Sovaldi, manufactured by Gilead Sciences, has been shown in trials to safely and efficiently treat the disease without the need to additionally administer interferon. This makes it the second drug approved by the agency in the last two weeks for hepatitis treatment, the other being Olysio.
Hepatitis C is a viral disease that causes inflammation of the liver, which can lead to diminished liver function and liver failure. According to the Centers for Disease Control and Prevention 3.2 million persons in the United States have chronic Hepatitis C virus infection.
Until recently the most used treatment for the disease was 24 to 48 weeks of weekly injections of interferon alpha combined with daily tables of ribavirin. Neither of the drugs were created to fight hepatitis C.
In trials, Sovaldi was found to be effective across multiple types of the hepatitis C virus, even in those patients who could not tolerate interferon or interferon-based treatments.
The drug is only the third drug with "breakthrough therapy designation" to be approved by the FDA. Drugs which demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases during initial clinical trials are given a breakthrough therapy designation.
But while there is interest in the drug's benefits, there is concern about the cost associated with the treatment.
“This is unbearable to the health care system and it is completely unjustified,” said Michael Weinstein, president of the AIDS Healthcare Foundation, which runs treatment clinics in the United States and abroad and has previously clashed with Gilead on the price of its drugs for H.I.V.