Tag Archives: Hepatitis C

Hepatitis C Prevalence Trends Highest in Western, Appalachian States

By: Marcus J. Hopkins, Policy Consultant

For much of HEAL Blog’s nearly six years, I have been banging the drum about Hepatitis C (HCV) infection rates in rural Appalachia so loudly that our neighbors have filed several noise complaints. Each year, around this time, both state Departments of Epidemiology and the Centers for Disease Control and Prevention (CDC) begin issuing the Acute HCV infection rates for the U.S. from two years prior (e.g. – in 2019, the figures for 2017 will be released), and between February and June, I spent much of my time trying to convince legislators, infectious disease advocates, HIV advocates, and local politicians about why it is vital to pay better attention to this disease.

State-Level Map Showing Impact of Hepatitis C Epidemic Across the U.S.

Photo Source: HepVu

For example, West Virginia – my home state – recently released a horrifying graphic: from 2016 to 2017, our rate of Acute HCV infections rose from 5.1 (out of 100,000) in 2016 to a staggering 9.1 in 2017(West Virginia Electronic Disease Surveillance System (WVEDSS), 2018). While these data are provisional (meaning that the finalized rate may be slightly lower), a 4-point increase in infection rates goes beyond a “call for alarm,” and into “disaster simulation” territory. Surrounding states – namely Ohio and Kentucky, as well as the District of Columbia – share equally troubling infection rates.

New findings published in the Journal of the American Medical Association Network Open indicate that, outside of Acute HCV infection incidence, HCV prevalence rates are high in several Appalachian and Western states. A total of 9 states (CA, TX, FL, NY, PA, OH, MI, TN, and NC) accounted for more than half (51.9%) of all persons living with HCV infection between 2013 to 2016 (Masoud, 2019).

So, what makes these prevalence numbers so different from infection rates (incidence)? For one thing, population. Incidence rates can be used to determine the likelihood or risk that someone will contract a disease. In states with a smaller population (like West Virginia), even though fewer people are contracting a given disease, the incidence rate will be higher than in a state where more individuals contract a new infection, but the population is exponentially larger.

For example: in 2016, there were 94 confirmed new Acute HCV infections in West Virginia, which had a population of 1,829,000, resulting in an incidence rate of 5.1 (out of 100,000 people); in New York, however, there were 179 confirmed new Acute HCV infections, but the population, there, was 8,615,000, resulting in an incidence rate of 0.9. The roughly 7 million additional people in the state lowers the risk of infection significantly.

With prevalence, we’re looking at the number of people who are living with a disease, regardless of whether or not they became infected during a specific year. So, if we are looking at a period of time – 2013 to 2016, for instance – anyone who was living with HCV during those years is counted in a prevalence count, even if they were notnewly infected during one of those years. To break it down in easier terms, “incidence” tells us the number of newly infected persons in a given year/period, whereas “prevalence” tells us how many people were living with the disease at that time.

What the JAMA Network Open study found was that the U.S. national prevalence for HCV from 2013-2016 was 0.84% in American adults who were not institutionalized and was adjusted upwards to 0.93% to account for those populations not included (Masoud). States whose prevalence rates were above that national average includes: AZ (1.10%), CA (0.99%), DC (2.32%), KY (1.16%), LA (1.30%), NM (1.61%), OK (1.71%), OR (1.48%), RI (1.16%), TN (1.28%), and WV (1.35%). Of these states, four are Western (AZ, CA, NM, and OR), and four are Appalachian (DC, KY, TN, and WV).

These findings indicate the need for additional resources, research, and outreach in Appalachia and the American West. Moreover, the study’s conclusion states that:

Prevalence of HCV infection varies widely in the United States. Highest rates are frequently in states deeply affected by the opioid crisis or with a history of increased levels of injection drug use and chronic HCV infection, particularly in the West. Progress toward hepatitis C elimination is theoretically possible with the right investments in prevention, diagnosis, and cure.

Truer words have rarely been spoken.

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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Study Findings Suggest Universal Hepatitis Screening for Cancer Patients

By: Marcus J. Hopkins, Policy Consultant

A study published in The Journal of the American Medical Association Oncology (JAMA) found that many newly-diagnosed cancer patients may be unaware of being infected with Hepatitis B (HBV), Hepatitis C (HCV), and/or HIV (Barrett, 2019). The study examined data from 3,051 patients who enrolled between 2013 and 2017 who received blood tests to determine their HBV, HCV, and HIV status, and is the largest study to date of these viruses in cancer patients.

The Journal of the American Medical Association

Photo Source: JAMA

Of the 3,051 participants, 6.5% of patients had HBV (0.6% with a Chronic HBV infection), 2.4% had HCV, and 1.1% had HIV. Of these patients, 87.3% of HBV-infected, 42.1% of Chronic HBV-infected patients, and 31% of HCV-infected patients were undiagnosed prior to this study’s screening. Researchers noted that these findings comport with infection rates in the general population (Ramsey, et al., 2019).

Most concerning is that many of those who were newly diagnosed with HBV and HCV had no identifiable risk factors for infection (e.g. – injection drug use). The researchers concluded that universal Viral Hepatitis screening of cancer patients may be warranted in order to prevent viral reactivation and other adverse clinical outcomes.

HEAL Blog has been calling for universal screening for years, not only for cancer patients, but for the general population. Numerous studies have found that routine rapid HCV testing (particularly in communities where drug use is prevalent) is incredibly cost-effective in both younger generations and older generations. Current CDC testing recommendations for HCV are incredibly narrow, focusing primarily on the Birth Cohort (1945-1965) and Injection Drug Users. Acute HCV infection data, however, indicate that people aged 18-55 are currently bearing the burden of new HCV infections. With these data in mind, it would be a smart move to expand those testing recommendations.

Undiagnosed and untreated HBV and HCV can both lead to serious health consequences; without universal screening, we will continue to see the hepatic and extra-hepatic impacts of Viral Hepatitis manifest in younger generations. These consequences are not only difficult to endure for patients, but are also incredibly expensive to treat. It is time for the CDC to welcome itself into the 21stCentury and expand screening to all adults.

References:

  • Ramsey, S.D., Unger, J.M., Baker, L.H., et al. (2019, January 17). Prevalence of Hepatitis B Virus, Hepatitis C Virus, and HIV Infection Among Patients With Newly Diagnosed Cancer From Academic and Community Oncology Practices. The Journal of the American Medical Association Oncology. Published online January 17, 2019. DOI: doi:10.1001/jamaoncol.2018.6437
  • Barrett, J. (2019, January 23). Study: Many Cancer Patients Unaware of Hepatitis Infections. Cranbury, NJ: Pharmacy & Healthcare Communications, LLC: Specialty Pharmacy Times: News. Retrieved from: https://www.specialtypharmacytimes.com/news/study-many-cancer-patients-unaware-of-hepatitis-infections

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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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Rural Missouri Seeing Increase in Hepatitis C

By: Marcus J. Hopkins, Policy Consultant

A news report from Ozarks First – a Nexstar Broadcasting, Inc. company – indicates that rural areas in Missouri are seeing an uptick in Acute Hepatitis C (HCV) cases. This, of course, is hardly news to anyone who has been tracking HCV in the United States over the past decade; increases in new HCV infections have been on the rise since at least 2012, with the hardest hit areas being rural Appalachia and rural New England.

Rural Missouri

Photo Source: ‘Home Stretch’ ~ Rural Missouri

What is frustrating about this article is the following section:

Meyerkord and Tucker especially recommend baby boomers get tested for the virus.

“Because so many folks came back from the Vietnam war, with Hepatitis C,” Meyerkord said.

“And the increase that people are seeing is partly because the baby boomers, it’s been recommended that they’re tested,” Tucker said (Ozarks First, 2019).

These statements need a bit of unpacking:

First and foremost, Lynne Meyerkord’s (Executive Director of AIDS Project of the Ozarks) attribution of HCV infection to the service in the Vietnam War is…troublesome, at best.

There are a number of reasons why the Birth Cohort (1945-1965) exhibit higher rates of Chronic HCV infection, the most relevant of which is the lack of Universal Precautions – standards that have been in place since the mid-to-late-1980s that dictates how medical personnel (e.g. – nurses, physicians, technicians, surgeons, et cetera) handle, disinfect, and sterilize the bodies, the clothing they wear, and equipment they use when dealing with patients. These precautions, introduced in no small part due to the outbreak of HIV in the 1980s, led to a revolutionary decrease in the spread of infectious diseases. The use of glass needles and other medical equipment that may not have been properly sterilized and disinfected (by today’s standards) was a large contributor to Birth Cohort HCV infection rates.

Additionally, advancements in technology allowed us to better screen, test, and identify bacteria and viruses in blood. HCV was only discovered in 1989, and it wasn’t until 1992 that reliable blood tests for the disease were created. This means that everyone who received blood or plasma products prior to 1992 was at risk of being exposed to HCV – anyone who underwent surgical procedures, received a blood transfusion, or was on hemodialysis was at risk for contracting the disease.

Thirdly, Injection Drug Use (IDU) was also a contributor to a significant portion of Birth Cohort infection rates. The increase in popularity of drugs like heroin in the 1970s, particularly among Veterans, led to a decent number of Baby Boomers being infected.

Service in Vietnam War has not, to the best of my knowledge, been identified as a primary means of infection within the Birth Cohort. Perhaps. Ms. Meyerkord meant to say that Veterans of the Vietnam War may have been exposed via IDU, but even then, it’s far likelier that members of the Birth Cohort were exposed in other manners.

The next part of those statements that needs unpacking is nurse Cindy Tucker’s statement about Baby Boomer infection rates. It istrue that the increase in new HCV infections is partly because the Birth Cohort are being tested more regularly for Hepatitis C. The U.S. Centers for Disease Control and Prevention (CDC), however, indicates that rates of new Acute HCV infections are being driven largely by people aged 20-49, with the 20-29 age demographic seeing astronomical increases in new infections (CDC, 2018).

The graph referenced from the CDC shows that, since 2010, rates of HCV have increased dramatically. Data indicate that much of this increase is attributable to IDU of prescription opioid drugs and heroin, which is both easier to obtain illegally and cheaper than illegally obtained prescription opioid drugs. These data hold particularly true in rural areas of the country, where the prescription opioid epidemic is ravaging communities.

So, while Ms. Tucker’s statement is “true,” it does need some further explanation.

AIDS Project of the Ozarks

Photo Source: TANF.us

The AIDS Project of the Ozarks provides medical, financial, and educational services in 29 counties in Southwest Missouri, and offers a wide range of services, including HIV testing and counseling, HCV testing (by finger prick), Case Management, Medical Care/Clinic Services, Family Case Management, Linkage to Care, Medication Adherence assistance, and a Client Pantry stocked with personal and cleaning products that cannot be purchased with SNAP Benefits (Supplemental Nutrition Assistance Program). Their main office is located in downtown Springfield, MO.

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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Nurse-Led HCV Treatment in Prisons

By: Marcus J. Hopkins, Policy Consultant

More than once, we, here at HEAL Blog, have called for the easing of restrictions not only on who can have access to curative Hepatitis C (HCV) Direct-Acting Agents (DAAs), but also on who can treat patients for HCV. Restricting the treatment of HCV to only hepatologists (liver, pancreas, gallbladder, and biliary tree specialists) and/or infectious disease specialists severely limits the number of physicians who are legally allowed to treat patients living with the disease. Obviously, this decreases access to care in rural, more isolated parts of the U.S. When we expand that thinking out to correctional institutions – that incarcerated individuals may only be diagnosed and treated by specialists – already limited access to treatment is further complicated.

Jail cell

Photo Source: Nursing Times

One of the growing arguments in the world of American healthcare provision involves the roles nurses play in the treatment delivery model. Most nurses are trained to provide far more medical services than they are currently permitted to do (in most states), which increases the wait times for all patients to be seen, diagnosed, and administered treatment. Requiring treatments to be administered and overseen only by specialists wastes time and resources. In correctional settings, inmates may often see only nurses for long stretches of time, as doctors may make only occasional trips to correctional facilities.

New findings out of Australia indicate that a nurse-led, decentralized treatment model for inmates was highly successful, resulting in a 95% rate of Sustained Virologic Response (SVR – “cure”) in all genotypes across 562 eligible patients (Papaluca, et al., 2019). Most patients were considered “low risk” and suitable for treatment based on nurse-led evaluation only and did not require a formal hepatologist assessment (82% of patients), while “higher risk” patients required a face-to-face consultation, telemedicine consultation, or both (Papaluca).

The model was implemented across multiple correctional facilities, utilizing a nurse-led treatment delivery model on the local level (at each location), the use of information technology (telemedicine and a central electronic medical record), and a centralized pharmacy distribution with real-time prisoner tracking (Papaluca). All of these were made possible by federal-level support for policies ensuring prisoners access to DAA therapies – something that would be hard to replicate in the U.S.

As HEAL Blog has highlighted several times over the past two years, Australia has made significate strides in their efforts to eliminate HCV by 2030 – a goal that is likely unachievable in the U.S. So, what makes Australia different from the U.S. that allows them such success while we continue to see growing rates of HCV? Well, a few things:

Healthcare: Healthcare in Australia is a mix between a public Universal Healthcare model and private providers (insurance), whereas the U.S. continues to rely upon an outdated, unwieldy, and high cost-ineffective for-profit private insurance model. The majority of healthcare provision in Australia occurs at public hospitals and primary care physicians, while the remaining portion is performed in private hospitals and allied healthcare providers (e.g. – dentists).

The U.S., conversely, has a system where health insurers essentially dictate where patients can and cannot go, and even when they go, the out-of-pocket costs can be astronomical. Ironically, 1 in 5 Americans are covered by what was supposed to be our own Universal Healthcare model – Medicaid. Despite this, the program is structed as a Federally-funded, state-administered program, meaning that what is covered varies from state to state, who can receive Medicaid benefits varies widely from state to state, and whether or not recipients have co-pays/premiums varies from state to state. This model – a uniquely American and highly inefficient model – creates numerous barriers to care and treatment.

Prison Stewardship: The Australian prison system is set up differently from the U.S., in that there is no separate Federal prison infrastructure – there are only state prisons. That said, the rules for how those prisons must operate (and who they must treat) are set at the Federal level. The U.S., however, has a setup that includes Federal prisons, state prisons, city and county jails, juvenile detention centers, and private prisons, all of which operate on different sets of rules, governance, and structures. The provision of services, what diseases prisons test inmates for, and medication dispensing policies for non-Federal prisons are all set at the state and local levels, meaning that one set of prisoners (let’s say those in Rhode Island) receive considerably better standards of care and case management than those in, let’s say, Arizona or Iowa.

This model creates a patchwork of disparate programs across the country where inmates may or may not be receiving the treatment they need. So poor is the treatment provision in state-run facilities that most states have had to be forced to provide treatment for HCV by way of individual or Class-Action lawsuits.

The nurse-led model of treatment, however, can be expanded outside of prisons, here in the U.S., and used in rural Appalachia and other isolated parts of the country to reach HCV patients for whom travel is a barrier to treatment. We would do well to examine this approach and apply it to our own country.

References:

Papaluca, T., McDonald, L., Craigie, A., Gibson, A., Desmond, P., Wong, D., Winter, R., Scott, N., et. al. (2019, January 14). Outcomes of treatment for hepatitis C in prisoners using a nurse-led, state-wide model of care. Journal of Hepatology. DOI: https://doi.org/10.1016/j.jhep.2019.01.012

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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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Restricting Access to HCV Treatment May Decrease Survival in HIV Co-Infection

By: Marcus J. Hopkins, Policy Consultant

A study published in Clinical Infectious Diseases has found that restricting access to Hepatitis C (HCV) Direct-Acting Antivirals (DAAs) may decrease survival rates among people co-infected with HIV (Breskin, et al., 2019). These findings comport with similar findings published in 2017 that found co-infection with both Hepatitis B (HBV) and HCV in HIV patients is significantly associated with increased all-cause and liver-related mortality rates (Thornton, et al, 2017).

On the cover: There they go, plucked, etching, burnished aquatint and drypoint, 1797–98, by Francisco de Goya (Spanish, 1746–1828). National Gallery of Art, Washington, D.C. Art Resource, New York, NY. Reproduced with permission. Like several prints from Los Caprichos (caprices), this image refers to a pun: the Spanish word desplumar, “to pluck”, has the same connotation as “to fleece” in English. These prostitutes are shooing out customers they have fleeced, to make room for new ones. Their bald customers, in a further play on desplumar, may also mean that they were suffering from syphilis, associated with hair loss, for syphilis was a common disease contracted from prostitutes. (Mary & Michael Grizzard, Cover Art Editors)
Photo Source: Clinical Infectious Diseases
[On the cover: There they go, plucked, etching, burnished aquatint and drypoint, 1797–98, by Francisco de Goya (Spanish, 1746–1828). National Gallery of Art, Washington, D.C. Art Resource, New York, NY. Reproduced with permission. Like several prints from Los Caprichos (caprices), this image refers to a pun: the Spanish word desplumar, “to pluck”, has the same connotation as “to fleece” in English. These prostitutes are shooing out customers they have fleeced, to make room for new ones. Their bald customers, in a further play on desplumar, may also mean that they were suffering from syphilis, associated with hair loss, for syphilis was a common disease contracted from prostitutes. (Mary & Michael Grizzard, Cover Art Editors)]

 

Essentially, people living with HIV who are co-infected with HBV and/or HCV will die more frequently than those mono-infected with HBV and/or HCV if they do not receive treatments for their disease.

Both studies come to the same conclusions: we need to increase primary prevention efforts to prevent co-infection with Viral Hepatitis (VH) from ever occurring, and we need to “thoughtfully revise access policies” (Breskin).

Isn’t that pleasant? “Thoughtfully revise” …why, if one listens closely enough, one might hear birds chirping and a babbling brook, so peaceful is this image.

Forgive my cynicism, but haven’t we really gotten beyond the point of politely asking for better access?

HCV HIV Co-Infection

Photo Source: Project Inform

Since DAA drugs hit the market in 2013, marginalized populations have had to fight tooth and nail for better access to these drugs – it has taken dozens of lawsuits, both of the Class-Action and Civil varieties, to force state agencies and institutions to agree to open up access to these medications. States all around the U.S. have entered into settlements with Medicaid recipients and inmates; a handful of other states have chosen to fight litigation as high as they can, and virtually every ruling goes against them, forcing them to pony up the money to treat high-risk populations.

Perhaps these types of polite requests work in other, more civilized nations, where healthcare is considered a human right, rather than a cash cow to be milked dry. Here, in the U.S., however, it takes gumption and the willingness to fight.  This has been true of HIV treatment; it is true of HCV treatment. And make no mistake: it will be a fight to gain open access to these medications.

In the meantime, until co-infected patients merit reliable access to HCV DAA drugs, they will continue to die faster than our mono-infected peers; they will continue to languish on wait lists, waiting for their livers to fail and suffer the extra-hepatic (non-liver-related) co-morbidities associated with untreated HCV. Maybe, if they ask politely, they will be given an extra comfy gurney upon which to do so.

References:

  • Breskin, A., Westreich, D., Hurt, C.B., Cole, S.R., Hudgens, M.G., Seaberg, E.C., Thio, C.L., Tien, P.C., & Adimora, A.A. (2019, January 07). The effects of hepatitis C treatment eligibility criteria on all-cause mortality among people with HIV. Clinical Infectious Diseases(ciz008). DOI: https://doi.org/10.1093/cid/ciz008
  • Thornton, A.C., Jose, S., Bhagani, S., Chadwick, D., Dunn, D., Gilson, R., Main, J., Nelson, M., Rodger, A., Taylor, C., et al. (2017, November 28). Hepatitis B, hepatitis C, and mortality among HIV-positive individuals. AIDS 31(18), 2525-2532. DOI: https://dx.doi.org/10.1097%2FQAD.0000000000001646

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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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What We Missed in December 2018

By: Marcus J. Hopkins, Policy Consultant

The month of December has tended to be a month of reflection for HEAL Blog – one where we look back on the year we have survived and all the successes and failures that came along with that. While we are doing all that reflecting, however, the rest of the world continues to operate, and news continues to be made. This first HEAL Blog post of 2019 will take a moment to look at some of those stories:

Looking Back

Photo Source: empowerla.org

  • Florida Failing to Treat Inmates

Florida, as per usual, made the news for failing to provide treatment for inmates currently incarcerated by the Florida Department of Corrections (FDOC). This time, two inmates at different correctional facilities have filed complaints against both FDOC, and two of FDOC’s private contractors – the GEO Group and Correct Care Solutions – alleging that the accused parties have violated their civil rights by denying these inmates the “best recognized treatment” for Hepatitis C (HCV).

FDOC has consistently failed to provide inmates with treatment that is the current standard of care, arguing repeatedly in various court proceedings that the cost makes doing so untenable. In this case, wrangling in the private contractors for failing to provide treatment despite the legal requirement (as well as a court ordered preliminary injunction ordering FDOC to do so that has been in place since November 2017) is an interesting take, suggesting that the contractors should be required to comply with the law/court order, regardless of whether or not they’re instructed to do so by FDOC (Schweers, 2018).

We will continue to follow this case s it progresses.

  • New Strains of HCV Found in Sub-Saharan Africa

Research published in Hepatology indicates that three new strains of the HCV virus were found in sub-Saharan Africa (SSA) after examining data from the largest population study of HCV. While currently HCV Direct Acting Antivirals (DAAs) have proven effective in treating HCV in most countries around the world, the presence of these new strains indicate that the regimens may not be as effective in treating strains specific to SSA.

Similar issues exist with the treatment of HIV-2 – a strain of HIV that is concentrated in and around West Africa and is more difficult to treat because it is intrinsically resistant to Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs).

The researchers and collaborators looking at these data have expressed the urgent need for more trials to be conducted in SSA in order to ensure that forthcoming DAAs are able to successful treat HCV in the region (Davis, et al., 2018).

  • Potential HIV/HBV/HCV Exposure at New Jersey Surgery Center

Here is yet another story of potential exposure to HIV, Hepatitis B (HBV), and HCV as a result of “lapses in infection control procedures,” this time in Saddle Brook, New Jersey. The exposure risk includes anyone who had procedures at the HealthPlus Surgery Center between January 2018 and September 07, 2018 (Eyewitness News, 2018a). The exposure alert and recommendation for testing includes an estimated 3,800 patients.

After the initial report on December 25thwas filed, ABC7 New York did a follow-up story on December 31stin which they detailed the nature of these lapses in protocol. These lapses include poor drug storage, an outdated infection control plan, and “unacceptable sterilization practices, according to a new state report” (Eyewitness News, 2018b).

From improperly cleaned and disinfected operating rooms, to rust-like stains on improperly stored and/or sterilized surgical equipment, to an undisinfected, blood-stained sheet left unattended on a stretcher in a hallway, the center seems to have gone above and beyond in their efforts to expose as many patients as possible to as many infectious diseases as possible. These myriad problems were so pervasive, the center was forced to shut down for three weeks in September after the New Jersey Department of Health received a complaint.

So far, one person has tested positive and a lawsuit has been filed. HEAL Blog will continue to monitor this story for additional developments in 2019.

As we sally forth into 2019, HEAL Blog will continue to provide weekly coverage of the latest news in Viral Hepatitis, and we look forward to celebrating our sixth anniversary in October of this 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 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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