Officials from the U.S. Food and Drug Administration are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver damage in patients who already have has some damage to their livers. The drugs are Viekira Pak and Technivie.
The FDA will require AbbVie to add new warnings to labeling for Viekira Pak and Technivie after reported deaths and the need for liver transplants in patients who already had liver damage caused by hepatitis C.
Both Viekira Pak and Technivie are newer high-priced treatments for hepatitis C. The warning could reshape the growing field of high-priced drugs to treat the virus. Other new treatments, both of which have high price tags, are Sovaldi and Harvoni, which are from Gilead Sciences.
The FDA said in a statement that the two AbbVie's drugs have been linked to multiple cases of severe liver damage in patients who already had liver cirrhosis, which is irreversible scarring of the liver. The agency determined 26 such events were "probably or possibly" related to the drugs, with the new liver damage usually occurring within four weeks of starting treatment. Ten people either died or needed immediate liver transplants. The agency said that the link between Viekira Pak and Technivie was due to the timing of the start of drug treatment and the severe liver damage.
AbbVie said that although a causal relationship between the two drugs and the liver damage had not been established, the drugs couldn't be ruled out as a cause. The company is updating the prescribing labels for both drugs to add warnings against their use in any hepatitis C patients with more advanced cirrhosis, and to advise doctors to check patients for liver dysfunction before starting treatment.
Viekira Pak and Technivie, along with Sovaldi and Harvoni, are part of a new wave of oral treatments against hepatitis C. In general they are more effective and have fewer side effects than earlier treatments.
Nearly 3 million Americans have hepatitis C, which develops slowly over decades. If hepatitis C is left untreated, it can cause liver failure and liver cancer, requiring transplant.
