AbbVie Receives FDA Approval for Viekira XR

By: Marcus J. Hopkins, Blogger

AbbVie, the makers of the Hepatitis C (HCV) Direct Acting Agent (DAA) drug regimen, Viekira Pak, have received final approval from the Food and Drug Administration (FDA) for their new combination regimen, Viekira XR. The move by AbbVie provides patients with a simpler regimen to follow, in the hopes of increasing regimen compliance.

Stamp marked, "Approved" next to the initial, "FDA"

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The chief complaints about the AbbVie regimens from physicians and patients, alike, have been the use of multiple individual component pills – four with the original Viekira Pak, three with Technivie, and now, three with Viekira XR – as well as the dosing guidelines, which require pills to be taken at different times of the day in order to maintain consistent levels of the drug in the body. These complaints hearken back to similar complaints made about multi-pill regimens used to treat HIV, that required multiple doses per day. Regimen compliance with multi-pill regimens is thought to be lower, because patients report feeling more burdened by having to stop what they’re doing, multiple times per day, in order to take their meds. This argument seems to hold sway, as many of the newest regimens for both HIV and HCV are single-pill regimens (occasionally boosted by a second pill), which require far less effort on the part of busy patients. Viekira XR responds to this by simplifying the regimen down to a once-daily dose of one pill containing ombitasvir, paritaprevir, and ritonavir, and a second pill containing dasabuvir.

Like Viekira Pak, Viekira XR is designed for use in patients living with HCV Genotypes 1a and 1b. Technivie, which has all of the same components as Viekira Pak minus the dasabuvir, is for use in patients with HCV Genotype 4, and was the first DAA drug that was specifically used for that genotype. AbbVie may, however, face considerable competition for their new drug, unless they choose to entre the drug into the market at a lower Wholesale Acquisition Cost (WAC) that Gilead Science’s latest pan-genotypic drug, Epclusa, which hit the market in late June at a price of $75,000 before discounts, rebates, or pricing negotiations. Viekira XR has not yet received a WAC announcement at the time of writing.

Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.


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