HCV Burden

Dr Stacey Trooskin (Perelman School of Medicine): So let's start off and talk about the burden of hepatitis C virus.

[00:10:57]

Global Call for HCV Elimination

So we're lucky enough to live in an era where we can actually imagine a time where we're living in a hepatitis C free world, and there has, in fact, been a global call for hepatitis C virus elimination. The World Health Organization's vision is to eliminate viral hepatitis as a major global public health threat by 2030, and we are on the cusp of ending 2024, soon to begin 2025, so we don't have much more time left to achieve these goals.

The targets for 2030 are to reduce 90% of new infections, to treat 80% of individuals living with hepatitis C and to reduce mortality by 65%. The CDC in the United States also has a strategic plan to reduce the number of new viral hepatitis infections, hepatitis related morbidity, mortality, and disparities, and to establish a comprehensive national surveillance program.

However, I think we can all agree that hepatitis C virus elimination in the US and likely worldwide, is not feasible without engaging and treating people who inject drugs.

In North America, 30.5% of all hepatitis C infections are among people with recent injection drug use, and it is up to 68% in some areas of the United States as well.

[00:12:27]

CDC Viral Hepatitis National Progress Report

The most recent – recent CDC viral Hepatitis National Progress report has shown that we are not quite meeting our metrics. In the far right hand side of – of this – this chart, you'll see that the only area that's green where we're meeting or exceeding our current annual target has been in our ability to reduce reported rates of – of HCV related deaths greater than or equal to 20 – 20%.

We are moving towards the annual target, but we have not yet fully met that annual target in both our attempts to reduce the estimated number of new infections, as well as to reduce the reported rate of new HIV infections among people who inject drugs by greater than or equal to 25%. So we're working towards it, but not – not quite there. So we – we have some collective work to do in these areas.

[00:13:23]

CDC HCV Surveillance Report 2022: Documented Risk Behaviors or Exposures in HCV Acute Cases

We know that injection drug use is the most commonly reported risk behavior or exposure among acute cases of hepatitis C. I do want to just point out here that the data missing, like the risk data that that is missing among – among some of these – these respondents is quite high. So folks – and I think that speaks to the stigmatizing nature of – of some of these risk factors that individuals may not – may not feel comfortable being forthcoming with – with some of their risk factors.

Among those that have reported, though, you will see in this chart that injection drug use does sort of top as the most common reported risk factor, followed by multiple sexual partners. Some individuals report surgery as a risk factor. Sex among men who have sex with men, sexual contact, needle sticks, and less so things like household non sexual contact, occupational exposures and such.

[00:14:27]

          CDC 2022: HCV Cases by Sex and Age

The epidemiology of hepatitis C has changed over the – the last decade or so. Some of you who have – who have been engaged in this work or follow CDC based testing guidelines may remember a time when we utilized something called birth cohort screening, and that really spoke to the fact that the generation and individuals that were born between 1945 and 1965 had a higher prevalence of hepatitis C that has since been eclipsed by a now a younger generation being impacted by the virus, really driven by the opioid epidemic.

So what we have now is a bimodal distribution, with the younger age cohort really exceeding the number of baby boomers that are – are living with hepatitis C. And really this is a full manifestation of – of our opioid epidemic and new generation now being included in what we describe as the epidemiology.

So you can see here that we have that older baby boomer birth cohort, individuals that are now 50 to 75 years of age and now individuals 20 to really 45 years of age with the highest number of infections.

[00:15:55]

HCV Screening

So with that base of epidemiology and understanding what – what we are – are trying to address, let's talk about the first step in addressing hepatitis C, which is screening and making folks aware of their infection.

[00:16:12]

AASLD/IDSA HCV Guidance: Screening Recommendations

Now I referenced the baby boomer birth cohort recommendation, which has since become vastly outdated. The AASLD and IDSA, as well as the CDC, have all changed their guidelines to respond to what this epidemiology looks like now and the fact that a new generation is being impacted by hepatitis C, and as such, the recommendation now is universal one-time HCV testing for all individuals aged 18 or older. And this is to be done in a routine opt out way.

So what does that mean? Well, those of us that are based in medical settings do routine opt out testing all the time. When we have patients who come in for a new visit, we say to them, listen, we're going to get some routine blood work today, and that's going to include your – your lipid panel, your CBC, a CMP, maybe where we're going to – to screen you also for HIV, which is routine opt out recommendation as well.

And so it's just including hepatitis C in that routine blood work. It's opting in, is saying, hey, I'd like to offer you a hepatitis C test today. Would you like one? And then the patient can opt in. We don't want to do that. We want someone to say, hey, you know what? I don't think I want any blood work today. So I'm going to opt out of what is the standard of care? A standard routine offer of routine opt out screening.

We also want to be sure that we are offering one-time testing to any individual that's younger than 18 years of age with an increased HCV infection risk. We also should be testing any pregnant person for hepatitis C as part of their routine prenatal care for each pregnancy.

We want to provide more frequent testing, either periodic or annual testing, for individuals who are at increased hepatitis C infection risk, such as people who are injecting drugs. And at least annual testing for folks that fall into that category, HIV positive men who have sex with men, and also men who have sex with men while taking PrEP. So we want to make sure that we're offering more frequent screening for those individuals.

[00:18:21]

          AASLD/IDSA HCV Guidance: Activities for HCV High Risk

In terms of the guidance that the AASLD and IDSA offer, the – the category that includes activities that are considered higher risk:

• Any current or past injection drug use, even if somebody only injected one time;
• Intranasal illicit drug use. Cocaine is among the most common, but not just limited to that;
• Use of glass crack pipes, the idea being that you can have some burns that come to the – to the lips from a heated glass crack pipe that can cause some bleeding and some open – open sores that can then be transmitted to others if you're sharing crack pipes;
• Engagement in sex with other men for those who identify as – as male; and
• Engagement in chemsex, which is may often be unprotected and include multiple individuals.

[00:19:18]

CDC: HCV Testing Algorithm

So how do we test for hepatitis C? The test involves 2 steps, but that doesn't mean we should be doing 2 blood draws. I'm going to walk you through what the testing algorithm looks like, and then also encourage everybody to be ordering what's called a reflexive test to make this algorithm happen within 1 blood draw.

So the first step is to look for hepatitis C antibody. And antibody tells us whether or not we've ever been exposed to a virus, particularly hepatitis C in this case. And I think all of us as a nation are probably more familiar with antibody testing. Many of us have antibodies to COVID-19 from being exposed, but that doesn't mean we have COVID-19 today. At least I hope not.

And so somebody with a negative antibody means that you haven't been exposed to hepatitis C virus that's non-reactive. No antibody was detected. So we're able to stop.

There is one caveat to that though. If I'm in clinic and I'm seeing a patient who says, hey doc, I – I – I think I was exposed to hepatitis C yesterday or the day before I was injecting drugs with a partner who told me that they were positive and I want to get checked out today. That 2 to 3 day period of time is not a sufficient amount of time for the body to make antibodies against the virus to which it was exposed. And so you're in a window period.

And at that point in time, the recommendation is going to be I'll test you today. But if it's negative and you were just exposed within that 3 to 4 and sometimes up to 6 week window period, depending on how efficient a body is in making antibody, I'm going to have to have you come back in another 4 to 6 weeks to get screened again, to look for that new infection.

If the hepatitis C antibody is reactive, that means that an exposure has taken place. But 15% to 25% of people who are exposed to hepatitis C can clear the infection on their own. And so it's important to do the next step, which is an HCV RNA test. If RNA is not detected, it means there's no current infection, but you still want to do additional testing as appropriate.

So individuals that would have a positive or reactive antibody test, but no virus present means either you cleared the virus on your own, or you were given a direct acting agent in the past cured the virus. That antibody will be maintained, but no virus will be detected when you test using HCV RNA testing.

If the HCV RNA test is – is detected, that means you have a current HCV infection and we link to cure. Now, as I mentioned, this whole algorithm can be done in an HCV antibody test that reflexes to PCR testing in the event of a reactive test. So what that means is somebody will get their blood drawn. You send either 1 to 2 tubes off to your reference lab. They do that first test. If it's reactive, they then take those tubes of blood and put it on the next machine and do that HCV RNA test.

It's a preferred way of doing that, because then you don't have to bring the person back for a second blood draw. And from prior studies, we understand that about 50% of individuals with a reactive test don't come back to necessarily get that second test. So this is a way to get the true diagnosis up front and be able to engage that patient in curative treatment.

[00:22:46]

What strategies can improve HCV screening among people who use drugs?

So with that, I want to shift and talk about strategies that can improve hepatitis C virus screening, specifically among people who use drugs.

[00:23:01]

          Poll 2

So I want to turn this to you and get some feedback. At your practice site, what barriers to hepatitis C virus screening do you experience? And just please include a short answer that – that you've experienced in your clinic.

So while you're working on that, I know that from some of the work that we've done in – in technical assistance with – with other with other programs, some common barriers that – that we've seen is that screening is often done with point of care testing that – that may not reflex to PCR testing. So there are – there are rapid antibody tests that are available.

And if phlebotomy is not on site, that – that is one way of doing it. And that then requires a referral out to other individuals.

I wonder, Mark, if – if you'd like to chime in and talk about any of the – the challenges that you've seen in the work that you've been doing?

Dr Mark Sulkowski (Johns Hopkins University): Yeah, sure. That's a great point. I think the issue of phlebotomy is one of the major challenges. So we will do community based point of care antibiotic testing with a finger stick. That's great. But now you've got to get that phlebotomy for the RNA test. And that's where we really struggled with community based testing programs. You know, perhaps with – there'll be an option – we'll be able to deploy an option for direct RNA testing with the newly approved device, but that remains to be seen. And that does take some time.

Dr Trooskin: Yes. Absolutely. Absolutely. So having a phlebotomist is key. I think also leveraging that routine opt out screening piece is really important and can sometimes be challenging. Substance use disorder treatment sites look very different depending on – on the services that are rendered. Not all have medical – medical availability. If it's not medication for opioid use disorder, then maybe there isn't an EKG or routine blood work. Maybe there's just therapy or counseling that's happening.

But really looking at each individual workflow to think about where could you integrate routine opt out screening, it's a lot easier if there's already blood work that's occurring on intake. It's a little bit harder if it's a place that is supporting people who use drugs, but it's just a therapeutic or group interventions and not necessarily medical – medical care being provided on site.

[00:25:45]

Nontraditional HCV Screening Sites: Meeting People Where They Are

Okay, great. So let's – let's move on and talk about some of these nontraditional hepatitis C virus screening sites. And really how do we meet people where they are. So lots of options, right? I think the key to elimination is really figuring out how we bring the testing, how we bring cure to individuals where they're already accessing services and not requiring individuals to kind of traverse a very complex healthcare system, which often requires insurance and referrals and making appointments.

I think the – the lowest barrier ways is to – to – to meet folks where they already are receiving services. So things like harm reduction centers like drug – drug and alcohol programs, substance use disorder treatment facilities, harm reduction programs like syringe services and – and outreach programs, sexual health clinics, other mental – mental health facilities, pharmacies, and so on.

And then really thinking about how we partner with community based programs. How we go out into community, whether it's a mobile health clinic or a testing vehicle, going to folks homes, looking in shelters integrating routine opt out screening into prisons and jails and then also providing the critical treatment that goes along with that in those settings. Health fairs, all kinds of things.

And so I – I think starting to – to think about delivery of testing and treatment in community is really, really critical. And the countries that are leading the charge to elimination have really employed a lot of these types of community based approaches.

[00:27:31]

          The Long Journey to an HCV Diagnosis . . .

It can be a very long journey to a hepatitis C diagnosis. And so a visit number 1 can be that antibody test. If in fact you haven't done a reflexive – reflexive test. And then if that antibody test is done point of care, as Mark sort of referenced, a finger stick. Then having a visit number 2 for a phlebotomy for that confirmatory test. And – and that visit, it's a short arrow on the graph – on the – the slide. But it can be up to months for Visit 1 and Visit 2 to happen.

After that test is done, getting the diagnosis, coming back for RNA testing, all of that can really prolong a process unnecessarily. And with each one of these arrows, which – each one of these steps, it creates an opportunity for – for patients to be lost to follow up. And so when we screen individuals, we really want to incorporate reflexive testing, bringing that phlebotomy where we're able to – to the individuals in community so that we can speed this process.

The gold standard really will be sort of a test and treat type of model. We have a little bit of a ways to go there, but we're getting closer and we really need to take out the stepwise process and get it all done with 1 blood draw, right where the patient is already accessing services.

[00:28:55]

          POC HCV RNA Testing

As Mark said, there is now a point of care HCV RNA test that is available. It allows for diagnosis and treatment in 1 visit. And so essentially we're – we're – we're removing the need for the antibody test. It can be done with – with a finger stick. It's implemented successfully in various settings like prisons, mobile clinics, community clinics, needle and syringe service programs, and also overdose prevention sites.

And compared to – to standard of care testing, which often involves phlebotomy, point of care assays are reduced time to treatment initiation. And so this test usually has a runtime of around 40 – 40 minutes to an hour. And so it still requires individuals to wait for the test result. But we're not coming back a week to a month later to do a next step in – in a diagnosis.

Studies have shown there can be increased treatment uptake and reduced loss to follow up. So moving us closer to that test and then immediate treatment type of – type of model.

In – in June of 2024, the point of care HCV RNA – RNA test was approved in the US. It's been used abroad for a much longer period of time. And as I said, the turnaround time is about 40 to 60 minutes, which is – which is great. And so this is a major breakthrough in our ability to move closer towards that test and treat model.

[00:30:27]

POC HCV RNA Testing        

A new section will be added to the AASLD and IDSA guidance on test and treat with that rapid point of care HCV RNA testing. So that is forthcoming.

[00:30:39]

          Poll 3

So here's your next poll. At your practice site, have you implemented point of care HCV RNA testing? Responses are:

1. Yes;
2. No; or
3. I'm planning on it.

Please respond.

Right. Okay. So I see a lot of you have not yet implemented on it, but there are a number of you that – that hope to do so, which is – which is excellent. Too far. Okay.

[00:31:22]

          Poll 4

So if you're not planning on implementing it, what are the barriers to implementation?

1. Are you Unaware up until this moment, that point of care, HCV RNA testing was available;
2. Is it the cost of implementation;
3. Is it the lack of an internal champion to support implementation;
4. Do you have concerns regarding reimbursement and sustainability; or
5. Is it something else?

Please respond. Okay. Excellent. All right. Sort of all over the board here. But I see that many of you were not – yet aware. And it is sort of hot off the press. This just happened over the summertime that it became available in the US.

[00:32:08]

Developments Still Needed to Optimize HCV RNA POC Testing

Okay. So there are developments that are still needed to optimize HCV RNA point of care testing. And so one of those is a faster time to result. And so most point of care tests that are antibody point of care tests have a turnaround time that's 20 minutes or less. Ideally we like to see that under 10. If someone is coming into a syringe service program, they want to be able to get syringes and then – and then leave.

And so to hold somebody for 40 minutes to an hour to await a test result may not be feasible. So it's – it's critical that we work towards a faster time to result. Cost is obviously a concern. Anytime we talk about large machine that has cartridges, there are costs associated both with startup and maintenance. And so getting a lower cost, particularly when we're talking about deployment in community based organizations that are often resource limited, that's a critical piece as well.

And then not requiring additional – additional equipment. The technology that we have available right now to us that was recently approved involves having, you know, a microwave size machine available and then small cartridges. We are all familiar with sort of what point of care testing looks like. Now, many of us, at this point in a post-Covid world, have done a point of care test in our own homes that are self-contained in a box. It's ideal when you have something that doesn't require any large equipment as well.

And I – I would also add that for a real test and treat model, we also want to be looking at hepatitis B diagnosis as well. Right. So it's important to know someone's hepatitis B infection status when – when initiating hepatitis C treatment. And so that's another piece of the puzzle to help us optimize and move closer towards a test and treat model.

[00:34:03]

Same Day “Test and Treat” HCV Model: Community-Based Pilot in Egypt

And so in – in Egypt, there was a same day test and treat hepatitis C virus model. It was a pilot project that was implemented at 2 community sites. There was both serologic screening for hepatitis B and hepatitis C and staging of – of disease and additional testing that – that was done. And the sites included a village in northern Egypt and then a government office in Cairo.

And so I think for - for us, the take home message here is that treatment was made, brought into community, highly accessible for – for individuals.

[00:34:45]

          Same Day “Test and Treat” HCV Model: Cascade of HCV Care

And the outcome of that same day test and treat HCV model, at site 1, 475 participants were screened; at site 2, over 3,000. And you can see here that – that there were a number, 93% of individuals that were – were positive for RNA were started on treatment, and then in site 2, 100%.

And so being able to implement treatment soon after diagnosis is – is a critical piece of this and highly effective in engaging folks in care.

[00:35:22]

What are other barriers and solutions to improve HCV screening among people who use drugs?

So let's move on to other barriers and solution to improve HCV screening among people who use drugs.

[00:35:29]

          Poll 5

So poll number 5. In your practice, what strategies do you use to improve HCV screening? Please go ahead and – and provide an answer.

And so with that Mark, I wonder if you would like to – to chime in here and talk about what strategies you've seen used in community to improve – improve screening?

Dr Sulkowski: Well, yeah, mention a couple of them. One is I think community based events. So we have a clinic-based in our hospital. Not a great place to screen. Obviously, if someone comes into the clinic we can screen them. But we go out. So our – our nurses and our community based team sets up. It could be a community health fair, it could be at a local church, and we'll do some screening there. That's been our most successful strategy.

It really – and then the other one I wanted to mention was bundling screening, where we'll try to do HIV and hepatitis C. We'd like to add hep B. It's a little bit more difficult to do in point of care.

Dr Trooskin: Exactly. I think that pan viral approach is – is really the way forward here. We know that there are strong CDC recommendations now for both hepatitis B and HIV and hepatitis C screening. So really trying to create some of – some of that - that bundled approach is critical.

Leveraging, if – if there is an electronic medical record that's being utilized, leveraging those order sets and templates and, you know, pop ups, all of those kinds of things can be – can be very, very useful.

[00:37:05]

Faculty Discussion

Okay. Thanks so much, Mark. So we've had a bit of a faculty discussion already. I do sort of wonder – and Ronni, feel free to – to join in here. So in terms of really thinking about more cohesive approaches to – to improving screening. Obviously, the point of care and the – point of care antibody and RNA test is a game changer for us. But in addition to – to leveraging those clinician reminders and electronic medical records, what are some of the other things that that you'd love to recommend to some of our learners today in terms of improving uptake of screening.

Ronni Marks (Founder and Director at The Hepatitis C Mentor and Support Group): As you have it listed there, education. I think the most important thing we can do with our patients is educate them as much as possible as to what it means, what they would be going through and what the end result is.

You know, with my organization, we're always get screened, get tested, get cured. And that's the message we try to send out to everybody.

Dr Sulkowski: Just chime in. I think that's a really important point. This is a curable infection. And not knowing – I noticed that some of the comments were that patients were reluctant or clients were reluctant to be tested. And that's a point, Ronni, to your point of education and discussing why – what – what's the barrier to reluctance?

Because not knowing is really a threat to their health because it is curable. So a really great point.

Dr Trooskin: Yeah, I agree. And I think just to sort of round out the discussion that the – the pan viral testing, also testing for antibody to hepatitis A and hepatitis B, allows for the opportunity to for intervention and vaccination. So not only are we able to – to cure individuals, but also prevention of other sort of negative sequelae or – or negative outcomes related to hepatitis C infection is we can protect you from getting another – another virus as well. So lots of – lots of opportunity around education and – and – and testing and prevention.

Great. Well thank you so much.

[00:39:26]

          Posttest 1

So with that, I'm going to give 1 posttest question to the audience and then turn it over to Dr Sulkowski. Going forward, for adults who use drugs, I will recommend for HCV screening at least annually. Do you:

1. Strongly disagree;
2. Disagree;
3. Neither agree or disagree;
4. Agree; or
5. Strongly agree.

Please respond.

And with that, Mark, it's all yours.

Dr Sulkowski: Well, great. Well, thank you very much. I see 75% strongly agree. That's fantastic. And most agree. So let me move forward. You know great discussion on identifying people and diagnosing.

[00:40:12]

HCV Treatment

And that really is the first step. We have to find the infection. And then we need to link to treatment. And you saw how rapid diagnosis can lead to treatment in that Egyptian study. And that's really some place we want to aspire to here in the United States.

[00:40:27]

          HCV Goals of Treatment

So what are the goals of treatment? The goal is to deliver cure. Now for a long time we used the term sustained virologic response. But we can be clear that unlike HIV, this is a curable viral infection that's defined as no virus in the blood by RNA testing 12 weeks after finishing therapy.

In a recent systematic review of the literature, cure has many clinical benefits. Reduction in liver related mortality, a 70% reduction in hepatocellular carcinoma, and all cause – all cause mortality reduced by 60%. And the regimens that we're using today, if patients take their pills for 56 days or 84 days in the 12-week regimen, we can expect response rates, cure rates in the 99% range. So very highly effective treatment that benefits the individual who's been cured.

[00:41:31]

          HCV Treatment as Prevention

Now there is also a benefit to the community. So if you think about people with active viremia, hepatitis C, if they're engaging in behaviors that might spread hepatitis C to another person, might transmit. If we cure them, they're no longer able to transmit the infection, whether it be sexually or through percutaneous exposure to blood through needles.

A really interesting study that looked at HIV cohorts, and they looked at incident or new cases of hep C overtime between 2019 and – I'm sorry, 2010 and 2019, nearly 46,000 people. And what you see in the figure is they looked at before we had these oral therapies, GP and sof/vel, and then in the middle a period of time where there was limited access that people really couldn't get them. They were limited to people who talk more about that.

And then during broad access. And you can see that when broad access to DAAs, where people had – were readily treated and cured, the incidence, that is, new infections in the entire community or clinic population decreased and it was very protective. So this we know, is treatment as prevention, a concept in HIV that's very well accepted. And certainly treating people can render them unable to transmit the infection.

[00:43:00]

AASLD/IDSA HCV Guidance: Simplified Treatment for Treatment-Naive Adults Without Cirrhosis

So there's been a great effort to simplify the guidelines from the Liver Society and the Infectious Disease Society. This panel met in 2019, right before the Covid-19 pandemic and said, you know, this treatment is so highly effective and safe that maybe we can simplify it. So what you see here is for people without cirrhosis. They recommend that patients can be treated with either GP for 8 weeks or sofosbuvir/velpatasvir. Both regimens are recommended in this situation.

There is no recommendation for genotype testing. There's no recommendation for resistance or RAS testing. There are some people that are not eligible, people who have failed prior therapy, people with active hep B because hep B might reactivate.

Pregnancy. That's a complicated issue but not recommended for simplified treatment. Known liver cancer or prior liver transplant. That's not to say they can't be treated, but that these individuals would be treated with a more complicated monitoring regimen. So what they're recommending here is a simple workup of virus testing that is confirmed the viral load. Routine liver disease staging with a complete blood count and chemistry profile. Delivering the treatment. No labs during treatment. And then confirm cure 12 weeks after finishing therapy. So again, no resistance testing and no genotype testing is necessary.

[00:44:41]

AASLD/IDSA HCV Guidance: Simplified Treatment for Treatment-Naive Adults With Compensated Cirrhosis

Now for cirrhotic patients, these are people with compensated cirrhosis. And we typically determine this by a FIB-4 or APRI, AST and platelet count are the key metrics there.

And here the patients can be treated with similar regimens. I'll comment on one difference. But patients who have decompensated liver disease or renal insufficiency really can't be treated in a simplified manner. Again, they can be treated but not in a simple manner.

So here you see the same regimens, glecaprevir/pibrentasvir for 8 weeks. And sof/vel for genotypes 1, 2, 4, 5 and 6. But if they have genotype 3, it's a little more complicated. This is the only place where resistance or RAS testing is recommended. Patient with cirrhosis for whom you're considering sof/vel. For non-cirrhotic patients, no RAS testing.

[00:45:40]

AASLD/IDSA HCV Guidance: Simplified Treatment for Treatment-Naive Adults With Compensated Cirrhosis

Now, the other really important point, you're going to want to look for drug interactions in every person you're considering to treat. But for both GP and sof/vel, there are no significant drug interactions with medications typically used to treat opioid use disorder, buprenorphine, methadone and naloxone. So no concerns with either regimen with these concurrent medications.

[00:46:06]

          Posttest 2

So we'll go to posttest number 2. It's up on your screen now. If following the AASLD/IDSA guidance, what would you recommend for a treatment-naive person with no cirrhosis who is receiving buprenorphine for substance use disorder?

1. RAS testing;
2. GP only;
3. Sof/vel only; and
4. Either GP or sof/vel.

So go ahead and vote. Well, great. We'll go ahead and move on.

Well about 15% of you have talked about ordering RAS testing and that would not be recommended here because the patient has no cirrhosis. So either regimen could be used in the bottom there.

[00:47:16]

          Posttest 2: Rationale

And there is the rationale popping up. No baseline RAS testing, no drug interactions with these. You can use either regimen for individuals who are treatment-naive without cirrhosis.

[00:47:31]

          AASLD/IDSA HCV Guidance: Treat People Who Inject Drugs

So what about people who are actively injecting drugs? This is an area where the guidelines panel that I've discussed has said that recent active drug use is not a contraindication to therapy. In fact, there's no data that suggests that you should be screening people for drug and alcohol use that only creates additional barriers and can exclude people from treatment.

So in fact, it's quite the opposite. If we want to eliminate hepatitis C as a public health threat, as Stacey alluded to, we need to treat people who are actively injecting drugs because they're the individuals, when they're actively infected, that could spread hepatitis C to other people. And that is the cause of the acute or new infections we're seeing.

So the panel – the AASLD/IDSA guidelines actually wants the opposite. They want us to treat more individuals.

[00:48:29]

What strategies can improve HCV treatment uptake among people who use drugs?

So what strategies can improve hepatitis C treatment uptake among people who use drugs?

[00:48:36]

          Poll 6

So we're going to do a poll question. At your practice, what barriers to treating someone do you experience? So go ahead and – and type in your answers. And maybe I'll ask Stacey to jump on and maybe talk through some of the barriers that you've seen. This is something you've worked extensively in Philadelphia on.

Dr Trooskin: Thanks, Mark. So in terms of barriers to hepatitis C treatment, I think up until recently in many states around the country, there was an issue with prior authorization. And so for those of you who are familiar with or unfamiliar with prior authorizations, this is really the need to go through an extensive amount of paperwork, submit a request to an insurer – insurance company to then get approval to prescribe medication, as opposed to most other disease states where you would just send a prescription to a pharmacy and the patient goes and picks it up.

But this is an arduous, time-consuming process that often involves a lot of person hours to get it done, sometimes even back and forth with the payer to appeal a denial. And it's a true barrier to – to being able to provide treatment and prescribe treatment at a – at a high volume, which is really what we need to be doing if we're working towards elimination.

Dr Sulkowski: Yeah, I think that is a major barrier. Unfortunately, I practice in a state where with Medicaid we still are required pre-authorizations. And it really then makes it so difficult to treat that patients get referred out, and that's where they don't end up coming to a specialty clinic and doesn't allow us to treat in the community.

So I'm going to move ahead and talk about some strategies that might work or be helpful to getting people onto treatment. We've now diagnosed them. And how do we get them onto treatment?

[00:50:31]

Colocalized Drug and HCV Treatment: Buprenorphine Treatment Retention May Improve Cascade of HCV Care

Well, in this study it really emphasizes the point of co-localizing treatment. If someone is coming for treatment of opioid use disorder and receiving buprenorphine, that may be an excellent place to consider treatment. And retaining people on their buprenorphine treatment was associated in this study with higher follow through during the care cascade. More people were evaluated for care, more people were offered treatment.

So really emphasizing the point of linking in people actively using substances to link it to treatment of substance use disorder. And although it's not reflected in this slide, the other key element is mental health disorders and actively linking treatment to addressing those problems.

[00:51:22]

CHAMPS: In People Who Use Drugs Coinfected With HIV/HCV, Treatment Nonadherence Did Not Predict SVR

The other strategy that I sometimes – the other concern I sometimes hear is that there might be a concern about people who use drugs, might not take their therapy.

And one of the real remarkable things about the current treatments with sof/vel or GP is that there is a high barrier to failure. And what I mean by that is that missing doses in that 84 or 56 day treatment course does not necessarily mean the person won't be cured. And in this study, which was done at Johns Hopkins, we looked at people with HIV and hepatitis C, and we measured elements of their adherence. We also tested the strategy of providing a peer support and contingent cash incentives. That's not reflected in this slide, but both were effective in getting more people to start treatment.

Now, this group, there was 44% of people had evidence of active use of either cocaine or heroin, and a third had heavy alcohol use. And when we looked at their adherence, we saw that people who missed more than 9 doses had the same cure rate as people who took all of their doses and finished treatment on time.

So if someone is missing doses, it's not – you want to reinforce adherence, but you don't want to discontinue, and would also emphasize that we don't want to prejudge someone's ability to adhere to therapy. People really can do quite well with this treatment, providing we give support and help them adhere.

[00:52:58]

Seek, Test, Rapid HCV Treatment in People Who Inject Drugs

So another strategy and you saw this in Egypt. Well, here's an example in New York City, where in this particular study, investigators decided to do an open-label randomized study at a syringe service program in the city of New York. And they took young people and they randomized them to rapid treatment. So that was the same day evaluation, confirmation and baseline laboratory testing.

Now they drew the blood and sent it out. And while they waited for it to come back, they gave the person a 7-day starter pack of sof/vel. The other people got usual care. They also had additional services for – to prevent overdose and other treatment of substance use disorder.

And what they found was that there was a faster time to initiation and a higher cure rate. Only 9% in the usual care were cured versus 64%. So really closing the window from diagnosis to treatment is essential to get people linked to care. The longer we delay, the – the greater the likelihood that they're going to be lost to follow up.

[00:54:10]

Strategies to Promote HCV Linkage to Care and Medication Adherence

So there have been a number of strategies to promote linkage to care and medication adherence. Certainly one of them to focus on is education at the time of testing and then linkage to care, really understanding how we're going to get someone to treatment. Having partners in the community, if you're not treating in your own setting. Finding partners that you can work with are committed to – to sharing with you those patients and leading to cure.

We'd also encourage people to think about treating in their own settings. A number of studies have demonstrated that treatment is safe, highly effective, and can be done really in any setting without the need for special skills or specialists.

So other things that are in this slide talk about things like coordinating care and addressing other things. I talked about the need to focus on people with active substance use disorder, people with active mental health disorders, but also addressing other barriers such as food insecurity, housing insecurity, try to help people get on their feet.

[00:55:17]

Additional Support to Improve Medication Adherence in People Who Use Drugs

So co-location with harm reduction services, I just talked about. And then the other one that's been quite powerful in some studies, including our own that I talked about earlier, was peer support. So using people with lived experience to provide support and help patients navigate through the healthcare journey.

And the last point on here, I already talked about housing assistance, things like that, is contingency management. So one of the things that is really important is understanding barriers that people need a way for transportation. Are there – is there a way to set up Uber rides to the clinic? Are there a way to provide gift cards or other financial incentives for people to – to walk through the – the treatment course? These things can be incredibly important.

[00:56:08]

          Navigating Cost Barriers

And then the other thing that we talked about was removing health system barriers. Remarkably, after more than 9 years of these oral therapies, when the CDC looked in some databases, they found that only 1 out of 3 insured people had been treated.

And if they were a Medicaid recipient – recipient, they were less likely to be treated than people with private insurance. And what's reflected here in this slide is that many Medicaid programs, since the launch of DAAs nearly a decade ago, have introduced systematic barriers that really impair our ability to link somebody to treatment.

Many of you typed in prior authorization as a barrier. And Stacey also referenced that. This idea of completing a checklist with laboratory tests that are not even recommended. So these barriers can be a major issue. There are some resources on here. If you want to see what happens in your state, if you're in the United States, the stateofhepc.org gives a report card, a grade, if you will, to your state and some resources to help navigate.

[00:57:23]

Cost Barriers: State of Medicaid Access

But the barriers we see prior authorization. Some Medicaid programs are still using active substance use barrier, although fortunately that has decreased dramatically. Some were requiring treatment by specialist. We have proven in study after study and example after example of the specialists are not needed. And this treatment can be given by clinicians with a wide variety of training.

Re-treatment. I will also emphasize that re-treatment should be offered to people if needed. So this is something to really emphasize when we think about patients in care.

[00:58:02]

What are other barriers and solutions to improve HCV treatment uptake among people who use drugs?

So what about other barriers and solutions?

[00:58:08]

Faculty Discussion

I'll ask my panelist to jump on and we'll talk about some models that they've used. We talked about – we mentioned a number of things, but what else should we be doing? Ronni or Stacey, any thoughts?

Dr Trooskin: So I – I think removing as many barriers as possible to accessing medication is critical. When we talk about really scaling up treatment, we need to make it as simple as possible. So we've already discussed the impact that prior authorization can have on already resource limited practices. Nobody has extra staff to be able to do a ton of paperwork or spend time on the phone with payers.

I think there are – there are some states that have completely removed prior authorization criteria, and some states have even gone farther by subscribing to what often is referred as the to this Netflix type model. Right? Netflix, we all subscribe, we pay a monthly fee, and we get unlimited access to all of our favorite, you know, media.

And so the same can be true for the states that have contracted with 1 of the 2 pharmaceutical companies that make these medications for a flat fee that can be budgeted for and expected every single year for a period of 3 to 5 years, you get an unlimited access to the DAA of choice, and then you can then scale up public health interventions to really figure out how to deliver that medication to where patients are.

I think that's – that's another step. And when I look at countries like Australia who are progressing towards elimination, they – they have done that.

Ronni Marks: Yeah. No, I agree with everything you just said. There's really nothing more that I can add to this at this point because I don't want to ruin my presentation.

Dr Sulkowski: Great. Well, you know, it's really removing barriers and making treatment readily accessible to people who need to be cured.

[01:00:03]

          Poll 7

So let's talk about the issue of reinfection. So in this poll question, how likely are you to retest for hepatitis C reinfection among people who use drugs, all the way from extremely unlikely to extremely likely. Go ahead and vote.

Well, great. We'll move on. So most of you are retesting. So let's talk a bit about reinfection.

[01:00:36]

HCV Reinfection Rates After SVR Among People Who Use Drugs

As I alluded to earlier, we want to be treating people who are actively injecting drugs. And we accept that reinfection can occur. But as this slide demonstrates, it's a meta-analysis of 36 studies that we also have the tools to reduce the risk of reinfection, reduce harm, if you will, and you can see that there were higher rates of reinfection among people who were not receiving in this study, opioid agonist therapy is OAT.

And the highest risk were in young people and during the first year after follow up. But highlighting the fact that with Syringe Services Programs and treatment of opioid use disorder, we can limit or reduce the harm that may come from reinfection.

[01:01:25]

HERO: HCV Reinfection Among People Who Inject Drugs

The other point is, and this is from a really interesting study called HERO, that the greatest risk, the horizontal axis in weeks was in the immediate year following. And the risk then declines. So it suggests that what we really need to do is emphasize that harm reduction, if you will, helping people avoid reinfection, at least for the first year, and then the risk becomes lower.

So I think the point here is reinfection may occur and that's okay. They can be treated and they should be retreated and cured.

[01:01:58]

Spotlight on People Who Use Drugs and Addiction Medicine and Harm Reduction Clinics

So what I'll do at this point, I'm going to turn it over to Stacey to talk through some of the things that, um, her group has done in the city of Philadelphia.

Dr Trooskin: Great. Thank you so much.

[01:02:09]

C Change: Eliminating Hepatitis C Among People Who Inject Drugs in Philadelphia

So I'm going to keep this brief. I'm going to just talk very briefly about a program called C Change, which started off probably about 6 or 7 years ago as an intervention to eliminate hepatitis C among people who inject drugs.

And over the last 6 years, it's really morphed into a pretty robust technical assistance program that has been partnering with the Philadelphia Department of Health, as well as the state Department of Health, and is focused our – our support in substance use disorder treatment programs to help them enhance systems, improve direct service, and develop infrastructure at each of these sites in order to support implementation of that HCV care cascade, all the way from testing to treatment.

[01:02:57]

C Change: Key Interventions Along HCV Care Cascade

And just to give you a sense of some of the work that we did early on, is we worked with our opioid centers of excellence, which is a designation that the state provides to locations that provide substance use disorder treatment, but also some degree of medical treatment as well.

And so depending on each site that we've worked with, we have went ahead and implemented everything from testing to supporting folks in EMR modification, if they have an EMR, to building on site capacity for hepatitis C virus treatment. And even if they don't have the ability to treat on site, helping folks to establish a referral or linkage to care protocol with other folks in the neighborhood or the general area that they can partner with to get their patients treated.

And so when you've seen one substance use disorder treatment site, you've seen one. Everyone is unique. And so part of the intervention is really doing a needs assessment, working closely with the staff, providing education and then helping that build out. And it's – it's been wildly successful so far, and the goal is to help build that public health infrastructure so we can meet patients where they are and get folks first informed of their HCV status and then treated.

[01:04:17]

Maryland Project: Adult Viral Hepatitis Prevention Program

Dr Sulkowski: Well, great. I'll pick up again and talk a little bit about something, a project in Maryland called Sharing the Cure. Now this was a program that was supported by the state of Maryland and at Johns Hopkins.

[01:04:34]

          Sharing the Cure: Integrating PCP Into HCV Care

And the major goal of the Sharing the Cure program was to bring treatment into the community. We wanted to train federally qualified health centers and other community based clinics to treat hepatitis C and overcome some of the barriers with referral to specialist. And what you can see in this figure is that the patients being cared for by these local community sites had an incredibly high rate of testing RNA, actually better than the other sites, and really learn to become experts in hepatitis C treatment over this period of time.

[01:05:09]

          Sharing the Cure: Continuum of HCV Care

And then if you look at the care continuum, the SVR rate, we – they cured about 20%. But don't focus on that because Maryland had very high barriers. Look at the number of people that actually completed all the testing they need to do. It was 70%, which is remarkable.

Now, the only reason people weren't treated was because the state of Maryland would only provide treatment, as you can see in the middle, to people with more advanced disease. Fortunately, that barrier is gone.

[01:05:42]

HCV Treatment Uptake Among People Who Inject Drugs in Baltimore: Distribution of HCV Viremia

So by bringing treatment into the community, what we were able to achieve. This is a study that looks at Viremic hep C across. And this is a map of Baltimore. The inner harbor is this sort of area right here. Johns Hopkins is over to your right. University of Maryland is over to your left.

And what you can see is a dramatic reduction in the prevalence of active hep C in Baltimore. And we achieve this by bringing treatment into the community away from the academic centers.

[01:06:13]

          Poll 8

So we'll do one – one more poll. In your practice, what strategies do you use to get treatment uptake higher. So go ahead and put some responses in there. Great.

[01:06:37]

Faculty Discussion

Let's – let's move to a discussion, and I'll ask my colleagues to jump back on.

[01:06:48]

          Discussion

So we've talked about this quite a bit about lessons learned. I'll start by saying, I think one of the biggest lessons that we learned was that we are not going to eliminate hepatitis C in Baltimore, at University of Maryland and Johns Hopkins. We need to get the treatment out into the community, whether it's – and we've used all kinds of tools, from mobile vans to telehealth to training, as we talked about local providers.

I think it's been probably the biggest lesson we've learned, at least in Baltimore. So curious what – what you've learned in Philadelphia. And, Ronni, curious from your perspective, you talk to people all over the place?

Ronni Marks: Yeah. No, I've learned the exact same lessons. We have to bring it to the people. The services need to come to them. They are not - it's too confusing for the average person. Never mind someone that has other issues going on.

Dr Trooskin: Yeah, I agree with that. I think integrating treatment and bringing it to where folks are is critical. I think also a lesson that we've learned, particularly through the technical assistance work, is the importance of a champion, having a champion on site to really carry the flag and move it forward doesn't have to be a physician, doesn't have to be a nurse practitioner. It can be a recovery, a certified recovery specialist. It just has to be somebody who really finds some meaning and passion in curing individuals and can help implement a new workflow, can be a champion and talk to patients about the value of a cure.

But I think finding that individual really helps build infrastructure and create momentum in a place.

Dr Sulkowski: Yeah, really an incredible point. We've seen where center was doing great with treatment. The champion left, and boom, all of a sudden treatment disappeared. And trying to build that new champion is hard to do. It's a really good point.

And then a lot of – a lot of talk, a lot of focus on education because I think there's this assumption hepatitis C is largely asymptomatic, and it's really easy to think you're okay when you could, in fact, have active viremia and even liver disease that hasn't manifested yet.

Education is incredibly important. So curious Ronni, what your group does a lot of education and how are you deploying that? Or maybe you'll talk more about that in a few minutes.

Ronni Marks: I would rather.

Dr Sulkowski: All right. Well maybe what we'll do is move on. And I am going to hand it over to you, Ronni. And I think the next section is yours.

[01:09:20]

What are Patients Saying?

What are patients saying? And – and all this has been such incredibly good information, but it does come down to what and how are the patients feeling about all this.

[01:09:35]

          Discussion: Stigma

And the number 1 barrier that I know we're all familiar with is that these people have been stigmatized, discriminated against and people that have experienced trauma. It's heartbreaking to me and I've had many patients say to me, I don't deserve to be treated because I did this to myself. Their family makes them feel that way. And that's why it's so important that we make them understand that it does matter. And it doesn't matter how you got it.

The point is, we want you to get cured. There are patients that have been walking around for years that know they have hepatitis C. Some still think – and this is when the education piece comes in so much, is that there's still an injection involved in the treatment. I've heard that from a number of people, and especially with people that have injection drug use problems. This is – this is just another addition to make them stay away.

[01:10:38]

          Posttest 3

So now is the posttest 3. Going forward, how likely are you to recommend hepatitis C treatment in a person who actively uses injection drugs?

1. Extremely unlikely;
2. Unlikely;
3. Neutral;
4. Likely;
5. Extremely likely.

Okay. Well, it looks good. Good answers. Extremely likely. I'm glad to hear that. Okay, let's move on.

[01:11:27]

Stigmatizing Language: Commonly Used Terminology to Avoid and Suggested Alternatives

One of the most important things that we have to keep aware of is language. And this goes for not only people who have substance use disorder, but people in general. It's just so important about how you treat people with dignity and respect and make them feel valued, because words have impact. Words have meaning.

And I have just seen people totally light up when I tell them, for instance, when I do a group. And we also always include advocacy in it and tell them how important it is that their voice matters, their story matters. And I've seen their faces light up. It's just so important that we make them understand that they do matter, and language can really be part of that. It can be stigmatizing itself.

So it's very important that you're very aware of what you are saying to people as you're speaking to them.

Before I jump into the next poll, because I didn't – let me go back for 1 second. Also now, especially in this world we're living in, pronouns, so important, and you have to feel comfortable and make them understand that you care. Tell them your pronouns or ask them what pronouns do you prefer me to use? It will really go a long way to show your respect for – for patients.

[01:13:12]

          Poll 9

So poll 9. How often do you ask your patients what pronouns they like to use?

1. Never;
2. Rarely;
3. Sometimes;
4. Always; and
5. Often.

Sometimes. Well, it's something I think that you should all start thinking about. It's very, very necessary to get that rapport with your patients.

[01:13:50]

          Use the Right Pronouns

And here is a chart very much on making the right pronouns. And do not make assumptions. Just because someone looks a certain way does not mean that that's the pronouns they use, or that's the life they use. So it's very important that you ask that question. Use their name if you feel uncomfortable, but it really does help if you do start by introducing yourself and saying that your pronoun is such and such.

[01:14:27]

          Faculty Discussion

Anybody have any other ideas that they'd like to bring into this?

Dr Trooskin: Ronni, I – I really appreciate you bringing in the use of pronouns into the conversation. I think it's – it's a critical piece of centering the patient voice. I think also using person first language, right? It's not a drug addict. This is a person who uses drugs. The substance use disorder does not define the individual.

Someone who is homeless – is experiencing homelessness is not a homeless individual. So I think there are lots of opportunities for us to – to really center the patient voice and their experiences.

Dr Sulkowski: Yeah, I certainly agree completely. And, you know, it's really important that as we walk through how we're running our clinical operations, that everybody from the very first person they meet at the door is practicing the principles that Ronni has outlined. The person first language is incredibly important and respect. And if that happens from the time they walk in the door. But by the time they go check in, get their vital signs done, and then reinforced by the healthcare provider. If any one of those steps makes that person uncomfortable or disrespected, they're not coming back. So it's everyone on the team.

Ronni Marks: Right. No, the – you need to make them feel comfortable to gain their trust. That's the only way that you will see them again.

And – and also it goes even further. You know, most of the people have the hood that they hang out in and everybody hears where they're getting treatment or how the provider has been. It's very important because that's the way that you will get new patients if you treat them correctly.

There is a chart here with helpful resources. There are some guides that really will tell you all the different ways to say things that may be helpful to you. So I would definitely copy these down and use them.

[01:16:43]

Q&A

Jacqueline Meredith: And I can step in real quick before we move on, if we can take a couple questions, since we do have some time from the Q&A session. And I know that there were a number of questions about both screening and treatment, but I might start here if that's okay with Maggie. Can anyone weigh in on SVR 4 versus SVR 12 as an easier way to confirm cure for people who might be difficult to retain and to care for 12 weeks post treatment? Have – either you using that or what's the data out there on that?

Dr Sulkowski: Well, I'll jump in. I think first of all there are – there's a push away from even needing to confirm cure. In other words, if someone took all their medications, they're likely cured. But there aren’t data that clearly demonstrate that no virus for weeks after last dose is highly predictive of cure. So that's better than no testing. We do like to confirm cure in our practice, but we know when we lose people, we find them a year later, 2 years later, they're cured. They just didn't come back for that SVR 12 visit.

Jacqueline Meredith: Thank you. And we have a question from Rebecca[?]. And this goes back to the simplified hep C treatment. And the question is, does that apply for people who are co-infected with HIV and hepatitis C?

Dr Sulkowski: So the short answer is it does. There was a study performed called the MINMON Study, which enrolled 400 people. They were handed a bottle of 84 tablets of sof/vel. No lab test, no visits. 144 of those individuals had HIV co-infection and their response rate was outstanding. No – no difference in terms of how we approach a person with HIV and a person without HIV.

Jacqueline Meredith: Thank you. And then this is going also towards HIV or hepatitis C treatment. And talk about drug-drug interactions. I know you guys touched base on drug interactions with substance use disorder medications. But what about the substances they might be using? So Jorge[?] is asking about what if they're using fentanyl? Is that still okay to use some of these hepatitis C regimens?

Dr Sulkowski: Stacey, you want to tackle that one?

Dr Trooskin: Sure. Happy to do it. So I think the – the reality is that there – those are minimally concerning drug-drug interactions. Not – not to be concerned about. I think the – the bigger question for folks that are continuing to – to inject drugs, particularly in places where fentanyl is like the principal drug in the drug supply, like it is in Philadelphia, is you don't have to worry about the drug interactions related to – to the DAAs as much. But we do want to make sure that we're prescribing Narcan for all of our patients, because the risk of overdose is really the thing that you’d have to be concerned about for a negative health outcome.

And so really centering that, that patient experience, making sure that folks know how to use Narcan for the people around them and that practicing some harm reduction counseling for your patients as well, if they are still actively using drugs through – through the course of their treatment, how do they hold on to their cure? How is a safer ways to be injecting, making sure that everyone around them who is in the vicinity while they're using, is aware of where their Narcan is so that they can have their life saved if they – if they should get a particularly strong – strong dose. So I think that that's my biggest concern with fentanyl.

Jacqueline Meredith: Thank you. We have another question that you guys touched a little bit about on non-adherence of therapy. But for patients that don't complete therapy and, you know, your repeat screening and you want to restart treatment if the patient's positive again, what's your best practice in approaching these type of cases?

Dr Sulkowski: Yeah it's a – it's a really great point. And I'll give you what we've done in our practice. If the interruption in treatment is less than a week, we generally just keep going and get the person back on treatment. Maybe they didn't have their medication.

If it's more than a week, we'll check in HCV RNA. And I can tell you we have found many people cured with only a month of treatment. So the cure rate is probably around 50% after 4 weeks in that ballpark. So don't assume that they failed, if they've been off more than a week.

Now if they do have recurrent viremia, meaning that the treatment wasn't long enough to eliminate or cure the hep C, we generally will retreat them. The debate that we have, and this is a debate, is do we use the same regimen or do we use an approved regimen for treatment nonresponse called sof/vel/vox. It's got a third medication in it called voxilaprevir.

And that debate is something that we'll usually discuss among our group and decide. But we have retreated with the same regimen and been successful many times.

Jacqueline Meredith: Excellent. And there's a couple of questions about scope of practice and prescribing medication – hepatitis C medications and some barriers with funding. Any advice on how to approach a non-hepatologist prescribing hepatitis C medications?

Dr Trooskin: Yeah. I can take that. So the reality is that – it's been my experience that treating hepatitis C is easier than treating diabetes and hypertension and other things that we encounter in a primary care setting. It's not – it's not called the simplified treatment model for nothing. It is super easy. And as Mark said, the MINMON study sort of demonstrated that you can set it and forget it. You give folks the full treatment course and then the at least per the recommendations, and we can have a whole separate conversation about whether or not we have – we really need an SVR.

But per recommendations and you bring them back for a cure check. It is something that any advanced practitioner could certainly do. It is something that any primary care provider can do. You do not need an MD or a DO, or a fellowship in gastroenterology or infectious diseases to do this work.

And if we're going to eliminate hepatitis C, we need all hands on deck. We need every advanced practice provider. We need every primary care provider to incorporate this into their scope of practice. And it is so simple. And it is so gratifying because unlike the other chronic illnesses that we manage in primary care setting, this is curable. It gets fixed, you take it off their problem list, patient is happy, provider is happy. So there's no reason to need any subspecialty training to do this – to do this work.

Dr Sulkowski: Yeah. Curing people with hepatitis C never gets old. It is rewarding every single time. And if you think about your daily practice in medicine, whatever your specialty, how often do we use the word cure? Not that often. I do want to also highlight one other thing. In the Sharing the Cure program what we also did is we gave – we trained literally hundreds of practitioners in the community, but they knew they could come to us. They knew us personally. They had our cell phones, they still do emails.

And when questions did come up, like, does this patient have cirrhosis? I'm not sure. Or what should I do here? They had someone they knew personally to reach out for. So I would recommend, you know, making those connections in the community, finding people who are champions for hep C elimination and want to partner with you. And they can help when things get a little more complicated than the simplified model suggests.

Ronni Marks: I also want to add, as a patient who has cured, what a difference in your life. You – you know, you've been – a lot of us that had hepatitis C, had it for so many years that we became very used to feeling a certain way. And then all of a sudden it all went away when, for instance, in my case, when I got cured. And I have seen in other cases where when this happens to people, they start to look at the rest of their life and they say, well, now I'm feeling better. Maybe I should be taking a different path. Not necessarily that they should be stopping anything, but it opens their eyes to – to how different life can be.

Dr Sulkowski: Yeah, it's a really good point. And sometimes we see people say, well, we'll treat your hepatitis C after you do this. You know, after you fill in the blank, whatever it may be. And I think that's actually the wrong approach because hepatitis C is empowering the treatment of it and cure. So rather than set -set these hurdles that people have to cure, they have to stop drinking, they have to stop using, they have to show up 3 times to your clinic. Treatment could actually be a very powerful tool to bring someone into care, where you can begin to address some of the other more complicated issues.

Jacqueline Meredith: Thank you everyone. There are a few questions about drug-drug interactions, and I know – I won't ask about the specific medications and drug interactions because I know that can be quite complex, but maybe some advice that you can share with our learners on what resources you might use to assess drug-drug interactions with hep C, medications or other people in the clinic that could help.

Dr Trooskin: There's an amazing website. It's the Liverpool Drug Interactions website. They have one for HIV as well as hepatitis C, and I highly recommend folks use that. If you just google Liverpool drug interactions HCV, it'll pop right up. It's a simple, user-friendly drug interaction checker where you have sort of 2 search bars and it pulls in all the meds. You can load a full patient medication list, and it'll give you all the drug interactions available and why there's a drug interaction, which is really helpful.

So I – you know, 10 out of 10 on that – on that recommendation. It's great. So definitely check it out.

Dr Sulkowski: I think that's used by anyone that treats hepatitis C around the world goes to that site because it's so good, so up to date and so easy to interpret their – their information they give you.

Jacqueline Meredith: Great. We have – I'll probably just do a couple more questions and we'll finish off with our key take home points. But we have another question from Jorge that asks about genotype 3. And you know, in the era of pan genotypic drug coverage, is there any concern with geno – patients with genotype C and, you know, their response?

Dr Sulkowski: Yeah, I can – I can touch on that. Early in the DAA era, we treated a lot of people who had more advanced liver disease, cirrhosis, and there was definitely this interaction between people with cirrhosis and infection with genotype 3. The response rates weren't quite as good. And that's why that one recommendation for sof/vel talked about resistance testing.

But our current experience, and really for the last 5 to 8 years, we have not seen what I would call difficult to cure genotype 3. And we no longer fuss about it, at least where we practice. We are doing genotypes because in the state of Maryland, the Medicaid programs require it. I would love to stop doing genotypes, but I need some cooperation from our state Medicaid program.

But we don't worry about genotype 3 anymore, particularly in people who are younger with more minimal liver disease.

Jacqueline Meredith: Thank you. And I'm going to end with one more question. And this is about, I think, really the barrier of retaining people in care. So it was a question specifically for same day test and treat models and retention and care. So I don't know if you guys are aware about retention and care and some of those models that you've seen. But either way, what are some suggestions to try and improve retention and care for patients with hepatitis C?

Dr Trooskin: Yeah, it's a great question, right. Because folks, particularly individuals who may be actively using drugs, there are a number of sort of survival priorities that individuals have staying well, avoiding withdrawal, sometimes housing, sometimes transportation. And even though getting perfect treatment adherence may be the clinicians goal or the team's goal for the patient on any given day, that may not be the highest priority for that patient.

And I think it's really about understanding what those priorities are in – in various different spaces where we've built these programs that we've worked, we've tried to bring in other resources for patients that may address some of those more pressing priorities, whether it's having hot microwaveable meals or snacks, or a warm pair of socks or gently used shoes and a – and a like a clothing closet that folks can utilize in winter months for something dry and warm.

So it's creating additional incentives to support individuals in their engagement in care and – and retaining them, sort of to – to support their adherence and on treatment.

Dr Sulkowski: I'll just add to that, one of the things that it would be helpful is difficult to do is to give the entire treatment course up front. Unfortunately, many insurance companies require 1 month at a time, and that creates that problem of loss to follow up. But if you – if you are able to give the entire treatment course as a single prescription that empowers the person to finish their curative therapy. I know that's not easy to do in lots of places, but it's something we advocate for.

[01:31:19]

HealthHCV: Join Our Capacity Building Assistance

Jacqueline Meredith: Thank you all for answering those questions. And I wanted to take an opportunity to invite our learners, so they can build on further skills to implement hepatitis C services in their practice. To participate in the HealthHCV’s CBA, or capacity building assistance program titled HCV Engage & Exchange: A Learning Community to Support System-Level Change in HCV Screening and Care.

So there is listed out all the different details about the program. I will say participation is limited. So if you are interested, please use that QR code to scan it and fill out the interest survey, and then someone from HealthHCV will be reaching out to you by the end of the year. And if you do have questions about the program, please email Marissa at HealtHCV and you can see her email there on the slide.

I wanted to send it back to Mark to bring it back to our key take home points.

[01:32:16]

          Key Take-home Points

Dr Sulkowski: Great. Well thanks, Jacqueline, and thank all of you for joining us today and fabulous questions and wonderful discussion. So thank you so much for all the comments and notes that you made. Really great.

The key take homes. Everyone should be screened and tested for hepatitis C at least annually. People with active substance use disorder should be tested more frequently. That is something we need to know. For people not actively using substances, a single test is recommended, but we do recommend at least annual testing.

Simplified treatment with either GP or sof/vel is recommended and really is how we practice today. There are no drug interactions medications used for opioid use disorder, and they're listed there. And that we really do want to encourage treatment of people actively using drugs, particularly people injecting drugs. And that's something that the field did not adhere to 20 years ago. But now is really the focus of who needs to be cured.

And we need to improve our test and treat models, minimizing the time from someone's diagnosis to treatment. And there are a lot of tools out there. So we hope that you'll take some of these things and think about how you can apply some of the lessons and best practices or good practices to where you treat patients or care for patients. And think about how we can deliver more treatment.

I think Ronni's points are really well taken. There's a lot of stigma around hepatitis C, and that hasn't changed. There's stigma around substance use. These are important things that anyone treating people with hepatitis C need to approach.

And the last point is really critical. We want to eliminate hepatitis C around the globe but start locally. Start in your clinic. We call that micro elimination. There's a lot of good work we can do together.