Technivie, (ombitasvir, paritaprevir and ritonavir)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved July 2015

Specific Treatments:

chronic HCV genotype 4

Find Related Trials for The Following Conditions

General Information

Technivie is a fixed-dose combination of ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor.

Technivie is specifically for use in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis.

Technivie is supplied as a tablet for oral administration. The recommended dose of Technivie is two tablets taken orally once daily (in the morning) with a meal without regard to fat or calorie content, for 12 weeks. Technivie is recommended to be used in combination with ribavirin.

Clinical Results

FDA Approval

The FDA approval of Technivie was based PEARL-I, a randomized, global, multicenter, open-label trial that enrolled 135 adults with HCV GT4 infection without cirrhosis who were either treatment-naïve or did not achieve a virologic response with prior treatment with pegylated interferon/ribavirin (pegIFN/RBV). Previous exposure to HCV direct-acting antivirals was prohibited. Treatment-naïve subjects were randomized in a 1:1 ratio to receive one ombitasvir 25 mg tablet, three paritaprevir 50 mg tablets and one ritonavir 100 mg capsule once-daily with food with or without ribavirin for 12 weeks. PegIFN/RBV treatment-experienced subjects received one ombitasvir 25 mg tablet, three paritaprevir 50 mg tablets and one ritonavir 100 mg capsule once-daily with food in combination with ribavirin for 12 weeks. The ribavirin dosage was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg. The primary endpoint was sustained virologic response defined as HCV RNA below the lower limit of quantification (<LLOQ) 12 weeks after the end of treatment (SVR12). The PEARL-I study demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who received Technivie and RBV for 12 weeks. Additionally, 91 percent of patients who were new to therapy achieved SVR12(n=40/44) after taking Technivie without RBV.

Side Effects

Adverse effects associated with the use of Technivie may include, but are not limited to, the following:

  • asthenia
  • fatigue
  • nausea
  • insomnia

Technivie is not recommended for use in patients with moderate hepatic impairment (Child-Pugh B).

Mechanism of Action

Technivie is a fixed-dose combination of ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, and ritonavir, a CYP3A inhibitor.

Additional Information

For additional information regarding Technivie or chronic hepatitis C genotype 4, please visit https://www.technivie.com/