A relive from hepatitis C: FDA approves a new drug

Oct 11, 2014 Ruchira Dhoke News 0

An early awaited approval happened on October 10, 2014 when the U.S Food and Drug Administration or the FDA showed the green flag to first combination pill to treat hepatitis C infection. The drug is a once a day pill called HARVONI which is a combination of drugs sofosbuvir (Sovaldi) and Ledipasvir. The medication is believed to give excellent results as it cures the disease nearly for all who will take it.

Hepatitis C is a contagious liver disease that results from infection with the Hepatitis C virus (HCV), which is spread primarily through contact with the blood of an infected person. Hepatitis C can be either “acute” or “chronic.” The drug Harvoni is to treat chronic hepatitis C virus (HCV) genotype 1 infection, the most common, without requiring the administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection. Harvoni acts by interfering with the enzymes which are needed by HCV to multiply.

Both interferon and ribavirin have significant side effects which include fatigue and flu-like symptoms that are hard to tolerate by the patients. Also only about half of patients who were prescribed with these responded to them.

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

Hepatitis C which is responsible for causing inflammation of the liver can also lead to diminished liver function or liver failure. It is asymptomatic in most people until liver damage becomes apparent, which may take decades. Chronic HCV infection patients develop scarring and cirrhosis over the years leading to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer.

Three clinical trials were conducted for Harvoni’s efficacy were 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis were enrolled. Fatigue and headache were the most common side effects reported in clinical trial participants.

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval.

FDA, Harvoni, hepatitis C virus

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Ruchira Dhoke

A qualified medical microbiologist with an avidity to read enchant a deep passion for creating a good impacting masterpiece with my words .I am very fond of good old English literature and like listening to music and paint in my free time.