Shay Reichert, PharmD, BCPS: Good morning, good afternoon. My name is Shay Reichert. I’m a PharmD by training as well as a board-certified pharmacotherapy specialist. I work for AbbVie as a hepatology medical science liaison or MSL. And a medical science liaison is someone who has advanced scientific training and expertise in a specific therapeutic area and is usually located throughout the country. And at the end of the presentation, I’ll send you my contact information so we can find out who your MSL is. So, let’s start. Let’s talk about tools and resources for simplifying hepatitis C care.
This education webinar is sponsored by AbbVie US Medical Affairs. We’re not offering CME credit for today, just education.
So today, we’ll look at some objectives. We’ll look at the changing landscape that we have for patients with hepatitis C. We’ll look at kind of what’s going on. Then, we’ll look at screening recommendations. We’ll who do we need to screen and how is that diagnosis is made. And then, we’ll look at what do we need to do before we start treatment, during treatment, and then after treatment as far as monitoring. And lastly, we’ll look at a website called HCV.com that was built with you in mind. And it has resources from all over with regards to treatment for hepatitis C as well as we’ll focus on the harm reduction resources.
And next, we’ll go ahead and play a video. So, if I can have the video being played, that would be great. And we’ll talk after the video, so enjoy!
[Musical interlude 1:47-4:16]
Well, I hope you enjoyed the video. Every single time I look at that video, I get very excited about the expanding number of patients that can be treated and cured. And we’re you surprised with any of the data? We’re you surprised to know there are people out there who don’t even know they have hepatitis C?
Well, let’s take a little bit further step and look at the prevalence of the hepatitis C virus here in the United States. And you can see we’ve got over 2.3 million patients out there double the amount of patients with HIV. And what’s even kind of depressing on the right side as we look at deaths and we see that we’re doing a great job as far as treating and curing people that are infected with other diseases, but with hepatitis C we’re just continuing to see a rise in those patients that die from the virus itself.
So, let’s take a look now at what is going on as far as those new cases. Initially – you’ve seen this slide before – the focus has been Baby Boomers, Baby Boomers, Baby Boomers – anyone born between 1945 and 1965. This graph was just like a hump, and that’s where we’ve put our focus. And that’s where we’ve put our screening efforts. But look at it there. We’ve got bimodal distribution. We’ve got increases now occurring in our 20 and 30-year-old patients as well as continuing those patients that are Baby Boomers between 1945 and 1965.
So, why do we have this bimodal distribution? What is going on? Well, let’s take a look. So, you may have heard we have this issue called an opioid epidemic. Well, yes, we do have one, and it’s growing even within this COVID epidemic that we have going on. We know that people who use drugs, 70% of the time their hepatitis C virus is going to be in these patients who use drugs. The sad thing to think about, every single person who uses drugs can spread the virus to over 20 additional people during the first 3 years of their infection. So, we need to do something about this patient population.
So, when we look at the screening recommendations, and you think back to 2012 when we started doing screening for Baby Boomers. That’s all you heard about was anybody born in 1945 to 1965 – these are the patients we need to be screening for the virus as well as anybody who uses drugs are high risk. What happened? Well, so in 2020, you’ll see that the United Services Prevention Services Taskforce made a recommendation – anyone over the age of 18. I’ll take you back. Remember that bimodal distribution. That’s the reason why they added the increase of screening at 18 or above. And then, just a month later the Centers for Disease Control added in screening for anyone over the age of 18. Let me kind of step back. What were we doing a year ago? COVID had just started. We just started staying at home. And so, that’s why it’s so important to share this newest information with you today so that you can be part of the cure team when we look at curing patients from hepatitis C virus.
So, we’ll look here, and in the middle part, we’ll talk about screening. Again, anyone that is over the age of 18 years, one-time opt-out screening for everyone. You still have those screening recommendations on patients who use drugs or men having sex with men with high-risk sex practices. That’s still existing, and you probably need to be screening those patients on a more frequent basis, maybe even once a year. The third picture down there of pregnancy. Remember I showed you that bimodal distribution. Those patients are in their twenties and thirties. Those are patients who are at childbearing age. And so, the American Association for the Study of Liver Disease has now recommended that anyone who comes in for their first prenatal care visit be also screened for hepatitis C to see if we can catch whether or not they’ve gotten the virus. When we talk about transmission, this virus is predominately transmitted by blood or body fluids. But there’s another way – all of those things as far as noninjectable apparatuses such as your cotton ball, the syringes. Anything! That virus can live for several weeks at a time. And so, when you think about what we’re doing now with COVID. We are using hand sanitizer as soon as we come back in the car if we’ve gone to the grocery store, etc. The same thing can be said here when we think about the virus of hepatitis C living there and being able to be transmitted not just from the direct blood-to-blood transmission. So, we talked about screening. Everybody over the age of 18, especially those people at high risk. But everybody over the age of 18! That’s means to me, you. That means your entire family that’s over 18.
How do we want to do that? We want to do an antibody test. And that is going to tell you whether or not the body has been exposed to the hepatitis C virus. You’re going to do that from the get-go. If negative, stop. No more further testing unless they’ve got high-risk factors. If it’s positive, then you’re going to do the next step, which is called an RNA test to see if that virus is active and living and breathing in the body. And oftentimes, what you’ll do is you’ll actually order a reflex test where the lab will automatically if they get a positive antibody test, they’ll check and see if that viral load is there. They’ll do the RNA test for you. Let me take you back – one big, huge teaching point. Once someone converts with an antibody to hepatitis C, they will have a positive antibody test for the rest of their life. The sad news, it doesn’t mean that they’re immune. They can still become reinfected with the virus. The big take-home message, especially for those patients who have been cured from the disease, is that they need to have an RNA test to detect whether or not they’ve been reinfected because that antibody test is always going to be positive. So, that’s very, very important from an education perspective for your patients.
Why are we here? Why am I out here trying to encourage you to join the team, to help us eliminate hepatitis C? It’s because we’ve simplified things. We’ve simplified the screening. We’ve simplified the diagnosis and treatment. We now have drugs that are oral medicines that are very easy and simple to use. That is why we are getting people like yourselves – those people who are not specialists – involved in the care. And when we think back, and what was mentioned on the video about the World Health Organization trying to get elimination of hepatitis C, we really need to look at it from a community. We need to get everybody on board as far as finding the patients and working with them to get them linked into care. And then, finally, we’ll take you through some protocols and simple guidelines on how you can become even further involved in helping your patient reach that end goal of getting cured from a disease. I mean, how cool is it that you can actually tell someone I’ve got a medicine that has a chance that can actually cure you of a disease? Not many things we’re able to do that. So, again, we talked about simplification. And the American Association for the Study of Liver Disease has developed an algorithm to actually simplify the care and get more people like yourself involved in that care cascade so that we can get more people actually treated because there’s not enough specialists to treat all of the patients. As an aside, I was just reading yesterday that they’re thinking hepatitis C is actually going to be rising after we get through this COVID crisis. So, that’s why we need your help to join us on our cure cascade as far as treating more patients.
So, what patients should be following this simplified algorithm? Those patients that have not been treated before. So, they’re called treatment naïve or TN for short. Those patients who have no liver damage. Those patients who are non-cirrhotic. So, they have to be treatment naïve, non-cirrhotic. Those are the patients that you can help get them the cure as well.
Then what do you need to do with the other patients? Well, that’s where you need to work with your specialists that are in your community. You need to have someone that you can call, that you can refer to for your patients with cirrhosis or treatment experience. And I’ll show you on HCV.com how to find those specialists that are available in your neck in the woods if you’re not already connected. So, I’ve talked to you about screening – everybody over age 18. We’ve talked to you about diagnosis. We’ve look at the antibody. We’ve seen the RNA is positive. Next step, you need to ask them, have you been treated before for the hepatitis C? The answer is no. the next step is cirrhosis. We need to find out if that liver is healthy.
The first step and the easiest steps is to just look at the platelet counts. Just look at that CBC. Look at the platelets, and if they’re above 150,000, you are good to go. But if they’re below, then you need to start saying, okay, they’ve got cirrhosis. Maybe we need to do a calculated value, which is that FIB-4. And I’ll actually show you on the website – HCV.com – on how to actually calculate that value. So, that’s the next step as well.
So, we’ve made the screening. We’ve done the diagnosis. We’ve asked if they’re on treatment. We’ve checked cirrhosis. What’s next? Well, that drug-drug interaction potential. You always need to double-check on this.
And what is wonderful in this space is that the University of Liverpool has come out with a way that you can double-check if that patient is going to have a drug-drug interaction with the medications that you’re going to prescribe. Listed here is the website as well as they’ve got a downloadable app. And all you have to do is choose which medication you’re going to be using for hepatitis C and then list everything the patient is on – their prescription drugs, their over-the-counter medicines, their herbal supplements – and then all you have to do is click check.
What will happen is you’ll get a green light, no interaction. Yellow light – well, there might be something that you need to watch out for. An orange is, well, there’s something you need to do about it. You need to maybe adjust some dosage. Red is do not use. It is important for you to recognize that there’s tools out there, but you’re going to have a partner in determining whether or not they have a drug-drug interaction. That partner is your specialty pharmacy, and we’ll talk about that here momentarily. So, we’ve gone through the screening. We’ve gone through the diagnosis. We’ve gone through treatment naïve. No cirrhosis. We checked medicines. What’s next?
We need to educate that patient. We need to educate them from a standpoint of adherence, taking the medicine, but we also need to talk to them about harm-reduction strategies.
We need to teach them to how to change their habits, so they don’t reinfect themselves. We need to get them into a needle- or syringe-exchange program, maybe substance abuse therapy. We need to treat them with vaccinations for other viruses such as hep A and hepatitis B. All of these things are called harm reduction, and if we did these, we could decrease new cases by 77%. Gosh, that’s wonderful!
So, last step before we start treatment, you need to do laboratory work. And that is going to be dictated based upon the health insurance coverage that they have. They’re going to have set labs that they want to see. They also want to look at your viral load. You need to check whether or not they’ve got HIV. And then, the final thing you need to check is whether or not they’ve got hepatitis B. Why is that? Well, hepatitis B may be reactivated with all the drugs that you currently use for hepatitis C. There’s a black box warning for reactivation on all those products. So, you need to find out. And then, refer them if they do have hepatitis B. The final thing, remember those patients. Remember what I talked about – that bimodal distribution. Those patients are of childbearing age. Make sure you do a pregnancy test. And finally, the genotype. There are several different genotypes. For drugs, it doesn’t matter because they cover all genotypes. But for insurance, you might actually have to do a genotype.
Now let’s look at the final step. Let’s talk about drugs! I mean, as a pharmacist, let’s talk about the fun part. Let’s talk about the advancements that have been made.
So, previously, we had injectable agents that didn’t work. You would give it to the patients for a year, maybe two. But here, recently, we have come out with oral medicines that really target the virus. We understand how the virus replicates. We go and hammer it where it replicates by using combination therapy. Again, oral medications. Very, very safe. Very, very effective. And you look at the bottom of the screen – 95% chance of cure. Ninety-five percent chance of cure and only anywhere from 8 or 12 weeks if you’ve never been treated before or you don’t have cirrhosis. So, again, once a day for 8 to 12 weeks, 95% chance!
Specialty pharmacy – and we talked about this earlier – these are going to be your partners. These are the people that will help you with getting the prior authorization filled so that you can get the prescription paid for. Not all people require prior authorization. There are some states that have removed this restriction, but for the most part, they are still there. They will also work on the drug-drug interaction as well as education. And finally, they will help you with patient-assistance programs if your patient doesn’t have the money to pay for their medication.
On treatment monitoring, two patients – the only patients you need to worry about. For patients who have diabetes, you need to worry about them checking their sugar and making sure that they check it to see if they actually are at risk for going low because the liver is healthier. It’s working better. And the second one – it goes without saying – warfarin. If you change anything, you always need to check the INR.
The bottom line – how do I tell if someone is cured? You use a SVR – sustained virological response. Twelve weeks after you’ve stopped therapy, you’re going to check the viral load, and you’re going to see if it’s positive. If it’s negative, you get to share the results as far as you have actually provided cure. And you know it all, right? I’ve talked to you about screening. Talked to you about diagnosis. Talked to you about treatment and what you need to do. You’re ready to go, right?
Well, what we’ve found out is that you might need some help. You might need some background. And that’s where comes HCV.com. HCV.com was developed with you in mind. And it’s loaded up with resources. With any website, you can go different ways, but the way we’re going to look at this website is we’re going to look at the Fight Against HCV first. And what you’ll see is the video that I shared with you earlier about the landscape changing. You can re-watch it there. It also talks about the World Health Organization report. On the far right, you’ll see MappingHepC.com. This is a resource that was also developed by AbbVie for you to find out whether or not you got a huge increase as far as hepatitis C in your neck of the woods. And you can go down by the state and also even look at some treatment rates. On the bottom of this screen, there are syringe-exchange programs and other things you can do for people who use drugs. And, again, if you don’t even have one, you might consider starting your own as well. The next tab is provider resources. And these were developed with you in mind. All of these are PDF formats that you can download and go through. And they’re very similar to the documents that I shared with you earlier as far as the monitoring. There’s additional information on labs and as well additional information on hepatitis B reactivation guide as well as patient brochures. All of these reference guides can be downloaded, but your local medical science liaison can actually order pamphlets for you that you can use in your treatment. The next thing that I’ll go through are some third-party resources and looking all the way from epidemiology, screening diagnosis. Here’s that FIB-4 calculator. That’s where you go to find out how to calculate that. Bottom, patient readiness. And you’ll say, what do you mean, Shay, patient readiness? I mean, you’ve got a cure, right? Why doesn’t everybody want to be treated? Well, there’s still a lot of misinformation out there. And so, these are some resources where you can help the patient find the confidence that you can help them be cured. On the right side, you’ll see the American Association for the Study of Liver Disease. The treatment recommendations. They’re online and that’s because they’re updated often when new science becomes available. Most recently, it was just updated on January 21st of this year. Harm-reduction resources – I stated that I would show you where they are. Here’s some more data as well. And then, the HCP Finder which is down at the very bottom. And you’ll go to the website. You’ve got to click patient, and then you can click where you’re at and what specialty you’re looking at. And you’ll be able to find a specialist that you can count on to help you with the treatment of your patients. Finally, I’ll show you HCV Academy. And, again, this is something that we designed for you based upon your feedback. You wanted to know more about the liver. You wanted to know more about cirrhosis and what is happening. And all of these are very short videos. There are also printable summaries as well. And bottom line, the big thing – and I’ll go back off the video and tell my person as well – it’s there for you. And if you have comments about that, please let us know how to improve it.
So, here’s my last slide. Help us, help your patients become cured. Help us to eliminate hepatitis C from the United States by getting involved, getting knowledgeable, and helping your patients with elimination strategies in the local community as well. Again, my name is Shay Reichert. I’m a medical science liaison. I’m going to show you contact information at the very end that actually will allow you to find out who your local medical science liaison is.
So, again, thank you for your attention. We’ll take some questions. I’ve got my colleague, Jana Carabino, on from Florida. She’s the MSL down there. I’m based up in Texas, if you didn’t notice by my accent. But again, I want to say a shout-out to Jana. She helped make these slides. She helped me practice and provide you the information. So, Jana, tell me what more can we say to people.
Jana Carabino, PharmD: Thank you, Dr. Reichert. That was a great overview of hepatitis C and the abundance of work that still needs to be done in the United States to reach those elimination goals. I also want to give you some questions that just came in.
Can you give a little more information on the mapping hep C and where that data comes from and how it’s populated? What sources are used?
Reichert: Most definitely! So, the MappingHepC.com comes from two large national databases of laboratory measurements. And what that allowed us to do is look at antibodies, look at RNA values, and even liver function tests. And what that allows us to do is for your state we can tell you what percent of the population has been screened and even diagnosed.
And then, lastly, they actually have some something using claims data and computer data mining in the backend to tell you your treatment rates. How well is your state doing? Are they treating at 100%? Probably not. Probably closer to 10 to 25% of your patients are actually being treated. And that’s why we need your help in getting more patients treated. So, thank you, Jana.
Carabino: No, thank you for the additional information. That resource Mapping Hep C is expected to be updated in the next several months with more current data up to 2019. So, I encourage everyone to continue to go back and check for that update.
The next question, you’re focused on people who inject drugs. Could you talk about those who are actively using? Should they be treated? What’s going on with that group?
Reichert: Right! And so, we have got data after data of actually using the medications in people who are actively using drugs. And the data shows us if you’ve got a patient that will come in and be seen by you, they can be successively treated with these agents, which is so nice. And really, I think more and more the insurance companies are allowing coverage.
Initially, in several of the states, they said no. If you’re actively using, we will not treat you. But now, we’ve got the data. You can be successfully treated even though your actively using.
Carabino: Could you review more information regarding reflex testing? How is that ordered? Any additional data or facts please.
Reichert: Yeah. In that reflex testing, so what happens? We’ve taken a several-step process, and we’re trying to decrease the number of steps that we have. And so, if you’ve done a blood draw for that antibody testing, if it comes back positive and you ordered it correctly, the laboratory people will actually reflex to an RNA. And then, if you further added to the laboratory, they will even reflex and tell you the RNA status as well as at the end of the day the genotype the patient will be.
And the bottom line is to decrease the number of times that patient has to come back in for laboratory visits. To make it simpler and get them linked to care the quickest as possible.
Carabino: Great, thank you. That is all the questions we have for today. So, if you’d like to close us out for the next 30 seconds.
Reichert: Great! And so, you’ve got my QR code. Scan it with your phones. Give me a shout. Give me a text. Give me an email. I would love for you to be connected with my team. We are here to help you help your patients to become cured from the hepatitis C virus. And we are here to help you with questions and therapeutic knowledge. And I know that my colleagues would really enjoy getting to meet you.
So, a couple of other things – the slides will be available for download. You’ll receive an email to the registered email address when those slides are available. And there will be a recording on this as well available.
So, thank you for your time. Thank you for your attention. And let’s go knock the crap out of hepatitis C. Thank you!