Sammi: Good evening everybody and welcome to this evening’s twilight online Prescribing Pre-Exposure Prophylaxis for HIV in General Practice part 1. We are joined tonight by our presenters, Dr Brad McKay and Dr Nathan Ryder. Before we jump in, I would just like to make a quick 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.
So I would just like to introduce our presenters for this evening. So Dr Brad McKay is a general practitioner at East Sydney Doctors in Darlinghurst and is an HIV S100 prescriber. He is also the host of the Embarrassing Bodies Down Under television show and a TV presenter and medical advisor for the Today Show and Today Extra on Channel 9 and host of HIV in podcast.
Dr Nathan Ryder is a sexual health physician with 15 years of experience in HIV management in urban and rural Australia. He is the Clinical Director of Sexual Health for the Hunter New England local health district and the HIV support Program Coordinator for the Hunter New England local health district, and also a conjoint senior lecturer at the Kirby Institute UNSW and the University of New Castle. So thank you Brad and Nathan for joining us this evening. I will hand over to Brad now to take us through the learning outcomes for this evening and then carry on with the rest of the presentation. So welcome, Brad.
Brad: Cool, thank you very much. Hi guys, we have got about over 110 people tuning in. Some people are just tuning in at the moment. So welcome to everybody, I hope you have all got your cup of tea handy as we are going to be going through a bit of prEP tonight. So yes, by the end of the online QI and CPD activity, you should be able to discuss the recent sort of PBS guidelines that are coming through and what the Pharmaceutical Benefits Scheme or the Advisory Committee has come up with. But you will be able to list steps to prescribe prEP to a patient and this is one of the biggest things. We want you to be pretty confident when patients are coming in and asking for prEP, and we are wanting to, yes, tell you where to go if you are needing a little bit of help as well.
So, we will sort of go and talk about what is prEP? So pre-exposure prophylaxis is what we are talking about tonight. So this is taking one pill a day to prevent people from getting HIV. So we will often say take one pill a day when you are brushing your teeth and that is the way rather than trying to fiddle around for a condom in the dark. It is a little bit easier for many people to do, and people will know that they are safe. So we are talking about two different medications in prEP. So one of them is tenofovir disoproxil, if I am saying that right. Nathan will probably correct me in a minute. And the other one is emtricitabine. And these are two different drugs that work together to stop HIV replicating and being able to get a hold and create a new infection in a new person. So, some of the product names that we will be talking about as well is Truvada, that is probably the most common. There has been lots of publicity around talking about prEP or Truvada. Other people will be talking about Tenofovir as another name for it, so yes tenofovir disoproxil emtricitabine Mylan. You do not need to know all of that, but mainly sort of yes, Truvada is probably the easiest way to go at this point in time.
Yes, so I am interested to know how many people have been asked for prEP already.
Sammi: And let us just show that up on the screen so we can see those results for everybody.
Brad: Cool, so we have got 31% of us are yes and we have got 69% of us are no. So yes, it is still pretty early days as far as prEP is concerned. So I have been working in Darlinghurst for about four years now. I feel like a bit of a baby when it comes to HIV medicine, even though I have been an HIV S100 prescriber for a while. But yes, it is something that you will be asked a little bit more and we are finding that the patients are very intelligent. They are all going on line and they are finding out often more about it than what we do sometimes. So, we will go to the next slide here.
So, yes, why are we using prEP? We have found that there has been still a number of new cases over time, of new HIV cases around Australia, so over the past few years it has sort of traditionally plateaued at about over 1,000 new cases. But what we are trying to do is drop that down, and so our aim is by 2020, this is an aim that is used all around the world, this is an international aim, to virtually eliminate HIV transmission by 2020. So, we are finding that prEP is already being powerful. It is very effective and we are starting to see a decline in new HIV cases where it has been plateauing for quite a few years. Since we started bringing in prEP, even people who were getting it on line and ordering it, we are seeing that decline in new cases. So this is really exciting.
And since the 1st April, April Fool’s Day, it was not anything to do with April Fool’s, this is really serious, prEP has been available from community pharmacies everywhere. So if your local pharmacy does not have it, then please give them a call and ask them to stock it as well, because a lot of people will start to ask about it and yes, even if you are putting up signs and saying that prEP is available, then even patients in the waiting room would be able to sort of have a bit more confidence to talk to you about it. If people are getting it from the pharmacy, it is about 30 tablets in a bottle and that is a cost under the PBS of $39.50 at this point of time and if people are on a Healthcare Card, then they will be paying $6.40 for a month’s supply as well.
And yes, any doctor, so I became an S100 doctor four years ago and yes did the training course and I have a high load of HIV patients that I look after every day. But this is available for you. So, everybody and anybody can prescribe prEP if they are a GP. So this is really, really good. We are trying to get prEP into different communities that may have not been able to have it before. We have had lots of trials around to enable us to get confidence and enable the government to get confidence with prEP, so this is really exciting, and Nathan will go into a little bit more of these details. I might just hand everything over, oh, after this slide, I will hand everything over.
So patients can use a prescription that is written by you to personally import the medication as well. So they can go into a pharmacy with it and get it over the counter or else they can go online, scan in the prescription that you have written for them, and they can get it from different websites around the net. So, one of the websites is prEP access now so you can google that and find that. There is another one called AIDS-drugs-online, with little hyphens between AIDS, drugs and online. So there are options and some people they might find that it is cheaper to get prEP online. They may not be able to get access to a pharmacy easily but they might be able to have something sent through to them in the post. There are a lot of people who will be coming in who are not on Medicare and so they will not be able to get PBS funding for it, but they still can go online and get it imported to them and yes, some people just do not want to have it on their record. They might want a personal choice of ordering in prEP or they might not want the government to pay for it for some particular reason, some ethical reason. But you know, we are trying to make it as available as we can. So it is certainly an option if people are fitting into those categories for them to be able to order it online and have it come to them in the post.
So I will hand over to Nathan now to talk a little bit more about prescribing prEP.
Nathan: Okay, thanks Brad. So yes, I am going to get into the details I guess about how we go about prescribing prEP and on the screen now is an example of a prescription which I am sure you have all seen plenty of. The reason that we have put that up is just to show you that it really is standard streamline authority script that we are using here. So the end result is highly straight forward, something you are doing all the time. It is just a matter of getting the hang of the initial assessments and the ongoing monitoring that is associated with this prescription.
So if we go on to the next slide. So what we are going to be really following along is the tool that was attached to the handout for this talk that is decision making and prEP New South Wales version. And really it is a pretty simple guide. It is two pages and it really tells you all you need to know. And so if you have that in front of you, that will make the rest of the night a lot easier to follow.
So do you want to move on to the next slide?
Sammi: Yes, and just for everybody, if you look in your control panel under your handout and click the dropdown menu, you will be able to find that Pdf that Nathan is talking about for you.
Nathan: So just to take a high level view of this page at the moment, so we want to start on the page that has got the arrows across the top with 1, 2, 3, 4 and 5. That is the side we want to start with. And essentially what it is going to step us through is assessing the eligibility which is really split up into two sections, so behavioural eligibility and that will guide you as to when you should offer or consider using PrEP. And then clinical eligibility which is about their medical contraindications really. The other testing that we are going to do is then how to prescribe it and then all the ongoing monitoring and education we need to provide. And then on the back page, there are some details around it.
So if we go on to the next slide and we will start to get into the detail. So the first thing obviously is to think about when we want to offer prEP or consider prEP and it is probably going to be a bit split there, so some of your patients are going to come in asking for it and some of them you are going to detect the risk there and either strongly recommend it or suggest they might consider it. And in terms of determining the risk, I think really the best way to look at it is, it is made up of two things really. It is made up of what broad group that person fits into in terms of their risk, and then secondly the individual behaviours that that person is having and then put those two together. That is what gives you the individual level of risk.
So if we move on to the next slide. So these are the sort of questions that we want to think about asking when we are gauging someone’s risk. So I think the best way to think about this is take an example, so by far and away the most common example I see is a man who has male partners coming in asking should I be on prEP, I have heard all about it, what do you think? And so in that group, so immediately we have got a man with male partners so that MSM is a risk group that is listed on the back of the guidelines and you can step through the questions, but essentially what we really want to know in that scenario is their partner, so are their partners known to be HIV positive and not taking effective treatments, or are their partners of unknown status. Are their partners regular or casual? Are they having anal sex and are they using condoms? And ultimately in that scenario any unprotected anal intercourse with a person whose HIV status they are not certain about would meet the criteria for prEP. But for the other groups it might be slightly different. So for example, heterosexual people who are mainly around HIV partners that are having treatment or partners from high prevalence countries and the back really steps you through each of those groups. So just a note, in the next webinar in this series there is going to be a bit more detail about how you go about doing this risk assessment in more detail. And obviously those skills have a lot of benefit in other areas of medicine as well. You know taking a good sexual history is not just about prEP.
So if we move on to the next slide. We have got a bit of a screen shot of that first section, so essentially we are working out if they are in the medium to high risk category and if they are, then we progress on to step two, but if they are not, so if they are not risky enough that we think they warrant using prEP then that does not mean that we do nothing. Of course there are other methods of reducing people’s risk, the main one obviously being condoms and there is an opportunity to really think about that.
So if we go on to the next slide, and so this is really a plug for the STI testing tool that New South Wales put out. So this is a really good step by step guide as to how to have that consultation about sexual risk and then leading on to obviously any testing and interventions you might do around that.
Okay, so once you have established that our person is at medium or high risk and we have decided that prEP probably is right for them, the next stage we need to do is a clinical assessment to see if from a medical perspective that they do qualify for prEP. And really, there are a couple of key things here and really from my perspective the two key things are that, 1. That they are definitely not HIV infected already. Because if someone is HIV infected and we put them on prEP, we do run some risks of inducing resistance. And really, we define negative as a negative test within seven days. So that can either be you have already done a test within seven days or you do a test today but you tell them not to take the tablets until they have got the results from you. And the second thing is around renal function. So really the main sort of adverse effect of tenofovir which is the key ingredient is the potential impact on renal function. So we really want to know if they have got a normal renal function to start with and they do not have any highly nephrotoxic medications that they are taking, or you know, obviously any other renal diseases that are going to impact on their renal function.
So then if we move on to the next slide. So that again just shows you the flow chart out of step 2 of the handout and just steps you through what you need to know. So the main thing as I said, no HIV, eGFR greater than 60, so no chronic renal disease and no nephrotoxic medications. So the middle bit there, it is probably just worth touching briefly on, so if someone is HIV negative but you are worried about a recent exposure within 72 hours, so that is where you would traditionally use PEP which is post-exposure or after the case exposure. So it is now recommended that if they are probably going to be at ongoing risk, we may as well just start prEP straight away. If you are in doubt or if it is a one off isolated event, say an occupational exposure, then ring the PEP hotline and get some advice around it. HIV positive is completely contraindicated. There is no situation in which you would prescribe prEP for an HIV positive person.
So if we go on to the next slide. So these are the sorts of tests that we are going to need to do to assess that clinical risk. So we need an HIV test, so just a standard HIV test. We need to assess their hepatitis B status and that is because tenofovir is also active against hepatitis B and if someone has chronic hepatitis B, we can still prescribe prEP but we have got to be careful because we do not want them to stop and get a flare of hep B. And then of course, just doing standard EUC to assess their renal function. And you can see you know, highlighted down there below is negative test within seven days. I think this is probably going to come up again and again throughout tonight because that really is the critical thing in terms of risk.
So if we go on to the next slide. So, once we have determined that they are clinically eligible, we have got to move on to the additional testing that is recommended. And the main there is around, based on their risk assessment that you performed initially, you are going to have a degree of understanding of their risk from sexual and injecting behaviours, and we would recommend testing according to the Australian STI guidelines which is going to be mainly around the other blood-borne viruses, especially hepatitis C, the STIs and you know, female patients a pregnancy test.
Okay, so this is the link to the STI guidelines that I just referred to. And if you, hopefully you have all seen this, it is a very well utilised guideline that gets good reviews from GPs. If you click on the populations and situations and choose your group, so the example I gave was a gay man, so we would click on the men who have sex with men tab there. There are tabs for all at risk groups. And that guides you through what sorts of tests you need to do.
If we move on again, now we get to the bit that actually probably generates the majority of my questions, is the nitty gritty of providing a prescription. So I am sure all of you are using electronic systems now, so you just need to search for tenofovir emtricitabine. As Brad pointed out at the start, there are three brand names in Australia. They are all equivalent. Occasionally I get questions because they are subtly different. Some of the salts and the exact milligrams are subtly different, but the active ingredients are exactly the same and there is no way of distinguishing. Truvada is the originator product, so that is why most people have probably heard of that the most. So if you search your practice software for tenofovir, you will come up with it. In terms of the streamline codes, they are prEP 7580. Just be aware that there are streamline codes for HIV treatment. You need to choose the streamline code for prEP. The description will be –
Brad: Yes, if you are looking at it you will see that the tenofovir for the prEP is 30 tablets and then there is two repeats. The one that is for HIV has I think it is 60 tablets and then five repeats, so that is more for HIV treatment. But yes, if you are looking at prEP it is going to be the 30 and then the two repeats. So, it is yes, another sort of safety feature that you are not ticking the wrong box.
Nathan: Yes, yes. And I mean I think it is pretty clear. I think you will see the first time you do it that it is not difficult to choose the right one.
Okay so if we move on to the next question. So we have generated the prescription now and we are giving it to the patient. They are about to wander off, so what do we need to tell them? So really there are a few critical things that they have to know before they walk out. So the first thing is, that it is obviously going to take a while for them to get protected. Walking out with the prescription does not immediately protect them. They need to take the tablets consistently for seven days to get high enough levels for protection. The levels take a lot longer to reach protective levels in the vagina. If they take it consistently for seven days, then that is enough, but that is particularly for the vagina, that does rely on them taking it every day of that seven days. If they decide they want to stop and we definitely recommend against stopping and starting, but obviously they may want to stop, then they need to continue it for 28 days following their most recent sexual exposure or most recent unprotected sexual exposure.
We want to discuss side effects. So the main one I warn patients about initially is nausea. Most people get some degree of nausea within the first couple of weeks. It almost always settles down within the first four weeks, but occasionally it persists. If they take it with food they get a lot less nausea and just experimenting with different times of day can help as well. It is important that we do not give people the impression that prEP will protect against everything. We definitely recommend condom use to protect against STIs. But in practice, many people who are coming in requesting prEP or who meet the guidelines for requiring prEP are having unprotected sex, and so it is just important that when you have that conversation it is not a lecture, it is a discussion around when they might chose to use condoms and encourage them to think about using them as much as possible for them.
And finally, it is important that they know that when they turn up to the pharmacy it probably will not be in stock. Some of the larger pharmacies may start to stock it, but many will need to order it in. In my experience even in rural areas, they will generally get it in within 24 to 48 hours.
So, after they have started taking it. So what sort of follow up will they need? So, the key first point of follow up is at 30 days after that first bottle. And at that point, we want to get them back and we want to test them again for HIV, and that is because we need to be 100% certain they did not have HIV before they started taking it. So if they were in the window period at that initial negative period, there is obviously a chance that they had HIV. And do not forget we have selected out a high risk group here. So we want to do another HIV test at one month to make sure that they do not have HIV. That is a good point to talk about what side effects they are having, how they are going with adherence and that sort of practical stuff. But that is all we really need to do at that point in time. Then at the first 90 day interval, we do all that again, but we also add in a repeat renal function test and STI testing. And then, from then on every 90 days we do an HIV test, the STI test and in females we do pregnancy testing if they might be pregnant. And we do the renal testing every six months, at every second prescription they get renal testing basically. And that can continue indefinitely. There is no maximum period of time that someone can be on prEP at the moment. So every script goes for 90 days and every 90 days they get that battery of tests.
One thing to think about, so we are recommending testing for hep B and hep C, sort of a base line and as required. So to think about then, if they are negative for hep B, vaccinating for everyone on prEP, and for men who have sex with men, thinking about hepatitis A vaccination as well. Hepatitis A can be sexually transmitted and there have been increase in cases in Sydney and Melbourne recently.
So if we move on to the next slide. So obviously in addition to all those assessments and tests we are going to want to provide some education. And really I think the key one here is about adherence. So, in the prEP studies, prEP was highly effective, but it did fail in around one in ten people and that was basically because they were not taking it. So, I am sure we all know from all areas of medicine, tablets do not work unless you take them. prEP is no exception to that. It is pretty forgiving though, so if someone does come in saying they are missing some, you can be encouraging. We know it works if they take four a week on average. We do not recommend people aim for four a week, because that is pretty hard to do and it does not give you any leeway. So we recommend daily, but four a week will protect you. Females on prEP are very rare, but if you do have a female on prEP, and I do have one myself, it is more important that they maintain 100% adherence because of that issue that the drug levels in the cervical and vaginal tissue really are not as high as the rectal tissue. So obviously using your chronic disease management skills that you have, just draw on those to really talk about how they might improve their adherence and how to manage side effects.
So the second part of education really is around ongoing risk reduction. So I guess, it is the same conversation that I touched on a few minutes ago around encouraging ongoing condom use. So it is not necessarily every single prescription, but you know, on a regular basis particularly if it is prompted by a diagnosis of an STI, or the patient asks questions about STIs, discussing where condoms might fit into the mix for that person. And I guess from my experience, you know some people do not use condoms at all. Some people use condoms almost all the time and treat prEP as a backup option type thing. But for the majority of people that I have had, they will describe to me that they make an individual assessment. So they might have a couple of people that they have unprotected sex with, but if they have sex with someone they really did not know at all, they are a bit more likely to use a condom in that scenario, and I guess I will focus my discussion around that sort of idea.
So it is probably also good to talk about communicating with their partners around prEP. You know, I think you will find this is already happening. So on many social sites, prEP status has become quite clear. But just having that open discussion with people about how they can communicate about their prEP use and others’ prEP use.
So if we move on to the next slide. So we have discussed really all of the required things, so all of the things that really should be part of standard practice. So now we are coming on to some of the things that really are not standard practice, but you probably should have some understanding of. And this might be a situation where sometimes you might want to get special advice. So, although the main risk we are concerned about is renal, tenofovir also does have an impact on the bone cells and it has been associated with some degree of osteopaenia. It is relatively minimal. It has certainly not been shown to be clinically significant in terms of fracture risk, and it is reversible on stopping prEP. But there is that risk there, so in people who have other risk factors and underlying risks for osteoporosis for other reasons, you might want to think about vitamin D levels and you might even want to think about measuring bone mineral density. Now remember this, as for most other indications is not listed on the Medicare schedule, so they would be paying for it. But of course, similar to I am sure you are already doing, you may want to think about doing that in some high risk people. And the second thing is because I have said already several times, we certainly do not want to be prescribing prEP to someone with HIV infection. If a person develops symptoms of seroconversion, then you want to get immediate specialist advice around that. I would caution against just testing and seeing how it goes, because we do want to stop as soon as possible if somebody is HIV infected, but we do not want to stop a high risk person unnecessarily who then seroconverts or contracts HIV a week after you stop them. So, if you think they might have early HIV infection, definitely call for specialist advice medically. I think in all areas of New South Wales Health, you will be able to get specialist advice immediately for that reason.
So if we go on to the next slide. So this really steps through in the broader sense, when you might think about getting additional advice. I guess really the one there that is missed off from the bottom, is you can always ask for specialist advice. So if you are ever uncertain, just ask. But, I would particularly encourage you to think about things, if someone has chronic hepatitis C, if they are under the age of 18 and remember that people under the age of 18 are not covered by the PBS and it would be off licence use of the TGA listing for people under the age 18. Anyone with an eGFR of less than 60, so that is really a contraindication of the decision making flow chart. Occasionally we might put someone on it if they are extremely high risk, but I think that would really be a specialist assessment. That might be a phone call, I am not saying they need to be referred, but we need to weigh up the pros and cons there. Pregnancy is a similar situation, so you know, prEP is a perfectly reasonable thing to use in pregnancy, but you would definitely want to weigh up the risks and benefits. And that issue that we discussed right back at the start, if they had a recent high risk exposure in the 72 hours to get some advice around the PEP versus prEP decision, and then as we just discussed the potential early HIV.
So if we go on to the next slide. So, how can you get this information? So, I have got the number there for the New South Wales Sexual Health info link. So that is staffed Monday to Friday and can connect you immediately to information. They will provide you with simple information straight away, but if you need to speak to a local specialist they will connect you to your local sexual health clinic. They also provide support to the general public, so you can give that number to your patients and their partners to call for advice around prEP. So I think it is over to you, Brad.
Brad: Sure, no worries. So, yes, so just looking at some clinical resources that can help you, so if you have got any questions, as Nathan was saying please give us a call and yes, getting advice over the phone is often quick and easy and specific to the case you are looking at. But, yes, there are a number of, I think we are going to link, there will be links to all of those that you will be able to get afterwards as well. But yes, you can just go to the New South Wales Ending HIV website to get a little bit more information after this session if you so desire.
We will just go to the next slide. And, yes, so just talking a little bit about this, so how effective is prEP? We have had a number of different trials around the world, including in New South Wales. I think New South Wales itself was one of the biggest trials that the world has ever seen with prEP and we have got, yes, lots of effective trials, mainly concentrating on men who have sex with men, but yes we have also looked at the ability for prEP to work in heterosexual adults and also with people who inject drugs as well, and one of the problems for these studies is that transgender people have not been well represented, and I have been to a number of conferences lately and trans people are certainly on the agenda. We are starting to enlist them. We do not really see, if it is going to work in a heterosexual adult, if it going to work in somebody who is male or female, we cannot see that it is going to be working any different in somebody who is transgender, but of course we like to get that scientific proof as well. But I would not be too worried about it. If there are any concerns or if they are on different medications then of course yes, talk to your local sexual health clinic or call the hotline that Nathan mentioned as well.
We will just got to the next slide. Yes, so this is just a reminder that for people who are taking prEP, we are really recommending them to take it correctly and consistently and we do not talk about compliance any more, we talk about adherence to their medication. So yes, it is trying to sort of talk with patients saying yes, if you are going to be prescribing it, then yes put it near your toothbrush or put it near your toothpaste or put it near something that you do every morning just like we talk with any other pill that we prescribe. And yes, we do not really know if people are taking it less than daily prEP if that is going to be protective. There is some information to show that it likely is. There is a lot of people talking out of San Francisco at the moment, saying that if people are taking four or more tablets per week that it should be okay, but we are really conservative in Australia still. So if they are missing the odd tablet every now and again, it is not the end of the world, there will be a bit of a buffer, but we do sort of really want to drum it in to people to take it every day and get into that routine of taking that medication every day. And I think I am passing back to Nathan to talk a little bit about the safety regarding prEP.
Nathan: Yes, thanks Brad. Yes, I mean just looking at those other slides, like it is incredible how efficacious prEP has been and I am sure as you know, Brad, that there really has only been three known cases where someone taking prEP has contracted HIV globally out of many tens of thousands of people, so it undoubtedly extremely efficacious. But the side of course is the safety and patients obviously want to know the details about this. So, I guess with the drug we are talking about we have had many years’ experience with HIV positive people and then we have got you know, several years’ experience from the prEP studies. Most of those studies have not had any awfully long period of follow up, but as you can see on the slide some of them went up as far as four years. So most people did get some degree of mild nausea as I have said already. But you know, generally the overall majority of people have not had those ongoing annoying side effects. They generally will subside. I have had just a handful of people stop due to those annoying little side effects that they get.
So if we go on to the next slide. So really in terms of the key safety issues, so as I mentioned already before, so renal function is really our major worry. So prEP will likely cause a small initial drop in renal function but it does not tend to worsen over time. When they stop prEP it does return to normal as well. So from the studies it certainly does not look like that is an issue, but it was more likely to occur if you had people over the age of 40 and not in the slide but people under the age of 20 as well, and people with pre-existing renal dysfunction but not to a level of chronic renal disease. So between 60 and 90 eGFR. So if you have got an older person or someone with a reduced eGFR but still greater than 60, that is the group you might want to think a bit more. So I still recommend you prescribe, but that is the group where you are definitely going to want to you know, assess their renal risk in general like you would normally and just make sure that they are having those regular renal follow ups. Make sure you keep updating their medication history to pick up any nephrotoxic medication.
So the next thing as we have discussed already as well is around the bone mineral density. So a small number of people that did notice a decrease in bone mineral density, not to the osteoporotic level, but osteopaenic, and that was reversible when they stopped it. And even in HIV affected people, they generally tend to have a lot more of these side effects for reasons we do not fully understand yet. This decrease in bone mineral density has not been associated with fracture risk, so it does not seem to be clinically significant. But I guess with both those two things, the impact on the kidney and impact on the bone, for an individual that might be important and I guess that is why we have got the category of consider, so the medium risk. So if someone is at medium risk of HIV and they are really worried about those sorts of side effects, well I mean maybe that is a reason to encourage them to think about increasing their condom use rather than prEP, but it is clearly going to be an individual discussion and decision. So the last thing, and probably one of the things that people worry about the most, that really has not panned out, is introducing resistance. So if someone contracts HIV while they are taking prEP because it is not a fully suppressive HIV regimen it could potentially induce resistance. That really has not happened. So there has been several cases of people contracting on prEP, well numerous cases really, due to poor adherence. And in those cases, the overwhelming bulk of people did not develop any resistance whatever. And in the small number of cases where they did, it really was not a significant degree of resistance so minor mutations that caused minimal impact on their future treatment response. So while that is something that we certainly need to keep an eye on, it is not at the moment, it is definitely not a reason to be cautious about prEP prescriptions so long as you are following these guidelines that we stepped out.
Brad: And in relation to that, Nathan, you mentioned that there has been about three recorded cases around the world where people have become HIV positive while on prEP. My understanding is that it was just a freaky virus that was resistant to both of the medications that was in the prEP. Is that your understanding?
Nathan: Yes, yes, two of the three were resistant viruses, so if the virus is resistant to the drugs we are using, well clearly it is not going to work. But the good thing is that we know, that in Australia and in New South Wales we have got particularly good data. We know that those resistant strains just really are not circulating in the community at any significant level at all. So while it is not impossible and I certainly do not say to people prEP is 100%, you know in practice it is extremely unlikely that it is going to fail if they are taking it. And in the one case where they were not resistant, I do not think we fully understand that one, but that is one case out of many thousands of people with, I hesitate to guess how many episodes of unprotected sex there would have been, but it is obviously an extremely rare event.
Brad: Yes. And we have just got a couple of questions coming through as well and I would encourage everybody, if you do have questions send them through. One of them is, do we need to a DEXA scan before initiating prEP. What are your thoughts on that, Nathan?
Nathan: Definitely not. So I would definitely restrict DEXA scanning to people who have pre-existing other conditions that put them at risk of osteoporosis, or you know potentially you know they have got osteoporosis and you want to know to what level where you are making a risk decision between you know, is prEP right for them or is the risk to their bones too great. So we have had one person that we did start. He had known osteoporosis. We did start him on prEP because his risk of HIV was extremely high. And of course if he got HIV, well he is going to have that risk of osteoporosis anyway. So we decided in that circumstance, that his DEXA was okay and that we would prescribe. But that is really the only time I have ever done a DEXA myself because the majority of people I am starting on prEP are young, they are mainly male, their risk of osteoporosis is extremely low so it is not indicated. So I guess the way to assess that would be the FRAX score. I am sure you are all familiar with using the FRAX score. So if someone has got a high FRAX score, yes you could think about doing a DEXA scan.
Brad: I always encourage my patients to go to the gym and buff up their bones from doing weight-bearing exercise, so that is one of my motivations for getting them exercising. There is also another question here saying, can you have bisphosphonates as well if you are on prEP?
Nathan: Yes, so I guess that is what I am getting at, that you have to make you know, assessment of that person’s risk of osteoporosis and risk of contracting HIV and it is not absolutely contraindicated but you know, you factor that into your decision. I mean, these are situations where you know, you might want to ring up and discuss it with your local specialist as to what they think the risk might be.
Brad: Okay. We will move on. We will come back to a few questions in a minute. But yes, talking about the EPIC New South Wales trial. This was well, we are sort of in the final stages of it at the moment. This was led by the Kirby Institute and funded by the New South Wales Government. They were funding all the tablets for everybody. And yes, this was as far as I am aware, this was the largest scale roll out of prEP around the world, targeting people at high risk. So there were over 9,000 people and I think we have stopped enrolling now and we are just tailing people off. But this was looking at real life and testing people regularly and seeing if prEP is actually working for people at high risk of HIV. And yes, so far around Australia and in particular New South Wales, we have not had any new HIV diagnoses in the people who have been in the trial who have taken prEP as we have instructed them. So it is always a miracle when our patients take medications as instructed, but this has been a really, really good thing.
So I will move on to the next slide and I think Nathan?
Nathan: Yes. So, yes. So the EPIC study has been incredibly successful in getting a lot of people on prEP in New South Wales and I guess we are now in the phase of rolling that over to PBS prescriptions. But during that time, it was really phenomenal to see the decrease in HV diagnoses of HIV in New South Wales. So you can see the numbers up there, that essentially there is a huge drop in new HIV diagnoses, especially with men who have sex with men and is the key risk group. It is important to recognise that at the same time as the prEP roll out was happening, we continued to dramatically increase the number of people being tested for HIV and getting people that are HIV infected on treatment virtually immediately. As I am sure you all know, if you are HIV infected and start effective treatment, your risk of transmission drops to zero quite quickly. And so between those two things, the high risk negative men being on prEP and HIV positive people being on effective treatment, probably the combination of those two things is what has led to this incredible drop.
But unfortunately it was not evenly distributed. So if you look on the next slide, it really highlights were we need to put some more work into it. So if we drill into the numbers, those large drops were mainly in Australian-born men who have sex with men. So other risk groups, so including young MSM, including MSM who live outside of the traditional gay suburbs of Sydney that have access to incredibly skilled GPs like Brad, the MSM that are overseas born, who may not necessarily reach all of these you know, resources and prevention strategies so easily, and not on the slide but just as importantly, heterosexual people. So those groups have not experienced such huge declines in HIV and potentially really have not taken up prEP to the same extent. And I guess from my perspective, particularly coming from a rural area where you know, all of my gay men live outside of traditional gay suburbs. I am thinking this is where GPs can really come in and make a big difference. So gay men that might be out there and they have heard of this but do not really know where to go and go to their GP, so just having confidence that their GP will know how to pull this flow chart up and follow it can make a difference to these groups that are currently being left behind.
So if we go on to the next slide. So, one of the things that comes up a lot is, well if everybody is taking prEP and not using condoms, won’t we just see more STIs? And we have not really seen that as yet. So, the rate of STIs is high, so the rate of STIs that we see when we enrol someone in prEP or start someone on prEP is really quite high, but that is because we have selected a really high risk group to start with. And if we follow them over time and we really did not see an increase in that and we are really not seeing much of an increase in the notifications State-wide. We are seeing an increasing trend, but that has been going on for a very long time. There are no real signs that this take up of prEP has led to an explosion of STIs. Now why it is happening, well I guess we will see over the longer term, but what we think is happening is what we hoped would happen at the start, and that is that we are testing a very high risk group very frequently and treating them. And so therefore they are not transmitting that to other people and you know not suffering the consequences themselves of course. So whilst we are probably seeing some decrease in condom use, that is being covered for I guess by that increased amount of testing and treatment.
So if we go on to the next slide. So this really shows the numbers, I guess what I was just saying there. So you can see the numbers that you know are high, no doubt that is a high rate, but they have been stable and that is really what matters. I think yes, that covers it for STIs.
Brad: So yes, I will continue on here. So yes, just a reminder that by 2020, we are trying to really get on top of this around Australia and hopefully have negligible new cases of HIV around. So there is a whole variety of different strategies that we are using. One of them is prEP, but there is a whole range of other things and we will – I am just having a look and seeing if there are other questions. There is a question that is here saying, can we use prEP for a doctor who has a needle stick injury. You would probably be asking for PEP in that regard and going through the normal category for that. And what else? I think we have - can we start prEP if the patient has an eGFR less than 60? I think Nathan spoke about that previously. It is sort of monitoring them and considering seeing a renal physician and closely monitoring their eGFR over time. And we will continue on. We will come back to a few questions if we have time at the end.
We will move on to a clinical vignette. So this is Dang, a 30-year-old male. So he was born in Thailand and has been living in Australia for about three years. So he is now a student and he travels back home two or three times a year. You have been seeing him for a couple of years and he just comes in with coughs and colds. He has sex with other men and at the most recent presentation, he has had a widespread maculopapular rash and he has been referred to the infectious diseases team at the local hospital. So no sexually transmitted infection or blood born virus have been undertaken. So, the, so yes, the infectious diseases team felt that the rash looked like secondary syphilis. This was confirmed with a positive TPHA test and an RPR of 32, showing that syphilis is active. He also took an HIV test and that was positive for HIV-1. Additionally, it showed that the CD4 count, so the lymphocytes was really, really low at 17 and that his HIV viral load was at 97 or 98, 000 copies in every mil of blood. So what is the HIV data telling us in New South Wales? So we will discuss the case as we are going. But yes, what is happening here? So there are a number of New South Wales residents notified with newly diagnosed HIV infection between 2011 and 2017 and we see that you know, back in 2011 it was between about 300 to 400 new cases of HIV. As I said earlier on, around all of Australia, it was about over 1,000 cases for quite a few years and we are starting to see that drop, so we starting bringing in prEP in about 2014, 2015 people were starting to use it and it sort of started to pick up speed over the last couple of years.
And we will go on to the next slide as well. Nathan, if you wanted to continue with this.
Nathan: Yes, so if you pull apart that drop, so as I think we sort of touched on before, that the predominant drop is in Australian born men who have sex with men. So there has been a 48% drop there, and really importantly early stage infections have dramatically dropped and of course you remember if someone has got late HIV they contracted 10 years ago, there is nothing we can do to prevent that case occurring. But we can prevent early infections and that 53% drop in there really shows how this is working. But unfortunately, if you look at overseas born MSM, that has increased 29% and early stage infections have increased by even more than that. And so these are infections that really should have been averted through these prevention methods but unfortunately were not. And you know, a group again that is not on there is heterosexuals and particularly heterosexuals that have travelled to areas where there is more HIV infection, that is still continuing to increase. And so we have really got to you know, look at how we can get prevention strategies out to that group. New South Wales Health are doing some work to better understand what is going on in this area at the moment.
Brad: So yes, so with this, this is some of the fliers that are going on, some of the posters that are getting out into the public. And we are trying to focus on different groups, so it sort of seems like men who have sex with men are low lying fruit. These are the people that we have really been focussing on for a while, but now we are sort of trying to broaden that web. As Nathan was saying, we are sort of seeing that people who are heterosexual are sort of increasing their percentage of new HIV cases. So with these two posters that are up at the moment. Have you seen the posters, yes or no? Okay, so most people have not seen it. 83% have not seen the posters, so that is really disappointing. We are not getting our messages out there and this is one of the things, this sort of highlights the point. With the case I mentioned before, with Dang, he is sort of like, yes, does not often talk about things. He might see his GP about coughs and colds and if we are not sort of thinking HIV, if we are not having those sexual health discussions, if we are not sort of like wondering about HIV as a diagnosis, then he can have HIV for a number of years and then present really, really late. And this is what we have found in the case, when his CD4 count was really, really low. It was showing that his immune system had been whittled away over time. So, yes, so we are needing your help to really get those messages out there and hopefully you will see a few more posters when they are put up around. So yes, we are saying like one in five people with HIV are heterosexual, so this is really important to keep in mind. Holiday sex or sex holidays as they usually call them. So sort of thinking about people and I always sort of think, do I do a sexual health check if someone is coming back from overseas. So it is really important to keep that in mind when you are seeing your patients.
So we will go on to the next slide. And yes, so cool. So yes, so as his primary health care provider, was there anything in his history that would make you think of offering an HIV test? So yes, so with that in mind, it would really be having sex with men and travelling overseas to Thailand as well. And yes, so we are just sort of like careful to keep that in mind. So, and yes, think outside the box as well. Ask people and ask if it suitable to do an HIV test with them. We are just not wanting to miss that and also take those opportunities to yes, to ask people about prEP, too.
So we will go to the next slide. And how are we going with HIV testing in New South Wales? So yes, so in 2017 GPs made approximately 41% of the new HIV diagnoses in New South Wales. So this is all of you guys, not the hospitals, not the sexual health physicians, but yes 41% are in GP clinics. Of these, 34% were diagnosed by GPs who were not accredited to prescribe antiretroviral therapy, so this is garden variety GPs who have not done specific training or are not working in HIV clinics. So yes, it is just over one third of cases are being diagnosed by you. So, increased testing leads to earlier diagnosis, so we are just wanting to make sure that we are thinking about it, and what happens when you make a new HIV diagnosis, so 31% are yes and 69% are no. So yes, so the majority is no, so it is not surprising if you are working in general practice and not specifically a sexual health clinic, but yes to keep that in mind to have a look and get some extra support if you are needing. So help is certainly available. In the instance that you do make a new HIV diagnosis, then yes it is sort of keying your patient in to further support, and there are a variety of different programs around depending on which area you are in. And yes, every person who is newly diagnosed with HIV infection, has the right to other support services and we try to provide that as much as possible. And, Nathan?
Nathan: Yes, so I am an HIV support person for my area and for New England, and so I will just briefly talk about how it works and it is really pretty simple and I have had 100% positive feedback so far for me. So essentially what happens is, when there is a positive HIV test, obviously the lab will tell you. They normally ring that sort of thing through and then they inform New South Health which is standard practice for a notifiable disease. They then notify the local health district HIV Support Program Officer, which is usually a sexual health specialist or an ID specialist in a sort of de-identified way. So we do not know the patient’s name or anything. We just know your name and the person’s sort of coded information so we can make sure we are talking about the same person. And if you want a call, and you can say no, but if you say yes, I would like a call, then they tell me when you want to be called and I will make an effort to call you at that time and just discuss what you need to do with that case really. So what I do is completely different for every call. Some people have diagnosed a few cases before and are totally across it. Other people will want a lot of information, so essentially we just talk through how you are going to manage initially and what the ongoing plan is.
So the next slide has got the five key support services framework I guess that we use and we sort of basically try and sort of use that as a framework to think about okay, what do we need to do. So the first thing obviously is management and treatment of that person. The next thing is, what sort of psychosocial support they might need. Firstly we look at, well what about others that might be at risk. So obviously if they have got a partner, thinking about whether that partner needs PEP if they have had recent risk. Letting people’s previous partners know about it, contact tracing your partner notifications and then making links to the specialist community services that that person might need, and you know, what ones are obviously going to depend on the individual. So we sort of step through that and the extent to which we go on each one really depends. You know, sometimes it is all about how to give that diagnosis if it was unexpected. Other times, you know, we might get into a bit more of that sort of stuff. Some of it does not happen until they have seen a specialist for treatment, but you know, we work it out individually what that person needs. I think it is back to you, Brad.
Brad: Yes, sure. So I always remember before I was working in HIV I would always have a new diagnosis of HIV and panic. And so it is always important when you get that reading back, to know that you can call the number that is on the screen there and yes, ask to speak with somebody and yes, get a bit of a plan of attack before somebody comes in and you need to deliver that information to them. So yes, just making sure that you are up to date with all of the knowledge and you know exactly what needs to be done and it is important to find out what is available in your local area.
So, I think we are needing to close up now. So just in conclusion, prEP is now available on the PBS after April 1st. GPs, everybody, everybody who is listening will be the primary providers of prEP in New South Wales and there are clinical tools and resources available to support GPs and prescribing prEP and we will have all of those links available. And yes, just remember to keep it in mind, do not forget about HIV and testing it at every opportunity because you are not wanting people to present late and have problems with it and yes, make sure if people are at risk that you are talking about prEP and making sure they are up to date and knowledgeable about it.
Sammi: Fantastic. That actually brings us to the end of this evening’s session. So, up on your screen at the moment we are just revisiting the learning outcomes that Brad took us through at the beginning. So we hope that you can now leave this session and have a bit of a better understanding of how you can prescribe prEP in your practices. We will be running part 2 of this webinar, Conducting Sexual History on the 7th August. In the follow up email that goes out after this webinar, there will be a link to the registration for that. So in saying that, I just want to thank everyone who joined us tonight and a big thank you to our presenters, Brad and Nathan for joining us.