Newer Hepatitis C Drugs Linked to Liver Damage

A report issued January 25, 2017 by the Institute for Safe Medication Practices (ISMP) has found that some of the newer drugs used to treat hepatitis C may put patients at risk for liver failure. The report is based on an analysis of 12 months of adverse events (side effects from drugs) reported to the U.S. Food and Drug Administration (FDA) from use of nine antiviral drugs from doctors around the world.

What did the research show?

The ISMP report found 524 incidences of liver failure associated with the drugs, and 165 of those 524 patients died from their liver failure. Another 1,058 patients had reports of severe liver injury. This report comes just after the FDA issued additional safety precautions in October 2016 of using these drugs in people with both hepatitis C and hepatitis B infections. The ISMP report states that while the antiviral drugs appear to suppress the hepatitis C virus, the treatment opens to the door to the reactivation of the hepatitis B virus. All of the 524 cases of liver failure included the direct-acting antiviral drugs, often in combination with each other or with ribavirin. In addition, the report found 761 cases in which the antivirals failed to work.

While the findings from the ISMP report show the need for additional research on the safety of these drugs, the report doesn’t give detailed information on the patients. These medications are approved for hepatitis C, a condition that already affects the liver. It is not clear whether the liver damage and liver failure cases would have existed whether or not the patients were treated with the antivirals.1-2

Expensive treatments get extra scrutiny

Two of the drugs mentioned in the ISMP report were Harvoni® (ledipasvir-sofosbuvir) and Sovaldi® (sofosbuvir), made by Gilead. These drugs are getting additional attention for the safety concerns as they are considered “blockbusters.” They have impressive cure rates and are expensive: ranging from $55,000 to $125,000 per patient, and bringing in significant revenues for Gilead. The ISMP report states the need for additional investigation into the possible “negative consequences of these expensive and important new drugs.” Other drugs included in the report were Daklinza™ (daclatasvir), Zepatier™ (elbasvir and grazoprevir), Viekira XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir), Viekira Pak (dasabuvir, ombitasvir, paritaprevir and ritonavir), Technivie™ (ombitasvir, paritaprevir and ritonavir), and Olysio® (simeprevir).1, 3

Things to consider when starting treatment

The antivirals are an important tool in the treatment of hepatitis C and have been shown to cure many patients. However, with the new safety data, it is important that patients be tested for hepatitis B before starting on one of these antiviral treatments. Patients should talk to their doctor about all medications they are taking, including both prescription and over-the-counter medications, vitamins, and supplements. In addition, patients can and should talk to their doctor about their prescriptions, including questions such as:

  • What are the risks and benefits of this drug?
  • What side effects should I watch for?
  • Are there any side effects that I should get emergency care for?
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