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Managing Hepatitis C in Primary Care

Good evening everyone and welcome to tonight’s Testing and Treating Hepatitis C in Primary Care forum. My name is Beth, and tonight our presenters are Dr Joseph Lawler and Dr Marie Healy. Before we get started, I would like to make an Acknowledgement of Country. We recognise the traditional custodians of the land and sea on which we live and work and we pay our respects to Elders past and present.
 
I would now like to introduce you to our presenters this evening. Dr Joseph Lawler was awarded his Medical Degree from the University of Sydney in 2004. He completed his advanced training in gastroenterology in 2011, having trained at RPAH and Liverpool Hospital in Sydney. He completed a Clinical Fellowship in Liver Medicine and Liver Transplant Medicine at Mount Sinai Hospital in New York City in 2014. He is now a consultant gastroenterologist and hepatologist in central Sydney and western New South Wales LHD.
 
Dr Marie Healy is a GP in Redfern working mainly in the areas of aged and chronic care. Marie is also an RACGP examiner and medical educator. I am now going to pass you over to Marie who will take us through tonight’s learning outcomes. Thanks, Marie.
 
 
Marie:
 
Oh hi, everyone and thanks for joining us. By the end of this online activity, you should be able to identify patients at risk of hepatitis C infection and talk about testing using sensitive language. Understand how to treat hepatitis C in general practice with specialist support if required and identify when a patient should be referred for specialist care.
 
So we just thought we would warm you up a little bit with a poll question and just thinking about your own practice. Do you have patients who may be at risk of hepatitis C? So put in your answers there.
 
 
Bethany:
 
Alright I am going to give you a few more moments to pop your votes in for those two questions.
 
 
Marie:
 
So it is really thinking about you know, people who are walking in your door and who you generally see who might be at risk of hepatitis C.
 
 
Bethany:
 
Okay. I am going to share the results with you now. So the results are up on your screens.
 
 
Marie:
 
Okay. And then that second one is, do you feel confident managing people with hepatitis C. So there is sort of 50/50 there is looks like.
 
Alright, we will have a look at those again at the end of the session and see how people are feeling about that now.
 
 
Joseph:
 
And we thought we would talk a bit first about why we want to treat hepatitis C and I think we need to think about the reasons behind treatment of hepatitis C. There are two main ones. And one is taking a population health kind of view, looking at decreased transmission. And the other is looking at the individual patient outcome, the individual with hepatitis C. So of course to decrease transmission, we want to treat all people with hepatitis C, so we reduce the risk of community transmission and move towards our goal, our national goal hepatitis C elimination.
 
Now moving across to the right side of this diagram, so looking at improving clinical outcomes for patients, in your non-cirrhotic patients, the goal of treating hepatitis C and eradicating hepatitis C is to reduce the risk of those patients with hepatitis C, reduce their progression to liver fibrosis and cirrhosis and improve their overall survival. In patients with established cirrhosis, we want to reduce the risk of clinical decompensation or progression of their liver disease and progression to decompensated liver disease which is a patient with ascites, jaundice and hepatic encephalopathy and variceal bleeding for example. And we know that treating people with cirrhosis and to a point, people with decompensated cirrhosis, they can demonstrate significant improvement in their liver disease and get regression of cirrhosis. In not all, but some. And we can improve their liver-related survival with hepatitis C medication.
 
In patients with more severe disease and decompensated cirrhosis, the goals of treatment in the specialist care context would be to reduce the further progression of their disease and sort of work in that tricky space between liver failure and liver transplantation. And that is a bit beyond the talk today. But just to point out that these medications can be used in the post-transplant setting and that has really revolutionized hepatitis C management in the transplant setting and can significantly improve transplant outcomes. And then finally there are things we do not think about often, and that is the quality of life issues and we know that neurocognitive function improves with hepatitis C eradication. Even things like mood disorders, so there is an unusual interaction with cerebral function. People can feel that they have more energy and then there are other complications of renal disease and cryoglobulinaemia and even lymphoma because of that chronic irritation of B cells because of the virus. You know, also in people with diabetes and particularly with genotype 3 infection, we can prove insulin resistance and outcomes in cardiovascular disease too. So lots of reasons to treat hepatitis C.
 
 
Marie:
 
Thanks, Joe. Yes, look some of the people I have treated too, they have actually, it has been a chance for them to put their hepatitis C you know behind them. It has had you know, good mental health effects, the treating of hepatitis C. I do not know whether you have ever sort of come across that, too?
 
 
Joseph:
 
Absolutely, yes.
 
 
Marie:
 
So looking at patients to test, it is really important that we can identify people you know so we can assess it and treat them. So, we are looking at priority populations. So it is important to initiate conversations about hepatitis C with people in a way that people can open up to you and you can get good histories and do an assessment. So the priority populations that you should be thinking about are people who have ever injected drugs. And that can years ago, and it might have only been a brief period, or it might be people who have ongoing injecting drug use. Aboriginal and Torres Strait Islander people. People born in high prevalence countries. And they are often an under-tested group. That includes Egypt, Pakistan, Mediterranean areas, Eastern Europe, Africa and South Asia. And people who have been incarcerated, have ever been incarcerated. And Joe, there are some other populations that people should think about.
 
 
Joseph:
 
So one of the things that you may come across in your clinical practice that hopefully will trigger the idea or motivation to test for hepatitis C, is patients you might have that have some evidence of liver disease. So that could just be as simple as someone with a persistent elevation in the ALT for instance. You want to think about it in patients that are infected with HIV and HBV, because all the blood-borne viruses have the same mode of transmission. So, if you are dealing with hepatitis B it is really important to know HCV status and the same with HIV. And we know with viral co-infections, liver disease progresses much more quickly, so that is a really important thing to be aware of. And it also kind of dictates where people can be treated. In co-infected people, they should be referred on to specialist care and out of general practice and we will touch on that again later.
 
Healthcare workers who practice with high-risk procedures, like anyone who can be exposed to needle stick or sharps injuries like dentists working in confined spaces, and some surgical procedures. Sex workers are a population to think about. Anyone that had tattoos or body piercings. That has become less of an issue as professional work, because of professional tattooists having autoclaves and sterilisation techniques, really important. But there are a lot of backyard tattooing in the community and also in the justice system, and that is certainly a high-risk activity. And blood transfusions or organ transplants before 1990, because it was 1990 that the hepatitis C virus was identified. Before that it was not tested for because we did not know about it. So, that 1990 cut off is really important when you are taking a risk factor history and exploring blood transfusion or transplantation. Children that are born to mothers with chronic hepatitis C, there is a less than 5% chance of vertical transmission so keeping in mind that testing the neonatal child is really important. Sexual partners of hepatitis C positive people comes up and I want to reassure you, and this is a conversation that comes up a lot in early discussions about hepatitis C, with monogamous partnerships, and heterosexual sex, the transmission risk is very low. There was a big study published, the HCV Partners Study from the US in 2013 which basically found a 0.07% chance per year of transmitting hepatitis C within a couple. And that amounts to one in 190 thousand sexual episodes. So really, really low risk which is quite different to hepatitis B. But that is a conversation that comes up a lot in hepatitis C and also of course thinking about needle stick injuries, that is definitely a time to think about screening for hepatitis C.
 
So in tonight’s session, we wanted to kind of focus in on two specific priority populations, and they are people who inject drugs, and also Aboriginal and Torres Strait Islander people in Australia. Now, the New South Wales Needle and Syringe program surveys clients over a two week period every year, and the most recent data has shown the hepatitis C antibody prevalence in people in utilising the needle and syringe exchange programs had a hep C antibody prevalence of 57%. So it is pretty high. So it indicates the importance of this population in terms of screening and providing access to treatment. And of these people that have antibody positivity, 71% acknowledged a history of receiving treatment, so we making in-roads in this population, but there are still gaps there and we still need to work hard at getting all those people at risk tested and treated. I think it is important to note too, that active injecting drug use or any illicit drug use from any other route of administration is not a contraindication to hepatitis C treatment and nor is enrolment in opiate substitution therapy. And there are loads of studies from the Australian context as well as the international context that have looked at real world data in this population, and overall treatment completion rates are very high, so approaching 100% and the cure rates, or sustained biological response rates are quite comparable to non-injecting drug-using populations. So it is really important to try and think about treating that population, because again, this is the community that will transmit and keep transmitting the virus if we are not identifying and treating the infection.
 
 
Marie:
 
Can I ask, Joe, as a ballpark figure, if they have got ongoing injecting drug use would you do a check for the RNA every year, or?
 
 
Joseph:
 
Yes. If they have got ongoing risk factors, repeating the HCV RNA once to twice a year, so every six to 12 months is really important. So you pick up on reinfection and get in early and treat. Yes.
 
 
Marie:
 
Okay.
 
 
Joseph:
 
So the other population that is really important to consider is the Aboriginal and Torres Strait Islander population in Australia. And from the last Census in 2016, it is estimated that about 3% of the population is indigenous, and yet they make up over 11% of all hepatitis C infections in Australia. And so clearly they are over-represented with this infection. And of most concern is the fact with this new DAA or direct-acting anti-viral era, we are seeing still increases in HCV notifications in Aboriginal and Torres Strait Islander people in Australia compared to non-Aboriginal people in whom we are seeing an actual decrease in notification rates. So again, there is that gap in health outcomes and hepatitis C is yet another example of inequality in health outcomes. The reasons behind this are really complicated and I mean in terms of looking at the needle and syringe program client, one in five of those clients identify as Aboriginal or Torres Strait Islander. We know that Aboriginal and Torres Strait Islanders do have riskier injecting behaviours and they are overrepresented in the justice system and incarceration is a risk factor alone for hepatitis C. So lots of reasons why this population is really, really important to focus on and address. And part of dealing with that is the Closing the Gap program which offers discounted hepatitis C treatment for people who identify as Aboriginal and Torres Strait Islander. So that can result in a waving of the co-payment if people have a Healthcare Card. If they do not and they are registered for CTG, there is a concessional rate for each 28 day dispensation of medications for hepatitis C. So whereby they will only be charged six dollars, and removing yet another barrier to accessing treatments, and that is something really important to be aware of.
 
 
Marie:
 
So we might do a recap on when to test for HCV. So a patient may request a treatment, they may have abnormal liver function tests as Joe explained, it may just be a small increase in the transaminase, symptoms or signs of liver disease, jaundice or acute hepatitis.  If you have a concern that they are a priority population of they have the presence of other risk factors that we discussed and we have been discussing, you know including people of Aboriginal and Torres Strait Islander backgrounds and the other priority populations. So, there is quite a few reasons that you might check for hepatitis C. And then we might do on to how to test for hepatitis C.
 
So, first of all, you will want to see if someone has ever been infected with hepatitis C, and that is the Anti-HCV antibody, or the antibody test. And that, if it is positive, it means they could have current or past infection. So they have been exposed to hepatitis C. But you then need to see whether they have current hepatitis C or ongoing hepatitis C infection. And then you need to do the PCR test or the HCV RNA. And as Joe mentioned previously, if there is ongoing risk you may repeat that every six to 12 months. Obviously if somebody is being treated or they have naturally recovered from the virus, their antibody test will remain positive. So it is the RNA test that you need to repeat to see if they actually have an infection. So there are two types of RNA tests, the quantitative one which was the viral load and you must specify that on the request form for the Medicare rebate, and then there is the qualitative one to detect RNA in a patient undertaking antiviral therapy. And you can do that up to four times a year. Joe, you might go into that a little bit more, could you?
 
 
Joseph:
 
With the genotype testing. Yes, so with the genotype testing, a lot of you might be familiar with this as the treatments have evolved. But now we have pangenotypic treatments. So, treatments that can cover all six viral genotypes of hepatitis C. So the PBS, and we will talk about this later, but the PBS have removed the requirement to know or to test for the genotype. But that still has a place clinically. And if you can, or if you remember to ask for the genotype, it can be helpful managing patients down the track, particularly in those high risk patients that are going to be at risk of reinfection. So it can help us differentiate between reinfection and treatment failure if a new genotype appears for example after somebody has cleared the virus. So whilst it is not part of the PBS prescribing criteria, it can be useful clinically.
 
 
Marie:
 
So here is the testing sequence for identifying current hepatitis C infection. Now, if you do the antibody test and it is negative, you do not need to go any further. If you get a positive antibody test, then test for the RNA. If that is not detected, they do not have current hepatitis C infection. So then they might have some, you can do other appropriate testing. If you detect the RNA, you can, sorry I need to move that slide along, that means they have current hepatitis C infection and you need to then embark on assessment for treatment in these people. So, this is the pre-treatment assessment and we have gone over this in previous webinars, but just to go over the assessment that you need on each patient. So, basically you need to show that they have current hepatitis C infection. The genotype as Joe explained, you do not need but often people still want to know it for example if they have a problem with treatment failure. So that is not needed for treatment at the moment. Treatment has been simplified. If they have had previous hepatitis C treatment, that is an important thing to know, so that is part of the history. And you need to actually take a good history and examine these patients. So you need to ask them about what medications they are on, the amount of alcohol that they drink, you need to check for pregnancy in women of childbearing age, check their BMI and do an examination for signs of chronic liver disease. And there are some basic baseline investigations. You want to know that they do not have renal impairment and signs of cirrhosis. So that is checking the full blood count, the liver function tests and they need a cirrhosis assessment before you treat them. So the APRI score, you have probably all been aware of and we will go into that a little bit later again just to refresh your minds, and Fibroscan to judge the level of fibrosis. So these are the sorts of things that you need to fully assess a person. You also need to know whether they have any coinfection, so HIV, hepatitis B, so those things are important as well in working up somebody for treatment. 
 
 
Joseph:
 
So we are going to just quickly bring up the dried blood spot test pilot, because I think some of you may have heard of it, some of you may not have, but you might come across it through patient enquiries. So this is a program that was launched by New South Wales Health in 2016 as part of community outreach testing. So it requires a capillary blood sample in a little envelope that can be sent to a central laboratory to be tested for the hepatitis C RNA. So it is a confirmatory test to move onto the antibody to see whether the virus is actually circulating. So this is delivered in normal clinical sites and it can be provided by non-clinical staff, so at healthcare centres, community health centres and at health information days and things like that. And it can be driven by peer support workers as well. Test kits can test for HIV as well as hepatitis C. And whilst it is not part of the diagnostic treatment algorithm per se, it is a good engagement tool to be aware of, particularly in a population that has difficult venous access, so people do capillary blood draws for confirmatory testing. So it is easy, confidential and you can have a self-sampling testing option, so patients can actually order the kit into their home and do the blood collection or do the sampling at home and send it into the central laboratory and continue that way. So there is some more information there on the website. So I just wanted to highlight it for you, to know that this exists as a research tool and you can have a look at that in your own time.
 
 
Marie:
 
So we have talked about testing patients and identifying them. Does anybody have any questions before we continue on?
 
 
Joseph:
 
Okay, is a genotype necessary for treatment? So, like we were saying before, it is not part of the PBS requirement any more, when you are calling up for the authority to prescribe these medications, whereas it used to be. So that came off the recommendation, off the PBS recommendation last year. But it can be useful clinically, so it is a useful test and it still does have its place, but it is not essential. So hopefully that answers your question.
 
Okay, how can we manage pregnancy with hepatitis C? Okay, good question. So look, there is no safety data for these drugs in pregnancy, so like Marie was saying earlier, we need to exclude pregnancy before commencing treatment and talk to women about contraception throughout the course of treatment. So yes, we cannot treat women that are pregnant and we do require contraception to avoid pregnancy while on treatment.
 
Now, what is the recurrence rate after treatment? So look, the recurrence rate, an SVR is deemed a durable cure, okay? So once you demonstrate that the virus is not circulating in the blood 12 weeks after treatment completion, that is a cure. If the virus reappears, it is reinfection. Okay? So, the recurrence rate just depends on the risk behaviours. So, anyone can get hepatitis C a multitude of times. There is no ongoing immunity. So yes, you need to be clear with people that they can get reinfected after treatment.
 
Okay. So the next one. They are all coming through now. Marie, do you want to take any queries?
 
 
Marie:
 
While taking medications for hep C treatment, do you need to monitor blood tests? No you do not. No. So in general practice, we treat patients who do not have renal impairment or cirrhosis and there is no monitoring during treatment. According to the current guidelines, you do not need to monitor the LFTs during treatment. Look, if somebody has you know, has a reaction or whatever, that is a different thing. But generally there is no on-treatment monitoring treatment required in the straightforward patient.
 
 
Joseph:
 
And we do cover, we go through a table that illustrates an example of how you might approach testing of someone on treatment. Now, what is the reason for asking about previous treatments? Does it affect future treatment? So, it is an important thing to note, because it is one of the differentiating factors about context of appropriate treatment. So it should be, if somebody has been treated for hepatitis C before, that should prompt a specialist referral. Okay? So in general practice, we are talking about treatment naïve or treatment inexperienced people. Okay? So it is important from general practice to establish whether somebody has been treated before, because it determines whether you can continue looking after them or whether you seek specialist assistance.
 
Okay. And then hepatitis C and hepatitis B combination treatment. So each virus is treated on its own merits. So, hep C has a cure as we have been discussing. Hepatitis B does not have a cure. And the treatment algorithm for treating hepatitis B is a bit different. It is really important to understand or to know somebody’s infection status because since these drugs have been used, it has been shown to have very low rates of reactivation of hepatitis B. So if something happens with the immunity when hepatitis C is treated and the hepatitis B can get out of control and you can have a flare of hepatitis B. So that is again, one of the indications that highlights the importance of screening for blood-borne viruses and referring people on to specialist care. So it is a really good question.
 
 
Marie:
 
So is there any option to reduce the risk of vertical transmission in pregnancy?
 
 
Joseph:
 
Yes, no there is not. Just with the birthing process, so with hepatitis B you might be familiar with the prenatal treatment or the third trimester treatments of hepatitis B to reduce transmission, but there is no such intervention with hepatitis C. So there is just the basic advice of trying to minimise blood exposure of the baby during the birth where possible. So avoiding scalp electrodes and intervention when it is unnecessary. So that is the limit of what you can do. But just remembering to screen children once they are postpartum, and refer to a paediatric gastroenterologist who specialises in hepatitis C if a diagnosis is made.
 
Okay. Alright. So we are talking about the populations, the priority populations and reference to the Middle East. So yes, Egypt is a good example. There was a national schistosomiasis treatment program across the country and needles were reused and injecting paraphernalia were reused, and genotype 4 hepatitis C was transmitted amongst the population so prevalence rates were very high in Egypt. And it is one of those examples where it illustrates the importance of taking a history and understanding people’s cultural heritage and their migration history. And so you know, people will import their risk and we have talked about that in different talks. So maybe a couple more questions before we push on. Because we do not want to run out of time. But thank you, it is great that people have asked some questions, so thank you.
 
 
Marie:
 
Is it necessary to test the partner with the low incidence of sexual one?
 
 
Joseph:
 
Yes, I mean look it is a conversation to have but I think it could be a very powerful conversation to have with couples just because it is a significant anxiety that we come across again and again in clinical practice and you can reassure people about that very low risk of transmission. It is entirely appropriate to screen.
 
 
Marie:
 
And then how frequently should you be testing for hepatitis C in HIV?
 
 
Joseph:
 
Yes, that is a good question. It all depends on risk factors. So, you know if there are ongoing risk factors, with ongoing injecting drug use and high risk sexual activities, because with hepatitis C and HIV risk, it is particularly unique to men who have sex with men, or gay men having penetrative anal sex and HIV seems to the co-factor there that increases the risk of sexual transmission. So that sexual transmission risk is different to the one we were talking about before which is the heterosexual monogamous partnership. So hopefully that answers that question. But yes, really, really important to be aware of that.
 
 
Marie:
 
That is great. So we might go onto the next slide. So, looking at the PBS requirements. Now these have been simplified too. So the treatment criteria is, must be treated by a medical practitioner or authorised nurse practitioner experienced in the treatment of chronic hepatitis C infection. Or in consultation with a gastroenterologist, hepatologist or infectious diseases physician. So once you have completed 10 treatments in consultation with them, then you are considered an experienced medical practitioner. And the information that must be provided on the application is the patient’s cirrhotic status. So you must state whether they have cirrhosis or they do not, and then the details of previous treatment regimens if they have previously been treated. Well that would be for a specialist. So as a GP you just need to know that they have hepatitis C and what their cirrhotic status is. So the medical records must document the evidence of chronic hepatitis C. Now you do not need to state genotype now, either. Is that right, Joe?
 
 
Joseph:
 
Yes, that is correct. So again I think it highlights that, just reminding the audience too, that the only thing you need to know is if somebody has been treated before, and that is the trigger to refer on. So you do not need to get confused about the different regimens for retreatment.
 
 
Marie:
 
Yes, so basically for GPs in this PBS requirement, we just need to know for us to treat, A, A and A are the things that you know we will be treating. We will be treating the people with hepatitis C that are not cirrhotic and then we are supervised for the first 10 treatments.
 
 
Joseph:
 
Okay. Alright. So I am not sure if you are all aware, but we have referred to it a few times tonight. So the Gastroenterology Society of Australia released a consensus statement at the release of the direct antivirals and it is a live document and it is updated all the time and the last update was in the middle of last year, and there were some six or seven key changes that we will just highlight and we have referred to them a couple of times tonight. So, the first point was that the two new pangenotypic drugs or regimens were listed on the PBS. One was Maviret which we will talk about. It is a combination of two drugs in three pills that are taken all together every day for eight or 12 weeks, and Vosevi which a three drug combination pill in one pill that is for treatment experienced patients only. And so, you know you do not have to worry about that drug, because that is prescribed in the specialist setting.
 
Now the second thing that has really changed in terms of the guidelines was the on-treatment monitoring and it is really simplified, so basically you have your treatment workup, complete your treatment and then you do not need any ongoing tests until 12 weeks after treatment completion. There are some more guidelines on managing people with hepatitis C and renal impairment, and Marie is going to talk a bit more about that later. Going on to the next slide.
 
There is now prescribing by nurse practitioners. These are direct-acting antivirals which is a huge thing. The removal of the PBS requirement to document the hepatitis C genotype as we have mentioned a couple of times and that is because of the advent of the pangenotypic regimens. Now children less than 18 years can be treated. They could not, until the middle of last year. But again, this is not in general practice. People under the age of 18 should be referred to a specialist paediatric gastroenterologist experienced in treating hepatitis C. And finally, there was the TGA approval of the Point-of-Care assay which can provide actually quantitative measurements of hepatitis C viral loads from a capillary blood prick. But that is only that is only just used in research, I think the Kirby Institute has a couple of machines that they are using for research purposes. But that is something that is not utilised in clinical practice at this time.
 
So this is a really important slide. And these are the two regimens that you need to know. So on the left, you can see the first drug listed is a combination of sofosbuvir and velpatasvir, and the marketed name is Epclusa. That is effective with genotypes 1 to 6, so pangenotypic. It is one pill once a day and for people without cirrhosis it is 12 weeks. You do not have to worry about the cirrhotic patients, it is the same duration. The next drug is the glecaprevir, I am struggling with the names now. So glecaprevir and pibrentasvir which is Maviret. So with that combination, it is squeezed into three pills. So two drugs in three pills taken all together once a day. And the beauty of that regimen is that in people without cirrhosis, you can treat them for eight weeks, so two months only. It is a huge advantage to consider when you are deciding between treatment regimens.
 
 
Marie:
 
So if the drugs are combined to reduce resistance essentially?
 
 
Joseph:
 
Yes, so working at different stages of viral replication. And we have seen this in other antimicrobial and antiviral therapies, like HIV is a perfect example where you hit the viral replication cycle at different points and it increases your viral suppression and eradication in hepatitis C chance, as opposed to HIV which is not curable.
 
Next slide. So we were talking about the on-treatment and post-treatment monitoring. So now if you look at this, week zero on the column on the right, sorry on the left. You do your pre-treatment blood test which includes the things that Marie was talking about before and in particular those liver function tests and hepatitis C PCR. Then you do not need to test anything while you are on treatment, because these drugs have so few side effects, we do not need to monitor in the context of non-cirrhotic treatment. Now, the most important thing to do is the test 12 weeks after treatment. And that is the SVR, that is the acronym that we throw about a lot in hepatitis C, that is sustained virological response which is cure. So 12 weeks after people have swallowed their last pill, you do a blood draw which will assess the liver function test and the viral load. If the virus is undetectable, that is considered a cure. And if the liver function tests have normalised with hep C eradication, they can be discharged from hepatitis C care if they do not have risk factors for ongoing infection.
 
So next slide.
 
 
Marie:
 
That is great, isn’t it? So, renal impairment. I think, well we have to do a baseline renal function. So that is part of a workup of a patient. And all people with renal impairment now, they are saying less than 50 there, but they are saying 30 to 80 you do not need any dose adjustment for the medications, the following medications. Could you comment on that, Joe, in terms of the level of renal impairment that GPs should be treating?
 
 
Joseph:
 
Yes, so I think if you are using the cut off of 50, an eGFR of 50, that is the decision-making point about the context of treatment. If it is above 50, you should feel very comfortable treating in general practice. If it is anything less, then that should prompt a specialist referral.
 
Now we brought this up because there was a bit of a scare in 2019 again when these drugs started to be used. And it just highlights the importance for confirming the presence or absence of cirrhosis before treatment. So with protease inhibitor containing regimens, so Maviret, Zepatier which is an older drug which we are not using any more, and Vosevi which has a protease inhibitor, which again you do not need to worry about in general practice, but just remember that Maviret, when those drugs were used in people with Child-Pugh B or C, and that is just a scoring system to assess the severity of cirrhosis, it captures those people with decompensated cirrhosis, so ones with jaundice, ascites, encephalopathy and the like. When those people are exposed to the drug, some people had devastating progression in their liver disease and there were deaths through acute or chronic livre failure. So these drugs cannot be used in people with advanced liver disease. They are safe to be used in Child-Pugh A, so compensated cirrhosis, but they cannot be used in decompensated cirrhosis. So again, this is important for you guys to be aware of, but it should not affect you or concern you about prescribing as long as feel confident in identifying cirrhosis.
 
 
Marie:
 
So the first question then takes us to that point exactly, so someone is asking, does that mean that everybody needs a Fibroscan of their liver to diagnose or exclude cirrhosis?
 
 
Joseph:
 
And the short answer is no. So you do not have to have a Fibroscan to make that assessment. There are other things you can use and I think we go into it a bit with the case study. So we mentioned the APRI test, it is an AST to platelet ratio index. So it is a free calculator that you can download from Google in a flash and just put in commonly ordered blood tests, so the AST, you have to know the AST level of the patient, the upper limit of normal for that assay from that lab, and the platelet counts. You put those numbers into that calculator and what you are looking for is a number less than one. And if the number is less than one, then cirrhosis is less likely and you should feel safe to treat. But do not be shy to use other modalities to assess for advanced liver disease, use your liver function test, use your INR, use the ultrasound appearance of the liver if you do not have access to Fibroscan. And if you are concerned, refer on. If you are unsure, refer on.
 
 
Marie:
 
There is a question here, which drugs pass into breast milk? Now, what about breastfeeding women?
 
 
Joseph:
 
Breastfeeding women, I would need to take that on notice. I would need to double check on that. I do not want to give the wrong answer. But we will distribute that answer after the talk.
 
 
Marie:
 
Yes.
 
 
Joseph:
 
And then going on to the next question, if a patient failed interferon therapy years ago, do I need to refer for a specialist for treatment? Good question. So, no. So the treatment experience is about direct-acting antiviral treatment. So if you can get a clear history of treatment failure from interferon-based therapies with ribavirin, then you should feel comfortable treating in general practice. It is about the patients that have been exposed to direct-acting antiviral therapy, so being really clear if they have had those treatments through clinical trial prior to 2016, or on PBS post-2016.
 
 
Marie:
 
So, here. What are the indications of hep C patients for referring to a specialist? So as a GP, I am comfortable and according to the guidelines I can treat patients who have never been treated with direct-acting antivirals before for hepatitis C. They do not have cirrhosis. They do not have renal impairment, so their GFR is greater than 50. They do not have any coinfections with HIV or hepatitis B. They are not pregnant. They are not under 18. So it is adults with uncomplicated hepatitis C without cirrhosis, coinfections and significant comorbidities, that I can treat as a GP. Would you agree with that, Joe?
 
 
Joseph:
 
Absolutely. And it goes perfectly to the next slide. So do you want to go to that slide?
 
 
Marie:
 
Okay. So as a GP, as I said, I am comfortable with the straightforward people with hepatitis C, even if they have ongoing drug use, I might say. So I am still comfortable to treat them. So that is not a reason for me not to treat someone if they have ongoing drug use. But if they have advanced fibrosis or cirrhosis, they need specialist treatment and may need on-treatment monitoring and they do need monitoring in an ongoing monitoring by a specialist anyway. Extra hepatic manifestation is a special thing too. So they are a little bit more complicated, those people so they should be linked up with a specialist anyway. And people with complex comorbidities and of course that includes renal impairment and HIV or hepatitis B virus coinfection, with hepatitis C. If they have failed their first line direct-acting antiviral treatment, or if they have acute hepatitis C and of course, previously we have also said children less than 18 is another group, and pregnant women. So, they are the ones that I would not treat and where you would refer them to a specialist.
 
 
Joseph:
 
And just back to the breastfeeding question. I just went back to the consensus statement, and because there is no data, no safety data, the recommendation is to avoid breastfeeding while on treatment.
 
Okay. My patient’s boyfriend in a fit of rage threw out her tablets in the Wizz bin. I do not know what that is. What to do? Difficult question. I would suggest it depends on where they are in the treatment, but just continuing on with the remaining medications and just reassess that SVR as per your usual rates, because as we know, some people did clear with shorter durations of treatment. I do not think there is any other way around that. Maybe some anger management for the boyfriend.
 
Okay. Could any treated patient develop cirrhosis? Okay. This is about looking after the post-SVR cirrhotic patient which again will come into co-management in general practice too. So, yes, we are focussing our discussions today on the non-cirrhotic patient but this question is about post-eradication in a cirrhotic population. Absolutely. The HCC surveillance and ongoing monitoring for progressive cirrhosis is really important, so at the very minimum six monthly abdominal ultrasounds and serum AFPs to assess that.
 
 
Marie:
 
With cirrhosis. Well.
 
 
Joseph:
 
We should just push on for a bit?
 
 
Marie:
 
Yes.
 
 
Joseph:
 
And then we might answer some of those outstanding questions.
 
 
Marie:
 
I think you were going to do this.
 
 
Joseph:
 
Yes. So look, I think we have not really addressed this in our previous talks. So stigma and discrimination are a real issue in this population because it is often a population that has a history of illicit drug use and injecting drug use and they can often encounter stigma and discrimination within the community, and also within the healthcare setting. So it is important to be aware of that and it is important to think about your own language as you are entering discussions with your patients about these issues because there is a lot of baggage that comes with this and it can go very wrong and you can really alienate people and prevent them from accessing testing and ultimately prevent them from accessing lifesaving treatment. And we wanted to point out a couple of non-government organisations that can help facilitate communication and they are Hepatitis New South Wales, and the New South Wales Users and AIDS Association, NUAA. So, they are great resources. So you can visit their websites and refer patients to their websites. They have got great peer support programs. Both organisations have invested a lot of resources into training people with lived experience of drug use and / or chronic viral hepatitis. And they can provide that bridge to cut through some of that discrimination and provide some support for people and guide them through that journey through testing through to treatment and cure. So it is really important to be aware of those.
 
Next slide.
 
 
Marie:
 
Oh we are on to the case study, James. This is where you know, we have got the patient in front of us. So here we have Jake who is 48 years old, and he has been looking for a GP since he was released from custody after six months. He is unemployed and he was injecting amphetamines since 1985 and he is still injecting occasionally. He rarely drinks alcohol and he has a past history of reflux, gastric reflux treated with esomeprazole 40 mg daily, and when you examine him you find he is thin, with a body mass index of 20, but has no signs of cirrhosis. So what other assessments are appropriate? And we have got some here. So we would want to check him for hepatitis C antibodies. So he has been in custody and that is an important test to see if he has ever been in contact with hepatitis C. Then the other tests are to look for other infections that also being in custody is a risk factor for, HIV, hepatitis A and hepatitis B. So they are the infectious ones you would be testing for initially.
 
 
Joseph:
 
And going on to the next slide, we have mentioned, because we have mentioned about the importance of assessing for cirrhosis and we have talked about the AST to platelet ratio index as an example of that. And an illustration in this gentleman who has a low score of 0.2, utilising his AST and platelet count, if you do not have access to Fibroscan, this is a perfectly reasonable tool to feed into that assessment.
 
So going into the next slide, using the Fibroscan. So Fibroscan is ultrasound technology. It is painless and soundwaves travel through the liver and back to the probe that is over the chest wall of the patient. And calculations are made on the basis of the speed of that wave travelling through the liver to work out how stiff the liver is. So, this gentleman’s Fibroscan result was 6.2. So if you look at that coloured arrow, seven is a key point there. And you look to the left and it is all green. So a marker of less than seven means that the liver is normal with no fibrosis or scaring and that is what you want, to treat in general practice. The other cut off that is really important to remember with Fibroscan is the 12.5 kilopascal and that is up to the red end of the graph, and 12.5 kilopascals and above is very suggestive of cirrhosis. And it is worth pointing out that the yellow and the orange zones between that, so in the grades of fibrosis before cirrhosis, it is not the best tool and I would suggest in those settings, if you have got any concerns or any questions, a specialist referral would be appropriate. But our study with our patient Jake, we are good to go. He has got 6.2 kilopascals, so he does not have cirrhosis.
 
 
Marie:
 
Okay, so we presume that we have done our assessment of Jake. So that includes, we have taken a history, and this can occur over one or two consultations, it does not matter. So you have taken a history of his drug use, when the infection might have occurred, examined him, found out what medications he is on, what other diseases he has and you have done your baseline tests. And you find that he has possibly been infected from the 1980s. He is positive for hepatitis C RNA and you did the genotype here which was 3a, and he has a viral load of that number there. His cirrhotic status is negative. There is no liver fibrosis, so on the Fibroscan it is nought to one, is that right, Joe?
 
 
Joseph:
 
Yes. Yes, so he was F zero to one. So, no fibrosis.
 
 
Marie:
 
And no indication of cirrhosis. So there is no liver disease that you have found, and he has a normal EUC. His comorbidities are his gastroesophageal reflux and amphetamine use. There is no coinfection found and his medication is omeprazole. He has had no previous treatment with direct acting antivirals and so you come up with a treatment plan. So, can Jake be treated in a primary care setting?
 
 
Joseph:
 
I would suggest that he is the perfect candidate for treatment in general practice. So his treatment, if he does not have any cirrhosis and no comorbidities or coinfections, we have talked about the comorbid – oh, that is the next question. But no, the answer is yes. I would say yes.
 
 
Marie:
 
And is ongoing injecting drug use a barrier to treatment?
 
 
Joseph:
 
Like we have discussed before, it needs to be considered and if you think it is going to affect compliance, because sometimes patients that are injecting drugs can be quite chaotic and it might not be the right time to treat them to get them through even eight weeks of treatment, let alone 12. So it is not an absolute barrier to treatment at all and it is certainly something that could be considered, but if in the setting of chaotic drug use and chaotic lifestyle, it might be a barrier.
 
 
Marie:
 
And what are the treatment options available for Jake and what duration?
 
 
Joseph:
 
So I think we have jumped to the next slide, and it goes back to a table that we looked at previously in the talk. So straight back to this slide which we have seen before. So it outlines the two drugs that we would think about treating Jake in general practice. The first is Epclusa, the sofosbuvir and velpatasvir combination. He has got genotype 3, that is pangenotypic so it can work, but we have to treat him for 12 weeks. The second option is the glecaprevir and pibrentasvir, the Maviret combination. So again, pangenotypic, three pills taken together every day for eight weeks. So that is a big advantage. So they are our two options.
 
 
Marie:
 
But we know he is on a medication. So we need to check.
 
 
Joseph:
 
We should check that.
 
 
Marie:
 
We need to check to see if there is going to be any interaction. So this is a really useful tool, and you just download it, you know, on your desktop and have it there and it is very quick and you just put in the name of the medication that they are on, and you go and look at the combinations that are available and you look to see if there is any interaction. And it looks like there is a weak, a potential weak interaction here between esomeprazole and the medication.
 
 
Joseph:
 
So there are a couple of options. So going on to the next slide. You always go back to reviewing the need for the drug. So review the need for PPI. It is a class of drug that a lot of people end up on and never come off. And it might be worthwhile considering to stop the medication. So maybe if we drop down the next responses. And so we can think about stopping the medication or switching to, if the patient was dead-set on using Epclusa because we have not checked, we did not check if there are significant interactions with esomeprazole and the sofosbuvir containing regimens. So you can switch to a H2-receptor antagonist if you want to use Epclusa, or alternatively, you could choose the Maviret. If you click on the next option, you can stay on the PPI and continue that safely, as evidenced by that Liverpool drug interaction checker. So there is a very low chance of interaction in that setting. So three options for this patient.
 
 
Marie:
 
Yes. So what testing does he need at the end of treatment?
 
 
Joseph:
 
Nothing.
 
 
Marie:
 
Yes, it is a trick question. Does he need any further testing?
 
 
Joseph:
 
He does, but not for another 12 weeks. So if he has finished his eight weeks of treatment, because we chose glecaprevir and pibrentasvir. So we just need to do qualitative hepatitis C test to see whether the virus is circulating and the liver function test to see if they have normalised.
 
 
Marie:
 
And of course with Jake we would talk about his ongoing use, and then maybe you know, have a recall every six to 12 months to see how he is going and if he needs a retest of the hepatitis C RNA.
 
 
Joseph:
 
Absolutely. And I think this comes up in the next slide. And we know that this gentleman, he achieved his SVR and his liver test were normal 12 weeks after treatment completion. So he has done really well.
 
So back to your question there, so does he need any follow up for the hepatitis C? So if he had no further risk factors for reinfection, he does not need a hep C follow up, because he does not have cirrhosis. He does not need to be maintained on HCV surveillance. And because his liver function tests were normal, we do not need to worry about other liver diseases like fatty liver disease for instance. So he is cured of his hepatitis C and he could be discharged from hepatitis C care. But, as we have mentioned a couple of times, he still uses intravenous methamphetamines and he is at risk of ongoing reinfection. So to monitor this guy, we need to do the RNA testing every six to 12 months. Remembering that the hepatitis C antibody has no role in surveillance for monitoring for reinfection because that antibody as you said before, Marie, can be positive for the rest of this guy’s life. It is not going to help us. So it is really important as you counsel these patients to educate them about the risks of unsafe injecting and not sharing any injecting paraphernalia from spoons through to tourniquets as well as needles. And then of course, refer them through to drug treatment programs.
 
 
Marie:
 
Okay, yes. So look, you can use any of these resources, but there are up to date guidelines for treating. There is one e-learning resources here through ASHM, there is the NPS MedicineWise e-learning and mdBriefCase e-learning and hepatitis C web resources at GESA, and you have got the hep C guidelines which we based the talk today on the latest guidelines, and they can be found on ASHM. And ASID is another good resource.
 
 
Joseph:
 
Okay.
 
 
Marie:
 
Hopefully at the end of this CPD activity, you should be able to identify patients at risk of hepatitis C infection and talk about testing for hepatitis C using sensitive language. Understand how to treat hepatitis C in general practice with specialist support if required. And identify when a patient should be referred for specialist care.
 
I hope that you feel confident about testing and managing people with hepatitis C. Just see if you can, do you feel confident about that?
 
 
Joseph:
 
So has the poll shifted? Oh, great.
 
 
Marie:
 
Look, that is great. And look, I have been treating people with hepatitis C, and I mainly treat older people, so it did not come naturally to me, but it is very easy. The guidelines are clear and it is a really good result that you get, because you know, the cure rate is so high. So, you know I would really encourage everybody to think about it when you see patients, and think about your at risk populations and really, you know, really have it at the back of your mind, you know when you are in general practice, it is a really excellent thing to do. It is much more simplified now.
 
 
Joseph:
 
And if you are ever in doubt, always refer. There is always that option, too.
 
 
Marie:
 
I think we have dealt with features of cirrhosis, basically.
 
 
Joseph:
 
There is a question about hep C and HIV coinfection. Who is the appropriate specialist? So absolutely an infectious diseases specialist would be ideal and gastroenterology, hepatology or infectious diseases would be the speciality that takes care of these patients. But the HIV coinfected, infectious diseases would be the best place to have that patient managed.
 
 
Marie:
 
In terms of compliance, there is just a question mark, but basically, you do want to encourage as good compliance as you can get in every patient, and you might use things such as they may have a mental health worker or a community worker who can assist. You could get a Webster pack going, those sorts of things, you know, you can try all sorts of things to help to ensure that they are compliant. You can use recall systems and whatever, so you do not have to leave the patient alone for all the time they are having treatment. By all means, you can you know, talk about lifestyle things and compliance issues and see them regularly during treatment. You just do not have to do the blood tests all the time. So.
 
 
Joseph:
 
Just a comment on what we were talking about before about the specialty. Sexual health physicians are another specialty that would manage that HIV, hep C coinfection patient.
 
Okay. Does a patient have increased risk of HCC if they have achieved an SVR after treatment? So really good question. So, getting rid of hepatitis C in a cirrhotic patient greatly reduces their risk of developing HCC, hepatic cellular carcinomas, so primary liver cancer, by an order of about 75% reduction. But obviously that does not go down to zero. So that is the rationale for maintaining cirrhotic patients on an HCC surveillance program, with six monthly ultrasounds and serum AFB. It is a really important point. So, the risk does go down, but it is not zero. Okay. Alright.
 
 
Marie:
 
And then we had one similar to the other one, they have thrown out their tablets, can you re-prescribe legally?
 
 
Joseph:
 
I think, yes, I am not too sure what the PBS requirement is, but you would not be able to order another course of treatment whilst there was an outstanding order if that makes sense. So you might just need to wait and monitor and then retreat. Okay. So I think that might close it out. If there is anything else to add, okay. Excellent.
 
Well thanks everyone for listening. Sorry for going over time. But yes, I would really encourage you all to treat. It is super easy and it is really rewarding.
 
 
Bethany:
 
Wonderful. And I just wanted to say a massive thank you to you Joe and Marie. It has been such an excellent session and thank you to everyone online. I know that we did go a little bit over time, but we did get all of the questions answered, so that is really great. I hope you enjoyed it. 
 
 
 
 
 
 
 
 
 
 

Other RACGP online events

Originally recorded:

5 July 2021

This online forum provides GPs with an opportunity to engage and learn with a clinical specialist about managing hepatitis C in general practice, with the aim of developing confidence and skills in:
• Identifying patients at risk of hepatitis C infection and having HCV testing discussions
• Prescribing and treating chronic hepatitis C in general practice, with specialist support if required
• Identifying when specialist referral is needed

Learning outcomes

  1. Identify patients at risk of hepatitis C infection and initiate testing discussions using appropriate and sensitive language
  2. Understand how to treat hepatitis C in general practice, with specialist support if required
  3. Identify when a patient should be referred for specialist care
This event attracts 2 CPD points

This event attracts 2 CPD points

Presenters

Dr Marie Healy
General Practitioner & Fellow of the RACGP

Dr Joseph Lawler
BAppSc, MBBS, MHPol, FRACP

Gastroenterologist & Hepatologist

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© 2021 The Royal Australian College of General Practitioners (RACGP) ABN 34 000 223 807