FDA Approves New Combo Treatment for Hep C

Hepatitis C treatment with Viekira Pak includes cirrhosis patients

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) In recent years, people with hepatitis C have gained several new treatment options. The US Food and Drug Administration (FDA) has added another option to the list.

The FDA approved Viekira Pak to treat patients with chronic hepatitis C genotype 1 infection. The approval includes treatment of patients with cirrhosis, a type of advanced liver disease.

Hepatitis C is a viral infection that damages the liver and can lead to liver failure and liver cancer. According to the Centers for Disease Control and Prevention, most people with chronic hepatitis C do not have symptoms until liver problems develop. In those without symptoms, hepatitis C is usually detected through routine blood tests.

Viekira Pak contains three new medications — ombitasvir, paritaprevir and ritonavir — packaged together with a fourth medication called dasabuvir. Dasabuvir is used to boost blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, another commonly prescribed hepatitis C treatment. However, that combination is not recommended for those with poor liver function.

"The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

"We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens," Dr. Cox said in a press statement.

Viekira Pak was approved after six trials of more than 2,300 chronic hepatitis C patients with and without cirrhosis. Results showed 91 to 100 percent of patients who received the recommended dose of Viekira Pak achieved sustained virologic response, which means the hepatitis C virus could no longer be detected in their blood at least 12 weeks after finishing treatment.

The recommended dose for Viekira Pak is two tablets of ombitasvir, paritaprevir and ritonavir at 12.5 milligrams (mg), 75 mg and 50 mg, respectively, and one 250 mg tablet of dasabuvir twice per day.

The most common side effects in these trials were feeling tired, itching, feeling weak or lacking energy, nausea and trouble sleeping.

Viekira Pak is marketed by AbbVie Inc.

Review Date: 
December 19, 2014
Last Updated:
December 20, 2014