August 10, 2015

Technivie and Daclatasvir Approved for Hepatitis C

By Editor

The US Food and Drug Administration (FDA) has approved two new drugs for the treatment of hepatitis C virus (HCV) genotypes 3 and 4 infections.

Chronic HCV infection affects about 150 million people around the world. Roughly 2.7 million Americans are infected with HCV, and genotype 4 is one of the least common. This condition is a leading cause of cirrhosis and cancer of the liver. Currently the standard treatment for chronic HCV has included a combination of three drugs: ribavirin, pegylated interferon, and a protease inhibitor. Used in association, these three drugs inhibit viral replication and increase the body’s immune response in order to eradicate the virus. This combination of drugs while effective poses a substantial financial burden, is cumbersome to administer and is associated with significant side effects.

The first newly approved drug is Technivie for individuals with HCV genotype 4 infections. Technivie is a combination of ombitasvir, paritaprevir, and ritonavir, available in a tablet for use with ribavirin. Daklinza (daclatasvir) was also cleared by the FDA for use with Sovaldi (sofosbuvir) to treat individuals with HCV genotype 3 infections.

Technivie for HCV Genotype 4

Technivie in combination with ribavirin is the first strategy that has demonstrated safety and efficacy to treat genotype 4 HCV infections without the need for co-administration of interferon.  The safety and effectiveness of Technivie with ribavirin were evaluated in 135 adults with chronic HCV genotype 4 infections without cirrhosis; 91 received Technivie with ribavirin once daily for 12 weeks and 44 received Technivie once daily without ribavirin for 12 weeks.

All patients who received Technivie with ribavirin achieved sustained virologic response at 12 weeks compared with 91% of those who received Technivie without ribavirin.

The most common side effects seen with Technivie plus ribavirin were fatigue, nausea, insomnia, itching, and other skin reactions.

Daclatasvir for HCV Genotype 3

Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin.

Daklinza plus Sovaldi administered once daily for 12 weeks was evaluated in 152 adults with chronic HCV genotype 3 infections and monitored for 24 weeks post treatment.

A sustained virologic response was achieved in 98% of the treatment-naive patients with no cirrhosis of the liver and 58% of the treatment-naive patients with cirrhosis. In previously treated HCV patients, 92% with no cirrhosis and 69% with cirrhosis achieved a sustained virologic response.

Patients with HCV genotype 3 and 4 infections now have new treatmention options to discuss with treatment option to discuss with their healthcare providers.

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CONDITIONS OF THE GI TRACT