In pharmacy technology news, Gilead Sciences Inc. hepatitis C pill Harvoni has been approved by both the Food and Drug Administration and Health Canada. The drug, which was given the thumbs up in early October 2014 by the FDA, is the first combination pill approved to treat chronic HCV genotype 1 infection, according to the administration.1 Harvoni is the combination of two drugs (one of which is a previously approved drug by Gilead known as Sovaldi) designed to cure patients with chronic HCV genotype infection 1 in eight weeks, although for serious cases a longer duration of treatment may be needed. Hepatitis C affects more than 3 million Americans and is curable, but in the past treatment options have been limited. This new course of treatment is the first to not require interferon or ribavirin, and hence provides an entirely new treatment option for health care professionals.
The Centers for Disease Control and Prevention defines Hepatitis C as a lifelong liver disease that results from the hepatitis C virus.2 An estimated 3.2 million people in the U.S. suffer from chronic HCV, although the infection does not always cause symptoms in those that have it. HCV is generally spread through blood by sharing needles or passed down from mother to offspring. HCV can also be transmitted through sexual contact, although the risk is considered low.
Historically, drugs have been able to cure this disease, however, the results have varied. According to Wall Street OTC, even a few years ago drugs only proved to be effective in curing about 40 percent of patients, and treatment could take as long as 48 weeks.3 Yet, pharmaceutical treatment options have advanced quickly as of late, and Gilead’s new drug Harvoni is perhaps the capstone of that progress. The new drug boasts being a complete hepatitis C treatment regimen with patients only having to consume one pill orally per day for eight to 24 weeks.
Recent test results from Harvoni trials found that of a 500 person patient pool with the liver disease, 96 percent were cured of the ailment.4 Another recent competing HCV drug, produced by Merck & Co., Inc., looks to decrease the time of treatment down to four weeks, but the company reports that in a recent trial it only cured 39 percent of patients.4 For the time being, Harvoni seems not only to have the most promising results, but also, due to the lack of interferon and ribavirin, make treatment less cumbersome for patients.
In an FDA news release, Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, explained, “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”1
Harvoni is considered a breakthrough drug, a designation the FDA does not take lightly. According to the administration, Harvoni is the seventh drug to receive this distinguished title.1
1 “FDA approves first combination pill to treat hepatitis C,” press release, Food and Drug Administration, October 10, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm
2 “Hepatitis C FAQs for the Public,” Centers for Disease Control and Prevention. http://www.cdc.gov/hepatitis/c/cfaq.htm
3 “Merck & Co to Help Cure Hepatitis in 4 Weeks with Gilead’s Sovaldi,” by David Pence, Wall Street OTC, November 10, 2014. http://www.wallstreetotc.com/merck-co-to-help-cure-hepatitis-in-4-weeks-with-gileads-sovaldi/212204/
4 “Gilead Sciences, Inc. Releases Impressive Results for Hepatitis C Drug,” by Sarah Roden, ValueWalk, November 12, 2014. http://www.valuewalk.com/2014/11/gilead-sciences-inc-gild-releases-impressive-results-hepatitis-c-drug/