Tag Archives: Viekira XR

Hepatitis C Therapies Added to WHO Essential Medicines List

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Since 1977, the World Health Organization (WHO) has published its Essential Medicines List containing the medications considered to be the most effective and safe to meet the important needs in a health system. This year, the organization has included the following Hepatitis C (HCV) Direct Acting Agents (DAAs) Sovaldi (Gilead), Olysio (Janssen), Harvoni (Gilead), Viekira/Viekira XR (AbbVie), Daklinza (Bristol-Myers Squibb), Technivie (AbbVie), and Epclusa (Gilead) (WHO, 2017). Notably absent from this list is Zepatier (Merck) – to date, the lowest priced HCV DAA with a Wholesale Acquisition Cost (WAC) of $54,600.

World Health Organization logo

Since the 2013 launch of Sovaldi and Olysio, new drugs to treat HCV have entered the market at a relatively rapid pace, from just two drugs in 2013, to nine drugs by 2016. That said, two or more new drugs hit the market in 2017:

AbbVie’s new next generation protease inhibitor & NS5A inhibitor known as G/P or GLECAPREVIR/PIBRENTASVIR; Gilead’s new triple [combination] of Sofosbuvir + Velpatasvir + Voxilaprevir which contains their new protease inhibitor (Vox.); [Merck’s new triple combination] (Uprifosbuvir) + Grazoprevir + Rusasvir; [Janssen’s] new triple AL-335 + Odalasvir + Simeprevir (Levin, 2017).

With so many treatment expensive options available to treat HCV, as well as the availability of reasonably priced generics in lower-income countries, there is little doubt that these medicinal cures for HCV should be included in every nation’s list of essential drugs. Furthermore, research shows that the generic versions of Sovaldi, Daklinza, and Rebetol (Ribavirin) are as effective as their brand name counterparts (Preidt, 2016).

Some concerns exist, however, that the high cost of treating HCV in nations who are forced to pay the high price for brand name drugs will prevent these cures from reaching the patients most in need. The Centers for Disease Control and Prevention (CDC) recently released a report detailing how restrictive state Medicaid policies – as well as state restrictions regard Syringe Exchange Services/Programs (SESs/SEPs) – are contributing to the vast increase in new HCV infections (CDC, 2017). Most states’ Medicaid programs require Prior Authorization (PA) standards for HCV drugs that are stricter than for most cancer-related treatments, in no small part because those prerequisites serve as cost containment tools – the more complicated and cumbersome the requirements, the less likely the program is to have to cover the cost of treatment.

While the inclusion of HCV DAAs to the WHO Essential Medicines List is an important step forward toward nations including them on their own lists, the high cost of the medications may prove prohibitive to some nations doing so. As the battle over “what the market will bear” soldiers on, HEAL Blog will continue to monitor the situation.

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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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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"

Photo Source: 3Dprint.com

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.
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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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