Tag Archives: Direct Acting Agents

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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Veterans Affairs Department Provides Reliable Proving Ground for HCV Treatment

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 Veterans Health Administration (V.A.) is one of the most frequently and vocally derided health systems in America. Since its inception in 1930, the V.A. has been plagued by scandal, fraud, malpractice, and quality of care issues. There has been no single decade since 1930 when the V.A. hasn’t faced some sort of scandal, whether it be massive oversights in patient care, exorbitant wait times just to be seen, squalid facilities, or infection outbreaks. One Veteran said to me, during an exchange, “The V.A. can’t get good doctors in there, because nobody wants to be associated with the V.A.” Realistically, the V.A. has earned its poor reputation through decades of mismanagement, underfunding, understaffing, and inconvenient locations. Furthermore, every President since Franklin D. Roosevelt has promised to fix, once and for all, the V.A. health system. None have managed to do so, in whole.

Logo: U.S. Department of Veterans Affairs

Source: U.S. Department of Veterans Affairs

But, it’s not all bad. Improvements, though incremental and rarely immediate, have been made, and there are areas where the V.A. performs brilliantly. Perhaps the best example of this is how the V.A. has dealt with Hepatitis C (HCV) within Veteran populations.

In March of 2016, the V.A. announced that it would be expanding coverage for HCV treatment using Direct-Acting Antivirals (DAAs) to all Veterans in its health system who have the virus regardless of their disease stage (Kime, 2016). Since that time, the V.A. has proven to be the most successful public or private health system in the U.S. for screening, testing, treating, and curing HCV. More importantly, they achieve this not by limiting care to the sickest, but by opening access to the cure for HCV to all members.

As of June 2018, 83.5% of the V.A. Birth Cohort (those born between 1945-1965) have been screened and received HCV testing (U.S. Department of Veterans Affairs, 2018). Since 2014, the V.A. has treated 110,220 (through June 2018), and an average of 323 Veterans are starting treatment every week. The cure rates with all oral DAA therapies is 95%. These statistics are phenomenal, and if they were to be replicated in every healthcare setting, we could likely beat the World Health Organization’s 2030 target for HCV elimination a year or so early. We likely won’treplicate the V.A.’s success in other programs, but that’s a whole other kettle of fish.

So, what does all of this success mean for everyone else? Well, because of the nature of the V.A., all of the data collected are an excellent source of…well, data for other researchers to use for the purposes of making retrospective analyses to assess the risks and benefits of modern HCV therapies (May, 2018). Essentially, because the V.A. has provided treatment using every HCV DAA available, we have a broad base of knowledge to do comparative analyses of efficacy between the various DAAs and across various age, race, and health demographics.

While the V.A. does have serious problems to correct, they are doing a lot of things “right.” HCV – the most fatal disease in the U.S. – just happens to be one of those.

References:

  • Unites States Department of Veterans Affairs. (2018, August). Hepatitis C Virus (HCV) VA IS A NATIONAL LEADER IN HEPATITIS C TESTING, CARE, AND TREATMENT. Washington, DC: United States Department of Veterans Affairs: Office of Public Affairs: Media Relations. Retrieved from: https://www.hepatitis.va.gov/pdf/VA-HCV-Fact-Sheet.pdf

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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 States Expand Access to Hepatitis C Treatment

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 the past two months, three states – California, New Jersey (Hester, 2018), and Rhode Island (Miller, 2018) – have moved or plan to move to drastically reduce the number of prerequisites to gain access to Direct-Acting Agents (DAAs)to treat and cure Hepatitis C (HCV). Here, at HEAL Blog, we have been advocating for such a change since our inception, though it would be hubristic to suggest that a single blog post could account for any change to state Medicaid policies.

As discussed in the previous blog linked above, California’s efforts to expand access likely relate to a couple of Class-Action lawsuits they’ve been facing over the past few years, both from Medicaid clients and incarcerated citizens. Rather than wait to end up paying exponentially more by way of settling or outright losing in court, the state wisely chose to expand access by providing more money through the budgeting process. This additional $176 million will allow the state to open treatment to more lower-income Medi-Cal recipients, as well as those incarcerated.

New Jersey has also broadened coverage for HCV DAAs to cover all Medicaid enrollees in the state once someone is diagnosed with the virus. This policy change was also facilitated by increased funding in the FY2019 budget to the tune of $10m. (Stainton, 2018).

New Jersey’s Medicaid program, however, is run a bit differently. Since 1995, the state’s Medicaid program has been administered by way of Managed Care Organizations (MCOs) – private companies who are contracted to provide and disburse benefits and payments to Medicaid recipients in exchange for a per member per month capitation payment. Currently, there are five private insurers who offer these services: Aetna, Amerigroup NJ, Horizon NJ Health, UnitedHealthcare Community Plan NJ, and WellCare. MCOs are designed to save state’s money by outsourcing the work to private companies for cheaper than the state itself would spend on salaries, pensions, and benefits to administer the program. Of the five MCOs in New Jersey, all but oneplan (Amerigroup NJ) provide drug coverage only for Mavyret (AbbVie), the newest pangenotpyic DAA drug on the market (which is conveniently also the cheapest). Amerigroup alone provides coverage to virtually every other DAA still on the market.

The problem with MCOs is that, because they are private companies providing this service, they are not always quick to adapt to new rules and regulations. There are several states which employ MCOs alongside traditional Fee-For-Service (FFS) Medicaid programs. The rub is that MCOs are required by law to provide the same coverage for clients as the FFS program, meaning that, if the FFS Program covers all available DAA drugs, the MCOs must also offer the same drug coverage. This is rarely the case, and few people, either from the state governments, or individuals who enroll in these plans, ever really push the point hard enough to ensure that MCOs are meeting this requirement. In the case of New Jersey, there is no FFS Medicaid programs; it’s entirely operated via MCOs, which essentially means that it will be difficult for New Jersey’s government to ensure that clients in all five MCOs are receiving access to this expanded treatment.

Finally, Rhode Island has also broadened coverage for HCV treatments. This was accomplished as a result of persistent lobbying by the Rhode Island Center for Justice, the Center for Health Law and Policy Innovation of Harvard Law School, and community activists and lawyers (Miller).

The ball got rolling on this change when a state resident receiving legal representation after being denied treatment by the state’s Medicaid program. The Center for Health Law and Policy Innovation has been tireless in its efforts to expand access to treatment of chronic illnesses both by government-funded programs, and by private insurers. Over the past three years, the Center has repeatedly stepped in on behalf of Medicaid recipients and privately insured individuals to use public pressure and threat of legal action to ensure that patients receive the coverage to which they are entitled, either by Federal law, or by state mandate. They have worked with several states to create HCV medication pilot programs that allow state AIDS Drug Assistance Programs (ADAPs) to offer coverage for HCV drugs that they might otherwise never receive.

All three of these states are moving in the right direction. Hopefully, we will see more forward momentum from other states in the coming months.

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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Absolute Denial of HCV DAA Treatment Not Only Common, But Rising

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 high cost of curing Hepatitis C (HCV) with newer Direct-Acting Antiviral (DAA) drugs has been the fodder of many an article since their introduction into the commercial market in 2013 with Sovaldi (Gilead) and Olysio (Janssen). When Harvoni (Gilead) entered the market in 2014, its Wholesale Acquisition Cost (WAC) of $94,500 for 12 weeks of treatment, it was dubbed “The $1,000-a-Day Pill” by the media and a Congressional investigation was launched in the U.S. State Medicaid programs insisted that treating everyone with HCV on their rolls would not only obliterate their pharmacy budgets, but do so exponentially.

Gilead Sciences tried to do their part by offering a manufacturer Patient Assistance Program (PAP) that offered drastically reduced or free fills on these prescriptions if patients were denied coverage by Medicaid, Medicare, or their private insurer. That program was quickly inundated by patients whose payors instructed them to “…go and get it for free from Gilead.” By 2015, Gilead was forced to restrict the PAP to only the uninsured and those whose insurance denied coverage.

Now, new research published in Open Forum Infectious Diseases has found that, between 2014-2017, 52.4% patients with private insurance who were prescribed DAAs to treat their HCV infection were absolutely denied treatment (defined as “a lack of fill approval by the insurer”). In addition 34.5% of patients on Medicaid were denied, and a paltry 14.7% of patients with Medicare insurance were denied (Gowda, et al, 2018). These findings are compounded by similar research conducted regarding HCV treatment in correctional settings that found less than 1% of inmates infected with HCV in state correctional facilities were receiving treatment (Paukstis, 2018).

denied square red grunge stamp

Photo Source: emdlaw.com

This appalling record of absolute denials of treatment are a large part of why the U.S. has fallen behind comparable nations in achieving the elimination goals set forth by the World Health Organization in 2016, calling for the elimination of HCV as a public health crisis by the year 2030. Worse, these denials have come as the cost of treatment has dropped dramatically, from its high point with Harvoni, to its lowest point with AbbVie’s Mavyret, which has a WAC of $26,400 for 8 weeks of treatment ($39,600 for 12 weeks). Moreover, Mavyret sports comparable Sustained Virologic Response (SVR – “cure”) rates to Sovaldi, Harvoni, and Epclusa (Gilead). Worse still is that the WAC is largely a useless price point, as the vast majority of payors enter into pricing negotiations with the drug manufacturers and receive discounts and rebates that reduce that cost to a mere percentage of the WAC.

And, yet…

America’s healthcare problems are all solvable…in we are willing to go on the offensive against the corporate interests that we’ve allowed to run roughshod over our nation’s healthcare system since the late 1970s. We have allowed private insurers, drug manufacturers, and other private entities to turn healthcare away from being a profession designed to cure people – a system that we, as a nation, helped to flourish and turned into the best in the world in the mid-1900s – and into a for-profit industry whose main priorities revolve around further enriching the already rich.

We can combat diseases like HCV; hell, we managed to eradicate polio in the U.S. by 1979 with a vaccine that was created in 1953 and came into commercial use in 1955, with an oral vaccine following in 1961.

Jonas Salk, the creator of the first polio vaccine, once told Edward R. Murrow, when asked who owned the patent for the vaccine, “Well, the people, I would say. There is no patent. Could you patent the sun?”

Since that time, countless business writers and corporate shills have derided Salk’s statement, going so far as to call it “Communist propaganda.” And, yet, it is because of Salk’s vaccine that we managed to eradicate polio in much of the modernized world.

We need to get back to this way of thinking, as it relates to healthcare. It’s time to pull the profits out of healthcare, altogether, and if that means dismantling the private insurance market, 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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Hepatitis C in Native American Populations

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 August 2017, HEAL Blog covered efforts by the Cherokee Nation to proactively combat Hepatitis C (HCV) within the tribe’s boundaries in Northeastern Oklahoma (Hopkins, 2017). The program, started three years ago, comprised several steps, including compulsory screening of all tribe members aged 20-69, expanding screening locations to include dental clinics, establishing a Syringe Services Program (SSP) within the tribe’s borders, and using Direct-Acting Antivirals (DAAs) to treat those infected with HCV. The tribe, itself, is absorbing the costs of treating its citizens (Juozapavicius, 2018).

Photo Source: HHS

Map of Cherokee Nation

According to the most recent report released by the Centers for Disease Control and Prevention (CDC), deaths related to HCV have been decreasing in every demographic since 2013, including in Native American (NA) populations. That said, NAs still had the highest rate of HCV-related death in 2016, with a rate of 10.75 (per 100,000), down from a staggering 12.95 in 2015 (CDC, 2018). These data indicate that, while the effort by the Cherokee Nation are certainly proving to be effective, there is still a lot of ground to cover.

As with other race demographics, the leading risk for HCV infection is Injection Drug Use (IDU). Doctor Jorge Mira, Director of Infectious Diseases for the Cherokee Nation, indicates in the Juozapavicius article that, over the past two years, he began hearing the word “heroin” more and more, every day. This trend of IDU is in line with other race demographics. The common factors across race demographics are high levels poverty and unemployment. In areas where these factors are present (particularly in rural settings), heroin use and IDU are almost a given.

The efforts to combat the disease within the Cherokee Nation need to be replicated at the state and Federal levels. The reality is that these problems are not going to go away, and in the areas where they’re most prevalent, they are going to get exponentially worse in the coming years. In the meantime, we can look to the Cherokee Nation for their leadership on the issue, and begin implementing them in small scale at the local level.

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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