What’s the Problem?
The hepatitis C treatment Technivie has been linked to an increased risk for serious liver disease which could require a liver transplant or even cause death, according to the U.S. Food & Drug Administration (FDA).
What is Technivie?
Technivie works by reducing the amount of hepatitis C virus in a patient’s body by stopping the virus from proliferating, which may help slow progression of the disease. The drug is manufactured by AbbVie, and was approved by the FDA in July 2015.
FDA Warning on Technivie Liver Disease
In October 2015, FDA issued a Drug Safety Communication warning that use of Technivie and Viekira Pak (another hepatitis C drug made by AbbVie) may lead to significant liver injury, particularly in patients with pre-existing liver disease. As a result of these problems, the agency required that information about the liver injury risk be added to the “Contraindications,” “Warnings and Precautions,” “Postmarketing Experience,” and “Hepatic Impairment” sections of Technivie drug labels.
A review of FDA’s Adverse Events Reporting System (FAERS) found cases of hepatic decompensation and liver failure — some of which resulted in liver transplantation or death — in hepatitis C patients who took Technivie or Viekira Pak.
Since Viekira Pak was approved in December 2014, at least 26 adverse events have been linked to it and Technivie. Of these, 10 patients experienced liver failure resulting in liver transplant or death. In most cases, liver injury occurred within one to four weeks of starting treatment.
Liver Disease Symptoms
Patients who take Technivie have been advised by the FDA to not stop using the medication without a doctor’s consent, as doing so could result in drug resistance to other hepatitis C therapies. If you take Technivie and develop any of the following symptoms of liver disease, you should contact your doctor immediately:
- Loss of appetite
- Yellow eyes or skin (jaundice)
- Light-colored stools
FDA is also advising healthcare professionals to closely monitor Technivie patients for signs of exacerbating liver disease including ascites, hepatic encephalopathy, variceal hemorrhage and/or increases in direct bilirubin in the blood.
How Hepatitis C Affects the Body
Chronic hepatitis C infection can cause scarring of the liver (cirrhosis). As the disease progresses, symptoms such as skin problems, blood disorders and fever may appear. Over the long-term, hepatitis C can lead to severe liver damage, liver cancer, and liver failure. These effects may be exacerbated by the use of Technivie.
Technivie Side Effects
- Liver disease
- Liver failure
- Hepatic decompensation
- Hepatic failure
- Allergic reactions
- Thinning blood
- Difficulty sleeping
1970s – Hepatitis virus identification
1970s – Non-A, non-B hepatitis virus identified as causing cirrhosis and liver cancer.
1989 – Virus Discovered
1989 – Hepatitis C virus discovered.
Dec 2014 – FDA approves Viekira Pak
December 19, 2014 – FDA approves Viekira Pak to treat hepatitis C genotype 1.
Jul 2015 – Approved for treatment
July 24, 2015 – Technivie approved for the treatment of chronic hepatitis C genotype 4.
Oct 2015 – Increased risk warning
October 22, 2015 – FDA warns of increased risk of liver disease with Technivie and Viekira Pak.
- “FDA approves Technivie for treatment of chronic hepatitis C genotype 4”. U.S. Food & Drug Administration (FDA). July 24, 2015.
- “FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie”. U.S. Food & Drug Administration (FDA). October 22, 2015.
- “Medications to Treat Hepatitis C – A Timeline”. Hepatitis Central. June 2016.