A "second-generation" drug that cures the hepatitis C virus in 80% of patients won the recommendation of an advisory committee, making it likely that the Food and Drug Administration (FDA) will approve the drug within 30 days.
The advisory group of 19 members unanimously recommended approval after a public hearing on October 24. The FDA generally follows the recommendations of the advisory group.
"We are pleased with the positive recommendation from the advisory committee for simeprevir," said Katia Boven, M.D., Janssen's Medical Department Head, Infectious Diseases and Vaccines.
The drug, simeprevir, is manufactured by Janssen and represents a modest improvement over current treatments for the virus. However, the drug's pending approval also signals the start of an optimistic new era for people with hepatitis C.
Several new hepatitis C drugs also are expected gain FDA approval within the coming weeks. When used together in a combination "cocktail," cure rates approach 100%.
Between 3 to 4 million people in the United States have chronic hepatitis C. The virus causes up to 15,000 deaths a year and is the leading cause of liver disease and liver transplants, according to the Centers for Disease Control and Prevention.
People born between 1945 and 1965 are five times more likely to have the virus when compared to other age groups. Most people contracted the virus by sharing needles, having sex with an infected person, or receiving a blood transfusion before 1992, when blood banks began testing for the virus.
The old standard treatment for hepatitis C was a year-long regimen of pills and injections. The injections consist of an immune-boosting drug called interferon, which often causes intolerable side effects. The pill regimen included ribavirin plus either Incivek and Victrelis—first-generation regimens that produced cure rates between 65% and 75%.
"Simeprevir cured 80 percent of patients who had not previously been treated for the disease," according to an FDA advisory report. Also, most patients were able to "cut their treatment time in half" from one year to six months.
According to an earlier study, when simeprevir is used in combination with another anti-hepatitis C drug called sofosbuvir, the cure rate after 12 weeks of treatment was 100%. Janssen is currently studying simeprevir in combination with various other drugs that do not require interferon injections.
First-generation regimens required patients to take up to four pills, three times a day. Simeprevir is one pill taken once per day. The recommended duration of simeprevir treatment is 12 weeks, along with ribavirin and interferon for either 24 weeks or 48 weeks.
The advisory committee, however, also noted an important limitation of simeprevir. The drug is not effective against a distinct type of hepatitis C virus with a mutation called Q80K. The committee recommends that doctors screen patients for the Q80K mutation before prescribing simeprevir.
Other side effects of simeprevir include cautions about skin conditions including rash, light sensitivity, and sunburn.
For more information about current and experimental hepatitis C drugs, see Positively Aware.