FDA Approves New Hepatitis C Therapy

Zepatier is a once-daily, fixed-dose combination containing with the NS5A inhibitor elbasvir and the NS3/4A protease inhibitor grazoprevir.

The hepatitis C treatment market received a new entry on Thursday following the FDA approval of a new therapy by Merck.

Elbasvir and grazoprevir (Zepatier) is administered with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 in adult patients.

Zepatier is a once-daily, fixed-dose combination containing with the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg).

“Today’s approval provides another oral treatment option for patients with genotypes 1 and 4 HCV infections without requiring use of interferon,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA Center for Drug Evaluation and Research.

In clinical trials, the safety and efficacy of the drug was evaluated in 1373 patients with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The patients were administered Zepatier with or without ribavirin once daily for 12 or 16 weeks to determine if the virus was no longer detectable in the blood 12 weeks after completing treatment.

The overall rate of sustained virologic response (SVR) ranged from 94 to 97% in patients with HCV genotype 1 and from 97 to 100% in patients with HCV genotype 4. The recommended length of treatment for Zepatier with or without ribavirin is specifically tailored to the characteristics of the patient and their virus.

Merck subsequently recommends providers screen genotype 1a-infected patients for specific viral genetic variations before treatment to determine dosage regimen and duration.

Elevations of liver enzymes up to greater than 5 times the upper limit of normal were reported in approximately 1% of patients, which generally occurred at or after 8 weeks. Therefore, liver-related blood tests should be administered prior to starting the treatment regimen and at certain times during treatment. The drug should not be administered to patients with moderate or severe liver impairment.

“Continued innovation is needed to help address the worldwide epidemic of chronic hepatitis C virus infection,” said Dr. Roger M. Perlmutter, president of Merck Research Laboratories. “Our clinical program was designed to study a broad range of patients infected with the hepatitis C virus, including difficult-to-treat patients such as those with stage 4 or 5 chronic kidney disease. The approval of Zepatier is a testament to Merck’s unwavering commitment to improving therapy for patients with hepatitis C virus infection, and we are eager to bring this innovation to patients and physicians in the United States.”