Monthly Archives: November 2017

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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