US food, drug administration approves $1,125 hepatitis C pill
"Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin [pill-and-injection treatments], two FDA-approved drugs also used to treat HCV infection," the FDA press release stated on Friday.
"Now, patients and health care professionals [in the US] have multiple treatment options, including a combination pill to help simplify treatment regimens," Edward Cox, FDA director of the Office of Antimicrobial Products, was quoted saying by the FDA in the release.
The FDA cleared the drug manufactured by the Gilead biotechnology company after extensive testing of effectiveness and side-effects. Three clinical trials were carried out on 1,518 participants who had either not previously received Hepatitis C treatment or who had not responded to previous treatments.
According to the FDA, the most common side-effects noted were fatigue and headaches, making this the seventh new drug with breakthrough therapy approved by the FDA.
"The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases," stated the FDA report.
Meanwhile, the cost remains a concern as a typical 12-week treatment could cost up to $94,500.
"Never before has a drug been priced at this level for such a large population," Michael Weinstein, president of the AIDS Healthcare Foundation was quoted saying by Fox News.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the FDA, most people infected with HCV have no symptoms of the disease until liver damage occurs. ■