albuferon

[chuckles333]

Is albuferon on the threshold of approval?
What is the expected rate of SVR for persons using albuferon instead of
pegylated interferon in treatment with Ribavirin?
Would albuferon with ribivirin and a protease inhibitor show promise for
type 1 patients?

[Lady Lauri]

Here is a report on Phase 3 study.

http://www.medicalnewstoday.com/articles/141599.php

[Lady Lauri]

I was in the albumin interferon study, but drew SOC (not the albumin) and got SVR, but being a Geno 2. Here's the report of the study after Phase 2, showing promise for even non responders with Geno 1.
Note: I was in Phase 3 study, and can't find the report on that yet. I believe the 1200 bi-weekly dosing was stopped, dropped to 900 due to serious pulminary issues. I was given 3 full pulminary testings through out trial and wasn't even on the trial drug.
In the reasoning of dose's every 2 wks, versus 4 wks. .....many get sicker on/after 'shot day', miss work, etc. This would surely be a better way to go. We 'forget' many things on tx ;). I had posty notes every where and one on my mirror to note my Riba every dose, so I don't think thats a concern versus less time sick, dosing.

Also, Don't quote me, but I heard they dropped, or intend to drop, the 4 wks, dosing. And I believe it should be approved by 2010.

http://www.medicalnewstoday.com/articles/55502.php

Also, another report on it below. Interesting that SVR had a higher rate in the 900mg group as opposed to the 1200 mg group!

Albumin Interferon (Albuferon) Administered Once Every 2-4 Weeks May Be As Effective as Once-weekly Pegylated Interferon
By Liz Highleyman

Albumin interferon (Albuferon) is a recombinant formulation of interferon alfa-2b genetically fused to the human blood protein albumin, which enables it to last longer in the body. Researchers have studied albumin interferon for the treatment of chronic hepatitis C in an effort to develop a therapy that can be administered less often -- and hopefully cause fewer side effects -- than conventional or pegylated interferon.

As reported in the August 2008 issue of Hepatology, Stephen Zeuzem and an international team of colleagues conducted an open-label Phase 2 study in which 458 treatment-naive patients with genotype 1 chronic hepatitis C were randomly assigned to receive either standard therapy with 180 mcg once-weekly pegylated interferon alfa-2a (Pegasys) or else albumin interferon alfa-2b at doses of 900 or 1200 mcg once every 2 weeks or 1200 mcg once every 4 weeks for 48 weeks. All participants also received 1000-1200 mg/day weight-based ribavirin.

Results

• In an intent-to-treat analysis, sustained virological response (SVR) rates were as follows:


• o 58.5% with albumin interferon 900 mcg once every 2 weeks;

• 55.5% with albumin interferon 1200 mcg once every 2 weeks;

• 50.9% with albumin interferon 1200 mcg once every 4 weeks;

• 57.9% with pegylated interferon (P = 0.64 for overall test).

• Rates of discontinuation due to adverse events were 9.3%, 18.2%, and 12.1%, respectively, in the albumin interferon arms, compared with 6.1% in the pegylated interferon group (P = 0.04).

• Dose reductions due to hematological toxicity were lowest in the albumin interferon once every 4 week arm, and comparable across the other groups.

• At week 12, participants receiving 900 mcg albumin interferon once every 2 weeks missed significantly fewer days of work due to treatment-associated adverse events compared with those taking pegylated interferon (1.1 vs 4.3 days; P = 0.006).


Based on these findings, the study authors concluded, "Albumin interferon administered [once every 2 weeks or once every 4 four weeks] may offer comparable efficacy, with an improved dosing schedule, compared with [pegylated interferon alfa-2a]."

[JennyPenny]

I am sorry. I am wrong about FDA approval for albuferon. It is still pending.

Focus groups have not found that cutting the injections in half matter to most patients. In fact it is believed that there would be more people forgetting to take the injection when there is a longer time between shots.

[Marcia2202]

If it has been approved, it must have been very recently. I'm not sure that it is even on the market, yet.

[chuckles333]

Let me get this straight. Why would we not cut our number of injections in half if we could? For type 1 patients, especially, this is huge 24 shots done every 2 instead of 48 done every week! Why is this not the standard of treatment instead of the pegylated interferon?

[JennyPenny]

Marcia is correct. And albuferon has been FDA apporoved.

[Marcia2202]

From what I understand the only difference between peg and albuferon is that the injection lasts 2 weeks instead of 1 week. So based on that, there is no difference in chances of SVR either.