Gilead Sciences’ hepatitis C drug, sofosbuvir, received a positive review from the U.S. Food and Drug Administration (FDA) on Wednesday after the agency found that the drug cured more patients with the disease in less time than other medications currently on the market. The medication offers hope to the population of baby boomers who are at a higher risk of having the disease and are expected to see symptoms appear in the coming years.
The FDA posted its review of sofosbuvir ahead of a meeting on Friday with an advisory panel of experts who will vote on the drug's approval. The review found that adding sofosbuvir to the typical drug cocktail cured 90 percent of patients in only 12 weeks, the Associated Press reports. Furthermore, the drug’s efficacy proved to be safe with regards to side effects, and “no major safety issues associated with sofosbuvir have been identified to date,” the review said.
Since 1986, patients were treated with protein interferon-alpha; however, it wasn’t suitable for everyone and cured less than half of those undergoing treatment, according to the SF Gate. Treatment involves taking several antiviral medications and blood tests for up to a year, according to the Mayo Clinic. Side effects include depression and flu-like symptoms, such as fatigue, fever, and headache. Some of these can become so severe that treatment must be delayed or stopped.
In 2011, the FDA approved two new drugs that could be used as add-ons to treatment for the most common type of hepatitis C. These drugs increased cure rates to between 65 and 75 percent. But pharmaceutical companies have been pushing for “interferon-free” drugs recently. These include sofosbuvir and Johnson & Johnson’s simeprevir, which was found to cure 80 percent of patients who had not previously been treated for the disease.
Hepatitis C is a blood-borne disease that causes inflammation of the liver, according to the Centers for Disease Control and Prevention (CDC). About 70 to 80 percent of people with acute hepatitis C don’t see any symptoms for decades; however, some can experience pain the right upper abdomen, dark urine, fatigue, fever, jaundice, nausea, and vomiting. People with acute hepatitis C tend to develop chronic infection as well. Chronic hepatitis C can cause cirrhosis — scarring of the liver — and is the leading cause of liver cancer and the leading reason for liver transplants.
About 3.2 million Americans live with hepatitis C, and many of them don’t even know it. With baby boomers born between 1954 and 1965 five times more likely to have the disease, the number of hepatitis C cases is expected to rise in upcoming years. Because of this, the CDC recommends a one-time blood test for all baby boomers.