Tag Archives: Mavyret

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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AbbVie’s Mavyret Found Safe and Effective in HIV/HCV Co-Infected Patients

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 analysis of two Phase 3 trials evaluating the safety and efficacy of Mavyret (glecaprevir/pibrentasvir) in patients co-infected with Hepatitis C (HCV) and the HIV-1 virus (the most common form of HIV in the United States) has found that the drug is highly effective and safe for use in treatment (van Paridon, 2018). Using a 12-week regimen to treat patients’ HCV resulted in an overall 98% Sustained Virologic Response (SVR – “cure”) in individuals with or without cirrhosis across genotypes 1-5.

Mavyret

Photo Source: Hep Magazine

A total of 152 patients without cirrhosis received an 8-week regimen, while 16 with cirrhosis received the 12-week regimen. Overall, the SVR across all patients was 98% with no relapses in any HIV/HCV co-infected patients with or without cirrhosis. Those patients without cirrhosis who received 8 weeks of Mavyret resulted in an SVR at 12-weeks post-treatment of 99.3%.

Treatment in HIV/HCV-co-infected patients has been tricky from the beginning in no small part because only Sovaldi (Gilead) served as a useable treatment for patients with HIV, because it had the fewest counterindications with the most commonly prescribed HIV drugs. According to an HIV/HCV drug interaction report prepared this month from HEP Drug Interactions – which can be accessed at the following address – which can be downloaded here – most of the HCV Direct-Acting Antivirals (DAAs) have no negative interactions with the individual component drugs of most HIV regimens. Most of the combination drugs – the single-pill regimens most commonly used to treat HIV for the last decade – do have some counterindication with the DAAs…except for Sovaldi (sofosbuvir). Gilead’s other sofosbuvir combinations – Harvoni, Epclusa, and Vosevi – seem to have a greater chance at interacting negatively.

Zepatier (Merck) is a prime example of the aforementioned prescribing circumstance: it works well with individual drug components, but with only one HIV combination drug – Biktarvy (Gilead). Biktarvy is Gilead’s newest HIV regimen and is not yet widely prescribed, though it is recommended as one of the initial regimens for most people with HIV (AIDSinfo, 2018). Zepatier, itself, is only good in treating HCV Genotypes 1 and 4, while Epclusa and Mavyret are pangenotypic (meaning they can be used to treat Genotypes 1-6).

At any rate, HIV patients who are co-infected with HCV are gaining more treatment options as newer drugs are released, which is always a good thing; and, as more regimens emerge, perhaps there will be fewer interactions in the future .

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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Washington State Unveils New Effort to Eliminate HCV by 2030

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

Washington state Governor Jay Inslee signed a directive on September 28th, 2018 that directs state agencies, tribal governments, and other local public health officials to coordinate on a strategy to eliminate the Hepatitis C Virus (HCV) from the state by 2030 (Pacheco-Flores, 2018). This is the first state-led effort in the U.S. to attempt to achieve the 2030 elimination goal set forth by the World Health Organization (WHO) in May 2016.

Gov. Jay Inslee

Photo Source: Spokesman.com (AP Photo/The Olympian, Tony Overman)

Inslee announced this directive at a news conference at Harborview Medical Center in Seattle explaining that the approach uses a combination of increased and expanded prevention screening and increased access to HCV Direct-Acting Antivirals (DAAs) that serve as a functional cure for the disease. Officials estimate that there are 65,000 people living with HCV in Washington state.

There is also a money-saving aspect to this plan that would involve pooling together multiple state departments with purchasing power for drugs (e.g. – Department of Corrections and Department of Social and Health Services). This method, which will also soon be employed in Massachusetts, would allow the state to pull funds into a general purchasing fund to purchase the drugs in bulk at a lower cost-per-capita. This is particularly useful given the relatively recent introduction of lower-priced DAAs such as AbbVie’s Mavyret that have lowered the cost of treatment-per-patient significantly since the initial introduction of DAAs in 2013.

One of the biggest barriers to elimination is going to be the screening/testing apparatus and implementation component. The majority of Washingtonians (and, in fact, all Americans) are unaware that they are infected with HCV, in no small part because there have been few properly funded efforts to adequately screen and test for the disease. While the rapid testing kits are relatively cheap, confirmatory blood testing and genotyping are considerably more expensive. As the directive was only just signed, there are few details about how these procurement and payment processes are going to work. Realistically, given the emerging demographics of new HCV infections nationwide – younger, poorer, and potentially drug-addicted, it is safe to assume that a large swath of those living with HCV may not possess the financial resources to afford to pay for these services. Is the state going to pay for those who cannot afford it? (Likely, not.)

Beyond just cost-related issues, it has been difficult, given the structure of the American healthcare model and funding, to ensure that high-risk demographic groups such as the homeless, rural populations, and People Who Inject Drugs (PWIDs) receive the proper amount of focus they deserve. These populations are notoriously difficult to engage in even basic healthcare services, much less preventative testing and follow-up care.

At the 2017 International AIDS Society conference in Paris, an Australian researcher and provider, when speaking of reaching rural populations stated, “It’s just not that hard.” In nations with universal healthcare, it ISN’T that hard to do proper outreach into these communities, because there’s no question of who will pay for it. In the backward, hackneyed U.S. healthcare system, however, “Who’s going to pay for this,” is a legitimate barrier to doing outreach. Without a specified payor lined up, there is no guarantee that there will be funds to pay for services either from the patients, from the state, or from private insurers. And the sad reality of the U.S. healthcare system is that the best of the suboptimal care is reserved for those who can afford it.

So, while Governor Inslee has taken a great first step, he must work to ensure that the initiative is adequately funded with the presumption that 80%+ of those who need services will be unable to personally pay for them.

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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Gilead Sciences Announces Authorize Hep C Generics for the U.S.

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

Gilead Sciences, makers of the breakthrough Hepatitis C (HCV) drugs, Sovaldi, Harvoni, Epclusa, and Vosevi, have announced that they will be releasing authorized generic versions of its two most popular drugs, Harvoni and Epclusa, in the United States (Hee Han, 2018). The drugs will be introduced into the U.S. market beginning in January 2019 at a list price of $24,000.

Gilead

If this seems counterintuitive to Gilead’s business model, consider the following: their most recent drug for treatment-naïve patients, Epclusa, was released in 2016 at a Wholesale Acquisition Cost (WAC) of $74,760 for a 12-week regimen or $890 per pill. In 2017, Merck introduced its own pangenotypic drug, Mavyret, at $39,600 for a 12-week regimen, with the recommended dosage for most patients being eight weeks at $26,400. Essentially, Merck came in at a little over 1/3 the cost of Gilead’s pangenotypic drug and became the fastest adopted drug for both Medicaid programs and AIDS Drug Assistance Programs (ADAPs) in just four months (Hopkins, 2018).

This decision comes on the heels of a rough couple of years for Gilead’s HCV market. The company managed to weather near-unrelenting attacks following the October 2014 release of Harvoni at a WAC of $94,500, quickly dubbed “The $1,000 Pill” by media outlets and advocates who were outraged at what they considered to be an outlandish price point despite the medication’s efficacy. So great was the furor that Congress convened hearings on the matter, reigniting the smoldering embers of rage against pharmaceutical company drug pricing. The optics weren’t great for Gilead, but despite that, Gilead’s stock price and profits skyrocketed as they essentially cornered the growing HCV market both in the U.S. and abroad.

Generic pill capsule

Photo Source: Forbes

Gilead is no stranger to authorized generics. Four years ago, Gilead struck a deal with seven Indian pharmaceutical manufacturers to develop authorized generics to be sold in poor countries roughly $10 per pill, roughly 1% of the U.S. list price (Harris, 2014). This further enraged Western critics who accused Gilead of price gouging. Gilead’s response, at the time, was that they were only charging “…what the market could bear.” Essentially, they were price gouging with the understanding that, regardless of the list price or any pricing negotiations, rebates, or 340B pricing, they were going to dominate the HCV treatment market with their superior product, and the U.S. healthcare system had no real systems in place to combat them.

In 2018, private insurers and public payors alike have quickly switched their preferred drug over to Mavyret from Epclusa. With the introduction of the similarly priced generics from Gilead in 2019, depending upon the uptake by insurers and public payors, it could potentially mean that Gilead could recapture lost ground in the HCV drug marketplace…assuming that other pharmaceutical companies don’t follow suit (they might).

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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Lower-Priced HCV Drugs Haven’t Improved Treatment Approvals

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 Free Market will work! Competition in the Hepatitis C drug market will force prices down, and everything will be okay!”

This has been the mantra of pharmaceutical companies and market watchers since the 2013 introduction of the highly-effective, but extremely expensive Direct-Acting Agents (DAAs) to treat and cure Hepatitis C (HCV). And, in point of fact, prices for treatment have decreased significantly since Sovaldi hit the market with a Wholesale Acquisition Cost (WAC) of $84,000 for twelve weeks of treatment. The latest (and cheapest) drug to hit the market – AbbVie’s Mavyret – sells for “just” $39,600 for twelve weeks of treatment. But, that twelve-week treatment period is for the most aggressive HCV cases; the recommended treatment for most patients is eight weeks, for which Mavyret goes for $26,400.

Curiously enough, however, healthcare payors have done their damnedest to not cover these drugs for patients. A study published in June of this year (2018), insurance companies deny coverage in 35.5% of cases (over 1/3 of the time); for patients with commercial insurance, the denial rates are even higher (Kaltwasser, 2018).

$100 bill with prescription medicine on it

Photo Source: Consumer Reports

As Kaltwasser points out in his MD Magazine article, previous studies published in 2016 indicated that the approval rate was much higher, and that Medicaid denial rates were higher. While Medicaid approval rates have improved (after a 2015 letter from the Centers for Medicare and Medicaid Services to state Medicaid directors informing that denials based on the cost of treatment violated Federal law), that does little to help the 56% of Americans with commercial insurance.

When patients are denied coverage, there are options – Patient Assistance Programs (PAPs) are designed to aid patients who are either underinsured or whose insurance plans deny coverage of certain drugs. Manufacturer-provided PAPs, like those offered by Gilead Sciences and AbbVie, pay for most (if not all) of the out-of-pocket expenses for purchasing the drug, whereas private PAPs, such as the PAN Foundation, provide assistance for patients whose insurance company agrees to pay for treatment and patients need assistance with the out-of-pocket costs.

Another, more common route is the appeals process, which can take weeks, if not months, and requires a lot of extra groundwork from all parties. Some patients have gone through numerous rounds of appeals and denials, just to get an approval. This process is exhausting, and frankly, it’s not good for the health of patients who go through unnecessary stress just to get the treatment they need (and pay).

Worse, still, is that, while the cost to payors has decreased along with WAC prices, the price to consumers has not.  In fact, for many patients, those costs have increased as insurers place HCV DAA drugs in “Specialty Tiers” or the highest payment tiers in their policy, meaning that patients will pay $100+ out-of-pocket for co-pays.

HIV medications – the newer ones, at least – often fall into this “Specialty Tier” as well. My monthly co-pay for my HIV medications, for example, sets me back $250/month on top of the $285+ monthly premium, for a total of over $500/month. Were these costs not covered by West Virginia’s Ryan White program, nearly ¼ of my monthly income would be dedicated solely to treating my HIV, and that leaves out the up to $500 that each of my biannual doctor visits cost me, including the $75 co-pay, plus the cost of the bloodwork, any X-Rays, or procedures I need done.

HCV patients get to go through all that, and worse, without the benefit of a Ryan White-style program that helps to cover the cost of treatment. And the cost of treatment is higher for HCV on an annual basis.

I know I’ve beaten this drum, before, but the fact is this: until such time as the U.S. joins the rest of the modern world and begins offering Universal Healthcare, patients are going to be the ones getting screwed at every turn, in addition to being nickeled and dimed for every cost a provider can cobble together every time they visit a doctor. Insurance company, pharmaceutical company, and for-profit hospital profits will soar, while patients will continue to struggle to afford even poor-quality healthcare that would be unacceptable in every other First World nation, never mind quality, comprehensive healthcare.

In the meantime, patients living with chronic illnesses are just going to have to suffer through denials, appeals, and ever-mounting medical debt that will leave us scraping by from month to month, just to make ends meet. But, hey! At least we won’t have to suffer the indignities of “Socialized Medicine,” where Conservatives insist that, as David Sedaris once put it, “…patients [will] lie dirty cots waiting for aspirin to be invented.”

Lucky. Us.

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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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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