FDA approves Technivie for chronic hepatitis C treatment
NEW YORK — The Food and Drug Administration announced Friday that it approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and cirrhosis.
Technivie in combination with ribavirin is the first drug that has demonstrated safety and efficacy in treating genotype 4 HCV infections without needing the co-administration of interferon, another FDA-approved drug for treating HCV infection.
“Today’s approval provides the first treatment option for patients with genotype 4 HCV infections without requiring use of interferon,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Approximately 2.7 million Americans are infected with HCV, of which genotype 4 is one of the least common, according to the Centers for Disease Control and Prevention.
A clinical trial of 135 participants with chronic HCV genotype 4 infections without cirrhosis studied the safety and efficacy of Technivie with ribavirin. Ninety-one participants received Technivie with ribavirin once daily for 12 weeks, while 44 participants received Technivie once daily without ribavirin for 12 weeks. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.
According to the study, 100% of the participants who received Technivie with ribavirin achieved a sustained virologic response. Of those who received Technivie without ribavirin, 91% achieved sustained virologic response.
Safety information was available for 316 participants with HCV treated with the recommended dose of Technivie, in addition to other anti-HCV drugs in clinical trials. The three drugs included in Technivie are also included in Viekira Pak, previously approved for the treatment of HCV genotype 1 infection. Additional safety information for those drugs was available from the Viekira Pak trials. The most common side effects of Technivie with ribavirin were fatigue, weakness, nausea, insomnia, itching and other skin reactions.
Technivie carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1% of clinical trial participants. The elevations occurred more frequently in females taking contraceptives containing ethinyl estradiol, which must be discontinued before starting Technivie. Hepatic laboratory testing should be performed during the first four weeks of starting treatment, and as clinically indicated thereafter.