Tag Archives: HBV

HHS Releases New HIV Treatment Guidelines

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 Department of Health and Human Services released updated Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV in October 2017, which included updates for best practices, treatment protocols and recommendations, which drugs not to use, treatment for virologic failure, regimen switching, adherence to the continuum of care, drug interactions, and Hepatitis B (HBV) and Hepatitis C (HCV) co-infection treatment guidelines.

Because emtricitabine (FTC – Truvada, Descovy, Stribild, Genvoya, Odefsey), lamivudine (3TC – Epivir, Epivir-HBV, Combivir, Kivexa, Trizivir), tenofovir disoproxil fumarate (TDF- Viread, Atripla, Complera, Stribild, Truvada), and tenofovir alafenamide (TAF – Genvoya, Odefsey, Descovy) have activity against both HIV and HBV, an Antiretroviral Therapy (ART) should include (TAF or TDF) plus (3TC of FTC) to fully suppress the viruses. Other HBV treatment regimens, including adefovir (Hepsera) alone or in combination with 3TC or FTC, are not recommended for patients co-infected with HIV/HBV.

Rx pill bottles and pills

Photo Source: HIVThrive.Com

HBV reactivation has been observed in persons with HBV infection during interferon-free HCV treatment. For that reason, all patients initiating HCV therapy should be tested for HBV. Persons with HCV/HIV coinfection and active HBV infection should receive two agents with anti-HBV activity prior to initiating HCV therapy.

For HCV, ART may slow the progression of liver disease related to HCV by preserving or restoring immune function and reducing HIV-related immune activation and inflammation. For most persons with HCV/HIV coinfection, including those with cirrhosis, the benefits of ART outweigh concerns regarding drug-induced liver injury. Therefore, ART should be initiated in all patients with HCV/HIV coinfection, regardless of CD4 T-cell count. All patients with HCV/HIV coinfection should be evaluated for HCV therapy and have their liver fibrosis stage assessed to inform the length of their therapy, ribavirin need (a concern with some regimens), and subsequent risk of hepatocellular carcinoma and liver disease complications

The document also includes an extensive list of the various drug interactions between HIV and HCV drugs, including the three newest HCV regimens, Epclusa, Vosevi, and Mavyret. HEAL Blog previously covered HCV and HIV drug interactions (Hopkins, 2016). While the document is clearly meant for medical and other healthcare professionals, if you would like more information, please check out the link below in the citation.

References:

__________

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.

 

 

Advertisements

Leave a comment

Filed under Uncategorized

Increase in HCV Cases Calls for Updated Screening Protocols

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

We, here at HEAL Blog, attempt to provide coverage of local outbreaks of Viral Hepatitis (VH), as well as to investigate and report them using evidence-based data to accurately characterize the issues at play. What consistently comes to the forefront of Hepatitis C (HCV) infection is the issue of Injection Drug Use (IDU) and the People Who Inject Drugs (PWID). More than any other risk factor, IDU in consistent across Hepatitis A (HAV), Hepatitis B (HBV), and HCV. According to the Centers for Disease Control and Prevention (CDC), in 2015, IDU was reported as a risk factor in 36.1% of all Acute HAV cases, ~34.3% of all Acute HBV cases, and 64.2% of all Acute HCV cases (CDC, 2017).

Hepatitis Screening

Photo Source: JAMA

In the five of the states with the highest rates of HCV – Massachusetts (MA), West Virginia (WV), Kentucky (KY), Tennessee (TN), Maine (ME), and Indiana (IN) – these data are undeniable:

And yet, none of these states have amended their HCV screening protocols to include compulsory “Opt-Out” screening in every healthcare setting. This is folly, at best, and dereliction of duty, at worst. If a state’s responsibility is to ensure the health and welfare of its citizens, it is incumbent upon them to take non-extraordinary steps to expand screening protocols. Moreover, they must begin regularly surveilling and reporting, including detailed risk-factor reporting.

If this sounds “revolutionary,” it’s simply not. Given the high rates of infection, mortality, co-morbidities, and the fact that there is a functional cure for the disease, there is simply no excuse for failing to expand testing to include compulsory “Opt-Out” screening for HCV, particularly in states where IDU is high. Is it expensive? Yes. But, again, when it comes to the health and welfare of people, sometimes short-term expenditures outweigh long-term costs of care. This is why there are grants; this is why people pay taxes.

Some of the most successful screening efforts are being conducted not in traditional healthcare settings, but at Syringe Services Programs (SSPs), which remain controversial among those who say that they promote and encourage drug use. These services are, however, vital to stemming the spread of disease. Perhaps the least successful screening efforts are conducted in incarceration settings, despite having essentially a captive demographic. These efforts are hampered, again, by cost concerns, as, if the results come back “Positive,” they are required by law to treat.

While expanding screening may be initially costly, it is the best way for us to go about eliminating HCV in the U.S.

References

__________

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.

Leave a comment

Filed under Uncategorized

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.

__________

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.

1 Comment

Filed under Uncategorized

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:

__________

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.

Leave a comment

Filed under Uncategorized

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.
__________

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.

 

Leave a comment

Filed under Uncategorized

Telling Us What We’ve Already Known

By: Marcus J. Hopkins, Blogger

National Academies of Sciences, Engineering, and Medicine. 2016. Eliminating the public health problem of hepatitis B and C in the United States: Phase one report. Washington, DC: The National Academies Press.
National Academies of Sciences, Engineering, and Medicine. 2016. Eliminating the public health problem of hepatitis B and C in the United States: Phase one report. Washington, DC: The National Academies Press.

The National Academies of Sciences, Engineering, and Medicine and the National Academies Press (NAP) have released their latest report, Eliminating the Public Health Problem of Hepatitis B and C in the United States: Phase One Report, in which they detail the best, most likely, and least likely ways in which the U.S. can effectively combat the growing HCV (and HBV) epidemic(s). In their findings, they report many conclusions that we in the HCV advocacy community have known for much of this decade, and in so doing, lend credibility and quantifiable evidence that we can use to better arm ourselves against a recalcitrant, uncooperative, and undependable federal government.

For some reason, accomplishing anything in Washington takes what feels like forever. Any initiative, regardless of the size or importance, faces seemingly endless hurdles and red tape, and it always seems as if every single person and committee has to get their hands on something before it comes to any sort of vote…if it even gets through said committees to make it to the floor. Combine this with the fact that, even with one party controlling both the House and the Senate, no one can manage to get anything of national import accomplished, and it’s no wonder Americans have gotten angry and feel largely disgusted with Washington.

Outsiders – those who are neither familiar with, nor privy to the “way things work” in Washington – often find themselves baffled that seemingly common sense measures take forever to put in place, especially when it comes to matters of life and death. Furthermore, excited reports of “success” in the realm of healthcare-related efforts often leave those of us on the outside feeling a little pissed off as what seems like largely incremental changes are heralded as “momentous” and “great strides forward.” Many times, I’ve found myself wanting to respond with, “Umm…you literally just got someone to say, on the record, that HCV is a big problem, and that we should really think about addressing it. What the hell is the big deal?!” And I know I’m not alone, in this regard; people living with HIV and HCV frequently find themselves frustrated at the glacial pace and seemingly miniscule results of progress.

In reality, there are hundreds of people who work tirelessly around the clock to ensure that these “minor” changes occur, and even though it’s difficult to see when you’re in the thick of things (i.e. – living with the problem), all of these seemingly minor chinks add up to destroy the armored barriers that have long prevented the HCV community from gaining the equal footing it needs to be seriously addressed.

This report from NAP takes all of the various bits of data we’ve been collecting over the last two decades and puts them together in what amounts to a significant report that will prove instrumental in convincing some of the less recalcitrant members of Congress to begin supporting better legislative efforts to address a very life-threatening and expensive problem. Those legislators who have feigned horror at the cost of HCV DAA drugs are usually the first to join our fight, but this tool will allow us to present the myriad data points related to HCV – screening issues, data collection barriers, barriers to diagnosis and treatment, and economic burdens (both personal and state) – in the hopes that even those who view HCV as mainly the problem of drug addicts, the poor, and the unemployed to take the looming healthcare disaster seriously.

Some of the key findings of this report include:

  • Injection Drug Users (IDUs) are driving the exponential increase in new HCV infections, and are more likely to transmit HCV than other patients
  • IDUs are increasingly living in suburban and rural areas, rather than urban areas, and adapting Harm Reduction to less densely populated areas will be difficult
  • IDUs are less likely to be tested for HCV or be captured in disease surveillance data
  • Deliberate attention must be paid to the highest risk populations (lower-income Whites and Native Americans living in suburban, rural, and reservation areas) in order to effectively stop the rapid spread of HCV infections
  • An element of passive racism – doctors being hesitant to prescribe opioid drugs to African Americans and Hispanic patients – has played a unique role in lessening the impact of HCV infection upon those populations
  • The high cost of DAA drugs has driven private and public payers to largely restrict access to these drugs, requiring an unreasonable amount of hurdles and prerequisites from patients for treatment
  • Half of people with Chronic HCV are undiagnosed
  • Even though HCV is twice as common and has a higher mortality rate than HIV, far fewer resources are allocated to its prevention, testing, treatment, and research
  • Even at current prices, DAA HCV drugs are cost-effective, as the long-term costs of HCV and HCV-related health issues will prove more expensive to treat; additionally, the benefits of treatment outweigh the cost
  • Surveillance data routinely fails to capture and/or include IDU, indigent, and prison populations, the latter of which accounts for 1/3 of Chronic HCV cases in the U.S., which prison healthcare systems are neither equipped, nor funded to address
  • HCV infection, much like HIV, carries with it a stigma, which serves as a barrier to treatment

To read the report, visit http://nationalacademies.org/HMD/Reports/2016/Eliminating-the-Public-Health-Problem-of-Hepatitis-B-and-C-in-the-US.aspx.

__________

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.

Leave a comment

Filed under Uncategorized