UT Health Science Center faculty at the center of research leading to safer, more effective treatments
SAN ANTONIO (Dec. 9, 2013) — The decades-long wait for better treatments for hepatitis C ended late last week, as the U.S. Food and Drug Administration gave final approval to the first in a new class of drugs with significantly better cure rates and relatively few side effects.
Researchers from The University of Texas Health Science Center at San Antonio not only played a central role in the clinical trials that proved sofosbuvir’s safety and effectiveness against the widespread and potentially deadly disease, but they have already made substantial headway in finding better ways to administer the drug.
The Lancet published research from Fred Poordad, M.D., and Eric Lawitz, M.D., that found an all-oral combination of sofosbuvir and just one other drug cures hepatitis C in almost all cases in as little as eight weeks with few adverse effects, even in patients who saw previous treatments fail.
“This is a revolutionary time in hepatitis C treatment,” Dr. Poordad said. “We are moving from an interferon era to a pills-only era with very high cure rates and minimal side effects. We will likely see a number of new treatment regimens approved in the next two years.”
The findings were first published online in November and will appear in an upcoming print edition of The Lancet. Drs. Poordad and Lawitz are clinical professors in the School of Medicine at the UT Health Science Center and see patients at the Texas Liver Institute in downtown San Antonio.
Hepatitis C is the most common chronic blood-borne infection in the United States, with more than 3 million people infected, according to the Centers for Disease Control and Prevention (CDC). It is potentially fatal and can cause complications including cirrhosis, liver cancer and liver failure.
Transmission rates were especially high in the 1960s, ‘70s and ‘80s, before the hepatitis C virus was identified in 1989. Baby boomers in particular were at risk of contracting the virus through recreational use of injection drugs, as well as through blood transfusions and organ transplants before screening for hepatitis C was routine.
The virus can lurk without symptoms for decades. As a result, the CDC recommended a year ago that all baby boomers get a one-time test for hepatitis C.
For more than two decades, the standard treatment for hepatitis C has been interferon therapy. Interferon is a protein that fights hepatitis C in several ways: It protects healthy cells, boosts the immune system and prevents the virus from multiplying.
But interferon therapy is associated with substantial adverse effects and can be given only by subcutaneous injection. And when interferon therapy fails, few treatment options remained until now.
FDA approval of sofosbuvir comes after the New England Journal of Medicine published results of two large-scale phase 3 clinical trials in May. Dr. Lawitz was lead author on those studies, which were funded by Gilead Sciences, developer of sofosbuvir.
One study combined a short, 12-week course of interferon therapy and the antiviral ribavirin with sofosbuvir, a direct-acting antiviral that interferes with the life cycle of the hepatitis C by suppressing viral replication. The other study examined an all-oral course of sofosbuvir and ribavirin, without interferon. In both studies, sofosbuvir had impressive cure rates, shorter treatment times and a good safety profile.
“Patients and health care providers have been waiting more than 20 years for safer, more effective therapies for hepatitis C – and it looks like they are finally here,” Dr. Lawitz said. “This is just the beginning of a new, exciting era. We are fine-tuning these regimens to be easy and short, offering patients a chance for a real cure.”
The new study in The Lancet featured results from a clinical trial dubbed LONESTAR. The open-label study, conducted exclusively at the Texas Liver Institute, enrolled 100 patients, including 40 who had seen previous treatment fail. Participants received treatment for either eight or 12 weeks and were given all-oral regimens of sofosbuvir and the experimental drug ledipasvir, either with or without ribavirin.
Every group – including previously treated patients – had cure rates of at least 95 percent. In all groups combined, 97 percent of patients were cured.
“These findings give us a glimpse into the near future, with emerging therapies curing the majority of people with hepatitis C in just a few weeks,” Dr. Poordad said. “These results are absolutely astounding compared with where we were just a few years ago.”
The researchers continue to enroll patients in a number of hepatitis C trials. Prospective patients can call the toll-free number 1-855-437-2267 to see if they are eligible.
The University of Texas Health Science Center at San Antonio, one of the country’s leading health sciences universities, ranks in the top 3 percent of all institutions worldwide receiving National Institutes of Health funding. The university’s schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have produced approximately 29,000 graduates. The $765 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 www.uthscsa.edu.