Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Steroid-free regimen with CellCept found comparable to standard therapy in liver transplantation

24.05.2005


No increase found in hepatitis C recurrence



Researchers seeking to enhance transplant patient care with less toxic drug regimens presented early findings of a steroid-free treatment regimen in liver transplant recipients with hepatitis C. One-year data from an open label study reported Sunday at the American Transplant Congress (ATC) suggests that a steroid-free treatment regimen including CellCept® (mycophenolate mofetil) provided comparable efficacy and safety to a standard steroid-containing protocol. CellCept is approved for the prevention of organ rejection in combination with cyclosporine and corticosteroids in patients receiving kidney, heart and liver transplants.

Steroids have been a cornerstone of transplant therapy for the past 50 years. However, long-term steroid use has shown significant side effects, which can include bone and muscle problems, eye disease, delayed wound healing and decreased ability to fight infection. For patients with hepatitis C, steroids are widely recognized to have an adverse effect on virus replication, putting them at an increased risk for hepatitis C recurrence following liver transplantation.


"The question has always been: how do we achieve the right balance of immunosuppression to prevent acute rejection without over-suppressing the immune system, which would allow hepatitis C virus to rapidly replicate?" said Goran Klintmalm, M.D., principal investigator, who is Chief and Chairman of the Baylor Regional Transplant Institute, Baylor University Medical Center, Dallas. "In our study, the steroid-free CellCept regimen demonstrated comparable efficacy, without increasing the risk of hepatitis C recurrence. We are encouraged by these trends at one year."

Study Background and Results (1)

A total of 312 adult hepatitis C liver transplant patients participated in the open-label, prospective multicenter study. Patients were randomized to one of three treatment regimens: tacrolimus and prednisone (arm one); CellCept, tacrolimus and prednisone (arm two); or CellCept, tacrolimus, and three-dose Zenapax® (daclizumab) without steroids (arm three). Primary endpoints in the study were clinically significant differences in acute cellular rejection (ACR) and/or clinically significant differences in hepatitis C recurrence. Acute rejection rates were 16%, 9% and 5% in the three arms, respectively.

A total of 151 patients had one-year follow-up data available for the preliminary analysis presented at ATC. Study results found that hepatitis C recurrence was comparable across all arms. Additionally, the CellCept-based steroid-free regimen was comparable to the standard steroid-containing regimens in organ survival, patient survival and incidence of adverse events (infections, malignancies, hyperlipidemia and diabetes).

Additional Study Underway

"With transplant physicians around the world using CellCept for more than a decade to prevent organ rejection in their transplant patients, Roche is looking to the future," said Robert Gordon, M.D., senior medical director at Roche and a former transplant surgeon. "We’re evaluating new, low-toxicity regimens with CellCept that we hope will further improve patient outcomes."

Roche recently initiated the Liver Spare the Nephron (STN) study, a prospective, open-label randomized trial to evaluate low toxicity regimens including CellCept. The study will take place in more than 35 transplant centers in the U.S. and Canada. The study, which will recruit 340 liver transplant recipients, is designed to evaluate the efficacy and safety of a regimen of CellCept with either sirolimus or standard calcineurin inhibitors (CNI). Investigators will evaluate the effect of these regimens on preservation of renal function and prevention of acute rejection, organ loss and patient survival.

CellCept – A Cornerstone of Treatment for 10 Years

CellCept is an immunosuppressant or anti-rejection drug approved for use in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving kidney, heart and liver transplants. Ten years after its approval by the FDA, CellCept is the most frequently used branded immunosuppressant in the United States with more than four million prescriptions filled. CellCept received FDA approval for the prevention of organ rejection in transplanted kidneys in 1995, in hearts in 1998 and in livers in 2000.

The FDA approved dosages for CellCept are: for adult kidney transplants, 2 g daily; for pediatric kidney transplants, oral suspension 600 mg/m2; for adult heart and liver, 3 g/day.

Additional CellCept Information

There are no adequate and well-controlled studies in pregnant women. As CellCept (mycophenolate mofetil) has been shown to have teratogenic effects in animals at subclinical doses on a body surface area basis, it may cause fetal harm when administered to a pregnant woman. CellCept should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within one week prior to beginning therapy even where there has been a history of infertility, unless due to hysterectomy.

Women of childbearing potential must use effective contraception before beginning CellCept therapy, during therapy and for six weeks following discontinuation of therapy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy occurs during treatment, the physician and patient should discuss the desirability of continuing the pregnancy (see complete product information).

Adverse events reported in >30% of renal, cardiac or liver transplant patients receiving CellCept (in combination with cyclosporine and corticosteroids) were pain, fever, headache, asthenia, anemia, leukopenia , thrombocytopenia, leukocytosis, urinary tract infection, hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough increased, hypomagnesemia, diarrhea, constipation, nausea, vomiting, respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and insomnia.

Patients receiving immunosuppressant regimens are at increased risk of developing lymphomas and other malignancies, particularly of the skin.

Warning: Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. For full prescribing information, visit www.rocheusa.com/products/cellcept/pi.html.

About Roche – More Than a Century in the U.S. and the World

Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world’s leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.

Roche’s U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine’s list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche’s Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche’s Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories worldwide.

(1) Fasola CG, Klintmalm GB, et al. Abstract #475: "Multicenter Randomized Hepatitis C (HCV) Three Trial Post-Liver Transplantation (OLT): A One-Year Follow-Up Report."

(2) Patients should be monitored for neutropenia. Dosing should be interrupted or the dose reduced if neutropenia develops.

: Adam Pawluk | EurekAlert!
Further information:
http://www.ketchum.com
http://www.roche.com
http://www.roche.us

More articles from Life Sciences:

nachricht A Map of the Cell’s Power Station
18.08.2017 | Albert-Ludwigs-Universität Freiburg im Breisgau

nachricht On the way to developing a new active ingredient against chronic infections
18.08.2017 | Deutsches Zentrum für Infektionsforschung

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Fizzy soda water could be key to clean manufacture of flat wonder material: Graphene

Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.

As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...

Im Focus: Exotic quantum states made from light: Physicists create optical “wells” for a super-photon

Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.

Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...

Im Focus: Circular RNA linked to brain function

For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.

While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...

Im Focus: RAVAN CubeSat measures Earth's outgoing energy

An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.

The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...

Im Focus: Scientists shine new light on the “other high temperature superconductor”

A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.

Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Call for Papers – ICNFT 2018, 5th International Conference on New Forming Technology

16.08.2017 | Event News

Sustainability is the business model of tomorrow

04.08.2017 | Event News

Clash of Realities 2017: Registration now open. International Conference at TH Köln

26.07.2017 | Event News

 
Latest News

A Map of the Cell’s Power Station

18.08.2017 | Life Sciences

Engineering team images tiny quasicrystals as they form

18.08.2017 | Physics and Astronomy

Researchers printed graphene-like materials with inkjet

18.08.2017 | Materials Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>