EU approves 16 week Tx for G2s and G3s

[CockSparrow]

Came across this on another forum. Might help with Tx duration for G2s and G3s.
Be careful if shortening Tx as unless you have LVL this isn’t for you.
Also LVL may well be different for G2s vs G3s 800K v 400K
The results NCore study will be interesting.

http://uk.reuters.com/article/rbssHealthcareNews/idUKL2631306720080626

UPDATE 1-EU clears shorter course of Roche hepatitis C drug
Thu Jun 26, 2008 7:53am BST

ZURICH, June 26 (Reuters) - Roche Holding AG said on Thursday it had received European Union approval for a shortened treatment course for Pegasys in combination with Copegus for certain hepatitis C patients.

The 16-week course will be available for patients with genotype 2 or 3 strains of chronic hepatitis C who have low virus levels before starting treatment and show rapid virological response, the Basel-based drug maker said.

The altered course of treatments is part of Roche's new response-guided therapy, which seeks to customise regimens based on how well patients respond to therapy.

Roche also announced the start of NCORE study to determine the best treatment time for patients who do not experience a rapid response

CS

[Lady Lauri]

Good thread, good points, good questions.
I also feel VL should be checked at LEAST weeks 2, 4, 6 and would like to see week 1,2, 3, 4. In my trial I was at weeks 2, 4, 6, 8 than 12 on on. We knew I dropped a lot by week 2, UND week 4, etc. I absolutley hate seeing people post in week 15..."UND week 15" and no VL at weeks 4, etc.!

Getting side tracked but good thread, good info. as always CS. Even when I get lost in the med. lingo I brief to get the point of it all :)

LL

[Marcia2202]

No, there was NO sarcasm at all. I really meant it... They should have seriously thought of that when they did the study. It would have definitely kept us from guessing.... and them too.

Marcia

[CockSparrow]

Its thought that when you are HVL more Hepatocytes are infected thus making it harder to eliminate all the little buggers.

Marcia
You may have been a liitle sarcastic with maybe they should have had the PCR at 1,2, 3 and 4 weeks. But thats what i want to do. Get a nice picture of the viral kinetics then.

I would also be reluctant to shorten if I had low platelets or high BMI
CS

[mar148]

I think they are being very safe in reducing it for a smaller group of patients that have the highest success rate.  For any group 4 week RVR is extremely good, but the relapse is higher for HVL patients.  So I think it is a conscientious and cautious approach.

[Marcia2202]

Oh, I get it....

Yes, that doesn't really make sense. maybe they should have had the PCR at 1,2, 3 and 4 weeks. That would have solved the guessing problem.

Marcia

[R Glass]

The study makes it clear; the 16-week treatment is for G2 & G3 that are LVL and RVR. It is evident that they came to this conclusion by testing both High and Low VL.

I would just like to know how or why VL makes a difference if both are RVR at 4 weeks (maybe see some Stats).
I see it like this, someone has 2 cups. One is full and the other is half full. You come back one hour later and both cups are empty. The amount that was in each cup doesn’t matter. They are both empty.

My only guess is that people starting with LVL may reach RVR in the in the first few days of tx This would give them about a 3 week jump ahead of those that have high VL and are RVR at 4 weeks.

[Marcia2202]

What I have understood is, that from the outcome of the studies they learned that high viral loads should NOT treat for 16 weeks. LVL UND by week 4 can go ahead with 16 weeks... The study showed that there was too much difference of SVR between the 16 w group and the 24 w group in VL above 400K, hence they do not recommend ppl with HVL to do 16 weeks.

[R Glass]

I am confused about the LVL. It seems to that if you are RVR, your previous VL should be irrelevant. I interpret Undetected means Undetected. Does anyone have an explanation?

[Marcia2202]

Thanks for the explanation. I agree that the outcome of the NCORE study will be maybe even more interesting. Together with this study it will finally give an overall picture of geno 2 vs 3. Unfortunately I will most probably have finished treatment when the results get published.

I am quite spaced out today... It's really up and down. It really is weird how one can be so clear in the head one moment and wham... feeling really stupid the next. And this is plain HCV and not TX.

Now I remember, I printed out the 20 something pages of the ACCELERATE study two days ago and put them in my yellow folder, I was going to sit down and read the whole thing over and over again.

marcia

[CockSparrow]

Hi Marcia
Accelerate has a VL breakdown for RVRs
G3s less than 400K had similar response with 16 and 24 weeks
G3s over 400K had a big difference in svr rates with 16 and 24 weeks

G2s reduced svr rate didnt really start until over 800K

So for G3s 400K is the HVL cutoff.
being between 400 and 800k has a higher svr rate than over 800K

Its the NCORE study i want to see the results for. However 400 people doesnt sound enough to me.

CS

[Marcia2202]

Thank you for your warning in the beginning of your post.

Could you please elaborate what you mean with difference in VL being low for the different genotypes. I am genotype 3 and was told that my VL being 580.000 is considered high.

Where can I find the info on this matter.

Thanks, Marcia

Sorry I posted the same 'news' as you. had just come across it on hepctrust.org.uk and hadn't seen your post.

[R Glass]

I am 2b (hopefully was 2b) and was RVR
I find this interesting because, I saw my Gastro. At week 17. It was to the point that I couldn’t function at work anymore and quitting work was not an option. I told him, since I already purchased the meds, I would try to make it to week 20.
His reaction is what I found puzzling. He told me, there are studies going on and in the near future, the treatment time for Gen.2 that are RVRs may be reduced. As for now, the standard tx is 24 weeks. I could tell there was more he would like to say but couldn’t.
He prescribed Elevil and Ambian and I was able to complete the 24 weeks (barely).
I also found some of the studies were “misleading” because you had to read them close to find the results of Gen.2 that were RVR.

[CockSparrow]

Heres another that discusses the same thing. Along with more details on the NCORE Study.
http://www.itnews.it/news/2008/0626080601757/european-approval-for-roche-s-pegasys-personalises-treatment-for-a-subgroup-of-hepatitis-c-patients-chance-for-cure-with-only-four-months-of-treatment.html

EUROPEAN APPROVAL FOR ROCHE'S PEGASYS PERSONALISES TREATMENT FOR A SUBGROUP OF HEPATITIS C PATIENTS: CHANCE FOR CURE WITH ONLY FOUR MONTHS OF TREATMENT

BASEL, Switzerland, June 26 /PRNewswire/ --
- Roche Also Announces Start of NCORE Study to Determine Best Length of Treatment in Patients who do not Experience a Rapid Response

Roche announced today that the European Commission has approved a shortened, 16-week course of treatment with Pegasys (peginterferon alfa-2a (40 KD)) plus Copegus (ribavirin) for certain hepatitis C patients.

The four-month treatment course will be for patients with particular strains of chronic hepatitis C (genotype 2 or 3) who have low virus levels before starting treatment, and who show a rapid virological response by clearing the virus from the blood within the first 4 weeks of treatment. This shorter treatment duration with Pegasys/Copegus will provide patients with the full benefits of therapy while reducing unnecessary drug exposure.

This is good news for eligible patients as previously, all patients with genotype 2 or 3 hepatitis C (HCV) received 24 weeks of Pegasys/Copegus therapy, regardless of their baseline virus levels and response while on treatment.

The approval marks an important milestone in a new treatment concept in hepatitis C, which is called "response-guided therapy" and seeks to customise regimens for patients based on how well they respond to treatment. Response-guided therapy is enabled by the use of Roche's highly sensitive, real-time PCR diagnostic tests, which accurately measure the levels of virus in the patient's blood. The automated COBAS AmpliPrep/COBAS TaqMan HCV Test is the newest and most advanced Roche product for measuring hepatitis C virus levels. The test is widely used in many global markets, and is pending FDA approval in the United States.

"Response-guided therapy in hepatitis C is an excellent example of how Roche is uniquely positioned to individualise healthcare and deliver real benefit to patients, physicians and healthcare payers by combining the power of innovative pharmaceuticals and diagnostics," said William M. Burns, CEO, Roche Pharmaceuticals Division. "This approval for 16 weeks of treatment in genotype 2 and 3 patients with a rapid response demonstrates the value of using diagnostic tools to determine an individual treatment regimen and hopefully will encourage more eligible patients to come forward for treatment. Together with the start of yet another large clinical study with Pegasys, NCORE, these initiatives underscore Roche's commitment to advancing the treatment of hepatitis and making personalised medicine a reality."

Shortening the Treatment Duration for Many
This approval is based on data from several studies that show shorter treatment duration in patients who have a rapid response to Pegasys/Copegus results in high cure rates, similar to those achieved with the currently-approved 24 weeks of therapy. (1-4) An analysis of a major study (ACCELERATE) which evaluated the efficacy and safety of 16 weeks vs. 24 weeks of treatment with Pegasys/Copegus in patients with genotype 2 or 3 HCV -- showed that a similar number of patients achieved a cure (82% versus 90% respectively). In patients with low virus levels before treatment and a rapid virological response (undetectable virus 4 weeks after starting treatment), the cure rates for 16 and 24 weeks of treatment were essentially identical (89% vs. 94%).(5)
"This EU approval is important, as it means that we can tailor a patient's treatment with Pegasys based on an early marker of response without a loss in the regimen's effectiveness," said Prof Stefan Zeuzem, Chief of the Department of Medicine I at the Johann-Wolfgang Goethe University Hospital in Frankfurt, Germany. "This is good news for doctors, who now have the reassurance of offering a shorter treatment regimen, and for patients themselves, who will have the possibility to be cured with only 16 weeks of treatment."
NCORE Study Commenced to Determine If Genotype 2/3 Patients Without a Rapid Virological Response Need Longer Treatment

Roche also announced the launch of the NCORE study (ENhancement of Cure Through Treatment Extension Guided by On-Treatment ResponsE in Patients Infected with G2/3 Hepatitis C; Roche study protocol number MV21371). The study aims to further improve treatment outcomes by examining whether genotype 2 and 3 patients who do not have a rapid virological response at 4 weeks should have treatment with Pegasys and Copegus extended to 48 weeks.(6) This global study will enrol approximately 400 patients at 90 centres in seven countries.

About Hepatitis C
The hepatitis C virus (HCV) is transmitted primarily through blood or blood products. HCV chronically affects 180 million people worldwide, which makes it over four times more prevalent than HIV.(7), (8) It is a leading cause of cirrhosis, liver cancer and liver failure, despite the fact that many patients can be cured.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people.
Additional information is available on the Internet at http:///www.roche.com .

CS