On November 22, the Food and Drug Administration (FDA) approved a new drug called Olysio to fight the hepatitis C virus.
On its own, Janssen’s Olysio (generic name simeprevir) offers a cure rate of 80%, representing a modest improvement over current treatments. However, when combined with other drugs in a “cocktail,” cure rates approach 100%.
The FDA is expected to approve other hepatitis C drugs within weeks, including Gilead’s sofosbuvir.
“The FDA approval of Olysio is an important milestone for people living with chronic hepatitis C,” said Douglas Dieterich, M.D., Professor of Medicine in the Division of Liver Diseases, Mount Sinai School of Medicine. “Patients have a new treatment option with the potential to cure this challenging disease.”
Hepatitis C is an infectious blood-borne virus that attacks the liver. When left untreated, the virus can lead to cirrhosis, liver failure, and death. In the U.S., 3.2 million are infected, many of whom are still undiagnosed.
Worldwide, 3% of the world’s population (about 150 million people) are infected. Globally, 350,000 people per year die from the disease. Many people contracted the virus before 1992, when blood banks began testing for it.
The previous standard of care 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 pills included ribavirin plus either Incivek and Victrelis—first-generation regimens that produced cure rates between 65% and 75%.
When Olysio is used with interferon and ribavirin, the combination “cured 80% of patients who had not previously been treated for the disease,” according to an FDA advisory report. Also, most patients were able to shorten their time on treatment.
While the FDA technically approved Olysio for use with interferon and ribavirin, it is widely expected that doctors will use Olysio “off label” in combination with other drugs.
According to an earlier study, when Olysio was used in combination with sofosbuvir, the cure rate after 12 weeks of treatment was 100%.
The FDA highlighted that Olysio was less effective against one strain of the virus that is especially common in the U.S. Doctors should test patients for this strain, called genotype 1a Q80K. If the strain is detected, other drugs may be more effective.
Side effects of Olysio include skin conditions, rash, light sensitivity, and sunburn. Janssen is currently studying simeprevir in combinations that do not require interferon injections.
“In addition to introducing a new treatment option for patients,” said Sue Simon, President of the Hepatitis C Association, “Janssen is establishing comprehensive programs to support and assist patients.”
For more information about current and experimental hepatitis C drugs, visit the Hepatitis C Association.