FDA Approves New, Once-Daily Viekira XR

The FDA (US Food and Drug Administration) has recently given the green-light to a new AbbVie drug, Viekira XR, that combats chronic hepatitis C virus (HCV). Specifically, the drug is intended to be used in individuals who have genotype 1 HCV. The drug is a modified version of AbbVie’s Viekira Pak, which has shown a cure rate of nearly 100% after 12-weeks of the $83,000 treatment.

The Viekira Pak contains the same components as the new Viekira XR, including dasabuvir, ombitasvir, paritaprevir, and ritonavir (which increases paritaprevir levels in the blood). The Viekira combines all of the components, with the exception of dasabuvir, into a tablet that is taken in the morning in a two-tablet dose. A second tablet type that includes dasabuvir is taken in the evening. All dosages are taken along with food.

The new Viekira XR is much simpler in administration, allowing for more flexibility for those with HCV. Three tablets of the Viekira XR are taken once daily along with food, as opposed to the previous multi-step treatments of its kind.

According to the FDA, six clinical trials that proved the efficacy and safety of Viekira Pak paved the way for Viekira XR’s recent approval, as both drugs contain the same cocktail of components. Common adverse effects from the medication, as shown in the trials, were weakness or loss of energy, nausea, itching, fatigue, and sleep troubles. The drug is not intended for use in those with hepatic impairment of a moderate to severe level.

Specifically, Viekira XR is intended for individuals who have compensated cirrhosis or do not have cirrhosis at all. Those with compensated cirrhosis have a 24-week treatment regimen, and those without cirrhosis only need half of the treatment time, with a regimen of 12 weeks. Viekira XR can also be used as a 12-week treatment plan for individuals with HCV genotype 1b. These individuals can have present or absent compensated cirrhosis.

Be on the lookout for more information from AbbVie and others about this new medication, along with others like it!1

For more information, please visit the press release from AbbVie.

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