The nod represents a significant shift in treatment paradigm
The U.S. has approved a breakthrough therapy for treatment of chronic hepatitis C that is expected to offer a more palatable cure to millions of people infected with the liver-destroying viral disease.
Approved by the Food and Drug Administration, the pill, Sovaldi (sofosbuvir) 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, an official announcement said on Friday.
“Today’s (Friday’s) approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, 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 (hepatitis C virus) infection.
On November 22, the FDA had approved Olysio (simeprevir).
The FDA said Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants, who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure.
Symptoms may include fever, fatigue, loss of appetite, vomiting, nausea, abdominal pain, dark urine, clay—coloured bowel movements, joint pain and jaundice, according to the CDC.
The once-a-day pill is the first approved to treat certain types of hepatitis C infection without the need for interferon, an injected drug that can cause severe flu-like symptoms. Hepatitis C, which is often undiagnosed, affects about 3.2 million Americans, killing more than 15,000 each year, mostly from illnesses such as cirrhosis and liver cancer. Most patients will be treated with the $1,000-a-day drug for 12 weeks, resulting in a total list price of $84,000, according to Gilead spokeswoman Cara Miller.
Last year, the CDC recommended that all baby boomers, born from 1945 to 1965, be tested for the virus. Introduction of blood and organ screening in the 1990s has dramatically lowered infection rates for younger generations.
The Gilead drug’s approval was supported by several studies showing that it helped to eradicate the virus in significantly more patients, with fewer side effects, than the current drug regimen.
Sovaldi is the first in a new class of medications known as nucleotide analogue inhibitors, or “nukes,” designed to block a specific protein that the hepatitis C virus needs to copy itself.