Officials with Gilead Sciences recently released data from an ongoing study of Viread, a treatment for chronic hepatitis B infection.
Company officials said that the new data was derived during the open-label phase of two Phase III clinical trials examining the four-year efficacy of Viread.
Dr. Patrick Marcellin, of Hospital Beaujon in Clichy, France, and one of the study’s investigators, said that no resistance to Viread emerged over 192 weeks of treatment. Futhermore, 10.8 percent of patients receiving Viread for four years experienced surface, or "s", antigen (HBsAg) loss, which is a marker of the resolution of chronic HBV infection.
Other data showed showed Viread to be very effective among several key patient subpopulations, including patients with high baseline viral levels, individuals of Asian descent and treatment-experienced patients.
“The complete absence of Viread-related resistance detected among study participants shows that this therapy has a high and durable barrier to viral resistance, which is essential for the long-term success of HBV therapy,” Marcellin said. “These four-year results underscore the long-term benefits of Viread for diverse patient populations, including those who are difficult to treat.”
Viread for HBV was approved by the U.S. Food and Drug Administration in 2008 and is one of the most-prescribed HBV medicines in the United States.
Officials say it is also the only recommended first-line therapy for hepatitis B to demonstrate continuous effectiveness during four years in pivotal studies.
In October 2010, the FDA expanded Viread's usage to include the treatment of chronic hepatitis B among patients with decompensated liver disease, the end stage of hepatitis B.