"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 Doctor Deborah C. Molrine. "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 does not become chronically infected."
Five international hospitals enrolled patients in the trial. 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 Doctor Fredric Gordon of Lahey Clinic Medical Centre.
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."
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 per cent 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.
MEDICA.de; Source: University of Massachusetts Medical School (UMMS)