Sovaldi Receives Nod From FDA to Treat Chronic Hepatitis C

The U.S. Food and Drug Administration has approved a third drug with a breakthrough therapy to treat chronic hepatitis C.

FDA has approved the drug Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection that causes inflammation in the liver and in advance cases leads to live failure. This is the second drug approved by the FDA this month. Prior to this, the FDA sanctioned Olysio (simeprevir). It was approved as a combination antiviral treatment regimen.

Sovaldi is the first safe and effective drug able to successfully cure certain types of HCV infection without the co-administration of interferon.

"Today's approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C," Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

Hepatitis C is a contagious liver disease resulting from infection triggered by HCV that spreads through contact with the blood of an infected victim. The liver disease can vary, its severity either being acute or mild.   It can even last for a life time and cause serious issues such as liver cancer or cirrhosis. Reports according to the CDC claim that nearly 3.2 million Americans have chronic Hepatitis C virus infection and most of them are not aware of the disease. Nearly 75-85 percent of people infected with the disease will develop chronic infection.

Marketed by Gilead, based in Foster City, Calif, the newly approved drug Sovaldi, is a nucleotide analog inhibitor that obstructs the particular protein that is required by HCV to replicate. The drug will be used as a component of a combination antiviral treatment regimen for chronic HCV infection. Since there are several types of HCV infection, the treatment regimen would be used based on the type of HCV infection the patient has contracted. The treatment regimen would either include Sovaldi and ribavirin or Sovaldi or peginterferon-alfa. The two drugs used with Sovaldi are generally used to treat HCV infection.

With the help of six clinical trials the researchers evaluated the effectiveness of the drug. The trials were conducted on nearly 1,947 subjects who had not received any treatment for the disease prior to this (treatment-naive) or they sought treatment but did not respond well to the previous treatment (treatment experienced), including the subjects co-infected with other virus such as HCV and HIV. The trials conducted were intended to measure whether the HCV was no longer present in the blood after 12 weeks after finishing the treatment (sustained virologic response), clearly indicating the subject has been cured and no longer carries the HCV infection.

At the end of the clinical trials the researchers noticed that the treatment regimen including Sovaldi was indeed effective in curing several types of HCV. Also, Sovaldi showed efficacy in those patients who could not tolerate or put up with an interferon-based treatment regimen and also in those subjects who were awaiting a liver transplant.

The common side effects noticed in the subjects when treated with Sovaldi and ribavirin during the clinical trials were fatigue and headache. In those treated with Sovaldi, ribavirin and peginterferon-alf, the most common side effects noticed were fatigue, headache, nausea, insomnia and anemia.