Tag Archives: HCV

The State of Hepatitis C Coverage in America – Part 2: Medicaid

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

In our final HEAL Blog post of 2018, we will be continuing from last week our analysis of Hepatitis C (HCV) coverage in the United States. While this was originally designed to be Part 2 of a three-part series, the decision was made to cut this month short by whittling that down to just two posts for the month of December.  As such, this final HEAL Blog will focus on the state of Medicaid coverage for HCV Direct Acting Antivirals (DAAs). Read Part 1, The State of Hepatitis C Coverage in America – Part 1: ADAP.

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

At the time of our inaugural report in January 2015, only 38 state Medicaid programs offered coverage for HCV DAAs. Even then, access to these treatments was severely limited by numerous onerous Prior Authorization pre-requisites, primarily those which required patients to suffer moderate-to-extreme liver decomposition and scarring – scores of F3 or F4 – before even being considered for treatment approval. Other pre-requisites include(d) sobriety requirements, drug use prohibitions, enrollment in recovery treatment programs, and numerous appeals.

In addition to these pre-requisites, both the states that ostensibly offered coverage and those that did not openly argued that made no bones about restricting or refusing coverage based on cost. So overt was their argument and pervasive the problem that the Centers for Medicare & Medicaid Services (CMS) issued a guidance letter to every state Medicaid program specifically stating that cost considerations “…should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections” (Center for Medicaid and CHIP Services, 2015).

With the CMS guidance was announced in November 2015, by August 2016, every state Medicaid program had expanded their coverage to include HCV DAAs. Since August 2016, every state has continued to offer coverage…again, ostensibly. Over time, several states have either reduced or eliminated the F-score requirements for treatment consideration, as well as removing other pre-requisites, the most recent of which was Oregon (this has not been officially announced, yet, so the citation is forthcoming).

As we have covered numerous times since Mavyret’s (AbbVie) August 2017 debut (including in last week’s HEAL Blog), the introduction of the drug at a remarkably lower Wholesale Acquisition Cost relative to other available DAAs allowed many programs to begin reducing or eliminating restrictions altogether. And, again, looking forward to the January 2019 release of Gilead’s authorized generic versions of their breakthrough drugs, Harvoni and Epclusa, the cost of HCV treatment continues to decline in part because of innovation, but mostly, because of AbbVie’s 2017 salvo with the lowest priced DAA on the market.

There are, however, newer DAAs in the pipeline. 2018 was the first year since 2013 in which a new HCV DAA was not released into the U.S. market. With prices demonstrably lower than the initially unconscionably high prices in 2013, it is unclear whether pharmaceutical companies will stay in the HCV game – Janssen, makers of the now-discontinued Olysio, the once-companion drug to Gilead’s Sovaldi – bowed out of game at the end of 2017, pulling Olysio from the shelves in May of this year. Companies that once assumed that their HCV drugs would enter into a highly competitive, high-priced market are coming up against incredibly popular and effective drugs that cost roughly 1/3 of the original DAAs. That difference in entry price does not bode well for newcomers or new drugs hoping to gain a foothold in the market.

The Community Access National Network will continue to monitor the state of HCV coverage in the U.S. Until next year, we wish you and yours the Happiest of Holidays and an even Happier New Year.

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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The State of Hepatitis C Coverage in America – Part 1: ADAP

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 month of December is filled with various holidays, parties, and celebrations. As such, we, here at the Community Access National Network, do everyone the favor of not releasing an 80+-page report to allow everyone the opportunity to take a break from poring over state-by-state treatment coverage charts, sifting through maps, and drinking in the latest news. Instead, we encourage you to pour yourself an eggnog, sift some ground nutmeg on top, and drink in some good cheer. In lieu of this month’s HIV/HCV Co-Infection Watch Report, we are doing a three-part HEAL Blog covering what has been a year of changes for the better, often despite the world around us.

HIV/HCV Co-Infection Watch

HIV/HCV Co-Infection Watch

In January 2018, we reported that there were 37 states (including the District of Columbia and Puerto Rico) that had expanded their AIDS Drug Assistance Programs (ADAPs) to include coverage for Hepatitis C (HCV) Direct Acting Antivirals (DAAs). To put this in perspective, in our inaugural edition in January 2015, there were only seven states (CA, CO, HI, IA, MA, MN, & NJ) that offered coverage for these drugs. Three years later, and 30 additional states have expanded coverage? That is a sea change of epic proportions.

In November 2018, we reported that there are 39 states (including the District of Columbia and Puerto Rico) that have expanded their ADAP programs to cover HCV DAAs. By comparison, in November 2015, there were 14 states that offered coverage, which, for that year, doubled the number of states covering DAAs. At the time, that was fantastically encouraging.

This trend of expanding coverage continued throughout the following years, and while these gains are impressive – particularly the fact that Mississippi expanded coverage – there is still work to be done. Including the U.S. Territories, there are still 17 ADAP programs (AK, CT, ID, IN, KS, KY, MT, NV, OH, SC, UT, VT, WY, Federated States of Micronesia, Guam, Palau, and the U.S. Virgin Islands) that offer no coverage or cover only Basic HCV treatment regimens (i.e. – Pegylated-Interferon and Ribavirin – treatment regimens that are no longer the standard of care for many years now).

Our colleagues over at the National Alliance of State and Territorial AIDS Directors (NASTAD) have done amazing work over the years to convince ADAP programs to expand their coverage, and Amanda Bowes, a Manager on NASTAD’s Health Care Access Team, presented an excellent set of reasons why ADAP programs choose to offer coverage (which can be found here – http://www.tiicann.org/urls/CANN-PPT-2-Bowes.pptx.

So, what will get these states and territories over the finish line? It is likely going to take an even more severe reduction in the cost of medications. With the impending release of Gilead’s authorized generic versions of Harvoni and Epclusa in January 2019 – the Wholesale Acquisition Cost (WAC) of which will be just $24,000 for twelve weeks of treatment (Hee Han, 2018) – we can hope that more states will decide that they can afford to expand coverage.

Of particular concern are Alaska, Indiana, Kentucky, and Ohio, three states that have been hit considerably hard by dual opioid and HCV epidemics in the past few years (as well as increases in HIV transmission related to Injection Drug Use among opioid and heroin abusers). With many of the newly infected HCV patients already being positive for or simultaneously contracting HIV andthe high burden of opioid and heroin abuse on the poor, it is likely that many of these patients will be eligible for their respective states’ ADAP programs. Coverage for HCV DAAs in these states is critical to ensuring that further costs associated with failing to treat and cure HCV are not shifted onto ADAPs.

As far as the territories are concerned, expansion of their respective ADAP programs to cover HCV DAAs is anybody’s guess. Every article we read about healthcare coverage in the U.S. territories indicates that they are essentially crumbling as a result of a fundamental failure of Congress to adequately fund territorial healthcare programs, including those that provide coverage of HIV or for the poor. The U.S. has long abdicated its responsibility to support these territories, and that is unlikely to change. Worse, still, despite having Congressional representation, these territories have little say in how the U.S. government treats them. If the Trump Administration’s response to Hurricane Maria’s total devastation of Puerto Rico is any indication, it is unlikely that they even know that the other territories exist, much less will they lift a finger to provide any resources to them.

All in all, 2019 may be the year that gets all the remaining states, at least, over the HCV DAA coverage hurdle.

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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Shorter Treatment Durations Prove Both Effective and Cheaper

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

Whenever I begin conversations about Hepatitis C (HCV) pharmaceutical costs, I use the following spiel:

The new drugs that treat Hepatitis C are phenomenal and have amazing success rates in the 90-100% range across all genotypes. That said, the first of these drugs was only introduced to the market in 2013 – Sovaldi – and it came out at a cost of $84,000 for only twelve weeks of treatment. In 2014, the next big drug – Harvoni – came out at $94,500 for twelve weeks of treatment. Since that time, newer, better drugs have been released after significantly lower prices. The cheapest, right now, is Mavyret, at $26,400 for eight weeks of treatment and $39,600 for twelve. While that is a significant reduction in the list price of these drugs, it is stillnot comparable to other conditions, like HIV. One of the newest HIV drugs, Biktarvy, is $35,839 per YEAR– for twelve MONTHS of treatment. It is essentially ¼ the cost of Hepatitis C medications per month, and what is worse is that exponentially more people are living with Hepatitis C than HIV.

When I give them this spiel, the response I consistently receive is, “FOR TWELVE WEEKS?!” “Yes,” I tell them.

Rx medicines on $100 bills

Photo Source: Consumer Reports

The argument against using these numbers – the Wholesale Acquisition Cost (WAC) – is that, in the complicated and clandestine world of pharmaceutical pricing, WAC prices are essentially “suggestions.” The actual prices paid for these medications by insurance companies, Medicaid, Medicare, the V.A., prisons, or patients is entirely subject to very secretive, entirely confidential pricing negotiations, rebates, purchasing agreements, and other arrangements that mean everyone EXCEPT for patients paying out-of-pocket with no insurance coverage wind up paying anywhere from 15%-90% of the WAC.

Even with these steep discounts, payors have used the high costs of these medications to deny or delay treatment for patients until they are “sick enough” to merit treatment, a practice that is both highly unethical, and can result in dire long-term health consequences. But, in the U.S. healthcare system, cash is king, and profits are more important that people, both to the pharmaceutical companies who make these overpriced drugs, and the insurers who refuse to pay for them.

New research, however, has the potential to benefit patients and payors, alike: shortening treatment time maintains efficacy and decreases cost associated with treatment in 50% of patients (DiGrande, 2018). For this 50% of patients, regimen length can be reduced to just six weeks of treatment without compromising the efficacy of the drug; essentially, we can achieve roughly identical results whether treatment lasts six weeks or twelve. The resultant savings could be as much as 20%, according to the first co-author, Harel Dahari, PhD (DiGrande).

Another potential benefit of these findings is that reduced treatment durations may result in more incarcerated persons living with HCV receiving treatment. One of the (several) “tricks” state prisons and county/city jails use to deny treatment to inmates is refusing treatment based upon the time they will remain incarcerated. So, when the treatment norm was twelve weeks, if a prisoner had only six months left to serve on their sentence, they would deny treatment, because they argue that the inmate will not be able to properly initiate and complete the three-month regimen before their release. See? They won’t be able to finish it, so…I mean, GOSH…we just can’t pay for that!” Unfortunately, few Federal judges are finding that argument convincing and are consistently ruling against state Departments of Corrections, demanding that all inmates (or, in certain cases, only the specified plaintiffs) receive treatment immediately. While there is little evidence to suggest that the “time-remaining” excuse will disappear, there is always the likelihood that these findings can be used in court to successfully argue that these excuses are fallacious, at best, and illegal, at worst.

As new drugs continue to be introduced onto the market, along with the introduction of Gilead’s authorized generic versions of Epclusa and Harvoni hitting the market in January at $24,000 for twelve weeks of treatment, the potential exists that the WAC of six weeks of treatment could be $12,000 – 1/7 of the cost of Sovaldi when it hit the market. Moreover, as the drugs improve, that 50% of patients may increase, meaning that even more patients could achieve Sustained Virologic Response in half the time, for even morecost savings.

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 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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Opioids Drive Hepatitis C Infections in New CDC Data

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 Centers for Disease Control and Prevention (CDC) has released new data that estimate that approximately 2.4 million adults are living with Hepatitis C (HCV) in the United States (Hofmeister, et al., 2018). This estimate was reached by analyzing 2013-2016 data from the National Health and Nutrition Examination Survey to estimate the prevalence of HCV in the non-institutionalized population in combination with literature reviews and population size estimation approaches to estimate the HCV prevalence and population sizes for incarcerated people, unsheltered homeless people, active-duty military personnel, and nursing home residents (Hofmeister).

Photo of the CDC Headquarters

Source: George Mason University

These data represent the latest effort by the CDC to more accurately reflect the severity of the HCV epidemic in the United States. The accuracy of this estimate has been significantly hampered by the failure of the CDC to classify HCV as a mandatorily reportable condition (like HIV). Instead, the CDC has left up to individual states whether or not they consider HCV a reportable condition, which has led to a range of wildly varying approaches from no reporting whatsoever, to incredibly detailed reporting that goes down to the county and/or jurisdictional level. These variations have led to certain states providing no functional data about the incidence or prevalence of this deadly virus in their states.

One of the primary drivers of new HCV infections has been the prescription opioid and heroin epidemic that extends into virtually every corner of the U.S.:

Earlier CDC research found that new hepatitis C cases tripled between 2010 and 2016. Most were traced to injection-drug use among younger adults addicted to heroin and other opioids. Adults under 40 have the highest rate of new infections (Norton, 2018).

In states where Injection Drug Use (IDU) is highly prevalent (suburban and rural areas of New England, the Midwest, and Appalachia), IDU accounts for a significant percentage of new HCV infections – in West Virginia and Massachusetts – the states with the second- and first-highest rates of HCV infection respectively – evidence suggests that it is the leading risk factor identified in HCV incidence reporting.

The recent news that Medicaid was expanded by voter ballot initiatives in Idaho, Nebraska, and Utah brings some hope that people living with HCV in those states will gain access to curative treatment. That said, even with Medicaid programs paying for treatment, it is both far cheaper, and more effective to prevent infection, rather than to play “Recovery Medic.” This can be effectively accomplished by establishing (and adequately funding) Syringe Services Programs (SSPs) which have been shown to reduce the number of new infectious disease infections and increase access to and utilization of drug abuse recovery services. Unfortunately, according to a 2017 CDC study, only three U.S. states have laws that “support full access” to both SSPs and HCV treatment (Norton).

For those of us in the HCV data game, these data are of little surprise. While this latest CDC estimate is down from the previous one, there are factors to consider when looking at this decrease: the introduction of HCV Direct-Acting Antivirals has decreased the number of people living with HCV as access to these medications has increase and people who wereliving with HCV have died in greater number as their disease ravaged their livers and other bodily organs. Essentially, people either got cured, or they died (Norton).

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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HIV Patients Co-Infected With HCV Face Higher Mortality Rates

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

A ten-year follow-up study has found that people living with HIV who are co-infected with Hepatitis C (HCV) face an increased risk of mortality by 4.3%, even when receiving treatment for HIV (Bender, 2018). The same study found that treatment with HCV Direct-Acting Antivirals (DAAs) resulted in a lower risk of mortality than those whose HCV went untreated, but that the harm caused by HCV still resulted in increased risk.

'Sensational' Hep C Response Rates in HIV Coinfection Trial

Photo Source: medscape.com

One of the primary consequences of untreated HCV infections is damage to the liver – damage that is no immediately repair itself once the virus is successfully treated. Liver fibrosis – scarring of the liver that prevents the organ from properly functioning – is not healed by HCV treatment, and depending upon the severity of the scarring, the liver may never completely regenerate. Those whose livers are cirrhotic – those with late-stage liver scarring – will likely never fully recover optimum liver function and may become dependent upon other prescription medications and dietary restrictions to aid in liver functions such detoxifying substances in the body, purifying blood, and making vital nutrients (Welch, 2017).

This issue is one that receives far less attention than it deserves and is part of why there is so much opposition against including Fibrosis Scoring in treatment determinations. While it may seem financially prudent in the short-term to limit treatment of HCV to those who are “sick enough” to be treated, the long-term negative health impacts of liver scarring are far costlier in the long-term. For those living with HIV, liver function is of critical concern as that is where most HIV medications are metabolized. If liver function is impaired, the drugs may not properly metabolize, making the treatment of HIV less effective.

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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