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Does Harvoni cause liver damage?

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 19, 2023.

Official answer

  • Reports of serious liver injury have occurred with several of the new, direct-acting hepatitis C antivirals, including Harvoni.
  • These reports are rare and experts say the findings are inconclusive and should not influence prescribing.
  • Underlying hepatitis B infections that are reactivated when hepatitis C treatments, such as Harvoni, are started can lead to liver failure, liver damage, and even death.
  • In addition, rare reports of liver cancer have been received, usually within 4 weeks of initiating a direct antiviral. However, it does not appear that antivirals are directly responsible.
  • The hepatitis C virus itself can cause liver damage.

Harvoni is a combination tablet containing ledipasvir and sofosbuvir. It may be used to treat certain genotypes of the hepatitis C virus in adults and children over the age of three.

Harvoni prevents the hepatitis C virus (HCV) from multiplying in the body. It is a single combination pill that is given by mouth once a day for 8, 12, or 24 weeks, depending upon your HCV status.

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 injury with Harvoni?

Although the risk of severe liver injury is rare, you should monitor your health and contact your doctor if you develop:

  • Fatigue
  • Loss of appetite
  • Nausea and vomiting
  • Yellow eyes or skin or light-colored stools
  • Weakness.

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

How does Harvoni work?

Harvoni is a combination tablet containing ledipasvir and sofosbuvir.

Ledipasvir works by interfering with a protein, called HCV NS5A that is needed by the virus to replicate itself.

Sofosbuvir interferes with the reproduction of genetic material of the hepatitis C virus, by inhibiting an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself .

The ingredients in Harvoni initially greatly reduce and then completely stop the production of new copies of the hepatitis C virus After a period of time, Harvoni will eliminate the hepatitis C virus in 95% of people who take it, technically curing them.


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