Tag Archives: Hepatitis B

Compulsory Viral Hepatitis Screening is a Pathway to Elimination

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 the International AIDS Society’s (IAS’) 4th Annual HIV/Viral Hepatitis Co-Infection Meeting in Paris, France, aside from all of the various data regarding rates of infection around the globe and various approaches to eradicating Hepatitis B and C (HBV/HCV, respectively) by the World Health Organization’s (WHO’s) target year of 2030, one assertion rang true throughout: all of these projections and approaches will require robust Harm Reduction measures to be put in place.

For the uninitiated, Harm Reduction measures are various laws, regulations, and statutes put into place in order to reduce injury or death from a specific cause; a good example of this would be a Seat Belt Law. As they relate to Viral Hepatitis (VH), Harm Reduction statutes include various methods of reducing the likelihood of infection (and thereby death), such as the mandatory use of Prescription Drug Monitoring Programs (PDMPs), ID requirements for the purchase of prescription opioid drugs, and prescriber education about the risks of prescribing opioids and proper opioid usage. One set of measures, however, would serve several purposes: mandatory or compulsory screening requirements for HIV, Hepatitis B, and Hepatitis C.

"Hepatitis" on a screen, with a stethoscope

Photo Source: CTV News

A handful of states (CT, FL, MA, NY, and PA) have considered or passed mandatory screening guidelines for the Birth Cohort (people born between 1945-1965). These guidelines are largely inefficient, because they rely upon an “Opt-In” method of screening, meaning that patients are offered screening, and must accept – it’s optional. Additionally, these measures focus only on the Birth Cohort, and understandably so, as they represent the largest percentage of existing HCV cases. These approaches, while well-intentioned, must be amended and updated on a national level, in order to effectively combat the spread of both HBV and HCV.

An estimated 70% of new Acute HCV infections are related to Injection Drug Use (IDU) by People Who Inject Drugs (PWIDs). That none of these screening guidelines make mention of these facts is indicative of our inability to accurately capture the data we need in order to adequately assess the scope and scale of the epidemic. Statistics at the state and national levels are largely reached using modeling that projects an estimated number that ostensibly accounts for underreporting. PWIDs are, however, notoriously difficult patients from whom to capture data, in no small part because we see them consistently in only a handful of healthcare settings: Hospitals for overdoses, Prisons, Jails, and Juvenile Detention Centers for incarceration, and Rehabilitation facilities. In addition, Syringe Services Programs (SSPs) are another excellent point of data collection, but it must be handled differently than those previously listed.

The most effective method of screening is to make it compulsory (mandatory) on an “Opt-Out” basis in which patients are informed that screening for HIV, HBV, and HCV are part of a required set of screenings, and they must provide “informed refusal” of the test. This requires that all hospitals, clinics, justice/incarceration settings, and rehabilitation facilities adopt this method of screening in order for the most effective use of time and money that will result in the most accurate data captures. When opioid and heroin users overdose and are the recipient of emergent care services, this is the prime location to capture data from PWIDs. The same holds true for those who are moved into justice settings, as well as those who enter rehabilitation services. Additionally, with the use of rapid HCV antibody testing, this can be accomplished in a relatively short period of time. The important part is ensuring that each Positive test result is followed up with an immediate secondary confirmatory screening, rather than scheduling a second appointment.

These types of compulsory screening requirements are paramount to achieving the WHO’s goal of eradication of HBV and HCV by 2030. Once patients know their status, with proper linkage to care services, they can be cured of HCV and treated for HBV with relative ease. This will, of course, require an investment on the part of state, Federal, public, and private partners, and until we have Federal movement on these issues, the best location to start is at the state-level. Personally, I am working on an endeavor with one of West Virginia’s delegates to work on building a workable and FUNDED compulsory screening requirement as close to the one I suggested above, given the complex nature of WV’s budgetary constraints. We at HEAL Blog invite you to do the same, in order to ensure that compulsory screening becomes a reality.

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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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U.S. Air Force Clinic Risks Potential 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

If one thing has been certain in the world of medicine since the discovery of HIV/AIDS, it’s that medical safety standards must always be followed. For 135 people receiving treatment at Al Udeid Air Base clinic in Qatar, a failure to properly “[clean] in a manner [consistent] with sterilization guidelines” opened them to the risk of exposure to HIV, Hepatitis B (HBV), and Hepatitis C (HCV).

Map of Al Udeid Air Base in Qatar

The issue is related to endoscopes – an illuminated optical (camera) used for upper and lower gastrointestinal procedures. As endoscopies are invasive procedures, failing to properly sterilize these medical devices poses a serious risk to anyone who undergoes procedures using them. The process for cleaning endoscopes has been readily available to all medical staff well before April 2008, the date when the devices were identified as having been improperly cleaned. These failures to follow basic sterilization protocols, particularly in a military base medical center, are unacceptable. That no one apparently noticed the improper sterilization methods until April 2016 is simply intolerable.

The issue came to light Monday, June 19, 2017, when the Air Force Surgeon General revealed the information in a press release. Sadly, this is not the first time that the U.S. Air Force (USAF) have had issues with improperly handled endoscopes. In September 2016, 267 patients at the Air Force Academy’s medical clinic in Colorado were notified that they were at risk for a number of infectious diseases due to improperly sterilized endoscopy equipment (Kime, 2016). While these instances are not exactly alike in circumstance, they do bring into question the training and quality of care provided by these clinics.

U.S. military and veteran clinics have consistently come under fire, over the past two decades, in no small part because of their failure to follow basic protocols that have been in place and consistently updated since the early 1990s. Numerous reports over the past two decades indicate a failure on the part of military and veteran medical personnel to protect patients from HIV, HBV, and HCV infection risks, causing many citizens and legislators to bring into question the quality of the healthcare provided. With rare exception, all of these incidents relate to the sterilization of medical implements that are supposed to be adhered to at every level of medical practice, from veterinarians to surgeons, and yet, military medical personnel just can’t seem to get it right.

Photo of Command Surgeon Colonel Walter Matthews

Source: LinkedIn

Every time one of these incidents occur, military personnel attempt to play down the risk of exposure: in the September 2016 Academy issue, Command Surgeon Colonel Walter Matthews said that the risk of infection to patients was “low, but it is not zero.” In the current scandal, Larine Barr, a spokeswoman for the surgeon general, said that the risk of infection is “very small, particularly in a deployed environment” (Losey, 2017). While these platitudes may be a great way to mollify everyone else, they serve as small comfort to those facing the risk of infection.

At what point will military and veteran medical personnel be subjected to the same level of scrutiny as every other part of the medical community? While timeliness and meeting deadlines is understandably important, these are the types of mistakes made by first-year trainees, not those in whose hands the lives and wellbeing of patients is being placed. Clearly, something needs to be done to ensure that all medical personnel are properly trained, and are consistently following every sterilization protocol; if they cannot live up to that very basic standard, they have no business providing medical services.

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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Do Black Boxes Mean Red Ink for Drug Companies?

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 U.S. Food & Drug Administration (FDA) has recently concluded that new Direct Acting Agents (DAAs) to treat Hepatitis C (HCV) require a boxed warning for the drugs advising clinicians and physicians to screen patients for evidence of a past or current Hepatitis B (HBV) infection before undergoing treatment for HCV. This warning, indicated by black box on the labels of all nine current DAAs, has many investors worried that, along with consistent questions about the Wholesale Acquisition Costs (WACs) of newer HCV drugs, stock prices may face volatility in the coming years.

The new DAAs for HCV have been on the market for roughly three years, beginning with the release of Sovaldi (Gilead) and the companion drug, Olysio (Janssen), in 2013. Since that time, there has been a tremendous outcry from virtually every stakeholder involved in the issue of pricing, save for the pharmaceutical companies, themselves. Additional concerns have been raised that the modules used by companies to determine initial WAC prices is neither transparent, nor representative of the will of consumers. Arguments that pricing structures take into account “what the market will bear” have served as little comfort to advocacy groups, state agencies, and Congressional panels, all of whom are becoming less tolerant of high drug prices.

Drug prices for specialty products – those that are designed to treat very specific conditions – continue to rise at meteoric rates, and regardless of what drug companies believe the markets can bear, state and Federal budgets are largely unequipped to handle the short-term costs to treat HCV without quadrupling their annual budgets, so vast is the pool of infected patients. Beyond just the traditional patient pool, the growing HCV infection crisis in prison populations, which is largely ignored in state reporting and which faces vast issues in screening, prison budgets may soon face extreme funding issues if Federal lawsuits go against them, and require them to provide treatment to all inmates infected with the disease.

These new concerns raised by the FDA represent just the latest hurdle for pharmaceutical companies whose HCV fortunes may turn in the coming years. HBV, an as-yet incurable form of the illness, is much more easily transmittable through sexual intercourse, which may pose an additional risk for HIV/HCV co-infected patients whose HBV infection flares up as a result of using DAAs for HCV. Whether or not the reactivation of HBV in HCV treated patients is widespread is unknown, as the FDA has only identified 24 cases at the time of their ruling.
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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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Intersection of Imprisonment and Healthcare

By: Marcus J. Hopkins, Blogger

“Nearly forty years ago, the U.S. Supreme Court ruled in Estelle v. Gamble that ignoring a prisoner’s serious medical needs can amount to cruel and unusual punishment, noting that “[a]n inmate must rely on prison authorities to treat his medical needs; if the authorities fail to do so, those needs will not be met. In the worst cases, such a failure may actually produce physical torture or a lingering death[.] … In less serious cases, denial of medical care may result in pain and suffering which no one suggests would serve any penological purpose” (American Civil Liberties Union, n.d.)

 

These words put forth in a Supreme Court ruling are vitally important in today’s society – one in which the Centers for Disease Control and Prevention (CDC) released its first ever National Survey of Prison Health Care, the results of which were rosy on the surface, but admittedly (on their part) limited in scope, because they only asked if the service was available, rather than checked to see if the services were actually delivered. In addition, numerous reports at the 2016 International AIDS Conference in Durban, South Africa point to a serious issue brewing in the world’s prisons, as the “War on Drugs,” mass incarceration of drug users, and the failure to provide proven harm reduction and treatment strategies has led to high levels of HIV, tuberculosis, and hepatitis B and C infection among prisoners—far higher than in the general population (Medical Express, 2016).

Two hands holding prison bars

Photo Source: News Limited

The U.S. is exceptional, when it comes to the number of inmates in prison for drug offenses: of the 182,924 inmates currently in Federal prison, 84,746 (46.3%) of them were there for drug-related offenses (Federal Bureau of Prisons, 2016). There are roughly 5 million drug-related arrests each year (Prison Policy Initiative, 2016), all of whom spend some portion of their time going in and out of the jail or prison population, which increases the risk of exposure to blood borne pathogens such a HIV, Hepatitis C (HCV), Hepatitis B (HBV), and Tuberculosis (TB) exponentially over that of the general population. As Injection Drug Users (IDUs) represent an ever-increasing percentage of new HCV infections in the U.S. and around the world, the risk of transmission amongst prison populations is an incredibly serious issue that needs to not only be watched, but addressed.

The unfortunate intersection of imprisonment and healthcare statistics is the reality of the HCV treatment landscape in our nation’s prisons. This has been brought into sharp focus, recently, by a Federal lawsuit against state prison officials in Tennessee, which asks the courts to force the state to start treating all inmates who have HCV (WBIR, 2016).. The Tennessean (part of USA Today) released a report in May 2016 finding that only 8 of the 3,487 inmates known to have HCV were being treated for the disease (Tennessean, 2016) – treatment to which these patients are constitutionally guaranteed, but for which few are ever approved. Further complicating the issue is that the number of HCV-infected inmates is likely much higher, but only a handful are ever tested, because “…acknowledging inmates have the disease means they must treat it.”

The lawsuit in Tennessee is just the latest in a string of Federal and class action lawsuits filed against state and Federal prisons over access to HCV drugs, which similar suits being filed in Pennsylvania, Massachusetts, and other states. Failure to adequately screen and treat all incoming patients for infectious diseases such as HIV and HCV is, in this writer’s opinion, a gross dereliction of duty on the part of prison officials that risks not only prison populations, but to all citizens at large, once those prisoners are released into general population. HIV and HCV that goes untreated is not only likelier to result to much more costly long-term health complications (and potentially death), but is also likely to result in greater overall infection rates, as untreated diseases are more easily spread from person to person.
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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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