FDA approves first pill to treat all forms of hepatitis C

It is noteworthy that the drug’s list price is $74,760 for 12 weeks.

Despite the cost concerns, Harvoni and Sovaldi raked in almost $20 billion in combined worldwide sales past year and have buoyed Gilead to the top of the hepatitis C market.

Epclusa is indicated for adults with hepatitis C genotype 1 through 6 with or without cirrhosis.

This new combination, which also sees its used with the older injectable drug ribavirin in advanced patients, sees the first-time use of its investigational NS5A inhibitor velpatasvir and has together with sofosbuvir demonstrated stellar results in hep C genotypes 1 through 6, curing 98% of patients within 12 weeks across three Phase III trials. The Food and Drug Administration approved the combination pill, Epclusa, from Gilead Sciences, for patients with and without liver damage.

The drug has been priced just below $75,000 for a 12-week regimen, around $10,000 less than Sovaldi and $20,000 less than Harvoni.

The next pill for hepatitis was Sovaldi and it came at a cost of $1,000 per pill. The disease typically becomes chronic, leading to possible complications including bleeding, yellowing of the skin and eyes (jaundice), abdominal fluid accumulation and liver cancer.

“In genotype 3, Gilead can use pricing to shift new patient flow”, Asthika Goonewardene, an analyst for Bloomberg Intelligence, said before the approval was announced.

While Gilead is the market leader in hepatitis C treatments, competition from Merck & Co. and AbbVie Inc. has slowed its sales.

In pivotal clinical trials, Epclusa led to cure rates of 95 percent to 99 percent in patients without or with mild cirrhosis after 12 weeks of treatment.

According to the FDA, the most common adverse events include headache and fatigue, and sofosbuvir/velpatasvir plus ribavirin are contraindicated for patients for whom ribavirin is contraindicated.

Epclusa carries a warning about a serious slowdown in the heart rate, while cases of pacemaker intervention have been reported when amiodarone and sofosbuvir were used in combination with another HCV direct-acting antiviral. The liver disease affects 130 million to 150 million people globally, according to the World Health Organization.

Gilead’s shares rose 3.7 percent to $81.12 at 11:46 a.m.in NY.

Yet first quarter results revealed a chink in Gilead’s armor, as US sales of Harvoni dropped by over half, and global sales fell by 15%.