Sovaldi – New Treatment Approved for Hepatitis C
On December 6, 2013 the U.S. Food and Drug Administration approved a new pill to treat patients with chronic hepatitis C virus (HCV) infection. It is the first antiviral product that has shown safety and efficacy to treat certain types of HCV infection (specifically Genotype 2 and Genotype 3) without the need for concomitant treatment with interferon. The manufacturer states that it can also be used along with ribavirin in Genotype 1 patients who are not candidates for treatment with peg-interferon. The new medication goes by the trade name Sovaldi (chemical name sofosbuvir), and it is marketed in the U.S. by Gilead Sciences, Inc.
Hepatitis C viral infection is a viral infection that mainly affects the liver. The hallmark of the disease in an inflammation of the liver, which can lead to decreased liver function or liver failure. Some patients with HCV infection develop cirrhosis of the liver after many years of chronic infection. Complications of cirrhosis include jaundice, bleeding, fluid accumulation, liver cancer, and death. The U.S. Centers for Disease Control (CDC) has estimated that approximately 1% (3.2 million individuals) of the U.S. population is infected with HCV.
Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed for hepatitis C viral replication. It is intended to be used as part of a multi-drug antiviral regimen. Depending on the type of HCV infection the patient has, Sovaldi is to be used with ribavirin, or with ribavirin plus peg-interferon alfa.
The FDA approved Sovaldi under a Priority Review and a Breakthrough Therapy designation. It is expected to significantly impact the treatment of patients with HCV, given the lack of a requirement for peg-interferon co-administration in certain HCV subtypes and the high rates of sustained virologic response (SVR) seen in the four pivotal trials submitted for approval.
Common side effects reported during clinical trials varied by treatment regimen. Headaches and fatigue were reported in patients treated with Solvaldi and ribavirin. In patients treated with Solvaldi, ribavirin and peg-interferon alfa side effects included headache, fatigue, insomnia, nausea, and anemia.
At the time of launch, the estimated Wholesaler Acquisition Cost (WAC) for Sovaldi was $28,000 for a bottle of 28 tablets.
For more information, see the Sovaldi information on the manufacturer’s website at Gilead Sciences, Inc. or the FDA’s news release at: FDA Sovaldi Announcement