FDA approvals

FDA approves Technivie for HCV genotype 4

The FDA announces it has approved Technivie to be used with ribavirin for the treatment of adults with hepatitis C virus genotype 4 infection without cirrhosis, according to an agency release.

“Today’s approval provides the first treatment option for patients with genotype 4 HCV infections without requiring use of interferon,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release.

Ed Cox

Edward Cox

Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie) is the first drug to be found both safe and effective in this patient population without the addition of interferon, according to the release, and the approval is based on clinical data of 135 patients. Of these patients, 91 received treatment with ribavirin and 44 underwent treatment without ribavirin. Overall, 100% of the patients treated with Technivie plus ribavirin experienced a sustained virologic response compared with 91% of patients who underwent treatment without ribavirin. 

According to the release, the FDA also wants to notify consumers and health care providers that liver enzymes elevated to more than five times the upper limit of normal in 1% of the clinical trial patients treated with technivie. This was more frequent in female patients taking contraceptives containing ethinyl estradiol, and recommend this type of contraceptive be discontinued prior to beginning treatment with Technivie.

The three drugs in Technivie are also found in Viekira Pak (ombitasvir/paritaprevir/ritonavir/ dasabuvir, AbbVie), a treatment regimen that was approved by the FDA in December 2014 for adults with HCV genotype 1 without cirrhosis, with or without ribavirin.

Disclosures: Cox reports being employed by the FDA.

The FDA announces it has approved Technivie to be used with ribavirin for the treatment of adults with hepatitis C virus genotype 4 infection without cirrhosis, according to an agency release.

“Today’s approval provides the first treatment option for patients with genotype 4 HCV infections without requiring use of interferon,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release.

Ed Cox

Edward Cox

Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie) is the first drug to be found both safe and effective in this patient population without the addition of interferon, according to the release, and the approval is based on clinical data of 135 patients. Of these patients, 91 received treatment with ribavirin and 44 underwent treatment without ribavirin. Overall, 100% of the patients treated with Technivie plus ribavirin experienced a sustained virologic response compared with 91% of patients who underwent treatment without ribavirin. 

According to the release, the FDA also wants to notify consumers and health care providers that liver enzymes elevated to more than five times the upper limit of normal in 1% of the clinical trial patients treated with technivie. This was more frequent in female patients taking contraceptives containing ethinyl estradiol, and recommend this type of contraceptive be discontinued prior to beginning treatment with Technivie.

The three drugs in Technivie are also found in Viekira Pak (ombitasvir/paritaprevir/ritonavir/ dasabuvir, AbbVie), a treatment regimen that was approved by the FDA in December 2014 for adults with HCV genotype 1 without cirrhosis, with or without ribavirin.

Disclosures: Cox reports being employed by the FDA.