So, thank you to ASLD and Drs. Rowe and Muir for the opportunity to speak with you today. Thanks Dr. Arora for setting the stage, leading everybody down the path to the next talk. These are my disclosures. So let's turn to people who inject drugs. Why focus on people who inject drugs? People who inject drugs carry the highest burden of hep C, with almost half worldwide living with hep C. Injection drug use drives transmission in middle and high-income regions. High levels of treatment and cure for this group can reduce incidence and prevalence. We have compelling evidence that DAAs are effective for people who inject drugs. For example, two recent meta-analyses show high cure rates for this population, whether or not they were on opioid agonist therapy, OAT. For all these reasons, international guidelines support prioritization and scale-up of treatment for this population, yet few are treated. The hep C care cascade has failed to reach people who inject drugs in sufficient numbers. Barriers are many and include, at the patient level, stigma and, as we've heard, difficulty accessing conventional health settings. When people receive addiction care in one place but no hep C care, or hep C care at one center but no addiction care, people are shuffled around, time passes, increasing the likelihood of dropping out of care and being lost to follow-up. At the provider level, there's reluctance to treat people who inject drugs. And at the system level, prescribing restrictions, barring drug-involved populations from DAA access. So what we want to do is simplify, provide key aspects of care on-site, at a single site, and reduce the time from infection to cure. Integrated care unites expertise in both hep C and addiction. So co-location can be physical. There are a growing number of successful models for hep C care for people who inject drugs on-site at accessible venues, such as needle and syringe programs, services for people who are unstably housed, and others. So why focus on OAT programs? Eighty-three percent of injectors mainly inject opioids. OAT is our key treatment. It reduces illicit opioid use, craving, and death. With integrated OAT care, we have patients already engaged in treatment for the chronic medical disease of addiction, ready to initiate DAAs. OAT can facilitate hep C screening, treatment uptake, and cure. And it can reduce hep C incidents and reinfection. Co-located OAT improves retention in hep C care and decreased loss to follow-up. And in the absence of a vaccine for prevention, it is DAAs delivered in combination with OAT and harm reduction that gives us our greatest prevention benefit. So in the U.S., for the two opioid agonist treatments, regulations limit access. For methadone, this was carved into law in 1974 with the Narcotic Addict Treatment Act of Congress. For methadone, patients must attend a federally licensed clinic organizationally and often physically separate from the general healthcare system. So again, the methadone clinic system in the United States is divorced from usual healthcare. Methadone maintenance programs are tightly structured. A physician evaluates patients and nurses dispense methadone daily under supervision. Take-home visits, which free patients then from the daily visits, are contingent on a slew of criteria including duration in treatment, negative results of tox tests, and others. We can leverage the methadone clinic infrastructure for on-site hep C care. And in fact, global expansion of methadone and the potential to integrate hep C services with methadone is a key step in the worldwide public health response to the hep C epidemic. So at minimum, we have a supportive environment for hep C treatment. Staff familiar with psychosocial needs not typically encountered in tertiary care hepatology clinics, low threshold, welcoming care that respects patients' preferences. Patients can receive care without shame or stigma. With the requirement for frequent attendance, we have daily or at least frequent contact with patients, enhancing support, and providing opportunity for directly observed therapy, DOT, to bolster adherence to DAAs. We can then incorporate prevention, different types of harm reduction, vaccination, prep to reduce HIV risk, an array of services, counseling, peer support. And then we layer on hep C care. Universal, there's no going after different populations, universal test to treat. So with universal hep C screening, whatever the best mean is. So in Scotland, that means dry blood spot testing for the viral load. If we're in Australia, that means the expert finger prick RNA test. We're behind the United States. Gotta catch up. We're talking about accelerated care with simplified pretreatment workup and on-treatment monitoring, serum biomarkers in place of elastography if patients have to go off-site for this, hep C education, and then the long view after treatment, post-treatment care for obtaining SVR, care of cirrhosis on-site, and ongoing risk reduction. Now ideally, the foundation here would be primary care plus care for related conditions, psychiatry, HIV. But again, in the US, methadone clinics are not often ambulatory care centers. Methadone clinics can have punitive regulations and practices, so we have to be careful. They may be viewed as a place of ration trust with themes of opiate agonist therapy, ruling people's lives, and fear of repercussions resulting from perceived breaches of clinic rules. So while co-location makes intuitive policy sense, hep C healthcare workers in the methadone space may be seen as agents of a shady system. So for effective hep C care, patients must build trust in hep C services and staff through clear boundaries between hep C care and methadone and promotion of success stories through trusted peers. So let's take a trip. Let's turn to two representative models of care in the US and Switzerland. I really want to see hands. Who has not been to a US methadone clinic? Who has not been to a US methadone clinic? Okay, let's go. Kodak is Rhode Island's only non-profit program. Providence is the largest of eight sites. We dose 1,000 patients a day. You can see this is an under-resourced clinic, doesn't look like a typical hepatology clinic. We have the largest patient population, 92% of our patients are Medicaid recipients. There is an electronic health record, EHR, for methadone delivery. There's our basement clinics for our hep C team, physician, nurse, pharmacist, stellar phlebotomist. We do now have onsite phlebotomy with some limitations in what we can order as well as counseling support groups and tobacco cessation. Now our medical director is board certified in addiction medicine and the methadone delivery is evidence based. But in Rhode Island and much of the US, there is no requirement that the addiction doc have any training in addiction medicine. All that's required is interest, imagine that in hepatology. And in fact, historically, Rhode Island's for-profit methadone clinics, again this one is a non-profit, Rhode Island's for-profit clinics were often an on-ramp back into medicine for physicians who lost their medical license for any reason and after some type of remediation could not get their old jobs back in their old profession and needed an on-ramp back into care. Now in 2014, we started an onsite hep C program with the goal of micro-illumination across our nine sites. With entry into care at the methadone clinic, there's universal hep C antibody screening with reflexive RNA and genotype, genotype because the payers in Rhode Island require genotype along with HIV, hep A, hep B, STIs and liver panel and CBC because we get the labs for everybody for apri and fib 4. Then the hep C nurse navigates the patient to the first visit with hep C doc. Here we assess hep C and comorbidities. Second visit, treatment initiation, ideally within a week, sometimes it takes three weeks. It depends on the prior authorization process, which is a system in the U.S. by which we have to apply to payers, public and private, to get DAAs. We offer DOT at the methadone window. It's optional. We're available daily, anytime to help patients with anything. We provide the cirrhosis care on-site. We fully exploit being outside the less flexible academic medical center where we started this program a few years back with a gentle and now highly trusted environment. Patients know if they miss 50 days, we're glad to see them on day 51. We schedule appointments, but most patients are walk-ins, same day visit. My nurse partner walks around the building upstairs where people get dosed, and by the way they're given a number, people are known by number upstairs, and says who would like to come down, anyone want to come down and see the docs? They walk downstairs and then they're referred to by name. For patients who are homeless, about half the population, we hold their DAAs. We have them delivered to us, they don't have an address. We bring them to people when they're incarcerated, which is a very frequent occurrence. There is no electronic health record for FCP care, we barely have computers. We use paper charts, we made forms and check boxes, and spend as little time as possible in documentation, but we have very long patient visits, as long as patients need. We communicate that we don't check talk screens, the hep C care is separate from the methadone system. We just want people to have a safe place to talk about difficult things and to get care. There is no primary care psychiatry. We are allowed to provide HIV and hep B care, vaccination, which took four years to get going, PrEP, medications to decrease the risk of HIV, harm reduction education, and naloxone. We're not able to dispense sterile injection equipment, but we refer people to needle exchange four miles away. So of the first 276 treatment initiators, setting aside 26 still on treatment or awaiting SVR, 82% achieved SVR. Excluding treatment completers lost to follow up prior to SVR 12, yields an intention to treat SVR of 94%. By the way, we couldn't get DAAs for patients without F3, F4 in Rhode Island until July 1, 2018. So we've treated more in the fifth year than we did in the first four, while we watched the epidemic mushroom. Now in contrast is Arood, a model for comprehensive care of people who inject drugs in Zurich, Switzerland. A primary care based addiction medicine institute with integrated hep C care and psychiatric services delivered by a multidisciplinary team all under one roof. Arood also dispenses free sterile injecting equipment. Now why Switzerland? A lot of wonderful work going on around the world. Switzerland was the first country in the world to establish a widespread government funded program of heroin prescription in 1974 under a policy aimed to curb overdose and HIV, which it did. Heroin assisted treatment is designed to treat a minority of people who fail methadone and buprenorphine. Patients inject at Arood under supervision. At Arood, heroin assisted treatment is offered along with methadone, buprenorphine, and long acting morphine. So from 2014 to 17, Arood treated 64 patients, 66% were on OAT, and 34% were on heroin assisted treatment with an SVR of 92%. Excluding those lost to follow up post end of treatment gives a modified intention to treat SVR of 97%. So back to the U.S. How do we expand capacity? There are challenges to embedding hep C care into our 1,613 methadone clinics. Virtual co-location can aid in the roll out for this group, and we've heard about telemedicine from our world expert, but we're going to look at it in the context of people who inject drugs. Here telemedicine, which again employs technology to bridge geographic separation between hep C expert and methadone clinic, with two way video conferencing between patient and specialist, imports hep C care into locales lacking not only hep C expertise, but infrastructure, again many methadone clinics don't even provide phlebotomy, and resources. So here's a photo of hepatologist Andy Talal conducting a study of telemedicine based hep C care for methadone patients in northern New York City. And here's the model. Patient is screened for hep C, then shown a video on what to expect. There is initial patient evaluation and discussion. Pre-treatment labs are formed on site, including Fibroshore. The expert documents in the EHR and works with staff here, our physician's assistant, at the methadone clinic and submits a bill. So they're billing for this work. This is how it works, because most methadone clinics in the U.S. cannot financially support ECHO. DAAs are dispensed with methadone, and in the pilot, SBO was 93%, and Dr. Talal is now currently conducting a randomized trial comparing telemedicine to usual care at 12 methadone clinics throughout New York, representing 10% of methadone clinics in the whole state. So how do we evaluate these models? Well, there was a systematic review last month by associates and colleagues on the impact of co-location of hep C and substance use services on hep C care. And while the narrative analysis did indicate that overall integrated care improved the cascade to cure, the quality of evidence was low to moderate. Heterogeneity between different models and lack of randomized or comparative studies precluded meta-analysis. 95% of studies were conducted in high-income countries, and only 14% were in the DAA era. So we do need more data. So I'm going to finish up by telling you about HERO, real-world DAA outcomes among people who inject drugs. In this national study involving eight states, we enrolled 754 persons currently injecting drugs to get 622 initiating cefosporavir vopatisvir. Participants were treated either at community health centers or methadone clinics. Outcomes include initiation of DAAs, adherence, completion, SBR, resistance, and reinfection over three years. Participants were randomized to direct leaps of therapy or patient navigation. Treatment's now complete. You'll have the final results soon. Both arms leveraged co-located care and our sample size will allow us to determine whether intervention effects vary by methadone clinic versus Community Health Center. So in conclusion, people who inject drugs must be engaged to achieve hep C elimination. Co-located hep C and OAT care plus harm reduction facilitate prevention and cascade to cure. We need to determine which co-located strategy is the most effective and scale up integration of hep C care into settings where people readily access OAT via physical and virtual co-location. We must also broaden access to evidence-based OAT and expand methadone availability across diverse clinical settings. Methadone clinics in the U.S. are not enough. We only have 1,600. Most of the opioid crisis is in rural areas. 94% of our methadone clinics are in metropolitan areas. We have a vast international experience. Switzerland, Canada, the UK, Australia, and others. Methadone may be prescribed in primary care and often dispensed in a pharmacy. So in this way we can embed hep C care not only in methadone clinics but in primary care where people who inject drugs receive methadone as in the Swiss model of whole-person care, whole-person fundamental health care. So hep C care looks like this with basic fundamental health care at the base. Thanks for your attention. Great, great talks both of you. It's fantastic. I'd like to open up for questions from the audience and I'll start with an initial question. So to both of the speakers, what are the challenges that you face in making programs such as ECHO and co-localized hep C treatment for injection drug users sustainable? Like how do you make these programs sustainable over time into the future? I think for ECHO the real issue for us, the biggest problem for us, is that currently in most states other than New Mexico now we have a model the rural site or the substance use site doesn't get any reimbursement for presenting the case. And so primary care clinician time is a major barrier. Now what has happening is there's an ECHO Act of 2016 that became a law in the United States. Five weeks ago Congress signed a letter to Health and Human Services, CMS, and Medicaid. 22 senators and 22 congressmen from both parties saying that CMS should reimburse ECHO in primary care sites etc. And third ECHO Act of 2019 is currently making its way through Congress. Essentially right now will be out within the next two to three months which will tackle this reimbursement problem. We ourselves are surprised how rapidly the model is spreading without any reimbursement for it but it seems to be going so. So I think as Dr. Thomas said public health plan, public health resources, public health funding to back the plan. Resources I think the eliminating factor even when we have national and global guidance the resources to back this up. What's happened for just for example in the US is the way hep C care has worked is just having champions in different places make this happen and when that champion leaves and that's the end of it. So we need resources to support the ongoing infrastructure so when different people leave things continue. At least with in the US with the 340 B program the federally qualified health centers are covered. I know when I was at the academic medical center I found out they said you know Lynn you're the cash cow we make eight hundred eight thousand dollars each time you write a prescription that funds our corporate medical program. Some of it's obviously supposed to come back and have C care that was at the HIV clinic but 340 B in the US right now doesn't cover methadone clinics substance use treatment and it's really funding that we need and the workforce. Thank you. Yes you can ask your first question. Thank you. Hi Lauren Canary National Viral Hepatitis Roundtable. I just want to follow up on that point before I ask my question. For anyone that does want to help fight for resources we could use more clinician advocates. We'll have a workshop tonight at 730 led by Dr. Stacey Truskin in at the Boston Sheraton for how to get involved in fighting for those resources. My question is for Dr. Taylor. A lot of the discussion today is has mentioned stigma towards people that inject drugs and I wonder what you think hepatologists can do to help dismantle that stigma and to actively engage in their communities with people that inject drugs. I have with me if anyone's interested I won't read in the interest of time the American Society for addiction medicines updated definition of addiction which is really instructive to understand that you know most of our patients did not grow up and aspire to be living in a tent struggling with with fentanyl and methamphetamine addiction. This is a chronic treatable preventable disease. It's a health issue and as much as we can medicalize this and understand that people are really struggling and their patients and I think even getting specific cultural training just as we may if we're learning how to interact respectfully with patients who might use sign language or any other issues if we could even at ASLD maybe it's a stretch but have specific cultural training on working with as physicians and health care workers talking about populations respectfully people so much appreciate it we have to realize that even I'm sure no hepatologist means ill will but one slight interaction that may hurt someone's feelings these can be fragile populations one phlebotomist standing over your I'm saying what's wrong with your veins you'll never see that person again and so our patients population can be very fragile and as gentle as we can be we're not enabling people I think the problem sometimes is that in traditional health environments you know where I came from the Academic Medical Center until you're enabling people get people to buck up and get to clinic on time and if they're 20 minutes late we're not seeing that we're trying to save people's lives you know 70,000 overdoses the Hep C is the easy part keeping people from overdosing and dying is the hard part and so if we can be welcoming over time you see that the change people say I'm treated like a human being people know I'm not a piece of nothing people do start at least to call and say hey I'm gonna be late I can't come and then a month later people start to come and they come on time and to never give up on people but I know nobody means badly but I just think it's just like me as a general internal medicine doc trained here with all of you to take care of patients because there's no one to send them for cirrhosis care to see if we can train hepatologists in the basics of addiction medicine yes the woman in white I believe you can't you were first yes hi I'm Caitlin coil from Hopkins I actually had a question about the echo model a couple years ago we tried to well we did expand treatment into federally qualified health centers and we tried to use a model inspired by echo and we ran into a couple hiccups one of which was how to sort of designate time in a primary care setting to do this especially in a fee-for-service model but one of the big ones we had was how to pay for the specialist's time and we were working with nurse practitioners so we had to have a collaborating physician but also it was had like and we we did work with try to work with Stacey Trueskin actually on this but we didn't know how to pay them and they were we did get 340 B but in a you know in an FQHC you can't say that all of it can go to hep C care specifically because they have other costs so I didn't know how you address that I think for FQHCs that use 340 B pricing for hepatitis C drugs every hepatitis C patient they treat results in a profit of about $10,000 per patient treated they don't need any more incentives to treat I can assure you it covers a lot it every patient you treat covers two months of a primary care doctor's salary in an FQHC so devoting a few hours is not a shouldn't be a problem and if there is there is somebody who needs to have some mathematical education there but I think that as far as the the specialists are concerned that is not a possible way currently to fund except in some states like in ours there is there are also multiple states now the way the insurance company is willing to cover the time of the specialist because the actual time of the specialist required and echo is very small two to four hours a week is the maximum amount of time required you have to figure out some innovative way either through the Health Department in our case the Department of Corrections our Health Department and our legislative and Medicaid also pitches in so there are multiple sources because every Medicaid agency in the United States has something called time and distance rules but a time and distance rules is there's a law saying you have to provide specialty care within a certain period of time within a certain distance and no Medicaid plan covers it so if you go to them and talk about that they can cover that little bit also okay the woman in the back yeah hi I'm Jan Diamond from East Bay in California so in our community although we've been very successful at integrating hep C care into the community clinics that the county actually now requires the clinics if they want to get money from the county that they have to provide care on site so we have 65 primary care providers who are treating hep C but what we haven't been able to do and this is my main question is in the methadone clinics say that they don't have funding they can't afford to screen and treat and I'm wondering how in dr. Taylor how your methadone clinic does pay for screening and treatment on site so in the u.s. the two main categories right of methadone clinics are for profit and not for profit when we have evidence that the for profits are less likely to screen it may be completely on their mission in Rhode Island the for-profit clinic is headquartered in Tennessee and I've looked it up the CEOs make millions and millions and millions and millions and the clinics look just like my clinic and the doctors mostly are not board certified in addiction medicine and I don't know that much I have my own concerns over the years about the quality of care so it's often just not in their mission well they say they can't bill they can't build medical even though in Medicaid exactly right I'm sorry to interrupt you so that is absolutely true so for example in Rhode Island it took us two years to get the methadone clinic which historically is only licensed to bill under one billing code in the u.s. called ICD 10 for opiate use disorder so the first two years I was there I couldn't bill at all it took two years of politics working with payers public and private to get to let us bill under any code they said you have a narrow mission you're not a health center you can only bill for opioid care that's it or then eventually buprenorphine and so it took it unfortunately it's gonna have to be for now unless we can work at the federal level state by state you have to we had to work it out for two years with our payers and our leaders to allow the nonprofit to bill under an ICD 10 code beyond opiate use disorder and get grants to cover until we could bill so yeah that's what you have to do you have to get the methadone clinics and again would be better if we could do this at the federal level given that hep C is the biggest infectious disease killer United States to with CMS has helped their people from CMS probably here I know Corinna Dan and other people here to get the methadone clinics to be able to bill for ICD codes beyond opiate use disorder so it was grant funded and then were you after you were able after the two years were you able to it is it sustainable financially even at a nonprofit no it's not for any of us taking care of Medicaid recipients even though Rhode Island has one of the lowest reimbursement rates for Medicaid reimbursement all hep C care is money losing even in the building I'm in at the low salaries getting HMOs and no doctors you know what is it called retirement all these things we lose money every day there are doctors in this room who are world experts in hep C who if you're not doing a procedure in the United States colonoscopy endoscopy you're not grant funded you're not a liver transplant center you don't have other income the care for hep C is a money-losing thing and doctors are told all the time in the US you're not meeting your relative value units you're losing money for the system because this type of care which is basically internal medicine care if you're not doing procedures is not highly reimbursed at this point in the United States so we we lost our funding which which and it's when we don't take pharma funding has to do with that trust of patients and the mistrust of patients the first question we started out was is there something in it for you or you want a speakers bureau or you involved with pharma the patients are very mistrustful so no I'm not we don't take that money I'm not judging anyone else who's involved that way but that would be we have to change of course the structure of reimbursement in the United States because it's an hepatology the procedures and the other things that enable the mid-levels and other people to do the work of hep C thank you and last question here I'm Brian Conway from Vancouver quite appreciate the session dr. Taylor some of the things that you're describing as in your nurse going upstairs and and seeing who may or may not be there and accepting patients who come the right day even if it is four or five hours late this is almost the stuff of sainthood rather than then health care and structurally the issue that that raises is as you expand to other opioid substitution type clinics who may not even have the structure that would allow that flexibility to enhance access to care so that they aren't open enough hours they don't have the right personnel the right number of individuals who are involved to to sort of allow the things that make your program work so I'd appreciate your thoughts on as you go into broader and broader types of clinics that have large hepatitis C populations and that may not have that sort of inherent dedication if I can use that word what kind of structure would you see that would allow us to access those patients because that's clearly a challenge that we face in in Western Canada we go into clinics and we say do like I do and they say well we can't even if we would like to so I so Brian I really respect you and you work but in this case I have to strongly disagree this is nothing about sainthood at all it's just basic health care for drug-involved populations and a lot of it for many of us just comes out of HIV epidemic we started in HIV and this is how we did HIV care and this is how it's done in nations all over the world whether you look at Australia Iceland Scotland Portugal we're not enabling people there's nothing about sainthood it's about how do you take care I hope you didn't take it as an insult no no I I have there's a very very very thick skin there's nothing I can't take my patients are living under 10 so I you can do anything to me I fine and I really appreciate your insights but I don't think at all it's anything about sainthood and for example many STI clinics get a lot of funding there's a lot of funding in this country for STI clinics so the STI clinic at our academic medical center works the same way they just have big open hours because they're well funded so I think we have models again we have for years and years around the world that just show you know I don't have one unique idea I just look at the literature and what people do in other nations that's been things that have been economical economical and successful we have cost-effective and cost-saving analyses from around the world showing that this makes good sense and over time with help with the treatment for addiction and evolution of care people then increasingly are able to make traditional medical appointments but I just don't think it's at all about sainthood it's just about structuring healthcare environments tailored to specific populations thank you well that concludes the end of this session

treatment prioritization

people who inject drugs

hepatitis C burden

direct-acting antivirals

integrated care

stigma challenges

telemedicine role