Tag Archives: Hepatitis C

Colorado Takes Big Step Towards Eradicating HCV

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 Colorado took the enormous first step towards eradicating Hepatitis C (HCV) in the U.S. by lifting HCV treatment requirements for citizens who receive health benefits from the state’s Medicaid program. The move comes after the American Civil Liberties Union (ACLU) of Colorado filed a class-action lawsuit against the state for continuing to ration HCV care for Medicaid patients, and after health officials in the state asked for those restrictions to be removed (Brown, 2017).

ACLU logo

Photo Source: ACLU

The ACLU has been instrumental in winning treatment for patients living with HCV in the country’s incarcerated populations, filing suits against several states’ Departments of Corrections for failing to adequately supply HCV treatment to inmates whose HCV status is known. Inmates are the only Americans who are guaranteed healthcare coverage under the Constitution after a 1976 Supreme Court ruling found that “deliberate indifference” to an inmate’s medical needs constitution “cruel and unusual punishment” under the 8th Amendment (Estelle v. Gamble, 1976).

In both incarceration settings and state Medicaid programs, various hurdles have been put in place that require patients to do extra legwork to gain access to treatment that the programs must offer in order to save money on what were extremely expensive revolutionary HCV Direct Acting Antivirals (DAAs) that effectively cure patients of HCV. The most expensive of these medications, Harvoni (Gilead), has a Wholesale Acquisition Cost (WAC) of $94,500 ($1,125 per pill) for 12 weeks of treatment – the standard regimen length used to achieve Sustained Virologic Response (SVR – “cure”). Since Harvoni’s 2014 release, several new DAAs have come on the market, and after much outcry from patients, advocates, and the U.S. Congress, prices have been driven down. The most recent DAA therapies – Vosevi (Gilead) and Mavyret (AbbVie) – entered the market at $74,760 ($890 per pill for 12 weeks) and $26,400 ($471.42 per pill for 8 weeks) respectively.

Mavyret, AbbVie’s most recent HCV therapy, has the potential to be a financial game changer for state-run healthcare programs that have struggled to ensure that patients receive the treatment they need while not simultaneously destroying their pharmacy budgets to pay for it. That said, WAC costs serve only as a baseline price for any drug that enters the market, after which the various programs and insurers (payors) begin a negotiation process with the drug manufacturers to determine the final cost paid after rebates, pricing agreements, and deductions. The conventional wisdom is, “Well, nobody pays the WAC price.” Unfortunately, these final prices are not readily available to the public, as they fall under existing Trade Secrets laws that prevent the programs from publicly stating the final cost they pay for the drugs.

AbbVie's Mavyret medication

Photo Source: AbbVie

State Medicaid programs have been under considerable fire from HCV advocates, as well as the Department of Health and Human Services (DHHS), who have long stated that Medicaid programs should remove barriers to treatment that have included fibrosis score requirements (“Is the patient’s liver damaged badly enough?”) and abstinence from drugs or alcohol. Colorado’s removal of these barrier to care is a phenomenal first step that should be followed by other state Medicaid programs.

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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International Research Effort Shows U.S. Lags in Interventions

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

Research published in The Lancet Global Health found that the U.S. lags behind other countries in terms of HIV and Hepatitis C (HCV) interventions in drug user populations. The study gathered and analyzed data from peer-reviewed, online, grey literature (government reports, issues papers, theses, dissertations, et cetera) databases, and disseminated data requests via social media and targeted E-mails to international experts (Larney, et al, 2017). The study found that just 93 of 179 countries with evidence of Injection Drug Use (IDU) have some form of needle or Syringe Services Programs (SSPs) available (Steptoe, 2017). This comes after previous reports indicating that the U.S. has fallen behind other first-world peers in the goal of eliminating HCV by 2030 (Kaltwasser, 2017).

Medical technician counting needles.

Photo Source: Daily Beast

SSPs are vital tools in the fight to end the spread of HCV and HIV amongst not only People Who Inject Drugs (PWID), but within the general population, as well. While HCV has been thought to be inefficiently transmitted via sexual intercourse, recent studies have shown an increased risk of sexually transmitted HCV if a patient is co-infected with another Sexually Transmitted Disease (STD) or HIV, has sex with multiple partners, or has rough sex (Centers for Disease Control and Prevention, 2017). This higher transmission risk is especially pronounced among Men who have Sex with Men (MSM).

SSPs are meant to serve as intervention points for PWID, providing not only syryinge exchange services, but access to basic health services such as HIV, STD, HCV, and HBV screening, some clinical services, referrals for disease and addiction treatment, counseling, and referrals for Medication Assisted Treatment (MAT) – currently the most effective method for treating opioid addiction. While many othern Western nations long ago saw the efficacy of these programs in preventing the spread of HIV/AIDS, STDs, and other blood borne illnesses, the U.S. has consistently dragged its feet in implementing this effective harm reduction measure across the nation.

Opposition to SSPs in the U.S. (and elsewhere) consistently rely upon fear-based messaging that imagines droves of drug peddling heroin addicts shambling into town like zombies, leaving in their wake a wasteland of used needles just waiting to be stepped on by unsuspecting children and white suburbanites. Recent HIV outbreaks in rural and suburban areas have convinced states and counties to begin allowing government-funded SSPs to open in areas previously thought unlikely to host such facilities. These are generally operated at and by county health departments and their employees, thought there are no standardized national guidelines on what data they must collect and report.

Other intervention points do exist within various healthcare settings – at routine checkups, visits to emergent care, et cetera – but PWID are a notoriously difficult population to integrate into traditional healthcare continua. Furthermore, few, if any, states have compulsory “opt-out” HCV screening regulations that require healthcare providers to screen for the disease in every setting. These measures would allow emergent care workers (for example) to screen from HCV once overdose victims regain consciousness and are able to provide informed denial of screening. Such compulsory screening would play a vital role in helping to eradicate HCV in the U.S…should it be implemented. Realistically, it likely won’t.

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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U.S. Falling Behind in HCV Elimination Goals

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

Nine nations are on track to eliminate Hepatitis C (HCV) by 2030 – Australia, Egypt, France, Georgia, Germany, Iceland, Japan, the Netherlands, and Qatar. Notably absent from this list is the United States. The World Health Organization (WHO) set a target goal of 2030 for the elimination of HCV as a public health crisis in 2016. Despite this goal, only nine nations are on target to meeting that deadline.

World Health Organization logo

Part of what makes the elimination of HCV so difficult, particularly in the U.S., is the steps required to actively combat the disease: treating 7% of the HCV-infected population without restrictions; actively working on harm reduction issues (e.g. – Syringe Services Programs); actively screening patients. These three steps require making HCV a political priority at a time when other issues – foreign intervention, taxation, economic concerns, and the provision of healthcare as a right – dominate the political landscape.

In the U.S., each of these key steps that make elimination a possibility are hampered by a fundamental disagreement between warring political factions about the role of government in healthcare. The current administration occupying the Executive Branch has taken numerous steps – cutting funding, leaving funding levels flat, and cutting/underfunding staffing – that further complicate already difficult issues related to adequately combatting HCV in the U.S.

At the heart of each of these steps is the issue of funding. The high cost of HCV Direct Acting Agents (DAAs) – the current standard of care for curing HCV – has led almost every state-run healthcare program to restrict access by introducing Prior Authorization (PA) pre-requisites in order to even be considered for treatment. These PA requirements can include liver fibrosis scores (F-scores) above a certain level, that prescribing physicians either be or work in conjunction with hepatologists, gastroenterologists, or infectious disease specialists, abstinence from alcohol and/or recreational drugs for a predetermined period, and other restriction not placed upon patients needing treatment for other deadly diseases. The purpose behind these PA requirements are ostensibly to ensure that only patients who are likely to complete the relatively short regimens receive treatment, but in effect serve as cost saving measures to ensure that programs don’t have to pay for the drugs.

Harm reduction programs are equally contentious within the U.S., though Syringe Services Programs (SSPs) are gaining in popularity as a result of the prescription opioid and heroin crises sweeping our nation’s suburban and rural areas. Despite the increase in approvals for the establishment of SSPs in otherwise politically and socially conservative areas of the country, many states and Federal regulations place restrictions on how funds can be spent, meaning that syringes and other injection supplies may not be allowed to be purchased using taxpayer-funded monies.

Image promoting needle exchange for IDUs

Beyond that, local communities are beginning to experience a pushback against SSPs from residents who fear that the very presence of the programs in their neighborhoods, alone, leads to or has created a public health concern. Several counties in Indiana, where both HIV and HCV infection rates have seen increases due to Injection Drug Use (IDU), have voted to remove approval for SSPs and other Harm Reduction Clinic efforts in 2017 in no small part because of erroneous claims that the programs create hazardous waste and attract unwanted People Who Inject Drugs (PWIDs) into otherwise “drug free” communities. These fears have been stoked by elected officials (sheriffs, prosecutors, and/or legislators) who stalwartly refuse either to believe the research and evidence presented to them, or the real world results of the programs.

Screening for HCV in the U.S. is another costly endeavor, as Federal funds for state-level screening efforts fall far short of what is needed to adequately combat the spread of HCV. Moreover, there is currently no Federal requirement that certain populations be routinely screened. This leaves screening, tracking, and reporting guidelines up to the individual states, most of whom simply do not have the funds to engage in such a costly effort. Without adequate screening protocols in place on a national level, the U.S. cannot hope to meet elimination targets.

The U.S., for much of the 20th Century, led the world in the eradication of public health threats. This status has been erased, largely because of political efforts to reduce the role that government plays in healthcare compounded with the ever-increasing costs of healthcare. It is time for the U.S. to take a stand, reclaim its standing, and put behind us the burden of for-profit healthcare.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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HIV/HCV Co-Infected Patients Show Similar Cure Rates As Monoinfected

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

Patients who are co-infected with both HIV and Hepatitis C (HCV) demonstrated similar cure (Sustained Virologic Response – SVR) rates as patients who were monoinfected with HCV, according to research published in Hepatology, a journal published on behalf of The American Association for the Study of Liver Diseases. These findings were gathered using a review of studies dated January 2004 to July 2017, and came to the conclusion that the designation of patients co-infected with HIV/HCV as a “special population” by the U.S. Food & Drug Administration (FDA) should be reconsidered, given the advent and increasing use of Direct Acting Antivirals (DAAs) to treat HCV.

aasld-primary-logo

The special population designation by the FDA is designed to allow physicians and researchers to take into consideration populations who, for a variety of reasons – weight, existing disease morbidity, age, body composition, pregnancy, et cetera – may not respond in a typical fashion to standard treatment regimens. For patients living with HIV, many of the HIV-specific treatment regimens, until the past decade or so, made treating co-morbidities not HIV-related difficult, as other drugs would hamper or have their effects hampered by the medications used to treat patients’ HIV. The advent of newer, more easily tolerated, and more effective HIV medications has allowed for more flexibility.

Thus is the case with HIV/HCV co-infection. Prior to the entry of HCV DAAs to the market in 2013, interferon-based treatments were the only way to actively achieve SVR in HCV-infected patients. Notoriously difficult to tolerate and with a high treatment abandonment rate, interferon-based regimens resulted in very low SVR rates for both mono- and co-infected patients. This, along with the fact that co-infected populations experience accelerated progression of HCV-related liver disease, as well as existing barriers to care, led the FDA to designated HIV/HCV co-infected patients as a specific population with unmet medical needs.

The newer regiments, which are both easier to tolerate and exponentially more effective at achieving SVR, have produced similar SVR rates in both mono- and co-infected populations. This serves as good news to physicians and patients, alike. While these findings are welcome news, physicians must still be certain to determine if HCV regimens will have any counterindications with existing HIV therapies. Current treatment recommendations advise against stopping HIV therapy to pursue HCV treatment.

References:

  • Sikavi, C., Chen, P. H., Lee, A. D., Saab, E. G., Choi, G. & Saab, S. (2017, November 06). Hepatitis C and Human Immunodeficiency Virus Co-Infection in the Era of Direct-Acting Antiviral Agents: No Longer A Difficult to Treat Population. Hepatology. Alexandria, VA: The American Association for the Study of Liver Diseases. Accepted Author Manuscript. doi:10.1002/hep.29642

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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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amfAR Releases Opioid & Health Indicators Database

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

amfAR, The Foundation for AIDS Research, has published their latest site, “Opioid & Health Indicators Database,” which pulls together, for each state, trends over time in opioid use and related infectious disease mortality, as well as state-by-state levels of Federal funding (Melville, 2017). The site was revealed at last week’s Association of Nurses in AIDS Care (ANAC) 2017 conference by Alana Sharp, MPH, from the Foundation of AIDS Research, a private organization that focuses on the various research and databases that informs their reporting.

AmfAR logo

Photo Source: amfAR

The website pulls together various data from a variety of sources and present this data for every state in the U.S., and puts them in the context of HIV, Hepatitis C (HCV), and the opioid crisis. This unique site is one of the first to actively connect these types of data in a user-friendly manner. They also make use of the supplemental data used to compile a list of 220 counties in the U.S. most at risk of HIV and/or HCV outbreaks due to a variety of similar circumstances that include: Drug Overdose Mortality, Prescription Opioid Sales, Mental Health Services, Insurance Coverage, Urgent Care Facilities, Vehicle Availability, Education, Income, Population Density, Poverty, Race/Ethnicity, Unemployment, Urban/Rural Status, and Buprenorphine Prescription Capacity (Van Handel, et al., 2016b).

Opioids Amplifying Impacts on HIV and HCV

Photo Source: opioid.amfar.org

From the front page, users select their either the state or congressional district from one of two dropdown boxes, and receive a fresh page that provides information. For states, the first page displays information on the Most Vulnerable Counties, taken from the Van Handel report, and after a click-thru, lands on a page that lists a considerably deep level of state statistics, including demographic data, HIV and/or HCV populations, opioid use statistics, healthcare-related statistics, and treatment and prevention services information, all of which are set against national statistics (e.g. – Percentage of People without Health Insurance (2015): West Virginia – 11.5%; National – 13.0%). After the numerical presentation, you can scroll down for more in depth coverage about state opioid policies, graphs of state health trends, Federal funding from various agencies, as well as a data explorer, that provides county-by-county HIV and HCV incidence and prevalence data broken, the same data by congressional districts, and by state for comparison.

If users select their congressional district, they’re asked to provide their zip/postal code, and are provided with a district profile providing numerical data similar to the state profile, and follows with the same graphic representation of data as presented on the state level, but Congressional district-specific.

This database, one of the first of its kind, helps provide a fantastic resource for state-level advocates and policy makers for informing good policy planning and crafting. For more information, please visit amfAR’s website at the following address: http://opioid.amfar.org.

References:

  • Melville, N.A. (2017, November 08). Opioid Crisis Inflaming Hep C, HIV in Hard-Hit Communities. New York, NY: Medscape, LLC: News: Conference News. Retrieved from: https://www.medscape.com/viewarticle/888219
  • Van Handel M.M., Rose C.E., Hallisey E.J., Kolling J.L., Zibbell J.E., Lewis B., Bohm M.K., Jones C.M., Flanagan B.E., Siddiqi A.E., Iqbal K., Dent A.L., Mermin J.H., McCray E., Ward J.W., & Brooks J.T. (2016b, November 01). County-Level Vulnerability Assessment for Rapid Dissemination of HIV or HCV Infections Among Persons Who Inject Drugs, United States. JAIDS Journal of Acquired Immune Deficiency Syndromes: November 1st, 2016 – Volume 73 – Issue 3 – p 323–331. doi: 10.1097/QAI.0000000000001098. Retrieved from: http://journals.lww.com/jaids/Citation/2016/11010/County_Level_Vulnerability_Assessment_for_Rapid.13.aspx
  • Van Handel M.M., Rose C.E., Hallisey E.J., Kolling J.L., Zibbell J.E., Lewis B., Bohm M.K., Jones C.M., Flanagan B.E., Siddiqi A.E., Iqbal K., Dent A.L., Mermin J.H., McCray E., Ward J.W., & Brooks J.T. (2016b, November 01). County-Level Vulnerability Assessment for Rapid Dissemination of HIV or HCV Infections Among Persons Who Inject Drugs, United States – Supplemental Appendix. JAIDS Journal of Acquired Immune Deficiency Syndromes: November 1st, 2016 – Volume 73 – Issue 3 – p 323–331. doi: 10.1097/QAI.0000000000001098. Retrieved from: http://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/QAI/A/QAI_2016_06_29_VANHANDELM_QAIV16762_SDC1.pdf

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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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:

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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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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

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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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