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FDA Clears Two New Oral Drugs for Hepatitis C

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Note: This article originally appeared on Medscape. To read the FDA release on Daklinza (genotype 3), click here. For the FDA release regarding Technivie (genotype 4), click here.


The US Food and Drug Administration (FDA) approved two new drugs today for hepatitis C (HCV), one for genotype 3 and the other for genotype 4.

The first medication is a combination of ombitasvir, paritaprevir, and ritonavir (Technivie, AbbVie) in a tablet for use with ribavirin in adult patients with hepatitis C virus genotype 4 infection without scarring and cirrhosis.

“Technivie 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,” the FDA notes in a news release.

Roughly 2.7 million Americans are infected with HCV, according to federal statistics. Genotype 4 is one of the least common.

The safety and efficacy 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 (SVR12) compared with 91% of those who received Technivie without ribavirin.

The most common side effects seen with Technivie plus ribavirin are fatigue, asthenia, nausea, insomnia, pruritus, and other skin reactions.

Elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1% of study patients, according to the FDA. This occurred more often in women taking contraceptives containing ethinyl estradiol. Contraceptives containing ethinyl estradiol must be discontinued prior to starting Technivie, the FDA says. They recommend that liver enzyme testing be performed during the first 4 weeks of starting treatment, and as clinically indicated thereafter.

The three drugs included in Technivie are also included in Viekira Pak (AbbVie), previously approved for the treatment of HCV genotype 1 infection.

Green Light for Daclatasvir in HCV Genotype 3

The NS5A replication complex inhibitor daclatasvir (Daklinza, Bristol-Myers Squibb) also cleared the FDA today for use with sofosbuvir ( Sovaldi, Gilead Sciences) to treat HCV genotype 3 infection.

“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,” the FDA said in a news release. “Today's approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a news release.

The safety and efficacy of daclatasvir 60 mg plus with sofosbuvir 400 mg once daily for 12 weeks were evaluated in 152 treatment-naive and treatment-experienced adults with chronic HCV genotype 3 infection. They were monitored for 24 weeks post treatment.

SVR12 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 the treatment-experienced group, 92% with no cirrhosis and 69% with cirrhosis achieved SVR12.

“The treatment landscape for HCV has radically evolved in recent years, and while we have achieved impressive SVR12 rates in genotype 1, genotype 3 still represents a clinical challenge,” David R. Nelson, MD, from the University of Florida in Gainesville, notes in a company news release.

“Not only are genotype 3 patients more complicated to manage, but the aggressive nature of their disease means there is a greater urgency to treat them. Daklinza in combination with sofosbuvir gives healthcare providers a new option to achieve a high overall SVR12 rate in this difficult-to-treat patient population,” he said.

Fatigue, headache, nausea, and diarrhea were the most common side effects seen with daclatasvir plus sofosbuvir.

Daclatasvir carries a warning that symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is given with sofosbuvir in combination with another HCV direct-acting antiviral, including daclatasvir. “Co-administration of amiodarone with Daklinza in combination with sofosbuvir is not recommended,” the FDA advises.

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