Public Release: 30-Apr-2015
SAN ANTONIO (April 30 2015) — A number of new,
highly effective oral treatments for various types of hepatitis C have
been approved in the past few years. However, two groups who have not
benefitted from the new treatments are patients with hepatitis C who
have advanced liver disease and patients who have received a liver
transplant but the advanced liver disease has returned because of
“The problem for these patients is that unless the hepatitis C is
cured, the virus continues circulating in their blood infecting the new
liver, usually within a few months of transplant. One-third of them have
cirrhosis again within five years,” explained Fred Poordad, M.D.,
clinical professor of medicine and chief of hepatology at The University
of Texas Health Science Center at San Antonio.
“This puts these patients back at high risk of dying from chronic
hepatitis C or liver disease,” said Dr. Poordad, principal investigator
of the ALLY-1 study, who presented the results April 25 at The
International Liver CongressTM of the European Association for the Study
of the Liver (EASL) in Vienna, Austria.
The Phase III clinical trial evaluated a 12-week course of
daclatasvir – the new drug being evaluated – combined with sofosbuvir
and ribavirin for patients with chronic hepatitis C. Patients accepted
into the trial either had a liver transplant with returning hepatitis C
or had hepatitis C with advanced cirrhosis (scarring of the liver).
Study results showed an overall cure rate of 94 percent for patients
with a liver transplant and returning hepatitis C, and 83 percent for
patients with advanced cirrhosis.
The study’s primary endpoints also were reached, with 95 percent of
post-transplant genotype 1 patients and 82 percent of genotype 1
patients with advanced cirrhosis being cured 12 weeks after treatment.
Patients with other genotypes of the disease were enrolled as well, with
benefits seen in all groups.
Genotypes are subgroups or strains of a disease, such as hepatitis
C. There are many subtypes of hepatitis C based on the geographic
regions where the strain is most prevalent. Over time, each strain
evolved differently so that treatments are based on the genotype of the
disease. For example, genotype 1 is the type of hepatitis C most common
in the United States and is the most difficult to treat.
The study regimen was well tolerated and showed few serious side
effects. “Transplant patients take a variety of medications to prevent
organ rejection that can complicate the treatment of hepatitis C. In
ALLY-1, we saw no drug-to-drug interactions between transplant and
hepatitis C therapies and no need to make close adjustments to patients’
transplant-related drugs while they received the hepatitis C regimen,”
Dr. Poordad said.
The ALLY-1 study was conducted at five major transplant centers in
San Antonio and Houston, Texas; Miami, Fla.; Ann Arbor, Mich., and
Hepatitis C is a liver disease found worldwide that is spread though
contact with blood or semen, such as shared drug injection needles,
inadequate sterilization of medical equipment, unscreened blood and
blood products, accidental needle sticks in the health profession, and
sexual intercourse with a person who has hepatitis C. The disease also
can be passed from mothers to their children through the birthing
According to the U.S. Centers for Disease Control and Prevention,
3.2 million people in the U.S. have chronic hepatitis C, and 70 to 80
percent do not have symptoms. Nonetheless, it is a serious disease that
can lead to long-term health problems such as liver damage, liver
failure, liver cancer and death. It is often discovered later, after
significant liver damage has occurred.
In the U.S., people born between 1945 and 1965 have the highest risk
of hepatitis C due to higher drug use. People in this age group are
urged to have a one-time blood test for hepatitis C to detect the virus
and begin receiving treatment, if necessary, before significant liver
damage occurs. There is no vaccine to prevent hepatitis C.
Daclatasvir, a drug developed by Bristol-Myers Squibb, was approved
in Europe in 2014 for use with other medications for genotypes 1 through
4 for the treatment of chronic hepatitis C in adults. It is also
approved in Japan as well as many countries in Central and South
America, the Middle East and Asia Pacific. Daclatasvir regimens also
have been included in the EASL’s recommendations for the treatment of
hepatitis C in Europe.
The U.S. Food and Drug Administration is reviewing daclatasvir for possible approval in the United States.
The University of Texas Health Science Center at San Antonio, one
of the country’s leading health sciences universities, ranks in the top
13 percent of academic institutions receiving National Institutes of
Health (NIH) funding. The university’s schools of medicine, nursing,
dentistry, health professions and graduate biomedical sciences have
produced more than 29,000 graduates. The $787.7 million operating budget
supports eight campuses in San Antonio, Laredo, Harlingen and Edinburg.
For more information on the many ways “We make lives better®,” visit http://www.uthscsa.edu.
The Texas Liver Institute’s mission is to set the standard of
excellence in care and innovative research in the field of liver
disease. The institute is affiliated with The University of Texas Health
Science Center at San Antonio. The physicians are professors and teach
at University Hospital of the University Health System and are involved
with the liver transplantation program of the University Transplant
Center, a partnership of the Health Science Center and the University
Health System. For more information, visit http://www.txliver.com.