Hepatitis C drug, Sovaldi, receives FDA nod

The U.S. Food and Drug Administration (FDA) approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection yesterday. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.

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Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval.

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

Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir).

Reuters reports that the price tag for the newly approved drug is $1,000 a day for a 12 week course of treatment–total cost is $84,000.

Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Ribavirin and peginterferon-alfa are two drugs also used to treat HCV infection.

Results from all clinical trials showed a treatment regimen containing Sovaldi was effective in treating multiple types of the hepatitis C virus. Additionally, Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.

The most common side effects reported in clinical study participants treated with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia and anemia.

Hepatitis C is a contagious liver disease that results from infection with hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C is usually spread when blood from a person infected with hepatitis C virus enters the body of someone who is not infected.

Hepatitis C can be either “acute” or “chronic”. Acute hepatitis C virus infection is a short-term illness that occurs within the 1st 6 months after someone is exposed to hepatitis C virus. For most people, acute infection leads to chronic infection. Chronic hepatitis C is a serious disease than can result in long-term health problems, or even death. There is no vaccine for hepatitis C.

According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV.

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