Exciting times for liver research trials
01 July 2012
Two commercial trials have just been added to the large and productive research programme, the research nursing team has expanded and new drugs are showing immense promise for helping patients.
Dr David Mutimer, a consultant liver specialist, says the current advances are extremely encouraging: “A whole range of new drugs and molecules is coming through for hepatitis C and showing a lot of promise.
“For an otherwise healthy person, hepatitis C can take 20 years or longer to cause severe liver damage requiring liver transplantation.”
However, damage from hepatitis C occurs much more quickly in the transplanted liver.
“Transplant patients take drugs which suppress the immune system to prevent the body from rejecting the new organ. This makes them much more susceptible to the effects of hepatitis infection, and severe damage can occur within a decade of transplantation. To be putting a liver into someone and then losing it five years later because of an infection is something we want to avoid.
“We are hoping that the improvements in antiviral treatment for hepatitis C will also benefit patients with hepatitis C after transplantation.
“For non-transplant patients, the standard treatment with Interferon and Ribavirin has a cure rate of about 40 per cent. The new drugs in these trials are increasing cure rates to around 70 per cent. We want to get that even higher so that we feel we can cure most cases. That’s very exciting for patients.”
The two new drugs approved this year are both protease inhibitors, which prevent hepatitis C from replicating.
One of these drugs, telaprevir, is about to be assessed for treatment of the post-transplant hepatitis C patient.
The trial will test whether the drug’s use alongside the existing interferon/Ribavirin treatment can eliminate hepatitis C in patients who have a transplanted liver.
“There is an enormous need for better antivirals for transplant patients and this is a very exciting study,” says Dr Mutimer, who is the Chief Investigator for the UK in this multi-national European study.
This trial also shows the value of collaboration between the liver medicine and liver surgical specialties.
“Having such a big, high-quality transplant programme means we have the transplant patients, we have all the surgical and medical specialists and we have a well-established partnership with the University of Birmingham to carry out the research.”
One of the most exciting developments within the Trust’s liver medicine department is the trial of a drug called ITX-5061, which is made by San Diego-based pharmaceutical company iTherX.
Pre-clinical trials show the drug prevents hepatitis C from invading liver cells, and UHB is hosting the world’s first trial in human liver transplant patients.
“This is a single centre trial, so we’re the only ones in the world testing this drug for transplant patients. We’re currently taking very detailed measurements from a group of 10 patients who fit the criteria but are not receiving the drug, so we will have a baseline,” says Dr Mutimer.
“Then we will look at ten patients to whom we give the drug, to see how their responses differ. If it proves as successful, it will be a huge step forward because it would effectively create a shield to stop hepatitis C from infecting the new liver.”
This Phase 1b trial of ITX-5061 in liver transplant recipients is funded through an educational grant from iTherX with the National Institute of Health Research Biomedical Research Unit.