Hepatitis C Drug Regimen Simplifies Treatment

People with genotype 1 hepatitis C, who make up about 74% of the hepatitis C population in the United States, have a simplified new treatment option available to them.

The FDA approved a New Drug Application for dasabuvir, ombitasvir, paritaprevir, and ritonavir (Viekira XR) in mid-summer, with AbbVie announcing the approval of the extended-release tablets on July 25. The once-daily medication includes active ingredients found in ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets (Viekira PAK) — which was also developed by AbbVie.

Viekira XR is intended for people with chronic genotype 1 hepatitis C, however, unlike Viekira Pak, it is not intended for people with decompensated cirrhosis. This is the first co-formulated three direct-acting antiviral (DAA) treatment approved for this population.

The prescription consists of three oral tablets taken once a day with a meal. The two options differ because the newer one combines the medications into one fixed dose combination tablet for a once daily therapy. Viekira XR also has a higher daily dasabuvir dose and includes that drug as part of the fixed dose combination.

A news release from the FDA described the criteria for the new treatment:

• Genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin
• Genotype 1b infection without cirrhosis or with compensated cirrhosis

Seven phase III clinical trials consisting of 2300 patients supported the use of Viekira Pak with or without ribavirin for 12 or 24 weeks. Two studies compared the two medications and continued to support its clinical use.

“The approval of Viekira XR provides a new treatment option for genotype 1 hepatitis C patients in the US with clinical trial data using the components of Viekira XR demonstrating 100% cure rates in genotype 1b patients,” said Rob Scott, MD, vice president of development and chief medical officer at AbbVie.