Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Experimental drug suppresses rebound of hepatitis C virus in liver transplant patients

08.11.2011
Next step will combine monoclonal antibody with antiviral drugs

A human monoclonal antibody developed by MassBiologics of the University of Massachusetts Medical School (UMMS) given to patients with chronic hepatitis C virus (HCV) infection undergoing liver transplantation significantly suppressed the virus for at least a week after transplant and delayed the time to viral rebound. Results from a randomized, double-blind, placebo-controlled, phase 2 study were presented this week at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases, in San Francisco.

"The challenge for patients with end-stage liver disease from HCV is that a transplant is not a cure. Because the virus remains in the blood stream, the new liver eventually becomes infected with the hepatitis C virus," said Deborah C. Molrine, MD, deputy director of clinical and regulatory affairs at MassBiologics. "These results show that a human monoclonal antibody targeting the hepatitis C virus can significantly reduce viral loads in infected patients who receive donor livers and moves us one step closer to clearing the virus so the new liver doesn't become chronically infected."

Five hospitals enrolled patients in the trial —Massachusetts General Hospital, Beth Israel Deaconess Medical Center, both in Boston, Lahey Clinic in Burlington, Massachusetts, Yale-New Haven Hospital in Connecticut and Mount Sinai Hospital in New York City. Patients enrolled in the study were treated with a total of 11 intravenous infusions of either the human monoclonal antibody, designated MBL-HCV1, prior to, during, and after surgery or a placebo (salt solution). The first three infusions were administered on the day of transplantation followed by a daily infusion in the first week following surgery and a final infusion 14 days after transplant. Of the 11 patients enrolled in the first part of the trial, six received the MBL-HCV1 antibody. "The commitment of the transplant team at each site working with study investigators ensured the delivery of the multiple infusions according to schedule and all infusions were well tolerated by the patients. The infusions did not add to any patient's length of stay in the hospital." said Fredric Gordon, MD, medical director of liver transplantation at Lahey Clinic Medical Center.

The group of patients who received the monoclonal antibody had a significantly greater reduction in viral load from pre-transplant levels at days three through six post-transplant compared to patients who received the placebo. One patient's viral load dropped below the detection limit starting at day two after transplant and didn't have a viral rebound until day 35.

"Because the HCV virus is prone to mutations, patients develop variants of the virus that can escape from the effect of a single type of treatment," said Molrine. "In the next phase of the study, we plan to combine the monoclonal antibody with another HCV antiviral agent to see if the activity of two drugs against the virus results in further suppression, if not clearance, of the virus."

HCV damages the liver and is the leading indication for liver transplantation, diagnosed in about half of the 6,000 patients who receive liver transplants each year in the United States. According to the US Centers for Disease Control and Prevention, 3.2 million Americans are chronically infected with HCV and approximately 10,000 die annually of the disease. Globally, as many as 170 million people are estimated to suffer from HCV infection.

For patients with end-stage liver disease from HCV infection, liver transplantation is the only option. While it can be a life-saving treatment, transplantation does not cure the disease. In nearly all cases, the patient's new liver is eventually infected by HCV because the virus remains in the patient's bloodstream during surgery. The course of recurrent HCV disease is accelerated after transplantation and up to 20 percent of transplant patients develop cirrhosis within five years. Unfortunately, the standard antiviral drugs currently used to treat HCV prior to the onset of end-stage liver disease are poorly tolerated after liver transplantation, leaving these patients with few options.

"The ability to prevent allograft infection using strategies such as immunoprophylaxis would have an enormous impact on outcomes of liver transplantation for HCV," said Raymond T. Chung, MD, director of hepatology at Massachusetts General Hospital.

About MassBiologics

MassBiologics, also known as the Massachusetts Biologic Laboratories, is the only non-profit FDA- licensed manufacturer of vaccines and other biologic products in the United States. MassBiologics produces 30 percent of the US tetanus/diphtheria vaccine supply. In addition to the HCV program, MassBiologics has discovered and developed human monoclonal antibodies to severe acute respiratory syndrome (SARS), and to Clostridium difficile (C. difficile), which has shown efficacy in a Phase 2 clinical trial, and to rabies which will be starting Phase 2 clinical trial soon in collaboration with the Serum Institute of India. MassBiologics traces its roots to 1894, and since then has maintained a mission to improve public health through applied research, development and production of biologic products. MassBiologics has been a part of the University of Massachusetts Medical School since 1997.

About the University of Massachusetts Medical School

The University of Massachusetts Medical School has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. The Medical School attracts more than $307 million in research funding annually, 80 percent of which comes from federal funding sources. The work of UMMS researcher Craig Mello, PhD, an investigator of the prestigious Howard Hughes Medical Institute (HHMI), and his colleague Andrew Fire, PhD, then of the Carnegie Institution of Washington, toward the discovery of RNA interference was awarded the 2006 Nobel Prize in Physiology or Medicine and has spawned a new and promising field of research, the global impact of which may prove astounding. UMMS is the academic partner of UMass Memorial Health Care, the largest health care provider in Central Massachusetts. For more information, visit www.umassmed.edu.

Jim Fessenden | EurekAlert!
Further information:
http://www.umassmed.edu

More articles from Health and Medicine:

nachricht Novel communication between intestinal microbes and developing immune cells in the thymus
24.01.2020 | Massachusetts General Hospital

nachricht Preventing metastasis by stopping cancer cells from making fat
23.01.2020 | Université catholique de Louvain

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

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

Im Focus: Integrate Micro Chips for electronic Skin

Researchers from Dresden and Osaka present the first fully integrated flexible electronics made of magnetic sensors and organic circuits which opens the path towards the development of electronic skin.

Human skin is a fascinating and multifunctional organ with unique properties originating from its flexible and compliant nature. It allows for interfacing with...

Im Focus: Dresden researchers discover resistance mechanism in aggressive cancer

Protease blocks guardian function against uncontrolled cell division

Researchers of the Carl Gustav Carus University Hospital Dresden at the National Center for Tumor Diseases Dresden (NCT/UCC), together with an international...

Im Focus: New roles found for Huntington's disease protein

Crucial role in synapse formation could be new avenue toward treatment

A Duke University research team has identified a new function of a gene called huntingtin, a mutation of which underlies the progressive neurodegenerative...

Im Focus: A new look at 'strange metals'

For years, a new synthesis method has been developed at TU Wien (Vienna) to unlock the secrets of "strange metals". Now a breakthrough has been achieved. The results have been published in "Science".

Superconductors allow electrical current to flow without any resistance - but only below a certain critical temperature. Many materials have to be cooled down...

Im Focus: Programmable nests for cells

KIT researchers develop novel composites of DNA, silica particles, and carbon nanotubes -- Properties can be tailored to various applications

Using DNA, smallest silica particles, and carbon nanotubes, researchers of Karlsruhe Institute of Technology (KIT) developed novel programmable materials....

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

11th Advanced Battery Power Conference, March 24-25, 2020 in Münster/Germany

16.01.2020 | Event News

Laser Colloquium Hydrogen LKH2: fast and reliable fuel cell manufacturing

15.01.2020 | Event News

„Advanced Battery Power“- Conference, Contributions are welcome!

07.01.2020 | Event News

 
Latest News

Researchers discover vaccine to strengthen the immune system of plants

24.01.2020 | Life Sciences

Brain-cell helpers powered by norepinephrine during fear-memory formation

24.01.2020 | Life Sciences

Engineered capillaries model traffic in tiny blood vessels

24.01.2020 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>