A GPs Guide to Pre-Exposure Prophylaxis (PrEP)

Sammi: Good evening everybody and welcome to this evenings twilight online HIV – A GPs guide to pre-exposure prophylaxis webinar. My name is Samantha and I am your host for this evening. Before we get started, 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. Before we jump in, I just want to introduce our presenters for tonight. So we have our facilitator, Dr Andrew Knight and our presenter, Nathan Ryder. So Andrew is a GP Staff Specialist at The Fairfield Hospital GP unit. He is Research Director for Integrated Care South Western Sydney Local Health District. He is Chair of the Nepean Blue Mountains Primary Health Network, Clinical Advisor to the Improvement Foundation and Conjoint Senior Lecturer at the University of New South Wales. Nathan is a Sexual Health Physician with 15 years’ experience in HIV management in urban and rural Australia. He is Clinical Director of Sexual Health at the Hunter New England Local Health District, the HIV Support Program Coordinator at the Hunter New England Local Health District and a Conjoint Senior Lecturer at the Kirby Institute, University of New South Wales and University of Newcastle. So in saying that, welcome Nathan and Andrew. Thanks for joining us tonight.

Nathan: Thanks very much. Great to be here.

Sammi: Fantastic. And I will hand over to Andrew now to take us through the learning outcomes for this evening and kick off the presentation.

Andrew: Well thanks very much. It is a pretty exciting time to be involved in this work because I guess in my career I have seen HIV go from a really serious, heart-breaking death sentence to something that is controlled and now to something that really hopefully will be largely preventable. That is pretty exciting. So tonight really is to discuss three things or three learning objectives. We hope by the end of this meeting you will be able to discuss the changes with regard to the access to pre-exposure prophylaxis through the PBS, very new announcement, describe what it means for you in your working life and also to list a series of clinical resources which will help you in prescribing PrEP. So, what is PrEP? Well, it is an acronym for pre-exposure prophylaxis. So it is a daily medication that can be taken by HIV-negative people to prevent HIV infection. So, just by way of introducing the topic, we thought we would ask you to answer a question and that is, have you had patients asking for PreEP? So these polls are kind of fun. I do not know if you have done them before, but you simply answer yes or no according to the question and do it as quickly as you can. We will watch it get totalled up and then we get an idea of how many of the 182 participants on this webinar fall into which camps. So away you go, answer the question and we will see what happens. We have closed it. So that you can see - I do not know if you can see the results – there you go, 70% of you are a no, but 31%, almost a third of people have had people coming in and asking for PrEP. So that is fascinating that it is out there and certainly that people for whom it is a risk are in the know.

Alright, we will keep moving along. So, why PrEP? And why now? Well, it is part of a strategy, what really has been an effective strategy. In New South Wales, there has been a really effective strategy looking at HIV over the last couple of years and this is stretching through to 2020, mainly to virtually eliminate transmission by 2020. There has been a lot of work done on this in getting people on to treatment who are diagnosed quickly, but this new strategy or it is not that new but it is certainly new in terms of access to PBS, is a key plank in the strategy, and that is the prevention of HIV through the use of PrEP. So, PrEP availability, up until now you have been able to get PrEP in three ways and many of your patients may have done this. The first is, the EPIC study. We are going to go into this in a bit more detail, Nathan is going to tell us a bit about this. Second of all, personal importation and this is something that many people have done and there is advice available about this. It is quite practical to do and legal to do. And finally, private script is the other option, a much more expensive option. But Nathan, I think you are much more across the environment here and I would appreciate it if maybe you can tell us a little bit about these methods.

Nathan: Sure. So I have got patients at the moment using all three of those methods. I think we are going to go into a bit more detail about how EPIC works in a couple of slides, but just give a bit of an overview at the moment. So the overwhelming bulk of people at the moment are accessing PrEP through EPIC. I think we have got about 8,000 people in New South Wales. So that is a clinical trial framework, so there is obviously some organisation around that. But not everybody is eligible for that study and not everybody wants to take it in that way, so people that are eligible but still feel they are risky enough to warrant it, some of them are personally importing it. We know the quality of imported drugs is pretty good and some are very comfortable with that option. And we have got a few people still just buying it. So it is $25 a tablet at the moment and some people that did not want to take daily PrEP but had quite predictable and limited periods of risk were just purchasing it themselves and a number of GPs had referred people in to me to get some advice around how to do that and then they would just see their GP when they needed a single bottle to take, usually for an overseas trip. So yes, people are using all three as options and we expect that that will probably continue even once it is on the PBS.

So in terms of the efficacy of PrEP, PrEP has been studied a lot and we got a really good understanding of how well it works and what some of the downsides are, so in the clinical trials we found that if people take PrEP that the overall efficacy was around 90%, but if you then drilled down a bit further into that 10% were it was failing, what we found was that the vast majority of that group either probably had HIV infection already and had tested negative on the initial test because it was very, very early or the other group were not actually taking the tablets reliably. So if you look at the group that definitely did not HIV and definitely took their tablets, then there has been only three failures so far globally out of several tens of thousands of people. So we think the actual effectiveness if it is being used properly, is pretty close to 100% which is absolutely amazing.

So if we move onto the next slide, that just summarises that. So essentially…

Andrew: It needs to be taken correctly and consistently and adherence determines efficacy. And the idea is to take it daily.

Let’s move along. So there is a safety in reasonably long trials and there you see some of the comments about that. The common side effects are not severe and usually noticed early on but subside quickly. Less than 2% users of Truvada and they report headaches, abdominal pain and weight loss.

Nathan: So yes for the longer term for a safety thing as opposed to annoying side effects, is around renal function and bone mineral density. So we know that tenofovir, really the main active ingredient does cause a decline in renal function. We mostly see that in people who have pre-existing renal function or other risk factors for renal disease. A big part of the initial assessment is trying to establish that. Although you do get a decline initially, generally with long term use it does not continue to worsen, particularly with time. The second thing which is very similar really is bone mineral density that we do see a decline in bone mineral density but for the overwhelming bulk of people it is not clinically significant. The only people we are concerned about are people that have pre-existing risk factors or osteoporosis in which case the obviously for both of those two things, it might be a contraindicator or it might be a matter of weighing up two risky things and determining for that individual what is best for them. And I guess the final risk which we are not really seeing much in practice, but it certainly can happen is that you could develop resistance to the antiviral drugs should you contract HIV. So in the study that seemed pretty rare. It mostly happens in people who have pre-existing HIV and were not taking their tablets reliably. We think in the recommended use, the rate of resistance would be very, very low, and even the resistance we do see generally has a very minimal impact on their treatment.

Andrew: Nathan, we have had a couple of questions about some of the earlier slides, about PreEP on demand and also the requirement to take it for four days in order for it to be effective. Can you just comment on that? It was at the end of efficacy I think, taking correctly consists of adherence and you said something before that.

Nathan: Sure. So currently what is recommended is that people take it daily and that is because that is where the evidence is. So there is a lot more evidence for daily PrEP than there is for other types of PrEP. In that circumstance, you need to take it for seven days if it is penis and anus sex that you are having, or three weeks if it is penis and vagina sex. That is before it becomes active and that is around the amount of time it takes for the drug to get to the right levels in the tissue. The rectum has a lot higher perfusion of the drug into the tissue so it is faster. You need to take it for 28 days after the last episode of exposure and as I said recommended daily minimum of four tablets per week. There have been a couple of studies looking at on-demand PrEP and that is basically taking a couple of tablets before sex and a couple of tablets after sex. In the studies it has only really been shown to be effective in people who are having risky exposures multiple times per week, so in the end they were taking quite a lot of tablets per week. We do not actually know how well that would work in someone who was having very infrequent episodes of sex because then they are obviously going to have a lot less drug in their body. So at the moment, it is an option and you can talk to the patients about what the studies have shown, but it is not recommended as a routine course of treatment.

Andrew: Okay. Another question about that is, what efficacy rate can we say to patients if they take it reliably seven days a week? 99% effective? Or what do you think?

Nathan: Yes that is a really good question. So, I just say honestly that in the studies it is 90%, but most of those people had reasons they contracted. In use we think it is probably close to 100, but I can never tell anyone that anything is 100% in medicine unfortunately, so there is an element of risk there.

Andrew: And a question about acronyms. TD/FTC. What do those acronyms mean?

Nathan: Yes, well they are the component drugs, so it contains tenofovir and emtricitabine and they are just acronyms for those drugs.

Andrew: Okay. Alright, so EPIC has been the major way that people have accessed PrEP to date and it was before the PBS question has been answered. It was framed as a study, ah the next slide, so that is what the acronym stands for, EPIC – expanded PrEP Implementation in Communities in New South Wales, led by the Kirby Institute, funded by the New South Wales Government with a large scale roll-out to high-risk people. So it is a real life implementation study with evaluation. And it has been a major undertaking. So a lot of clinics involved. It has been going now for a couple of years. It aimed to enrol 3,700 HIV-negative people and as Nathan said we are now up over 9,000, so that has been huge. So Nathan, do you want to talk to what the study has shown us? I think there was some recent findings presented?

Nathan: Yes. So the early findings from the study were presented really only quite recently at the International CROI conference and it has been quite amazing what we have found in the study, so obviously we cannot draw 100% conclusion that EPIC has led to these findings, but essentially in 2017, 11% fewer people were diagnosed with HIV than the previous six year average. So prior to the sort of move toward getting more people on treatment and getting people on PrEP, we were seeing the HIV notification rate increasing so having a turn around and such a large turn around, is really, really encouraging. And if you drill down to the details, it gets even better, that the number of early stage infections decreased by 29%, because obviously we cannot do anything about later infections with PrEP, and additionally if you look at the group that is really accessing PrEP that is MSM or gay men, there has been a 44% decrease. So really, you know, rolling out this PrEP in a huge way and it is probably the largest PrEP rollout globally I believe, seems to coincide with a massive decline in new infections in the group that we are targeting for this initiative, which is really encouraging. And if this continues, it is going to have a huge impact on the overall HIV rate and the health of people at risk of HIV.

Andrew: Do you know, Nathan, I do not know and I am asking a question without notice, do you know if the plan is to continue EPIC given the changes in availability of the PrEP on PBS.

Nathan: No. No so it was always in the clinical trial protocol that this was a really demonstration project and a way of getting a new start before it was available so all the patients have been consented that they will get a grace period and then they will roll over onto accessing PrEP through the PBS. But of course, not everyone has access to Medicare in which case they do not have access to PBS, so that is going to be a bit of a challenge for the public, how we can use personal importation and other compassionate means to make sure PrEP is available to everybody.

Andrew: So what we are referring to is a recent decision and a recommendation of the PBAC that PrEP be listed on the PBS and the Government accepts recommendations from the PBAC and that means it is going to be available to patients through Medicare and it will be listed we are thinking, on the 1^st April which is really soon and it will be listed as an S-85 and what that means is, that at the moment HIV medications are listed as S-100 which means highly specialised drugs and prescribing restrictions, but S-85 is general schedule and any doctor can prescribe it. And so what does that mean for you and me? It means that we are going to be able to prescribe it to anyone who holds a Medicare card and it means we need to be prepared for people walking through the door and requesting PrEP and this webinar is part of the preparation for that. We had a plan before the announcement but I know the planners knew the announcement was coming so it has also been partly for that.

Alright, so just thinking a little bit more about the HIV strategy, it has really set the scene in New South Wales with regard to HIV. The goals of the strategy up to 2020 are to virtually eliminate HIV transmission by 2020 and sustain it particularly in people who inject drugs, sex workers and from mother to child and it focuses on priority populations and a range of priority settings are also identified which includes general practice and primary care. Increased testing by you and me in general practice will be a key driver for achieving the goals. Most, as you probably know, most STIs and HIV diagnoses are made in mainstream general practice and we have the contact with the unlikely patients. So for example, heterosexual people who may not know that they are infected and are warned not to come into contact with sexual health clinics as they do not consider themselves as risk.

So what is the data telling us about HIV? Well, here is some data. In 2017, there were 313 infections with HIV. Now I am a bit confused about this Nathan, because we are saying there is an 11% reduction on the year before. That does not look like an 11% reduction on the year before. Are you familiar with this data? Does that make sense to you?

Nathan: Yes, look sometimes when you try and transfer across two different data sources they do not always 100% match up. But yes the 11% is definitely correct.

Andrew: Right. Okay.

Nathan: This is the number of newly diagnosed cases, so that is probably essentially a different way of cutting it.

Andrew: Okay. The number that has been quoted in the data that we were given to give you, is that the previous six year average, well okay, the previous six year average was 351.5. So the previous six years on average, 351 diagnoses. This year there is 313. So I think we are seeing a trend there, certainly seeing a trend there is reduction of diagnoses. So the key messages from the HIV data, Nathan, do you want to comment on these?

Nathan: Sure, yes. These are really just pulling out what is a massive surveillance exercise into the main key points. And like we said before, the really headline number is the slightly more than 40% decrease in HIV among Australian born men who have sex with men, and an even larger decrease in early stage infections. But what we are seeing is that we are seeing an increase in overseas born men who have sex with men and an even larger increase among heterosexual people. And they are the two groups that probably have not been accessing these prevention methods as much Australian born MSM have. So we know that in the EPIC study, compared to what the notification data is showing us, we are not really reaching those overseas gay men in the levels that we should be. And the heterosexual increase is a bit more complicated because we are not even really confident that heterosexuals at risk are really even testing enough yet and certainly accessing treatment less often than gay men are. So there is a lot of work to be done in those groups.

Andrew: Yes, and that is where mainstream GPs come in, people who see people in the community. It is worth realising that the majority of these diagnoses are made in general practice. 41% of new HIV diagnoses in New South Wales were made in general practice and of these 34% new diagnoses not accredited to prescribe anti-retroviral therapy. So they are not S-100 prescribers who may have a skewed practice population, actually mainstream general practice. And the key message here is that increased testing leads to earlier diagnosis which is better all round. You get better patient health because they get on to treatment earlier, but also for the population they are not infectious. So that means we get less transmission of the virus. So it is a really important message that we need to be having HIV there in our mind, especially when we here about groups of people who may be at risk, so people who may have travelled overseas, people who may have other risky behaviours. We need to be aware of this and be testing in the context of other STI tests to be finding these early diagnoses in these less predictable groups. It is really our job.

Alright, Nathan, a little bit more information about GPs and PrEP.

Nathan: Yes. So a lot of the highest enrolling sites in EPIC were actually GP sites. I think the highest by a considerable margin was a GP practice and I think whilst those are GPs that have had an interest in HIV medicine, it does show that you can integrate PrEP into general practice settings. A number of GPs in my area as I have mentioned earlier, refer people in for assessment and are prescribing PrEP off label outside of PBS already. We really think that PrEP is the ideal thing for general practice. It is a preventative health measure. It is very straight forward to do, but you know, it is assessing people with risks for chronic diseases and interactions with drugs which GPs are doing all the time, is really the only things you need to do. I think it is a great preventative strategy for general practice.

Andrew: So it is clearly something that we are going to be involved with, prescribing PrEP. I wonder if you could just walk us through it a little bit? Some of the considerations in prescribing.

Nathan: So there is a great guideline so I think there is a link on the page there now. So that is The Australasian Society for HIV Medicine, or ASHM. That is the national guideline. It is pretty easy to follow and I think there are lots of tables in there if you refer to that one if you have forgotten what we discussed tonight, you cannot really go wrong. So I think if we move to the next slide, it just steps you through the stages, so what you need to do. So you need to know when to offer or consider PrEP. You need to know what the eligibility criteria are, what the testing is and any other services there are. And I think the slide then sort of steps us through each of those points, the upcoming slide. So yes, so obviously the first thing is when to offer or consider PrEP. So this is when you might offer it to one of your patients or if they request it, helping them work out if it is for them. So basically, it is recommended if people fall into the medium to high risk category and that is essentially around their risk of contracting HIV and that obviously varies depending on what they are doing and who they are doing it with. So the most common one, I think by a long way, has been men who have sex with other men who are not using a condom. And that would account for the overwhelming bulk of people currently accessing PrEP. If you are a heterosexual person and you have a partner with HIV, then you certainly could use PrEP. But we now know that treatment works really well with prevention. So it is only really someone who does not have an undetectable viral load on treatment which is actually quite a small group, but we do have some people in that category. Trans and gender diverse people, we would consider that a risk similar to men who have sex with men, especially male to female trans people have quite a high risk of HIV and anyone that injects drugs and shares equipment we think is high enough risk to warrant PrEP. So that is looking at the behavioural risk factors and whether they are high enough risk to warrant using PrEP.

And then if we come on to the next slide, we look at the eligibility criteria. So once you have screened them and think yes, they are high enough risk, then we have got to look at both behavioural and clinical factors to see if yes it is right for them. So we have sort of discussed the behavioural already. So the second part of that is the clinical assessment and there are four things there. I mean, they are all equally important. So the first thing is, that they need to be confirmed to be HIV negative. We have discussed before that there is a risk of inducing resistance and therefore we do not want to give these medications to someone who is already HIV positive. So we need to test them. So we definitely test them at baseline and we generally recommended they are tested in a month as well. We also ask about signs and symptoms of acute HIV infection because we know in that circumstance the test may miss it and we will definitely want to do a test at one month. Or not prescribe and wait.

Andrew: We have had a few questions. What about like, men who have sex with men who have partners with undetectable level, and is their only partner, should they be taking PrEP or do they depend on the fact that their partner has an undetectable level, male or female?

Nathan: Yes, so I think the slide sort of simplified it somewhat. The guideline does go through it in more detail. But yes, I mean if the person has only got a regular partner and that person is known to have an undetectable viral load, then no, we do not recommend PrEP. There is the odd person who takes it anyway because they do not trust that their partner is going to take their tablet, but on the whole, no you do not need it in that circumstance. So the risk is mainly around unprotected sex with casual partners and it is riskier for the receptive person rather than the insertive person, so there is a bit of nuance there as to exactly that person’s level of risk.

So yes, on to assess at the clinical stage and the last ones I did not get to was the renal function and the meds. I think you have flashed up the STI testing tool, so that is from the STI programs unit website which is a great tool to step you through taking a sexual history in a sort of simple and approachable way that is appropriate for general practice. They have got a really easy to follow table which shows you what tests to do and then gives you some tips on collecting samples and contact tracing and what not. So that is a really good way of doing that initial assessment stage.

Than if you jump onto the next slide around testing. So this is the sort of baseline testing that you would do. So remember we have done a HIV test. We do a full STI test at base line and we do that according to the Australian STI management guideline framework, so it will depend on the person exactly what tests you did. We always test and vaccinate if not immune to hepatitis B, because as I am sure you all know tenofovir that is in PrEP is also a Hep B active drug and we do not want to induce a flare by stopping and starting that. And finally, we generally consider testing for hepatitis C. Although that is not generally considered to be sexually transmitted, in high risk gay men it probably can be sexually transmitted and we think it is good practice to exclude hepatitis C.

Andrew: I had another question, Nathan. You mentioned testing a month later, and there is a question there about the window period. Does that mean the window period has changed from what we were previously taught?

Nathan: Yes. So the official window period per test is three months and people get tested every three months as a part of PrEP follow up. However the vast majority of people test positive a lot earlier than three months. So the one month test is a practical way of identifying the overwhelming bulk of people who had HIV at initial test but tested negative. So the three month is 100% make sure you capture everyone. A month will capture virtually everyone.

Andrew: Okay. Thanks everyone. I am trying to capture your questions as they come in. There are a lot of them, but we will try and make sure we do address what you ask.

Nathan: So think if you flip to the next slide, this is just a screen shot from the Australian STI guidelines. So we said there is that STIPU testing tool which is great. That is a pdf. This one is an online guideline, if you look up the populations, and you look up you know, gay men or transgender people or heterosexual men it will quickly tell you what tests you need to do and I cannot recommend that guideline highly enough.

And it think, yes, the next one gets on to, so if we assume we have got someone. We have done all those baseline tests. We have made sure they do not have any contraindications, then what we would generally do is write them a script for 90 day supply. We do not recommend writing longer than 90 days. I have not seen anything, I am not 100% sure what the PBS dispensing units will be but I am assuming it will probably be 30 tablets with two repeats because there is never really any reason you want to prescribe more than 90 days at a time because you really need them to come back to have their monitoring tests. And as we have discussed already, you need them to take it for seven days before they can be considered to be protective. So it says seven days here, but most guidelines recommend a bit longer for vaginal sex as I said.

Andrew: I had a couple of questions about specific cases. What about sex workers? And what about people planning on sex tourism? Is there a difference?

Nathan: Yes, so I have not had any sex workers requesting it and the vast majority of sex workers use condoms. If you are using condoms that would be protective enough. Yes, I mean in theory I guess you could look at it that way. The risk of contracting HIV for a female sex worker having sex with male clients in Australia would be extremely low and probably would not be worth the side effects for the majority of people. For a male sex worker having sex with males, it almost certainly would and you would have to have an individual discussion with them around that. But really you should be able to apply the same principles as you do for your other patients. And what was the other one? Oh, the sex tourism. Yes, look I think that is going to be a big one personally. Not necessarily a huge market but something that we will have to deal with and potentially can be really helpful for people. That is the group that I was saying before that I have had a number of people buying it at the moment because they go overseas. We know that overseas acquisition is a big issue for heterosexual people in Australia. Often they might intend to use condoms but drugs and alcohol get in the way and if they know that is going happen, so perhaps a really good backup strategy for them. So in that circumstance that is where I would say start seven days before, use it when you are there and keep going for 28 days after you get back.

Andrew: If we write a script today, can they get it after the 1^st April? It is probably not going to be in the prescribing software.

Nathan: We do not know yet whether, sorry unless someone else knows, but as far as I know, we do not know if it is going to be a streamlined authority on it or not, in which case you would need to know the code numbers and things like that.

Andrew: Yes, sure.

Nathan: Yes, so ongoing monitoring and education. So basically it steps you out there what you need to do at baseline and then the 30 day test and essentially every 90 days from then on. It is pretty straight forward, it is mainly around checking for HIV and other STIs and then checking for your kidney function intermittently. So this guideline is recommending every three months initially and then every six month for an eGFR and a urine protein: creatinine ratio. Pretty much then it just sort of links in with every time they come in for the next script then you do the battery of tests. Hopefully the practice software will make a test set for this, because we certainly use it a lot in our system.

I am not sure if we have any slides around the, yes, okay. So that is the sort of biomedical monitoring but of course there is more to it than that. So the majority of people, they need some assistance with medication adherence. I am sure I cannot give any advice to a group to GPs about that, just use the same strategy that you are using for all your other patients are exactly what you need.

People are a bit concerned about the side effects. So, constantly reflecting on that, so for them individually just reflecting every now and then is their level of risk still worth the possible side effects and that changes over time obviously, especially if you have got an older cohort starting new medications, potentially having declining renal function due to other things, it may change over a number of years and you may decide to withdraw PrEP if their level of risk has gone down for HIV but their level of side effects has gone up. Obviously, PrEP is only protecting against HIV. So we do recommend condom use. A part of our starting PrEP is going through that and recommending that people think of PrEP as a backup strategy and to use condoms as often as possible. And obviously for some people that is straight forward for them and that is what they intended to do. Other people think no, well I am taking PrEP because I want to have unprotected sex and we take a very much a risk sort of reduction framework there and we sort of then talk to that person about okay, well I understand that and what might be some situations where you might use condoms? Some people identify things like people that they do not know at all, or if they have sex while they are travelling, whereas if they have got a semi-regular partner, perhaps they might not chose to use it with them. And then we also talk to them about talking to other people about PrEP. It has become quite a common thing that people will sort of ask each other about whether they are on PrEP and use PrEP as a prevention strategy, and that had probably got a lot of positives about it, but potentially some risks too, and just talking about the pros and cons of using what people say about what they take as a definite means of reducing their risk. So that is mainly about the monitoring and education.

So the next slide goes on to the testing that we only do very occasionally.

Andrew: Nathan, there was one question about the monitoring slide. Do you know where that came from? It was a couple of slides ago, a little table you had about the monitoring.

Nathan: That will be from the ASHM guideline that flashed up earlier.

Andrew: Thanks.

Nathan: So, yes in terms of optional testing. So these things are not done very often at all but you might consider it. So in part of your initial assessment you work out that someone has got some risk factors for osteoporosis, you may want to do a bone mineral density initially to determine if they do or do not, because that might determine whether you prescribe or not and obviously on an ongoing basis you might monitor that. The same goes for vitamin D levels. And if you think someone may have an early infection, you might think about doing a proviral DNA test. That is in the guidelines and is listed in the guidelines. I would caution though that it is not Medicare rebated, so the patient will be up for about $300, so I actually do not order that very often, I just order the normal serology test and do it again after a week or two, but if you are really concerned that someone might have early infection, I would definitely encourage you to get some advice from your local HIV specialist.

Andrew: The same issue applies I guess to bone mineral density. I do not know if being on PrEP actually qualifies you under the MBS for a bone mineral density.

Nathan: No, it certainly does not. But there is no other way around that if you have got someone who is at really high risk and you are really not sure whether prescribe it or not. Some people are quite insistent that they really want PrEP, you know, you may well go down that path. I guess the thing with the proviral DNA test is that there other alternatives. You can just do the serology again and it is almost as good.

Andrew: Is there a renal threshold, if people have a certain renal function that you cannot put them on PrEP? Is that how you approach them?

Nathan: Yes well the threshold for the EPIC study was 60 and that is pretty much what most of the guidelines say. So if you eGFR is less than 60 then PrEP is probably not for you. Although I would say that there is probably some element there for some discretion and discussion with the patient, because ultimately you are weighing up the risk of renal disease against the risk of HIV. So if someone’s risk of HIV is low, well yes, you are certainly not going to prescribe it in that circumstance. If someone has an extremely high risk of HIV infection and they have got very stable renal function say it may have declined through some disease or drug that has now been withdrawn and not really at ongoing risk of decline, then I think in some circumstances maybe you would prescribe. But that is probably a good example where you might want to seek some advice.

Andrew: There was a question about interactions and particularly with anti-malarial if someone is heading overseas on sex tourism and they take their PrEP. Are there significant interactions with other medications?

Nathan: So the main interaction is around renal risk, so we do not want someone taking a medication that is strongly nephrotoxic at the same time as the tenofovir because that is your main concern. So the common ones that we have had is that we have people on lithium and we have to closely monitor them. Another one would be very high dose non-steroidals. There are a few reasonably common drugs that are reasonably contraindicated, although as I said we have got some people that are at very high risk and we just monitor them monthly rather than three monthly. What I would encourage people to do, is to look up interactions. There is a great website called HIV drug interactions, but presumably your practice software would do the same. It is very hard to keep track of interactions of all the medications I find and so I just look them up.

Andrew: Okay, so we might press on. So there are going to be a lot of resources available to help. There is going to be an online learning module, a prescribing pathway, a patient information book and when these are finalised they will be available as part of this program and you will be sent a link and you will be able to access those. And the other resource is a phone line that we can ring for advice and guidance, particularly for complex cases. What is a complex case? Nathan, have you got any ideas on what sorts of things people ring about?

Nathan: Yes, so that is a special info link and you can ring that really for any advice around sexual health and HIV. Yes, the complex ones that we get probably around what I was saying before about weighing up the very high risk of HIV versus some degree of renal impairment or bone risk, so weighing up those two things. The other situation would be the one that you brought up around sex tourism and someone really wants to take it in an unusual way. So we often get advice around the latest thing there. That is likely to change as more studies look at on demand PrEP and different ways of taking it.

Andrew: Okay, great, thanks. Look the other thing we wanted to just speak about briefly was the whole issue of when we make a new HIV diagnosis. It is not a common thing that we do in general practice, but it does happen and it is a point of significant interaction and a point of stress in our relationship and you really want to get it right when it happens. So there is a whole program to support GPs when they make a new HIV diagnosis. It is called the HIV Support Program. It is an excellent name. I am wondering if any of you have heard of it or have had contact with it. We are going to do another poll and just ask you, if you have had contact with the HIV Support Program or have heard of it, we would like you to tick “yes” just to give us some idea out of the attendees, now 238 attendees, what proportion have heard of it or have had contact with the program. So there you go, let us see what we get. Okay. Bottomed out. So 27% of people said yes and 73% said no. So about three quarters of us have not had contact or heard of the HIV Support Program, which is hardly surprising, because an HIV diagnosis in general practice, even though it is the place where most diagnoses are made, it is not a common occurrence. I am going to tell you a little bit about it, just so that you know, what it is and how it works.

So, the next slide says that if you make a diagnosis, obviously wrapping care around that patient at the right moment, the right care that that patient needs and helping you to provide care to that patient is key. So when you make a diagnosis, so you know you do a test and the test comes back positive, that test is via various methods notified to New South Wales Health and your local HIV Support Coordinator will be notified. You will be contacted and asked if you would like help, basically. And then if you would, the HIV Support Coordinator will give you a call and help you in providing the appropriate services for that patient. So I think it is an extremely good example of integration of care to provide the right sort of intervention for this particular condition. Obviously, things that we deal with commonly we do not need that sort of support. Something, a really important event that happens rarely, we cannot be expected to be right across it necessarily but it is excellent that the system provides the support at the right moment. So when we talk about five key support services that an HIV positive, a newly diagnosed person with HIV needs and the next slide helps us look at the pathway, when it comes up. There it is. So, you test, send it to the lab. The lab notifies the diagnosing doctor and the New South Wales HIV Surveillance Officers of the positive diagnosis. The HIV Surveillance Officer provides the details of the doctor who ordered the test to the local coordinator, the HIV Support Program Coordinator based in your local health district, so they know the services available to you, and that person is a clinician with specialised training and they will then contact you and offer help. Depending on how much help you need you can accept it or not. And the sorts of things they will be encouraging you to do are around these five supports that every patient with a new diagnosis needs, and that is on the next slide.

Obviously we need advice about management including treatment. Patients need psychosocial support at that point. It is really important that the infection is not further spread and so there is the whole issue of partner notification and then the connection with specialist services in a timely way. So, bad news is something that is part of life when you are a GP and you get trained in it and we get hopefully better at it and HIV in that sense is no different. But there are key specialist bits of information that we need about this. Okay. And you are supported to do that.

Now, we can also contact the support service if we go on to the next slide. So that if you have not heard from them, there is a number that you can call to speak with a Surveillance Officer and they can get you in contact with your local coordinator. So sometimes a lab might call you to advise that a screening test is positive, but yet you know, there is the confirmatory test may not have been done. So in this situation, you can certainly – you will not get that phone call until that confirmatory test is done, but you can certainly contact the service for the support and advice.

Alright. So a couple of questions. What about pregnancy? Nathan, so if someone gets pregnant while they are taking PrEP, any advice about that?

Nathan: PrEP is not recommended in pregnancy at the moment, but again you would need to have an individual assessment there.

Andrew: Yes, okay. A few questions about people who are interstate and look I am afraid I just do not know the answer, I know this applies the HIV Support Program applies in New South Wales. I do not know if there are equivalent programs in your states, so you will just need to look into that yourself, I am sorry.

One person is saying it is not working as well as you might think and then another doctor is saying it is awesome, they have had the experience and it has worked really well.

Alright, we are towards the end of our presentation and so this is the conclusion. The important thing to know is that PrEP has been listed on the PBS, the date we think it is going to be the 1^st April but this is to be confirmed. You and I will be playing a key role in HIV prevention both through early testing, particularly in at risk groups and also through the prescription of PrEP to people who have at risk behaviours and are HIV negative. And I hope now that you can see that there are really important tools and resources available to you to help in the prescription of PrEP and in the managing of HIV.

 

So if we go back to our learning objectives, what did we hope that we would achieve? That you would be able to discuss, be equipped to discuss, I say discuss because that is sort of a demonstration that you have learnt something if you can discuss it. The information about the listing of pre-exposure prophylaxis for HIV on the PBS. And then to describe some of what that means for GPs, the actual technical aspects of prescribing, who to prescribe to, what to look for and how to monitor. And then we hope that you would be able to list some of the resources that will support you in doing this.

Alright, so thanks very much, Nathan, I think we have worked through most of those learning objectives and I think we have looked at most of the questions that people have asked. We have certainly tried to. There have been a couple of questions about rates of STIs. There is a bit of concern and I think you raised it too, Nathan that there may be some overconfidence or various reasons why PrEP users may be getting more STIs. Is there any evidence around that from for instance the EPIC study?

Nathan: Yes, well we are certainly seeing more STIs but we do not seem to be seeing a higher proportion of STIs so it seems that we are just doing a lot more testing. So in the longer term obviously there is a concern that it might change sexual behaviour overall in society and drive increased STI rates but on the other hand we are getting a bunch of people that in many ways were already high risk and we are testing them every three months and treating them and so that might cause a decline in the STI rate. So I do not think at the moment there is any strong evidence either way and so there is definite population health, the main effect there is that we can virtually eliminate HIV transmission and possibly have an impact on STIs as well in a good sense and so there is no reason not to be doing it.

Andrew: There is another question about the acronyms. The acronyms refer to the drugs that are in PrEP. And yes another question, if I said that PrEP was for at risk people who are HIV positive, I was wrong. It is actually for people who are HIV negative as we are seeking to prevent it.

Alright, I think we have done what we set out to do. I would like to thank you, the many people who participated. Over 200 people participated in this webinar. We trust it has been helpful. I would like to thank Nathan for his expert input and to wish you a very good night. I think we are completed. Good night everybody.

Sammi: Fantastic. Thanks everybody for joining us tonight and a big thank you to Andrew and Nathan and everybody enjoy the rest of your night.

Andrew: Thank you. Good night.

Nathan: Good night.