Gilead Sciences, Inc. (NASDAQ:GILD) has revealed that the United States Food and Drug Administration has given approval for Vosevi, a drug used to treat patients suffering from hepatitis C and who are unresponsive to other treatments. The Gilead drug is the first one to get approval as a treatment of hepatitis C patients who have been treated with other drugs such as Sovaldi which act by inhibiting the NS5A protein.
“Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past,” Edward Cox, an official at the Center for Drug Evaluation and Research of the FDA, said.
Three-month study
Vosevi’s approval came after two late-stage studies were conducted. The studies were done over a period of 12 weeks during which time the drug was evaluated in patients who had been previously treated. Approval of Vosevi, however, carries a warning in that there is the risk of reactivation of hepatitis B virus in patients who had been infected with both hepatitis B and hepatitis C viruses.
Earlier in the year Gilead Sciences had warned that sales of its expensive drugs were falling as a result of rising competition and fewer patients passing the eligibility test for treatment. In the first quarter results, sales of Gilead’s hepatitis C treatments including Epclusa, Harvoni and Sovaldi fell from the $4.3 billion that was posted in 2016 in a similar period to $2.6 billion.
Hep C symptoms
Patients suffering from hepatitis C experience liver inflammation which can result in liver failure or diminished organ function. The CDC – Centers for Disease Control and Prevention estimates that in the United States there are between 2.7 million and 3.9 million individuals suffering from chronic hepatitis.
Some of the symptoms of the disease include yellowish skin or eyes. Such patients may also develop various complications including bleeding, liver cancer and accumulation of fluid in the abdomen. This may even result in death.
On Tuesday shares of Gliead Sciences Inc rose by 0.76% to close the day at $71.69.