Tag Archives: Hepatitis C

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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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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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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