House Democrats have sent a letter to Gilead Sciences demanding that the pharmaceutical company justify the price of its new drug, Sovaldi. The FDA approved the drug in December of 2013, giving it Priority Review and a Breakthrough Therapy designation. The hepatitis C drug costs $1,000 a day, which has raised suspicions from Medicaid programs, insurers, and lawmakers. Gilead stocks fell as the official inquiry from Congress concerned investors. Gregg Alton, executive vice president at Gilead, said, “We think the price is fair. It will save the system money long term.”
Hepatitis is family of viral infections that cause liver inflammation. Diseases, drugs, toxins, and alcohol abuse cause hepatitis. Hepatitis C is a contagious liver disease spread through blood. Severity ranges from mild to severe. Patients are diagnosed with acute Hepatitis C within 6 months of exposure. Many acute cases turn chronic because the virus stays in the body. Severe cases result in cirrhosis of the liver and/or cancer. In the U.S., more than 4 million people have Hepatitis C. Established treatments do not work for everyone.
Sovaldi is an inhibitor drug, disallowing a protein that the virus needs to replicate. It is one component in different regimens to treat chronic infection. Treatments include Sovaldi with ribavirin and Sovaldi with ribavirin and peginterferon-alfa. Six clinical trials evaluated Sovaldi’s effectiveness. 1,947 participants who were treatment-naïve (had not previously received treatment) or who had not responded to previous treatment measured sustained virologic response to Sovaldi. If the virus was no longer present in the blood after at least twelve weeks, the participant’s infection was considered cured.
Results showed that Sovaldi was effective in treating different types of Hepatitis C. People who could not tolerate an interferon-based treatment regimen also benefitted from treatment, as did those with liver cancer. Side effects included fatigue, headache, nausea, insomnia, and anemia.
Members of the pharmaceuticals community, as well as investors, are concerned that, if Congress starts with one drug, it will proceed to put all drugs and their pricing under the microscope. Gilead maintains that, compared to cancer, HIV and other Hepatitis C drugs, Sovaldi is a one-time cost for a complete cure that lasts for life.