TRENTON, N.J. — Patients with chronic hepatitis C have a new option for treating the liver-damaging virus, with the approval of a combination treatment developed by AbbVie.
The Food and Drug Administration on Friday approved the sale of a packaged treatment called Viekira Pak made by AbbVie Inc. of North Chicago, Illinois.
It includes a combination pill, which contains the antiviral drugs ombitasvir, paritaprevir and ritonavir, along with a tablet of dasabuvir. All the ingredients are new except for ritonavir, which works to increase blood levels of paritaprevir.
It's among several new pill-only hepatitis C treatments that are big improvements over earlier treatments that are less effective, require injections and cause flu-like side effects.
About 3.2 million Americans are infected with hepatitis C, which generally doesn't cause noticeable symptoms until the liver is damaged.
Without proper treatment, up to 30 percent of those people will eventually develop cirrhosis, an advanced liver disease in which excessive alcohol, fat and other substances kill off liver cells, causing scarring of the liver tissue. The virus can cause liver failure and liver cancer, resulting in the need for a liver transplant.
For decades, patients had no options but older treatments centered on injections of interferon, a synthetic version of an immune system protein that caused many of the nasty side effects. Those treatments could last a year or more, were so unpleasant that many patients dropped out and still barely cured one-half of patients.
Much more effective treatments with easier side effects have hit the market in the last several years, including three others approved by the FDA since November 2013. Those are Johnson & Johnson's Olysio and two from Gilead Sciences: Sovaldi and Harvoni.