AbbVie explains label changes for Viekira Pak, Technivie

In relation to an FDA Drug Safety Communication report released last week about hepatitis C drugs Viekira Pak and Technivie potentially causing liver injury, AbbVie spoke to Healio.com/Hepatology about the changes they have implemented to the drug labels to reflect the risk for injury.  

“The label update contraindicates the use of Viekira Pak and Technivie in patients with Child-Pugh B cirrhosis, also known as decompensated cirrhosis,” Barry Bernstein, MD, vice president, infectious disease development, AbbVie, told Healio.com/Hepatology. “The label updates last week were based on postmarketing reports we have received this year on patients mostly with advanced cirrhosis who had decompensation which was complicated by the need for a liver transplant and in some patients, resulted in a fatal outcome.

Barry Bernstein

“We have been monitoring these reports and analyzing with the FDA and agreed to update our label to reflect these reports.”

In the safety report, the FDA stated that AbbVie, the manufacturer of Viekira Pak (ombitasvir/paritaprevir/ritonavir plus dasabuvir) and Technivie (ombitasvir/paritaprevir/ritonavir), was instructed to add information about safety risks to the drug labels after 26 cases of liver injury were reported and considered to be possibly related to Viekira Pak or Technivie use.

“Of the 26 assessable cases in which causality to components of Viekira Pak or Technivie was attributed to be possible or probable, 10 patients experienced hepatic failure resulting in transplantation or death, and 16 patients experienced various degrees of liver dysfunction,” an FDA spokesperson told Healio.com/Hepatology.

Bernstein explained that the reports are postmarketing reports that are spontaneously received and not from a clinical trial.

“[This makes it] difficult to estimate or establish a causal relationship to the drugs,” Bernstein said. “However, safety is certainly a primary concern for patients receiving any of our medications including Viekira Pak and in consultation and discussion with the FDA, we decided to update the labels to reflect reports.”

The FDA also told Healio.com/Hepatology that these types of cases can be difficult to evaluate. “The postmarketing cases of hepatic decompensation and liver failure are difficult to interpret because they occurred mostly in patients with underlying advanced chronic liver disease,” the spokesperson said. “However, temporal association from starting Viekira Pak or Technivie and resolution of symptoms in some patients after the medicine was stopped suggest a potential causal association.”

According to Bernstein, the original label for Viekira Pak indicated that its use was not recommended for patients with Child-Pugh B cirrhosis, but the update includes the contraindication for this subset of patients, which represents about 3% to 5% of all patients with HCV in the U.S. The indication for use in patients who have Child-Pugh A cirrhosis, or compensated cirrhosis, and those without cirrhosis remains unchanged, according to Bernstein.

“We do monitor all reports received of adverse events and will continue to monitor additional reports of similar adverse events in the future,” Bernstein said.

AbbVie has reached out to clinicians and health care providers to indicate the changes in the label, according to Bernstein.

“We take patient safety and responsibility very seriously and have communicated through multiple different channels.”

The new updates are reflected on both the Viekira Pak and Technivie labels and are exactly the same. However, Technivie had never been indicated for use in patients with any level of cirrhosis, according to Bernstein.

“The labels were slightly different in that regard, but both reflect label changes now,” Bernstein said.

“The FDA emphasizes that Viekira Pak and Technivie are contraindicated in moderate and severe hepatic impairment,” the spokesperson said. “Technivie is not indicated for use in patients with cirrhosis. Some of the postmarketing cases of hepatic failure occurred in patients for whom Viekira Pak and Technivie are contraindicated or not recommended. Some cases provided insufficient data to definitively assess baseline liver status.”

Despite some amount of patients experiencing injury or fatal outcomes, Bernstein said AbbVie is “very confident” with the drugs and their treatment for HCV.

“We remain very confident in the safety profile and we feel Viekira Pak and Technivie are very important therapeutic options for patients with hepatitis C and will remain so,” he said.

The updated label for Viekira Pak can be viewed at http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s008lbl.pdf. The updated label for Technivie can be viewed at http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931s001lbl.pdf. – by Melinda Stevens

Disclosure: Bernstein is employed by AbbVie.

In relation to an FDA Drug Safety Communication report released last week about hepatitis C drugs Viekira Pak and Technivie potentially causing liver injury, AbbVie spoke to Healio.com/Hepatology about the changes they have implemented to the drug labels to reflect the risk for injury.  

“The label update contraindicates the use of Viekira Pak and Technivie in patients with Child-Pugh B cirrhosis, also known as decompensated cirrhosis,” Barry Bernstein, MD, vice president, infectious disease development, AbbVie, told Healio.com/Hepatology. “The label updates last week were based on postmarketing reports we have received this year on patients mostly with advanced cirrhosis who had decompensation which was complicated by the need for a liver transplant and in some patients, resulted in a fatal outcome.

Barry Bernstein

“We have been monitoring these reports and analyzing with the FDA and agreed to update our label to reflect these reports.”

In the safety report, the FDA stated that AbbVie, the manufacturer of Viekira Pak (ombitasvir/paritaprevir/ritonavir plus dasabuvir) and Technivie (ombitasvir/paritaprevir/ritonavir), was instructed to add information about safety risks to the drug labels after 26 cases of liver injury were reported and considered to be possibly related to Viekira Pak or Technivie use.

“Of the 26 assessable cases in which causality to components of Viekira Pak or Technivie was attributed to be possible or probable, 10 patients experienced hepatic failure resulting in transplantation or death, and 16 patients experienced various degrees of liver dysfunction,” an FDA spokesperson told Healio.com/Hepatology.

Bernstein explained that the reports are postmarketing reports that are spontaneously received and not from a clinical trial.

“[This makes it] difficult to estimate or establish a causal relationship to the drugs,” Bernstein said. “However, safety is certainly a primary concern for patients receiving any of our medications including Viekira Pak and in consultation and discussion with the FDA, we decided to update the labels to reflect reports.”

The FDA also told Healio.com/Hepatology that these types of cases can be difficult to evaluate. “The postmarketing cases of hepatic decompensation and liver failure are difficult to interpret because they occurred mostly in patients with underlying advanced chronic liver disease,” the spokesperson said. “However, temporal association from starting Viekira Pak or Technivie and resolution of symptoms in some patients after the medicine was stopped suggest a potential causal association.”

According to Bernstein, the original label for Viekira Pak indicated that its use was not recommended for patients with Child-Pugh B cirrhosis, but the update includes the contraindication for this subset of patients, which represents about 3% to 5% of all patients with HCV in the U.S. The indication for use in patients who have Child-Pugh A cirrhosis, or compensated cirrhosis, and those without cirrhosis remains unchanged, according to Bernstein.

“We do monitor all reports received of adverse events and will continue to monitor additional reports of similar adverse events in the future,” Bernstein said.

AbbVie has reached out to clinicians and health care providers to indicate the changes in the label, according to Bernstein.

“We take patient safety and responsibility very seriously and have communicated through multiple different channels.”

The new updates are reflected on both the Viekira Pak and Technivie labels and are exactly the same. However, Technivie had never been indicated for use in patients with any level of cirrhosis, according to Bernstein.

“The labels were slightly different in that regard, but both reflect label changes now,” Bernstein said.

“The FDA emphasizes that Viekira Pak and Technivie are contraindicated in moderate and severe hepatic impairment,” the spokesperson said. “Technivie is not indicated for use in patients with cirrhosis. Some of the postmarketing cases of hepatic failure occurred in patients for whom Viekira Pak and Technivie are contraindicated or not recommended. Some cases provided insufficient data to definitively assess baseline liver status.”

Despite some amount of patients experiencing injury or fatal outcomes, Bernstein said AbbVie is “very confident” with the drugs and their treatment for HCV.

“We remain very confident in the safety profile and we feel Viekira Pak and Technivie are very important therapeutic options for patients with hepatitis C and will remain so,” he said.

The updated label for Viekira Pak can be viewed at http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s008lbl.pdf. The updated label for Technivie can be viewed at http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207931s001lbl.pdf. – by Melinda Stevens

Disclosure: Bernstein is employed by AbbVie.