FDA Issues Positive Review of Hep C Drug

WASHINGTON, D.C.—The Associated Press has reported that the Food and Drug Administration (FDC) issued a positive review yesterday "for a highly anticipated hepatitis C drug from Gilead Sciences, saying the pill cures more patients in less time than currently available treatments." A meeting is set for tomorrow during which government experts will vote on whether to approve the drug. The article continues, "Between 3 million and 4 million people in the U.S. have hepatitis C, a blood-borne disease that causes liver damage and is blamed for 15,000 deaths a year. The drugs currently used to treat the virus cure about three-quarters of people and can take up to a year of treatment. FDA said that adding Gilead's sofosbuvir to the standard drug cocktail cured 90 percent of patients with the most common form of the virus in just 12 weeks. For the past 20 years, the article added, the treatment for hep C involved "a grueling one-year regimen of pills and injections that causes flu-like symptoms and cures less than half of patients. Then in 2011, the FDA approved two new drugs from Merck and Vertex Pharmaceuticals that raised the cure rate to about 65 and 75 percent, respectively, when combined with the older treatments." But Gilead's once-a-day pill has significantly improved that percentage, according to a company study that involved "327 patients with the most common form of the disease, 90 percent of participants had undetectable levels of the virus after 12 weeks of treatment. The form of the disease studied in the trial accounts for about 75 percent of hepatitis C cases in the U.S." For the 25 percent of the population that has the two less common forms of the disease, "sofosbuvir cured about 67 percent of patients who had not previously taken other hepatitis C drugs," which Gilead said still represented an improvement in treatment for those patients, and which the FDA said "provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile." Gilead is but one company rushing to develop a pill form treatment for hep C, with anticipated annual revenues for the drug maker. "Similar efforts are underway from Abbott Laboratories, Bristol-Myers Squibb Co., Vertex Pharmaceuticals and others," reported the AP. A short-window, high-percentage cure would obviously be a positive development for the adult entertainment industry, which recently added hep B and C to the required testing protocols. According to the Centers for Disease Control (CDC), "Hepatitis C is usually spread when blood from a person infected with the Hepatitis C virus enters the body of someone who is not infected. Today, most people become infected with the Hepatitis C virus by sharing needles or other equipment to inject drugs."