Sovaldi approved to treat chronic hepatitis C

FDA has approved sofosbuvir (Sovaldi, Gilead) to treat chronic hepatitis C virus (HCV) infection. According to FDA, 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.

Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. FDA recently approved simeprevir (Olysio, Janssen Therapeutics) for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. 

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

Hepatitis C causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV.

Sovaldi, a nucleotide analog inhibitor, blocks a specific protein needed by the hepatitis C virus to replicate. FDA said Sovaldi can be used as a component of a combination antiviral treatment regimen for chronic HCV infection.

Depending on the type of HCV infection, FDA said treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin, and peginterferon-alfa.  

Six clinical trials involving 1,947 participants were used to evaluate Sovaldi’s effectiveness, FDA reported. Trial participants had not previously received treatment for their disease or had not responded to previous treatment, including participants co-infected with HCV and HIV. FDA said the trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment, suggesting a participant’s HCV infection has been cured.

FDA said the trials demonstrated that a treatment regimen containing Sovaldi was effective in treating multiple types of the hepatitis C virus. In those trials, 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.

FDA reported that the most common side effects reported in clinical study participants treated with Sovaldi and ribavirin was 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.