Daklinza Approved for Genotype 3 HCV Patients

The FDA approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. This is the first drug, among the new breed of anti-HCV molecules with the potential for cure, that is indicated for genotype 3 infections. Gilead's Sovaldi and Abbvie's Viekira Pak are both primarily indicated for individuals infected with genotype 1a and 1b of the virus. 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 according to the FDA release.

Hepatitis 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 scarring and poor liver function (cirrhosis) over many years, which can even develop into cancer. According to the CDC, approximately 2.7 million Americans are infected with HCV of which, approximately 10% are genotype 3. “Today’s approval provides a new option for patients with genotype 3 HCV, including those patients who cannot tolerate ribavirin,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The safety and efficacy trial of the combination was conducted in 152 treatment-naive and treatment-experienced participants with chronic HCV genotype 3 infection. Participants received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24 weeks post treatment. Results showed that 98% of the treatment-naive participants with no cirrhosis of the liver and 58% of the treatment-naive participants with cirrhosis achieved sustained virologic response (SVR). Of the participants who were treatment-experienced, 92% with no cirrhosis of the liver and 69% with cirrhosis achieved SVR. The most common side effects observed were fatigue and headache.

Today's approval will once again raise the cost debate with these drugs, as was seen when Viekira Pak brought in competition for Sovaldi. The pharmacy benefits manager (PBM) Express Scripts initiated price negotiations with the manufacturers, which resulted in Abbvie's drug acquiring a preferred status on the PBM's formulary. It'll be interesting to see how payers and PBMs react to this new approval.