HEP C -- new tx approved last week!

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As some of you may know, I was dx'd with Hep C during my first semester of RN classes in 1999 and was inable to continue in school. I was treated with the 3x weekly interferon and ribaviron and was lucky to be among the 40% who sustained a viral response. At that time I attended conferences, support groups etc. and spent my 48 weeks on tx learning everything I could about this disease. The day my post tx (6 month) PCR showed undetectable, I enrolled in school again. I have tried to stay informed and very active in Hep C programs, though with school it has been difficult. Anyway, here are a few articles...

FDA Approval of Pegasys

Roche announced today, October 16th, 2002 that the U.S. Food and Drug Administration (FDA) has approved PegasysÒ (peginterferon alfa-2a) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated cirrhosis. Pegasys has already been approved for use in 50 countries, including all European Union countries.

About Pegasys

Pegasys is made when interferon alfa-2a undergoes the process of pegylation, in which one or more chains of polyethylene glycol, also known as PEG, are attached to another molecule. In Pegasys, a large, branched, mobile PEG is bound to the interferon alfa-2a molecule and provides a selectively protective barrier. Pharmacokinetic behavior (the way a drug is metabolized and acts within the body) of the end product depends on the length of the PEG and the nature of the link between the PEG and the protein. The high molecular weight (40 kilodalton) of branched PEG in Pegasys has been shown to provide sustained pegylated interferon alfa-2a exposure over the entire one-week dosing period.

Pegasys Effectiveness

Pegasys was granted approval based on the results of three pivotal Phase III clinical trials which demonstrated that it is an effective treatment for patients with chronic hepatitis C, including cirrhotic patients with compensated liver disease, versus treatment with Roferon-A® (interferon alfa-2a). Two of these pivotal trials were published in The New England Journal of Medicine. The sustained virological response rate in the Pegasys treated patients was as high as 38 percent in the overall population versus 19 percent in the interferon alfa-2a group. The sustained virological response in patients with cirrhosis treated with Pegasys was as high as 30 percent versus 8 percent in the interferon alfa-2a group. Higher sustained virological response results were also found in patients with genotype 1 (the most common genotype in the U.S. and most difficult to treat) compared to the interferon alfa-2a group. On Pegasys treatment, 23 percent, versus 6 percent on interferon alfa-2a, achieved a sustained virologic response - a fourfold increase in genotype 1 patients. Sustained virological response was defined as undetectable serum hepatitis C RNA levels 6 months post-treatment.

Pegasys Side Effects

The most common adverse events (side effects) reported for Pegasys, observed in clinical studies to date, were headache, fatigue, myalgia (muscle ache), pyrexia (feverish), rigors (stiffness), arthralgia (joint pain), nausea, alopecia (loss of hair), injection-site reaction, neutropenia (low white blood cells), insomnia, depression, anorexia (loss of appetite), and irritability. Other less common serious adverse events include bone marrow toxicity, cardiovascular disorders, hypersensitivity, endocrine disorders, pulmonary disorders, colitis, pancreatitis, and ophthalmologic disorders. The Pegasys phase III monotherapy trials showed a side effect profile very similar to standard interferon but with slightly less flu like symptoms and depression. The incidence of neutropenia, however, is higher with pegylated interferons, including Pegasys, than with standard interferons.

Predicting Response with Pegasys

Clinical trials of Pegasys have shown that patients can determine at 12 weeks if they are unlikely to attain a sustained virological response with Pegasys. Pegasys investigator, Donald Jensen, MD, director of Hepatology at Rush-Presbyterian-St. Luke's Medical Center, Chicago said, "With Pegasys, we can determine at week 12 of therapy those patients who are unlikely to achieve a sustained virological response to treatment. This reduces the cost and burden of taking therapy for patients who are unlikely to respond to therapy. This may help patients adhere to therapy that can be difficult on them, particularly during the first few months."

Roche Sample Program - Free Pegasys

Roche will be providing physicians with samples of Pegasys for the first 12 weeks of therapy. These samples will be provided at the request of a physician for the first 15,000 patients who are started on Pegasys therapy prior to December 31, 2002. Twelve weeks was selected because at that point physicians can predict those patients who will not respond to Pegasys therapy. Samples are available to all physicians.

According to a Roche company spokesperson this sample program is designed to help physicians gain experience with Pegasys, establish Pegasys' 12 week predictability marker, and alleviate fears around supply and demand issues. Additionally, approval of Pegasys/Copegus (Pegasys in combination with ribavirin) is anticipated by completion of the program. It was also stated by the company spokesperson that no patient data would be collected for marketing purposes, a practice that has been highly scrutinized by the HCV community in the past. Physicians will be responsible for applying for the sample drug and patients will be given a unique identification number without having to divulge any personal information. Details of Roche's patient drug assistance program as well as their patient support programs for Pegasys will be available shortly.

For more information about the programs, call 877-Pegasys. Please note that only physicians can order the free Pegasys sample drugs.

How is Pegasys Supplied?

Pegasys is expected to be available in pharmacies within two weeks. Pegasys is a premixed solution that is dosed at 180 µg for all patients regardless of body weight (except for patients on hemodialysis). In contrast PEG-Intron needs to be reconstituted and is dosed by body weight.

FDA Expedited Review - Pegasys Plus Ribavirin

The FDA has granted Pegasys in combination with Copegus® (Roche's ribavirin) priority review status, and a decision is expected by the end of 2002. The FDA grants priority review status to products which, if approved, are expected to offer a significant improvement over existing therapies in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.

It should be noted that Pegasys plus ribavirin has been widely studied in many difficult to treat patient populations, such as African Americans, HIV/HCV coinfected, transplant, end stage renal disease, cirrhotics, non-responders/relapsers, as well as naïve patients. Pegasys/ribavirin is also being studied in the NIH HALT-C maintenance trial designed to study histological improvement (improved liver health) in virologic non-responding cirrhotics who, at this time, have no further treatment options.

FDA Responsiveness to HCV Community

The FDA has recently become more responsive to the HCV community which has repeatedly asked for more open-forums to discuss treatment advances in hepatitis C. The first open-forum was a review of the Peg Intron/RBV data in 12/2001, and there is also scheduled a review of the Pegasys/Copegus data on 11/14/2002, which will be telecast for those that cannot attend. It should be noted that anyone can attend these forums, and, as a member of the HCV community, I would encourage HCV patient involvement in this and other advocacy efforts. The louder our voice the more we can accomplish as a group.

For more information about Pegasys:

Read the ADIS Drug Evaluation of Pegasys-click here

Product Information Guide (Roche) http://www.rocheusa.com/products/pegasys/pi.pdf

Medication Guide (Roche) http://www.rocheusa.com/products/pegasys/PEGASYS_MedGuide.pdf

Copyright - October 2002 - Hepatitis C Support Project - All Rights Reserved. Permission to reprint is granted and encouraged with credit to the Hepatitis C Support Project.

Visit our web site at http://www.hcvadvocate.org

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AND ANOTHER ANNOUNCEMENT:

NUTLEY, N.J. (October 16XX, 2002) - Roche announced today that the U.S. Food and Drug Administration (FDA) has approved PegasysÒ (peginterferon alfa-2a) for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated cirrhosis.

Pegasys is a pegylated interferon that remains active in the bloodstream longer and at a more constant level than interferon alpha. Currently, 2.7 million Americans are chronically infected with hepatitis C.

"The approval of Pegasys is an important milestone for the hepatitis C patients in the United States who are waiting for treatment," said George B. Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc. "Roche has supported Pegasys with the most extensive development program ever undertaken for a hepatitis C treatment. The result is that patients and physicians have an important new option for treatment."

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Pegasys was granted approval based on the results of three pivotal Phase III clinical trials that demonstrated it is an effective treatment for patients with chronic hepatitis C, including cirrhotic patients with compensated liver disease, versus treatment with Roferon-A® (interferon alfa-2a). Two of these pivotal trials were published in The New England Journal of Medicine.

The sustained virological response rate in the Pegasys treated patients was as high as 38 percent in the overall population versus 19 percent in the interferon alfa-2a group. The sustained virological response in patients with cirrhosis treated with Pegasys was as high as 30 percent versus 8 percent in the interferon alfa-2a group. Higher sustained virological response results were also found in patients with genotype 1, on Pegasys treatment (23 percent) versus interferon alfa-2a (6 percent), the most common type in the U.S. and most difficult to treat. Sustained virological response was defined as undetectable serum hepatitis C RNA levels post-treatment (on or after study week 68).

Clinical trials of Pegasys have shown that patients can determine at 12 weeks if they are unlikely to attain a sustained virological response with Pegasys.

Pegasys investigator, Donald Jensen, MD, director of Hepatology at Rush-Presbyterian-St. Luke's Medical Center, Chicago said, "With Pegasys, we can determine at week 12 of therapy those patients who are unlikely to achieve a sustained virological response to treatment. This reduces the cost and burden of taking therapy for patients who are unlikely to respond to therapy. This may help patients adhere to therapy that can be difficult on them, particularly during the first few months."

12-Week Sample Program for Up to 15,000 Patients

As part of Roche's commitment to treating patients with hepatitis C, Roche will be providing physicians with samples of Pegasys for the first 12 weeks of therapy. These samples

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will be provided at the request of a physician for the first 15,000 patients who are started n Pegasys therapy prior to December 31, 2002. Twelve weeks was selected because at that point physicians can predict those patients who will not respond to Pegasys therapy. Samples are available to all physicians.

Pegasys, available as a premixed solution, is expected to be in pharmacies within two weeks. Pegasys is dosed at 180 ?g as a subcutaneous injection once a week for a recommended duration of 48 weeks.

Pegasys is supported by the most extensive development program ever undertaken for a hepatitis C treatment. The FDA has granted Pegasys in combination with Copegus® (Roche ribavirin) priority review status, and a decision is expected by the end of 2002. The FDA grants priority review status to products that, if approved, are expected to offer a significant improvement over existing therapies in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.

About Pegasys

Pegasys has been studied in a variety of patient populations, including those with the most difficult to treat form of the disease - patients with genotype 1 and with cirrhosis (scarring of the liver).

Pegasys is made when interferon alfa-2a undergoes the process of pegylation in which one or more chains of polyethylene glycol, also known as PEG, are attached to another molecule.

In Pegasys, a large, branched, mobile PEG is bound to the interferon alfa-2a molecule and provides a selectively protective barrier. Pharmacokinetic behavior of the end product depends on the length of the PEG and the nature of the link between the PEG and the protein. The high

-more-

molecular weight (40 kilodalton) branched PEG in Pegasys has been shown to provide sustained

pegylated interferon alfa-2a exposure at clinically effective levels over the one-week dosing period.

In contrast, interferons with smaller PEGs are excreted more rapidly by the kidneys, requiring more frequent dosing, according to earlier Roche studies, using smaller PEGs developed by the company.

Pegasys has been approved for use in 50 countries, including all European Union countries.

Pegasys Adverse Events

Alpha interferons, including Pegasys, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping Pegasys therapy.

Pegasys is contraindicated in patients with hypersensitivity to Pegasys or any of its components, autoimmune hepatitis, and decompensated hepatic disease prior to or during treatment with Pegasys. Pegasys is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in neonates and infants which are sometimes fatal.

The most common adverse events reported for Pegasys, observed in clinical studies to date, were headache, fatigue, myalagia, pyrexia, rigors, arthralgia, nausea, alopecia, injection-site reaction, neutropenia, insomnia, depression, anorexia, and irritability.

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Other serious adverse events include bone marrow toxicity, cardiovascular disorders, hypersensitivity, endocrine disorders, pulmonary disorders, colitis, pancreatitis, and ophthalmologic disorders.

The complete package insert is available upon request.

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver, the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S., is transmitted through body fluids, primarily blood or blood products, and by sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people infected with hepatitis C are unaware of it because it may take years for symptoms to develop. Hepatitis C chronically infects an estimated 170 million people worldwide (three percent of the world's

population), with as many as 180,000 new cases occurring each year. It is estimated that less than 30 percent of all cases are diagnosed. If left untreated, hepatitis C can be fatal for some patients.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious

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diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.

For more information on the Roche pharmaceuticals business in the United States, visit the company's website at: http://www.rocheusa.com

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[renerian, BSN, RN]

Good for you that your back in school! So glad your feeling better!

renerian

[shudokan-RN]

I dc'd a 12 yr old from home health Weekly peg-intron inj, and po

rebitol 800 mg qd.... she tested neg for viral load after 4 months

I was thrilled for her

[Vsummer1]

Originally posted by renerian

Good for you that your back in school! So glad your feeling better!

renerian

Thank you for your kind thoughts. It was such a relief that I could go back. Of course, now I am wishing it was over because it is so hard (notice, never happy LOL).