Does Harvoni cause liver cancer or liver damage?

Liver cancer has been reported with direct-acting HCV antivirals, such as Harvoni, but these reports are rare. There are also reports of worsening liver function or liver failure that have mostly been reported in people with pre-existing liver disease. The FDA considers the risk of serious liver injury or liver cancer is rare and the hepatitis C virus itself can cause liver damage.

The risk of developing liver cancer after a cure of HCV with antivirals such as Harvoni is increased in people who also have conditions such as diabetes, non-alcoholic fatty liver disease, or who drink alcohol.

Harvoni also carries a Boxed Warning for the risk of hepatitis B (HBV) reactivation in people coinfected with HCV and HBV, because reactivation of HBV can lead to liver failure, liver damage, and even death. Before starting treatment with Harvoni, your healthcare provider will do blood tests to check for HBV.

Harvoni and Liver Cancer, Liver Failure Reports

A report by the ISMP (Institute for Safe medication Practices) in 2016 identified 524 cases of liver failure associated with direct-acting antivirals for hepatitis C, such as Harvoni (121 cases were attributed to Harvoni), and another 1058 cases of severe liver injury that had not progressed to liver failure. Almost half reported encephalopathy (a decline in brain function that occurs as a result of severe liver disease). 31.5% had died at the time of the report. The authors concluded further investigation is required. Experts say the findings are inconclusive and should not influence prescribing.

The FDA has also acknowledged reports of serious injury with the use of other hepatitis C medications, including ones that also contain sofosbuvir (such as Vosevi), resulting in worsening liver function or liver failure, typically within the first four weeks of starting treatment and mostly in people with moderate to severe liver impairment. In most cases, symptoms resolved or improved after stopping the medicine. The FDA considers the risk of serious liver injury is rare.

Liver damage may also occur if a person being treated with Harvoni for hepatitis C, also has an underlying hepatitis B infection, and it reactivates, causing liver damage. There have also been reports of hepatocellular carcinoma (liver cell cancer) developing within weeks of starting direct-acting antivirals, such as Harvoni, but it does not appear that the antivirals are directly responsible.

In many people, the hepatitis C virus has already caused liver damage. This is because the virus causes inflammation in the cells of the liver, mostly because of the immune system responding to the virus. This inflammation leads to enlargement of the liver in over 60% of people with hepatitis C. This enlargement can cause the sheath that surrounds the liver (called Glisson’s capsule) to stretch, which can cause pain in the liver area. Inflammation also starts the process of fibrosis, which results in a build-up of collagen around the cells. This is seen as scar tissue and it prevents the liver cells from accessing vital nutrients and oxygen, which leads to their death.

What are the symptoms of liver disease?

Your healthcare provider will monitor you throughout Harvoni treatment but call them right away if you develop any signs of liver problems such as:

• Right-sided upper abdominal (stomach) pain
• Unexplained fatigue, tiredness, or weakness
• Loss of appetite
• Nausea or vomiting
• Yellow eyes, yellow skin, or pale (almost white) colored stools.

Your risk of liver injury is also increased if you have preexisting liver impairment, a history of alcohol misuse or you smoke.