U.S. Food and Drug Administration today 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 poor liver function (cirrhosis).
in combination with ribavirin is the first drug that has demonstrated
safety and efficacy to treat genotype 4 HCV infections without the need
for co-administration of interferon, an FDA-approved drug also used to
treat HCV infection.
approval provides the first treatment option for patients with genotype
4 HCV infections without requiring use of interferon,” said Edward Cox,
M.D., director of the Office of Antimicrobial Products in the FDA’s
Center for Drug Evaluation and Research.
C is a viral disease that causes inflammation of the liver that can
lead to diminished liver function or liver failure. Most people infected
with HCV have no symptoms of the disease until liver damage becomes
apparent, which may take several years. Some people with chronic HCV
infection develop cirrhosis over many years, which can lead to
complications such as bleeding, jaundice (yellowish eyes or skin), fluid
accumulation in the abdomen, infections or liver cancer. According to
the Centers for Disease Control and Prevention, approximately 2.7
million Americans are infected with HCV, of which genotype 4 is one of
the least common.
safety and efficacy of Technivie with ribavirin were evaluated in a
clinical trial of 135 participants with chronic HCV genotype 4
infections without cirrhosis. Ninety-one participants received Technivie
with ribavirin once daily for 12 weeks. Forty-four 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.
showed that 100 percent of the participants who received Technivie with
ribavirin achieved a sustained virologic response. Of those who
received Technivie without ribavirin, 91 percent achieved sustained
information was available for 316 participants with HCV treated with
the recommended dose of Technivie in combination with 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 (asthenia), nausea,
insomnia, itching (pruritus) and other skin reactions.
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 percent of clinical trial
participants. The elevations occurred more frequently in females taking
contraceptives containing ethinyl estradiol. Contraceptives containing
ethinyl estradiol must be discontinued prior to starting Technivie.
Hepatic laboratory testing should be performed during the first four
weeks of starting treatment, and as clinically indicated thereafter.
Technivie and Viekira Park are marketed by AbbVie Inc. based in North Chicago, Illinois.
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.