FDA approves Harvoni, the $1,125 pill for curing Hepatitis C

The US Food and Drug Administration (FDA) today approved a new antiviral; drug for treating hepatitis C virus (HCV) genotype 1 infections that lays claim to two “firsts,” the agency announced today. This new drug developed by the Foster City-based Gilead Sciences works faster, drops the usual injections and is worth $1,125 per pill.

Though this new pill comes with a steep price tag, it is expected to be really effective. It was shown in trials to cure up to 99 percent of patients within two to three months, depending on the previous treatment history of the patients and whether they had liver scarring.

This daily pill named Harvoni costs USD 94,500 for 12 weeks and USD 63,000 for eight weeks. Both these drugs are cheaper than some existing hepatitis C treatments, according to the drugmaker. But critics are already unhappy over Gilead’s first hepatitis C therapy, Sovaldi, which became the best-selling new drug after being released late last year at USD 84,000 for 12 weeks.

Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the trade name Sovaldi in December 2013.

Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load.

The FDA granted Harvoni a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over available therapies.

Harvoni is the first treatment for hepatitis C that does not require administration with interferon or ribavirin, which can cause side effects like headache, fatigue and nausea.

Edward Cox, director of the Office of Antimicrobial Products at the Food and Drug Administration said the new treatments were “changing the treatment paradigm” for people with hepatitis C.

“Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens,” he said.

Harvoni is the third drug approved by the FDA in the past year to treat chronic hepatitis C infection.

Others include Olysio (simeprevir), marketed by Janssen Therapeutics in New Jersey and approved in November 2013 and Gilead’s Sovaldi which was approved in December 2013.

Hepatitis C, or HCV, is a viral infection that affects the liver, and may cause no symptoms for years until liver damage becomes apparent in the form of cirrhosis, jaundice or cancer.

Between 130 million and 150 million people worldwide are infected with HCV, which kills as many as 500,000 each year, according to the World Health Organization.