Bristol-Myers wins approval for 1st hepatitis C type 3 drug

Technivie (ombitasvir, paritaprevir and ritonavir) has been approved by the U.S. Food and Drug Administration, in tandem with ribavirin, to treat hepatitis C genotype 4 infection among people without poor liver function (cirrhosis) and without scarring.

The FDA said the combination therapy was the first to show safety and efficacy in treating genotype 4 hep C virus infections without interferon, another drug for the infection. As reported by the Centers for Disease Control and Prevention, approximately 2.7 million Americans are infected with HCV of which, approximately 10 percent are genotype 3.

Bristol-Myers says the list price for Daklinza, also known as daclatascir, will be $63,000 for a course of treatment, though insurers likely will seek big discounts to cover it.

Symptoms of cirrhosis may include a yellowing of the eyes and skin called jaundice, abdominal fluid retention and liver cancer.

The safety and efficacy of Daklinza in combination with sofosbuvir were evaluated in a clinical trial of 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection. Ninety-one participants received Technivie with ribavirin once daily for 12 weeks. Results indicated 98% of treatment-naïve participants without liver cirrhosis and 58% of the treatment-naïve participants with cirrhosis achieved sustained virologic response at 12 weeks. All sufferers who acquired Technivie with ribavirin achieved SVR12, in comparison with 91 % of sufferers handled with Technivie with out ribavirin. Additional safety information for those drugs was available from the Viekira Pak trials. The most common side effects of Daklinza with sofosbuvir were fatigue and headache. Contraceptives containing ethinyl estradiol must be discontinued prior to starting Technivie.

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, as said by the release, and the approval is based on clinical data of 135 patients.