The hepatitis C infection treatments Viekira Pak (AbbVie) and Technivie (AbbVie) may increase the risk for serious liver injury, particularly in those with underlying advanced liver disease, the US Food and Drug Administration (FDA) warned today.
The FDA will now require the company to add information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.
"[T]he labels now state a [contraindication] in patients with moderate to severe hepatic impairment (Child-Pugh B and C). The label previously did not recommend Viekira Pak in Child-Pugh B and was contraindicated in Child-Pugh C," according to an AbbVie statement.
Both medications are used for treatment of chronic hepatitis C infection. Viekira Pak is available in a tablet that contains a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir, and is used with or without ribavirin, which is also used to treat hepatitis C infection. Technivie is available in a tablet that contains a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, and is used in combination with ribavirin.
"Viekira Pak with and without ribavirin remains indicated for genotype 1 HCV patients with compensated cirrhosis, including Child-Pugh A," the AbbVie statement continues. "The safety and efficacy of Viekira Pak, with and without [ribavirin], has been studied in Phase 3 trials in more than 2,300 patients and is one of the recommended regimens in the [American Association for the Study of Liver Diseases] guidelines for these patients. Technivie in combination with [ribavirin] is indicated for genotype 4 HCV patients without cirrhosis."
Hepatic Decompensation, Liver Failure
The FDA approved Viekira Pak in December 2014 and Technivie in July 2015. Since then, at least 26 worldwide cases reported to the FDA Adverse Event Reporting System (FAERS) database were deemed to be possibly or probably related to one of the two drugs. In most instances, liver injury developed within the first 4 weeks of treatment.
The FDA reviewed adverse events that were reported to FAERS as well as those reported to AbbVie. During that review, the FDA found cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking either of the two medications. In some cases, patients required liver transplantation or died.
Most of the reports were in patients taking Viekira Pak who had evidence of advanced cirrhosis before they began treatment with it.
"Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy," AbbVie said in the statement. "Because post-marketing events are reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established."
In some of the cases, the drugs were either contraindicated or not recommended. Because FAERS includes only those reports that have been submitted to the FDA, there are probably more cases of which the agency is not aware, according to the FDA.
The FDA recommends that healthcare professionals closely monitor patients for "signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal haemorrhage, and/or increases in direct bilirubin in the blood."
"The updated [US Product Insert] for Viekira Pak also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients," the AbbVie statement explains.
Healthcare professionals and patients should report adverse events or side effects related to these medications to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online or by calling 1-800-332-1088 to request a reporting form.
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Cite this: Viekira Pak, Technivie May Up Serious Liver Injury Risk: FDA - Medscape - Oct 22, 2015.