The ID Pipeline: FDA Activity From the Week of August 25, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of August 25, 2019.

FDA Warns of Rare Instances of Serious Liver Injury or Failure With Certain Hepatitis C Treatments

On Wednesday, August 28, 2019, the FDA issued a warning to patients and health care professionals regarding the risk of rare but serious liver injury or failure associated with certain hepatitis C treatments.

When used to treat chronic hepatitis C in patients with moderate to severe liver disease, the use of Mavyret, Zepatier, or Vosevi has resulted in rare cases of worsening liver function or liver failure.

“Hepatitis C virus remains a significant public health issue, but effective therapeutic options have helped patients to receive important curative treatments,” Debra Birnkrant, MD, director of the Division of Antiviral Products within the FDA’s Center for Drug Evaluation and Research, said in a press release. “Chronic hepatitis C, or HCV, is a viral disease that causes inflammation of the liver that can lead to serious liver problems if left untreated. Hepatitis C medicines reduce the amount of HCV in the body by preventing it from multiplying and eventually curing a patient of HCV, which can prevent or slow down the progression of liver disease."

"While FDA-approved treatments for HCV, including Mavyret, Zepatier and Vosevi, have been widely used for many years and are safe and effective, the FDA has received reports of rare but serious instances of worsening liver function or failure when these treatments were used in patients with signs and symptoms of moderate-to-severe liver impairment or other serious liver problems," Birnkrant continued. "It’s important for patients and health care professionals to recognize these drugs are not indicated for use in patients with moderate-to-severe liver impairment and that there are other effective FDA-approved treatment options available for those patients with those conditions. Approved HCV treatments can save lives and when prescribed as indicated, these medicines continue to be safe and effective.”

The full press release is available here.