FDA-Approved Hepatitis C Drug Sofosbuvir Called a "Game Changer"
A pioneering treatment for chronic hepatitis C has been approved by the Food and Drug Administration (FDA), and it is expected to be a “game changer” in that it will be the first all-oral, interferon-free therapy to use sofosbuvir, a first-in-kind nuceotide analog inhibitor with dramatically high cure rates.
Research data supporting the effectiveness of sofosbuvir, which will be marketed under the brand Sovaldi by Gilead Sciences, was presented in October to an FDA advisory committee meeting for the treatment of adults with chronic hepatitis C virus (HCV) infection. Experts are calling it a major advancement.
Greg Fitz, MD, president of the American Association for the Study of Liver Diseases, told reporters last month that this is a very exciting time in the treatment of liver diseases, and that “the move away from interferon and toward a high probability of success is remarkably encouraging” for everyone.
“Suddenly, it's realistic to think we can cure most patients with hepatitis C," he said.
Liver experts say sofosbuvir will help HCV patients achieve high cure rates in only 12 weeks. The drug also has several advantages over existing chronic hepatitis C virus treatments, including a greater safety and efficacy profile, not to mention that it’s well-tolerated among different HCV genotypes and across different patient populations.
Dosing for sofosbuver is also easier, especially since it’s the first all-oral therapy for treating hepatitis c virus, which in and of itself is a major benefit and advancement, especially for HCV patients unable to tolerate previous treatments.
The FDA’s approval of sofosbuvir follows 6 clinical trials involving a total of 1947 participants with different HCV genotypes. Among them, 89 percent to 95 percent sustained viral clearance at 12 weeks for genotype 1 and genotype 2. Another 61 to 63 percent sustained viral clearance at 12 weeks for genotype 3.
The vast majority of Americans with HCV have genotype 1, which accounts for approximately 70 percent of all hepatitis C virus cases in the U.S. Last June, a government-backed panel urged American baby boomers to get screened for hepatitis C.
Meanwhile, there are reports that a minimum of 4 different pharmaceutical companies are in the midst of developing their own interferon-free treatments for HCV patients with genotype 1, which are expected to be available within the next couple of years.
All of these new treatments are predicted to significantly boost treatment options for HCV patients while also simplifying the treatment process.
In the meantime, there are ways to prevent hepatitis C.
SOURCE: FDA ANTIVIRAL DRUGS ADVISORY COMMITTEE MEETING BACKGROUND PACKAGE FOR NDA 204671, SOFOSBUVIR (GS-7977), Oct. 25, 2013.