Tag Archives: Viekira XR

AbbVie Launches Website to Improve Awareness of Hepatitis C

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

At this year American Association for the Study of Liver Diseases conference, The Liver Meeting 2018, AbbVie – makers of Viekira Pak, Technivie, Viekira XR, and Mavyret – announced the launch of MappingHepC, an interactive online resource “…committed to improving the awareness of Chronic Hep C epidemiology in the United States” (AbbVie, 2018). This resource is intended to help fill the gap left by inadequate Hepatitis C (HCV) reporting at the local, state, and Federal levels by “…compiling and analyzing data from two large national laboratory companies representing the majority of U.S. patients screened for HCV antibody and/or tested for HCV RNA from 2013-2016” (AbbVie), and is updating soon to include data from 2017.

This tool is an excellent resource of advocates and people within state and Federal governments to visualize various aspects of the HCV epidemic, including the prevalence of antibody screening, HCV RNA-positive test results, age demographics, rates of infection, and HIV co-infection. The latter is incredibly exciting as few states have actively sought to combine datasets from HIV databases and HCV databases within their own Departments of Epidemiology to track HIV/HCV co-infection.

MappingHepC

Photo Source: MappingHepC

The mapping tool is relatively easy to use, with a variety of options that allow for the comparison of data between any two states by clicking on the state. Selecting a state will bring up a floating box that shows a chart, graph, or data point for that state (e.g. – the overall number of HCV RNA+ test results in 2016). This user-friendly design allows for concise data point retrieval – something that is highly sought in the advocacy world, because, let us be honest: whom amongst us really wants to read a detailed report, aside from the data geeks (n.b. – I am a data geek)? If advocates do not want to parse these data-heavy reports, without fail, state and local legislators and executive office holders have even less time or patience with them.

One of the most useful tools for treatment advocacy is the number of people who have initiative treatment. For example, despite West Virginia having the highest rate of infection in the nation, a mere 580 patients have actuallyinitiated treatment. According to the HCV RNA+ map, 4,229 people were HCV-positive in 2016, meaning that 13.71% of patients have been treated for their HCV infection. Compared to Massachusetts – the second-highest rate in the U.S. – where out of 13,783 HCV-positive patients, 2,796 patients initiated treatment (20.28%). These kinds of data are invaluable to patients and advocates fighting to expand access to treatment.

You can access this new site (and its data) by registering on the site: https://mappinghepc.com/.

The registration is quick and painless, and you canopt out of receiving AbbVie E-mail updates.

References:

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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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Three HCV Drugs Quietly Pulled From Market

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

Johnson & Johnson’s hepatitis C virus (HCV) drug Olysio (simeprevir) reached blockbuster status during the second quarter, clocking about $1.2 billion in sales for the first six months of the year (Sheridan, 2014). 

This article from 2014, ominously entitled, “In evolving HCV market, Johnson & Johnson’s Olysio is a blockbuster, for the moment,” a staff writer for BioWorld – a site that provides “actionable intelligence on the most innovative drug development science…” – essentially foretold Olysio’s doom.

The groundbreaking drug first approved by the U.S. Food and Drug Administration (FDA) in 2013 was meant to serve as a companion drug to Gilead’s Sovaldi (sofosbuvir) for the treatment of HCV, Olysio was quickly became the odd man out, in terms of treatment regimens. With a Wholesale Acquisition Cost (WAC) of $66,360 for twelve weeks of treatment, Olysio’s use in combination with Sovaldi (WAC – $84,000) had patients and payors looking at a combined cost of $150,360 to cure HCV in 12 twelve weeks. Unsurprisingly, payors balked at this price point, and instead recommended Sovaldi in combination with the much cheaper ribavirin, with a WAC of between $550-$850 for twelve weeks of treatment. It may not have been as easily tolerated as Olysio, but damn it – it was exponentially cheaper.

Olysio

Photo Source: stoprod.se

By the end of 2014, Gilead had gone the extra step to push Olysio into obsolescence by releasing their breakthrough combination therapy, Harvoni (ledipasvir-sofosbuvir) at a WAC of $94,500. This single-pill regimen could be used in most patients without a ribavirin booster, and proved much easier to swallow, despite the high price point.

And then, came Viekira Pak…

And then, came Daklinza…

And then, came Technivie, Zepatier, Epclusa, Viekira XR, Vosevi, and Mavyret…

In just a few years, Janssen might as well have not even entered into the HCV market. In 2017, the company announced that it was exiting the market. And then, in May of this year (2018), Janssen pulled the plug on Olysio, altogether. Effective May 25th, 2018, Olysio became unavailable in all markets. Janssen reasoned that the availability of [cheaper] pangenotpyic drugs to treat and cure HCV had made Olysio’s presence on the market untenable.

Then, in June 2018, AbbVie – makers of Viekira Pak, Technivie, Viekira XR, and Mavyret – quietly pulled the plugs on both Technivie and Viekira XR. Neither of these drugs really got off the ground and were essentially rendered obsolete within a year or two by Mavyret, which is far cheaper and a better product. Both of these drugs will become unavailable on January 01, 2019.

These won’t be the last casualties of the HCV, either. Some Medicaid programs are playing an interesting game, at the moment, when it comes to contracted drugs for treatment. Hawaii’s Medicaid program, Med-QUEST, operates using five different Managed Care Organizations (MCOs) – AlohaCare, HMSA, Kaiser Permanente, ‘Ohana Health Plan, and United Healthcare Community Plan. AlohoCare, from June to August pared their Preferred Drug coverage for HCV treatment to only Harvoni, Zepatier, and Epclusa – a strange move considering all three drugs are more expensive than AbbVie’s Mavyret.

I say “strange,” because nearly every other Medicaid program in the U.S. has shifted to Mavyret as their preferred drug, with Epclusa and Zepatier straggling along behind. In fact, the other four MCOs that service Med-QUEST have all reduced their coverage to include only Mavyret. AlohaCare is unique amongst the other MCOs in that it is a non-profit organization wholly local to Hawaii, whereas the other MCOs are backed by large national insurers – BlueCross/BlueShield, Kaiser Permanente, WellCare, and United Healthcare. That a local non-profit would reduce its coverage of HCV to exclude the cheapest drug on the market is, again, strange.

While I cannot definitively say that there’s anything nefarious afoot, my guess is that Gilead has cut a deal with AlohaCare to offer Harvoni and Epclusa at much lower prices than Mavyret. How low? Well, we aren’t legally allowed to see those prices, because of existing trade secrets laws.

I anticipate that Daklinza will be the next drug on the chopping block, but that’s just speculation.

References:

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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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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.

References:

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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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