Monthly Archives: August 2018

NVHR, HRC, and Center for HIV Law & Policy Come Out Against Hepatitis Criminalization

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

The National Viral Hepatitis Roundtable (NVHR), Harm Reduction Coalition (HRC),  Center for HIV Law & Policy (CHLP) have released a comprehensive new fact sheet regarding the criminalization of Hepatitis (NVHR, 2018). This issue is one that HEAL Blog has covered a number of times in the nearly five years since we’ve been in publication, and one that is vitally important to those who are living with Viral Hepatitis (VH).

According to the fact sheet, 13 states have laws that specifically target people living with VH by criminalizing the transmission of Hepatitis A, B, and C (HAV, HBV, and HCV, respectively), even in cases where the risk of transmission is so infinitesimal that almost no risk exists. These laws generally adhere to the equally unscientific panic associated with HIV criminalization and are intended to reduce the number of transmissions by way of penalizing people, rather than getting to the root of the issues.

Inmate looking out window with bars on it

Photo Source: thedenverchannel.com

For example – the primary manner in which HCV has been transmitted in the U.S. for much of the past decade is via Injection Drug Use (IDU). According to the Centers for Disease Control and Prevention (CDC), the prevalence of HCV among People Who Inject Drugs (PWID) is estimated to be 53.1%. Rather than focus on preventing the spread of disease among PWID by funding options that are much cheaper than incarceration – Syringe Services Programs (SSPs), increasing drug treatment facilities and funding, and placing limits on opioid prescription amounts and dosages (to reduce initial addiction) – these states instead decide to focus their efforts on criminalizing behaviors, resulting in higher rates of incarceration – the most expensive option the ensures that the state will have to be exponentially more to house, feed, and inadequately treat PWID.

Some of the scientifically unfounded “infection risks” include spitting, “allowing” someone to come into contact with blood, semen, urine, feces, or other bodily substances (NVHR). The state of Ohio, for example, makes exposure via these methods a Class 3 felony. In January of this year (2018), a man living with HCV was charged with four felonies for spitting at first responders during the course of an arrest (Jankowski, 2018). HEAL Blog covered this specific arrest in the final post of January (Hopkins, 2018). As we noted in January, neighboring Indiana classifies “Spitting While HCV” as Class 5 and/or Class 6 felony battery, depending on the circumstances and, if you can believe it, the disposition of the “offender” (e.g. – if they are rude, angry, or insolent while exposing someone to a bodily fluid).

These criminalization efforts extend beyond the general population, reaching into state and Federal prisons, resulting in far harsher punishment for inmates living with VH. For current inmates charged under HCV criminalization laws, the punishments can extend sentences for any number of years for violations that can stem from simply spitting at a guard – an action that has virtually no chance of spreading HCV.

It is time for more national organizations to stand up to states’ unscientific criminalization of both HIV, and VH. If that means going to court, then, so be it.

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 Patients Who Abuse Alcohol Suffer Worse Health Outcomes

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

Patients living with Hepatitis C (HCV) have been shown to suffer worse health outcomes if they also abuse alcohol, according to a new study published in Clinical Epidemiology (Specialty Pharmacy Times, 2018)

In addition to the common deleterious effects of excessive alcohol consumption, patients living with HCV who drink excessively also face worse rates of liver-related mortality.  Additionally, between 10-20% of those who abuse alcohol regularly develop liver disease, and 20% of patients with alcoholic hepatitis – an inflammation of the liver that occurs as a result of alcohol consumption – have HCV.

Man holding alcoholic beverage

Photo Source: everydayhealth.com

There are some basic limitations to the study – a lack of data on changes in alcohol consumption over time, as well as a lack of data on the severity of some patients’ alcohol consumption in comparison with others. These limitations make generalizing the results slightly more difficult. That said, researched pointed to previous research findings that indicate up to 30% of people living with HCV may abuse alcohol.

While these limitations exist, it is definitely worth concern, particularly in patients who have not been, or are unlikely to be tested for the virus. This concern is exacerbated in areas of the U.S. with limited access to comprehensive medical treatment, but less limited access to alcoholic beverages. When combined with other factors – endemic poverty, unemployment, and other socioeconomic woes that are shown to lead to an increase in high-risk consumption behaviors – the risk to patients living with HCV who are undiagnosed grows exponentially.

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, American Legion Team Up For Veterans

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

Drug maker AbbVie (Viekira Pak and Mavyret) has teamed up with the American Legion in an effort to extend their Hepatitis C (HCV) outreach efforts to Veterans across the U.S. Their new nationwide campaign, “Take on Hep C,” launched on August 4th, 2018, and will work to provide free HCV antibody testing to Veterans and their communities, beginning with the Sturgis Motorcycle Rally in South Dakota (Bennett, 2018).

AbbVie

Photo Source: dddmag.com

The U.S. Veterans Administration (V.A.) first opened treatment access to all eligible Veterans in 2016 (Kine, 2016), quickly proving to be one of the most successful HCV treatment efforts in the U.S. Because the V.A. receives what is called “Best-Pricing” on pharmaceuticals, they have been able to keep costs contained where other government healthcare payors have been less successful (particularly Departments of Corrections). In fact, the V.A. is on track to eliminate HCV in all Veterans by the end of 2018, curing 59,200 Veterans at a cost of roughly $25,300/soldier (LaMattina, 2018).

Curing U.S. Veterans will no doubt serve as a great first step toward stemming the spread of disease, but there are concerns that still exist. When U.S. healthcare authorities speak of “elimination,” there are always communities who will be left behind – the homeless, the very poor, sexual, racial, and ethnic minorities. These populations are often left out of these treatment opportunities because they may feel ostracized by policies previously held by the military. Of particular concern are those Veterans who received dishonorable or other-than-honorable discharges from the military for being lesbian, gay, bisexual, or transgender either under the Don’t Ask, Don’t Tell (DADT) or prior policies that prohibited open service. These discharges may impact their ability to obtain services through the V.A. With the repeal of DADT, it is possible for LGBT Veterans to receive upgrades to their discharge paperwork (OutServe-SLDN, n.d.).

Ensuring that all U.S. Veterans are cured of HCV is vitally important, and this new effort by AbbVie and the American Legion will go a long way toward achieve that goal.

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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