Liver Transplant Patients Receive Experimental Drug to Prevent Hepatitis C Infection-Arizona Should Take Notice
Posted Jan 21 2011 6:57pm
Perhaps if folks knew about this new drug with liver transplants they would have not enacted the budget cuts that deprived one man of his liver transplant who had hepatitis C and was denied coverage on that basis. With going into phase 2 they are hoping that once the transplant is done that hepatitis C does not return. In many cases the new liver may end up being re-infected in time and this new therapy is designed to hopefully prevent the return.
This drug is given between one to four hours before surgery and then a second dose during the phase when the diseased liver is removed. If the drug is successful, Arizona will have to look for a new qualifier for budget cuts. In reality, they need to do that anyway, but it may not be happening any time soon with the Governor signing a bill seeking a Medicaid waiver today to temporarily remove nearly 300,000 people from its Medicaid rolls. BD
The first patients were enrolled in the study in December. The primary goal of this randomized, double-blind, placebo-controlled study is to test if the monoclonal antibody, designated MBL-HCV1, prevents re-infection of patients chronically infected with HCV who are undergoing liver transplantation.
MassBiologics plans to enroll 16 patients in the first part of the study. "We are hopeful that positive results from this study will meet an important public health need, and we could not take this important step without the willing and thoughtful participation of these volunteers," said Donna Ambrosino, MD, executive director of MassBiologics and a professor of pediatrics at the Medical School.
A Phase 1 study in 31 healthy volunteers completed in 2009 showed the antibody was well tolerated, with no serious side effects. The Phase 1 study also measured the levels of the antibody in the bloodstream and its ability to bind and inactivate the virus, thereby helping to establish the dosage and protocol for the Phase 2 study now under way.