.  I have a call into her office to get orders.  He (my surgeon) thinks I am a little obsessive compulsive because I want another one (since the first one was 1/1) but, heck, he'll take my money anyway.

I think I am leaning towards not treating again. My liver enzymes are in the 20s and everything else is well. Last viral load done was 880,000 IU/mL (not that that means much).  I told the surgeon that I thought I put the medical profession at risk, carrying this virus and he said that was the risk they take.  He said he never checks to see if the patient has hep C.  You take the standard precautions and that is that.  I don't think all the profession looks at it that way, though.
Kathy
Avatar universal
In my case I did the PegIntron for 8 weeks in 2002, and only got one log drop.
Dr said it was not working and stopped.

Right now after 4 weeks on Pegasys (new dr) I got 2 log drops in half the time.
So looks like for me, Pegasys is better.
Avatar universal
I was listening to an audio presentation from Liver Convention and I seem to recall that there was no benefit associated with induction dosing of interferon. I could be wrong and I don't have time to check but it's available on the Clinical Care Options Site if you have the time to listen. I believe it was Afdhal speaking but I could be wrong.
It sounds like you're doing well. I'm might be one of the few who believe that in the absence of cirrhosis low LFTs are a good thing to see and a good predictor.
I generally think biopsies are a valuable tool even if just to allay anxiety so I wouldn't argue against you having one. Hey, the more the merrier. Just eat Chinese food afterwards and I think you'll be fine.
Good Luck, Mike
Avatar universal
Kathy, there was a study done recently and it proved that "Italian food" was actually better than Chinese after a bx. As a matter of fact the Chinese food study didn't show good results at all. I wish people would post studies before making statements. I'll post the "Italian food" study later when I get a minute.
Good luck,
MO
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