Tag Archives: Hepatitis C

Kentucky Moves to Prevent Vertical Hepatitis C Transmission

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 Commonwealth (state) of Kentucky has become the first state in the U.S. to require pregnant women to be tested for the Hepatitis C virus (HCV). This comes as the state is in the grasp of a crippling opioid addiction epidemic that has led to an increased number of new Acute HCV infections in the Appalachian Mountain region (Smith, 2018). This may, in fact, be the first piece of U.S. legislation that makes mandatory the testing of any specific demographic who are not incarcerated, as I have yet to see another law that requires testing, rather than simply mandate that a certain demographic – usually the Birth Cohort (people born between 1945-1965 – be offeredtesting.

The article cited above makes a curious claim:

“The disease can easily spread from mother to child, so starting this month, pregnant women in Kentucky must be screened.”

This asertion is questionable, at best, as the most recent data I’ve seen from the Centers for Disease Control and Prevention (CDC) indicates that vertical transmission occurs in only 5.8% of infants born to mothers monoinfected with only HCV, and 10.8% of infants born to mothers co-infected with HIV and HCV (Koneru, 2016). While vertical transmission is certainly a concern, the data available do not support the claim being made, nor do they necessitate the passage of mandatory testing protocol. In fact, CDC recommendations, which admittedly have not been revised since 2015, list pregnant women under “Persons for Whom Routine HCV Testing Is Not Recommended (unless they have risk factors for infection)” (CDC, 2015).

HCV Screening

Photo Source: Passport Health

I am certainly in favor of universal screening protocols, as evidenced by myriad HEAL Blog posts calling for expanding testing protocols to make testing mandatory in all healthcare settings. That said, it is curious to me that Kentucky has chosen pregnant women as the target of mandatory testing. The cynic in me wonders if this is truly a forward-thinking approach to reducing incidence of HCV transmission, or if it serves another, less altruistic purpose: using test results to infer opioid abuse.

Much of the HCV epidemic in Kentucky can be traced back to Injection Drug Use (IDU) of prescription or illicit opioid drugs (and occasionally stimulants such as methamphetamine). As of June 2018, in 22 states and the District of Columbia, substance use during pregnancy constitutes child abuse, and in three states ((MO, SD, and WI) can result in civil commitment (Guttmacher Institute, 2018). The state of Kentucky has not, yet, criminalized substance use during pregnancy, but given the current political temperament in the state, it isn’t outside the realm of possibility that state legislators will do so in the future. I fear, though there is no current evidence that this is the case, that legislators may use any findings of increased vertical transmission of HCV – HCV infection that may be attributed to IDU – as cause to join those 22 states and DC.

My secondary concern relates to the affordability of HCV testing. The costs of pregnancy are consistently increasing, while wages have remained relatively stagnant. Kentucky’s poverty rate hovers around 19.0%, which makes the various costs associated with being pregnant already burdensome; adding an additional testing requirement that may increase the amount of out-of-pocket spending for pregnant families is a concern.

Those concerns aside, it is always a good thing when HCV testing protocols are expanded. It will be interesting to see if this change in protocol will result in a higher incidence of new Acute HCV infections, or if it will have the desired impact of reducing vertical transmission.

References:

  • Centers for Disease Control and Prevention. (2015, October 15). Testing Recommendations for Hepatitis C Virus Infection. Atlanta, GA: United States Department of Health and Human Services: Centers for Disease Control and Prevention: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention: Division of Viral Hepatitis: Hepatitis C Information: Testing Recommendations. Retrieved from: https://www.cdc.gov/hepatitis/hcv/guidelinesc.htm
  • Guttmacher Institute. (2018, June). Substance Use During Pregnancy. New York, NY: Guttmacher Institute: State Laws and Policies. Retrieved from: https://www.guttmacher.org/state-policy/explore/substance-use-during-pregnancy

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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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French Study Finds Universal HCV Screening Cost Effective

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 May 2016, the World Health Organization (WHO) adopted a goal of eliminating Hepatitis B (HBV) and C (HCV) by 2030.  Some major nations are on the way to achieving that goal (Australia, for instance); others, like the U.S., are not. One reason why the U.S. is falling so far behind others is that we frequently fail to identify patients who are infected with HCV because the screening guidelines are woefully outdated, focusing primarily on “one-time testing” for patients in the Birth Cohort (those born between 1945-1965) and patients whose doctors knowthey use or have used injection drugs.

Journal of Hepatology

Photo Source: EASL

A new study out of France, however, has found that a combination of universal screening for and immediate treatment of HCV was the most cost-effective way to combat the virus. The study, published in the Journal of Hepatology, found that, using their model which did away with “highest risk” screening models like the one used in the U.S., reduced the incidence of hepatic events (i.e. – cirrhosis, decompensated cirrhosis, and liver-related mortality) in undiagnosed adults over the age of 18. The model also considered treatment initiation for all patients with fibrosis scores of 2 or higher, which resulted in reduced Chronic HCV prevalence in one year’s time; treatment initiation regardless of fibrosis score decreased prevalence significantly. A Healio article on this study has a much better explanation of the findings than the Journal of Hepatologysummary, and it can be found at this link:

https://www.healio.com/hepatology/hepatitis-c/news/online/%7B7c00ba17-af2b-4ddb-b0b2-26c8d6fed926%7D/universal-hcv-screening-in-adults-cost-effective-decreases-prevalence

While universal screening and treatment likely would be cost-effective in France (as well as other countries that offer Universal Healthcare), I predict that it would be incredibly difficult to replicate that finding here, in the U.S., primarily because of the way our for-profit healthcare system is structured. Between being constantly (and increasingly) bilked by private insurers and pharmaceutical companies, and the resultant exorbitant costs of testing and treatment, the U.S. is not currently positioned to adopt this strategy. In order for this strategy to be successful, the U.S. would have to fundamentally overthrow the existing healthcare payor model and adopt an intelligent policy of universal provision – an unlikely occurrence given the current legislative and executive political makeup.

That said, there is little stopping better prepared and positioned nations from adopting this strategy, and ensuring that their nations are able to eliminate HCV by 2030.

References:

  • Deuffic-Burban, S., Huneau, A., Verleene, A., Brouard, C., Pillonel, J., Le Strat, Y., Cossais, S., et. al. (2018, July 01). Assessing the cost-effectiveness of hepatitis C screening strategies in France. Journal of Hepatology. https://doi.org/10.1016/j.jhep.2018.05.027

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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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California Plans to Allocate $176 Million to 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

The state of California has revised its 2018-2019 state budget to include $176 million to expand Hepatitis C (HCV) treatment to low-income citizens (Bartolone, 2018).

For low-income recipients of Medi-Cal (California’s version of Medicaid) and inmates in state prisons, access to the Direct-Acting Antivirals (DAAs) that cure HCV by allowing a patient to achieve Sustained Virologic Response – SVR – has been extremely limited. For recipients of Medi-Cal, there were several prior authorization requirements that served as barriers to treatment (Department of Health Care Services, 2015). For patients incarcerated in California state prisons, access has been so difficult that inmates have had to file a Class-Action lawsuit in an effort to force the state to provide the Constitutionally guaranteed access to treatment they should be receiving (Bayse, et al. v. California Department of Corrections and Rehabilitation, et al.).

Medi-Cal

Photo Source: Kaiser Health News

The newly allocated funds – $106m – will primarily go to the correctional system, as the rate of HCV infection is much higher in correctional settings than in the general population (Holzer, 2018). In speaking with colleagues at the National Viral Hepatitis Roundtable, the scuttlebutt around California is that this revision to increase HCV funding is a preemptive step to resolve the pending Class-Action suit against the state. The thinking seems to be that it will be cheaper to pony up the money to treat inmates, now, rather than to wind up paying a potentially much higher amount to accomplish the same goal, as well as potential damages awarded for failing to provide access to treatment.

While these funds are a fantastic development, history has shown that, even when the money is there, changing course is often difficult to implement with any immediacy. We’ve seen, before, that there will always be bugs in the system. Though Medi-Cal hasn’t yet moved to alter the existing prior authorization restrictions, it is highly anticipated that the agency will do so within the coming months (Bartolone). The $70m in additional funds designated to pay for treatment of approximately 2,090 patients. Let’s see if that comes to fruition.

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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Cherokee Nation Hospital Faces Questions About HIV, Hepatitis C Exposure

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 Cherokee Nation in Tahlequah, Oklahoma is once again in the news, though now, for much less laudatory reasons. John Baker, the son of Principal Chief Bill John Baker, resigned from the tribe’s employ on May 1st, 2018, due to actions he took while performing his duty as a nurse at W.W. Hastings Hospital. During his time as a nurse, Baker used the same vial of medication and the same syringe to inject more than one IV bag (though no patients ever had direct contact with the needle).

If this sounds like an egregious breach of protocol, that’s because it is. Tribal councilman David Walkingstick stated in an interview:

“I hope that this was accidental, but Nursing 101, this is common sense. The other side of it is, was it intentional?  Was he out to harm people?  Or was he out to get the extra medicine?” (Newcomb, 2018)

As a result of his “lapse in protocol,” 186 people were possibly exposed to HIV and Hepatitis C (HCV). As of the June 18th, 2018 article detailing this exposure, 118 were tested, with no resultant infections being discovered (News On 6, 2018).

Cherokee Nation Medical Facility

Photo Source: KOTV News On 6

This incident comes on the heels of several positive evaluations of the Cherokee Nation’s efforts to combat the spread of HIV and HCV within the tribe’s borders, which we have covered twice within the past year. Despite these strides, the actions of Baker have sparked fears amongst its members. Native American tribes have, for several centuries, been the victims of various crimes committed against them by governmental and medical authorities, which has fostered a culture of distrust of medical providers within the members. How can tribe members be expected to trust going to W.W. Hastings Hospital if these kinds of “lapse[s] of protocol” – ones that are some of the very basic universal precautions taught to nursing students – are allowed to occur?

The Cherokee Nation has established a panel to investigate what happened, and more importantly, what happens next. If past exposure incidents serve as any indication, Baker may face any number of charges, many of which could be increased if any of the identified patients test positive for HIV or HCV. That said, because the Cherokee Nation has sovereignty – a Federally-recognized status recognized by treaty and law – there is a question concerning whether or not he will face state or Federal charges.

HEAL Blog will continue to monitor this issue and report as the story develops.

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 Death Rate High Among Uninsured and Medicaid Recipients

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

Researchers presenting at Digestive Disease Week found that, between 2000-2010, adult who were infected with Hepatitis C (HCV) were more likely to die if they were either uninsured, or recipients of Medicaid benefits (Basen, 2018). Being HCV-Positive correlated with higher mortality rates (10.4% compared to 3.1% for HCV-Negative patients).

The limitations of these data are several – (a.) the data are nearly a decade old; (b.) these HCV mortality rates are from an era where the only curative treatments for the disease had a treatment abandonment rate of between 40-80%, because the Pegylated-Interferon treatments were almost impossible to tolerate; (c.) an artifact of those older treatments was that the Centers for Disease Control and Prevention (CDC) were not proactive about pushing HCV testing beyond the Birth Cohort (1945-1965).

While these data are nearing ten-years-old, they do reveal some interesting patterns that HEAL Blog has been contending for some time: (1.) Medicaid recipients were more likely to be infected with HCV than those with insurance; (2.) HCV infection rates were highest among the uninsured; (3.) HCV-Positive Medicaid recipients had higher rates of extra-hepatic (illnesses other than those affecting the liver) comorbid conditions, such as diabetes, congestive heart failure, and stroke.

Outpatient Medicaid Office

Photo Source: VinNews.com

Essentially, much like HIV, although neither disease discriminates against any class, color, or education level, those who are poorer, less educated, and minorities are disproportionately impacted by these fatal diseases. More to the point, there is no single rightway to deal with these issues; none of these issues exist in isolation:

  • less education correlates with and contributes to poverty, as well as leaving people less able to understand health risks and how to deal with any diseases they contract;
  • people who are impoverished tend to have less access to comprehensive (or even basic) healthcare services, and if they are poorly educated, they are less likely to utilize healthcare services, because they often don’t recognize symptoms of disease;
  • people who are have less access to healthcare services are likelier to develop chronic illnesses that prevent them from working, thereby increasing their likelihood of remaining in poverty.

Because these problems are interconnected, dealing with just one aspect is an ineffective approach – we cannot just address access to healthcare, because we’re not also addressing how people will pay for healthcare and treatment, nor are we considering the impact that accessing healthcare can have for people who have to miss hourly-wage jobs in order to access said care, and thus lose money, only to have to spend more money.

And, honestly, I don’t know what the answers in today’s America are. In a perfect world, we would have Universal Healthcare paid for by tax dollars that would low- to no-cost out-of-pocket, as well as expanded and affordable public transportation, higher wages, rent control, and free college and university paid for by taxes (like most of the rest of the modernized world). But, we don’t have those things, and it’s not likely we’re going to get those things any time soon.

In the meantime, looking at these data are a great way for us to craft policies to address these issues, particularly as new HCV infections are trending younger and younger, and younger people are less likely to be insured. Food for thought.

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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AASLD & IDSA Release New Hepatitis C Guidance

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 America Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) have released updated Hepatitis C (HCV) guidance for the “…rapid formulation and dissemination of evidence-based, expert-developed recommendations for Hepatitis C management” (HCV Guidelines [dot] Org, 2017).

Using the Guidance on Your Mobile Device

Photo Source: HCVGuidelines.org

The web-based portal was developed over the past few years by ASSLD and IDSA in an effort to address management issues ranging from testing and linkage to care to the optional treatment regimens in particular patient situations (HCV Guidelines). The latest recommendation updates include:

  • One-Time HCV Testing protocol recommendations that include testing for those with risk factors such as Injection Drug Use, Intranasal Drug Use, Users of Long-Term Hemodialysis, et cetera
  • Annual HCV Testing protocol recommendations for People Who Inject Drugs (PWIDs) and HIV-Positive Men who have Sex with Men (MSM)
  • Initial HCV Testing and Follow-Up recommendations that include initial antibody testing, HCV-RNA testing, HCV-RNA testing for those who are risk of reinfection after clearing, Quantitative HCV-RNA testing prior to initial antiviral therapy to determine baseline level of viremia, HCV genotype testing, and notification of no evidence of currently active HCV infection
  • Counseling recommendations for people who test positive for HCV
  • Recommendations that all people who test positive for HCV be linked to a clinician for comprehensive management (HCV Guidelines, 2018)

In addition to those testing updates, guidance is also provided for unique populations, including HIV/HCV co-infected populations, those with decompensated cirrhosis of the liver, patients who develop recurrent HCV infection after liver transplantation, renal impairment, pregnancy, pediatric patients, et cetera. These recommendations are vital for allowing providers to know how best to treat their patients, particularly in areas of the world where several comorbidities tend to exist.

The new guidelines also include guidance for the testing and treatment of HCV in correctional settings, a drum which HEAL Blog and the Community Access National Network in general has been banging for several years, now. These patients, in particular, are going to be a key population in the fight to end HCV and Viral Hepatitis, in general.

The latest guidelines can be found at the following website: https://www.hcvguidelines.org/.

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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