The “C” in HCV Stands for “Curable”

Hi everyone! It has felt so good to find myself back in the throes of hospital life. My time in the classroom during the first half of medical school was great—but this new chapter is what makes medical school very worth it. As with any new hospital, orientation was pretty run-of-the-mill: administrative paperwork, employee/student health clearance, and yet another Mantoux PPD (despite having a current QuantiFERON—lab family, you get me).

However, after all the introductory logistics, I finally reported to my first rotation. It is an elective clerkship in primary care focused primarily on patients with HIV and/or Hepatitis. My familiarity with hospital life made the transition back easy enough as I made my way to the nurses’ station looking for my attending. Being forwarded in the direction I had to go, I knocked on the door and started to introduce myself—but was abruptly interrupted. There were already two fellow student colleagues in that room with my attending and a patient. I was enthusiastically included in the process right away, and it has been non-stop since then. I am told this is a “different” rotation where I’m going to feel lucky to have so much hands-on experience, and so far, I agree. While I reminisce on these past few weeks, it’s not a specific patient or case that has stuck with me, but an overall theme I’ve noticed in this rotation. With heavy utilization of the right test at the right time (I’m sure we’re all familiar with ASCP’s Choosing Wisely campaign) and proper interpretations of lab data, patients’ chronic illnesses are being managed well and even cured.

Essentially, pharmaceuticals have been advancing so well in the last 5-10 years that treatment regimens for chronic diseases like HIV and HCV are now being actively controlled and cured, respectively. Why does this pique my interest enough to share it with all of you? As I try my best each month to provide you a window into the life of a medical lab scientist/medical student, I do so while focusing on the lab details that seem to be present in every aspect of my journey. The cures and treatments I’m currently working with are tied to lab tests like CD4 counts, viral loads, liver and kidney function tests, and many other routine values. Diagnostic criteria for different patients’ stages of hepatic damage are classified using a Child-Pugh (CTP) score from clinical information such as ascites and encephalopathy along with lab data like INR, bilirubin, and albumin. Patients with chronic conditions come back for follow up week in and week out for lab tests that let us as care providers adjust therapy accordingly. The clinic I currently rotate in provides its patients with the most up to date treatment protocols based on current literature. For example, The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) regularly publish their recommendations for patients with Hepatitis C. It’s heavy reading, and anyone who goes through literature on standards of care knows it’s dense, so I’ll leave the link to the most recent guidelines on HCV testing, management, and treatment here (https://www.hcvguidelines.org/sites/default/files/full-guidance-pdf/HCVGuidance_September_21_2017_g.pdf). Actively and accurately incorporating these treatment protocols into the patient care algorithms works and demonstrates great utilization of lab driven data with new available therapies.

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Figure 1. AASLD and IDSA HCV Recommendations Standards, 2018.

As a baseline it is critical to understand that patients with positive HCV antibodies will always test positive; once exposed at any point patients will remain positive. While 20% of patients can clear the infection on their own, the remaining majority develop a chronic HCV infection. There is no vaccine for HCV currently; however, there is potential to cure patients—assuming the lab values are interpreted correctly. So, we’ve established that positive HCV antibodies don’t necessarily provide diagnostic data, so the next logical step is to examine a patient’s HCV viral load. Since 2015, the New York State Department of Health established a mandate and protocol for reflex testing HCV Ab positive patients with HCV RNA viral loads. Read the public letter here (https://www.health.ny.gov/diseases/communicable/hepatitis/hepatitis_c/docs/reflex_testing_letter.pdf). While it makes logical sense, it’s still taking some time to get off the ground as I have seen patient records of different clinics’ providers ordering repeat HCV Ab testing for in-house confirmation—not the best use of resources or lab data. A clear example here of Choosing Wisely for the appropriate lab test. However, so long as HCV viral load stays undetectable by a validated testing method, patients with chronic HCV are promoted to a status of “cured HCV” and need no further testing or follow-up unless new clinical reasons appear to add testing as needed.

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Figure 2. HCV Infection testing and treatment algorithm seen in literature from the Centers for Disease Control and Prevention (CDC), the NYS Health Department, the AASLD, and the IDSA.

Protocols for treatment are based on things like genotype, cirrhosis, and naïve vs. previously failed treatment; treatment schedules last from 8 weeks up to 24 weeks. So, what does a patient’s first visit for HCV treatment therapy look like? Right away (assuming a positive HCV Ab has been obtained) a Hepatitis C RNA viral load is ordered, along with genotype (older treatments are dependent on genotype due to potential for resistance, while newer treatments are pangenotypic), hepatic fibrosis scans (because cirrhosis status determines length of treatment), PT/INR, CBC, CMP, HIV, RPR/CG and other STI screening, and urine drug testing. New generation therapies allow us to proceed despite any comorbid conditions, while maintaining upwards of 95% or greater cure rates. Coinfected patients with HIV or otherwise compromised immune systems are no longer contraindicated to receive HCV treatment. The only significant contraindication in the standards of care currently is that patients not be terminal (i.e. they must have a general prognosis of greater than 6 months).

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Figure 3. Calculated FIB-4 and APRI scores are useful in prognostic and treatment decision-making, demonstrating how crucial laboratory-driven data is in managing chronic illness.

Being able to watch these treatment protocols in action is great, but one patient in particular will stay with me beyond this clerkship. We received lab results back for a male in his 60s. It was his final HCV viral load based on his treatment schedule. His chart had a box at the end of his schedule labeled “test for cure” and it had remained non-detectable the whole time through treatment. The staff at this clinic does painstaking follow-up with their patients via telephone with impressive results in patient adherence and treatment success. My task one day was to call this patient and inform him that, unless he needed any medical treatment outside of his annual physical, he no longer needed to come in for therapy or testing—his Hep C was cured. He was extremely delighted to hear this news, and I was happy to give it to him. He had been on therapy for less than a few months but had lived with HCV for years. It was an excellent experience! And even more excellent—being part of the connection between lab tests, clinics, and patients. When I started I was just excited to wear that white coat and go visit the hospital’s lab, but I was pleasantly surprised to see the impact on patients’ treatments. Especially considering using the right test at the right time, and truly making a visible difference with excellent data.

See you next time!

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Image 1. Me (center) and my medical student colleagues Ahmad M. Khan (right) and Emeka Ajufo (left).

 Post script: listen to a new podcast my colleagues and I are in where we discuss clinical stories and pearls of wisdom through medical school. As they relate to my posts here on Lablogatory I’ll include a link—this post will focus more in depth on what I presented here regarding HCV cures and lab data.

 

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Constantine E. Kanakis MSc, MLS (ASCP)CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student at the American University of the Caribbean and actively involved with local public health.

A Primer on HIV, Hepatitis, and Clinicals: A Bronx Tale

Hello again everyone! Last time on Lablogatory, I discussed the importance of patient advocacy and how it was especially poignant around the recent holiday season. We all have families, and sometimes those families and our medical professions intersect. Since then, I hope you’re all having a good start to the new year!

For me, the new year means a new start in medical school with clinical clerkships in New York City. Building off the theme I started last year, I hope to continue a message of patient advocacy through a laboratorian’s lens as I learn and navigate the clinical side of our field. My first such rotation is in a clinic serving a population with very significant statistics, both from the standpoint of laboratory data and epidemiology: HIV, hepatitis, and chronic infectious disease. As such, let me use this as a primer and explore what that really means for the patients in that community.

Now it’s no surprise that laboratory professionals like ourselves are deeply involved with public health efforts aimed at mitigating chronic/infectious diseases through screening, collaborating, and advancing technology. Last year I was fortunate enough to be part of the 2017 ASCP Annual Meeting in Chicago. Participating in sessions, and roundtable discussions, I was also able to listen to US Global AIDS Coordinator, Deborah L. Birx, MD had to say regarding ASCP’s global contributions to HIV/AIDS research and public health efforts. She spoke about resource limited laboratories and how ASCP has been an active and longstanding partner to the President’s Emergency Plan for AIDS Relief (PEPFAR), a global health initiative to address HIV/AIDS.

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Image 1. My wife Kathryn C. Booth, RN, MSN, CNL, and I, take part in a roundtable discussion at ASCP Chicago 2017. From Critical Values: 2017;11(1):34-39. doi:10.1093/crival/vax040
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Image 2. US Global AIDS Coordinator Deborah Birx, MD, delivers the scientific general session at ASCP 2017 in Chicago. From Critical Values: 2017;11(1):34-39. doi:10.1093/crival/vax040

The relationship between laboratory data and epidemiology is evident, as results from screening and routine testing demonstrates both snapshots of evolving health statistics as well as progress in public health initiatives like PEPFAR. ASCP’s global initiatives reach all the way to Africa as those resource-limited laboratories gain support from telecommunications and shared materials. From rapid HIV tests with Western Blots, to Zika seroprevalence research, laboratory data and public health are dependent on each other. So how does this manifest in a place like New York, specifically the Bronx where my clinical rotations are located?

First, let me illustrate a snap shot of the scene in this New York borough. Something that demonstrates important data are a region’s social determinants of health—something I have found in my research and experience to be invaluable pieces of information when trying to address health concerns and influence outcomes with particular patient populations.

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Figure 1. A clear layout of New York’s Boroughs. I currently live in Manhattan and go to clinical sites in the Bronx for my clerkship rotations. (Alamy stock photo. Photo credit: http://www.alamy.com/stock-photo-new-york-city-5-boroughs-map-96927034.html)

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Figures 2-5. 2015 NYC Rates of Persons Living with Diagnosed HIV compared against variable social determinants of health including poverty, high school education, median income, and income inequality. Accessed through AIDSVu.org interactive map, visit it here: https://tinyurl.com/y8u9op8v

It’s clear to see here that the Bronx area has the most significant epidemiologic presence of active and new HIV cases. Parallel to this, the data demonstrates that the social determinants of health illustrated in Figures 2-5 are clearly correlative. More so, in the most recent report by the New York City Department of Health and Mental Hygiene (DOHMH) and the office of HIV Epidemiology and Field Services Program (HEFSP), data collected since 1981 from reported clinical encounters, viral loads, CD4 counts, and HIV genotypes reveal significant social health statistics. According to their 2016 NYC HIV/AIDS Annual Surveillance Statistics, the Bronx remains plighted with high numbers for HIV. It would appear as well, that regardless of HIV status, an overwhelming majority of the population (>71%) live in very high poverty—defined as >30% of the federal poverty line. According to data from Community Board 6, the local representation for the Bronx and specifically the zip code around my clinical site, the median household income is $24,537. A majority of this population is comprised of minorities as well, >40% Black and >40% Latino. The data differs slightly between men and women (including transgendered men and transgendered women) with regard to transmission risk. For men the highest risk factor continues to be sexual transmission between homosexual men, or men who have sex with men (MSM). For women, the risk stratifies to a high majority of heterosexual transmission (>70%). Read the full 2016 NYC DOHMH report here: https://tinyurl.com/ycf82xld. According to AIDSVu.org nearly 3,000 people out of 100,000 residing in the Bronx are living with active diagnosis of HIV/AIDS. The same source reports that between 2011 and 2015, the number of new cases approaches 200 annually.

Another valuable function of the AIDSVu.org website is their HepVu.org companion site which provides incidence and infographic data about Hepatitis infections. The Hepatitis B and C Annual Report for 2014 published by the NYC DOHMH in 2016 also provides information about this chronic condition and how it affects the population. The maps below demonstrate that chronic Hepatitis is a serious and prevalent problem, and at a slight majority directly affects patients proportional to age.

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Figures 6-8. Maps from the DOHMH NYC Hepatitis B and C Annual Report for 2014 published in 2016. (Source: https://www1.nyc.gov/assets/doh/downloads/pdf/cd/hepatitis-b-and-c-annual-report.pdf)
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Figure 9. Mortality rates of HepB, HepC, and HIV in New York City at large. Note the decrease in HIV and slight increase in HepC. (Source: https://www1.nyc.gov/assets/doh/downloads/pdf/cd/hepatitis-b-and-c-annual-report.pdf)

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Figures 10-11. Maps that demonstrate that even though New York State has a lower-than-average HepC prevalence rate, it has a relatively higher rate of mortality. Source: https://hepvu.org/resources/

But what does all this data mean? First and foremost it means progress. Progress for our patient populations because we’re busy tracking and keeping ahead of health statistics as they happen, and progress in our innovative ways to test earlier, screen better, and use the data wisely. None of this would be possible without the lab. From every hepatitis viral load, antigen immunoassay, and serology, lab data becomes translated to health data. And, all the while, clinical encounters with real patients experiencing real chronic illnesses are reported into epidemiologic data. Together we use those two sets of data to improve patient outcomes—I talked about that a lot with Zika in Sint Maarten.

I am honored to be at that bridge between the lab and the patient. Translating data back and forth from bedside to primary source is something that brings me a real sense of purpose. As part of this clinical rotation I will have to be involved in patient education, delivering presentations and conducting follow-up with those in the community who these public health messages are targeted to. So, instead of boring you some more with facts about lab science, testing/screening opportunities, and a promising future for those with chronic illness, I’ll go ahead and get a presentation ready for them!

Talk to you soon with some more in-depth clinical case-based blogging! Thanks for reading!

 

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Constantine E. Kanakis MSc, MLS (ASCP)CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student at the American University of the Caribbean and actively involved with local public health.

The Voice of Sint Maarten

It’s often difficult for a medical student to take time out of their schedule and work on projects in their community. Our free time is often encumbered with the “fire hose” of information that we all need to process and master before we sit for board exams. To be fair, there isn’t any free time per se. It is apparent (in medical school more than any other time I’ve known) that every minute of the time we schedule is, by choice, purposeful or not. With that noted, something exceptional happened this month in a span of three days that I am truly proud of. My “Z-Pack” Zika virus prevention initiative team all came together and tackled three extraordinary events around our Sint Maarten community.

If you’re just joining the Zika-related action, check out the background behind my work as well as some of the major accomplishments, achievements, and noteworthy lessons along the way this past year. My team’s work bridges a gap that exists between public health and the data we laboratorians acquire through diligent research.

The whirlwind of public health outreach events the Z-Pack was able to do were highly productive to the cause:

  • We have bolstered our public health and source reduction message on local radio, television, and print.
  • We have engaged and partnered with innumerable entities within this community and were an integral part of a mainstay annual health fair.
  • We engaged with local community members, not as students, but as public health liaisons fielding in-depth questions and addressing real concerns of the local population.
  • During these episodes, we were able to procure true data which we continue to collect, analyze, and use to formulate new approaches to positive health outcomes.

The first exciting development I listed was the debut into our media campaign. Being invited to the local radio to advertise our work and promote upcoming events was both exciting and reaffirming. In a short interview, I addressed Zika and other virus threats to the island community and discussed epidemiologic data and what it means in the scope of public health. Talking about our work alongside two of my team members and the project manager of the Ministry of Health’s vector control program was a thrill. A fellow team member and I were also fortunate enough to be flagged down by a local cable access television program to promote our work on a short video spot during our presence at the Lion’s Club Annual Health Fair I’ll discuss shortly. These media outlets reminded me of moments back in the laboratory when I had to present data clearly and field questions “on the fly.” Whether it was a staff meeting, educational resource assessment, or CAP inspection response, I couldn’t have been more prepared to handle the translational bridge from data to public view.

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Image 1: “Z-Pack” on the radio!

(Listen to the 16 minute radio spot here from PJD2 102.7FM/1300 AM The Voice of Sint Maarten)

I mentioned the Health Fair the local Lion’s Club sponsors each year, with booths that address a plethora of health education outlets from diet/nutrition, to diabetes, to (of course) mosquito reduction.  Partnering with our colleagues in the Ministry of Health we set up several tables in a tented booth and made available all kinds of educational resources for the public. There was a station designated to secondary interventions for combating mosquito risk reduction such as fogging guns and larvicides for standing water areas. I designed some clear-message flyers to distribute to patrons and others passing by our booth and was able to spark some interesting conversations with local community members and business owners who wanted more information—they wanted to distribute and display the same information in their offices and homes. Gaining popularity with the local community, we decided to record those interested parties and give them the title of “official community partners.” Not only will they feel more involved in the process of empowering and advocating for health for their community, but they will be motivated from within! I will say that my absolute favorite part of this health fair was the station our Ministry partners set up which included all their laboratory equipment they use to speciate, quantify, and analyze the local mosquito threat. This, alongside with our friends in local laboratory medicine who were collecting specimens to screen for Zika serologically, made this a very friendly environment for a laboratory professional like myself. You can bet I was happy to talk to visitors about epidemiology and risk reduction over a few microscopes!

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Figure 1: Clear-message informational flyers for public patrons to our booths at the health fair.
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Image 2: Health fair snapshots, a fogger gun, and some team building with microscopes.
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Figure 2: Preliminary data processing reveals an improvement in perceptions, attitudes, and behaviors toward Zika virus and overall arbovirus risk reduction.

On a more serious note, I want to speak briefly on the amazing opportunity that our community meeting offered for my team and I to learn some real truths about public health here on the island. With the success of partnering with laboratory services, research work in the field, and participating in a growing media campaign, the Z-Pack arranged a community meeting at a local religious center. Our “community meetings” as proposed in part from our earlier work focus on presenting audience and culturally specific information about reducing arbovirus risks and addressing health within the community. A community liaison connected us to a local Islamic center, where we conducted one of these meetings. Our presentation was received well, and a vigorous discussion followed. Having a partner from the Ministry of Health with us that day provided some clout to our discussions. I drew heavily on my interpersonal skills as a laboratorian when I fielded some really challenging questions from the adult crowd. Concerns in this particular community included specific objections to the effectiveness of the Ministry’s work on reducing mosquito populations, frustration over tourist-heavy areas receiving unfair attention, and true worry over improving health outcomes in a constructive and collaborative way. Taking the time to share their personal experiences was greatly appreciated by my team. Really engaging with the community on an individual level really makes it feel as though we are creating positive change. As a part of our work, data was collected on the effectiveness of our message. Still in its early stages, the data (Figure 4) shows qualitative improvements toward answers in post-presentation surveys which reflect new facts learned, potential for social/behavioral change, and establishment of health risk as a community priority.

 

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Constantine E. Kanakis MSc, MLS (ASCP)CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student at the American University of the Caribbean and actively involved with local public health.