ASHM Report Back

Clinical posts from members and guests of the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) from various international medical and scientific conferences on HIV, AIDS, viral hepatitis, and sexual health.

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Self-Perceived Problematic Relationship with Drugs and the Use of Alcohol and Other Drug (AOD) Services among Gay and Bisexual Men

Self-Perceived Problematic Relationship with Drugs and the Use of Alcohol and Other Drug (AOD) Services among Gay and Bisexual Men

Professor Adam Bourne

Statistics show drug use, including cannabis, cocaine, ecstasy and methamphetamine for example, is up to three times higher among the Gay and Bisexual male population, nationally and globally.

Drug related harms occur from risky drug use, increasing the risk of disease transmission. For example, methamphetamine use and erectile dysfunction has been reported to increase the odds of HIV infection among this population.

Other drug related harms among Gay and Bisexual males have been observed from the use of GHB and crystal meth. Of concern is the increased mortality rates attributed to GHB overdoses in London, with one death reported every 12 days between 2014 and 2015 in addition to poor ART adherence secondary to crystal meth use.

The Flux study aimed to understand how drug use is situated among gay and bisexual men. How comfortable are they engaging with alcohol and other drug (AOD) services? What are the barriers? One point of note was that there was a fear of judgement and the perceived lack of understanding from AOD services in terms of the synthetic types of drugs being used and the different ways Gay and Bisexual men use the drugs compared to other populations.

A comment from the audience triggered the response that a move forward may be to try to meet the needs of people who are sexually active and who chose to use crystal meth, exploring ways of how to use it safely.

The overall aim is to reduce disease transmission and improve engagement with AOD services for all, but in particular for those who believe their drug use is problematic.

Day 2 Morning Session.

Good morning folks, welcome back. The sun is shining, its still a bit cold in Canberra but you wouldn't recognise the place. I started the morning with the Opening plenary for the Sexual Health Conference, some fantastic speakers with valuable insights. Prof. Kit Fairley from Melbourne Sexual Health Centre was a highlight (fantastic speaker) as was Prof. Gracelyn Smallwood speaking on Indigenous HIV and sexual health with her career highlights numerous. Not just an informative session but also very entertaining. Wonderful speakers.

Our last speaker for the morning was Dr Ayden Scheim from the University of California speaking on Trans Rights, sexual health and HIV, referring to the studies, or lack thereof, in regards to Trans people in HIV and Sexual Health research. This as another area where work needs to be done and the way in which we as clinicians or researchers attend this will greatly impact on our ability to be proactive and effective. If I say something from personal and professional experience, work with us, not on us.

I will get off my high horse now and am currently sitting in the next session with Leah Williams, a Nurse Practioner from Perth Hospital speaking on the REACH Programme where maintaining clinical contact with at risk patients more likely to not be presenting.

Normally where referred patients would be discharged from care after two missed appointments, the Immunology clinic sought a change in the structure of clinic visits which is REACH. Candidates were identified as living in metropolitan area, with a detectable viral load and who would avoid or miss clinical appointments.

A cohort of 108 patients was found for the programme, consisting of 65% men, 32% women and 3% people identifying as trans. The research found that the most hard to reach people were Australian and not  born overseas. Interestingly a number of these people were identified as attending the clinic weekly despite no appointments, an indicator that people felt safe to be within this clinical area and with staff. Collaborating with other services, such as Emergency Department presentations by REACH clients being notified to the clinic and staff being able to take the opportunity to engage with the client.

Once i the programme, REACH patients could turn up whenever they like, which was no different to many of their previous attendance. No appointments were made on the books and so no data on "Did Not Attend" was recorded, a huge plus to the clinics KPI's. Focus was on the presenting issues of the patient rather than making visits specifically HIV focused. Another important change was having clinic Administration staff aware of the clients being part of the REACH programme and no reason for a visit was necessary, another way of making clients feel welcome and the clinic appear more accessible.

The "Virtual Clinic" was one innovation of REACH where patient case files were reviewed weekly by a multidisciplinary team and any changes in care or needs were identified in order to facilitate the above changes and give appropriate patient care.Ensuring more support was avaialble to patients commencing new treatments early on and after diagnosis was identified as an effective strategy and client medications were also made available to be picked up from the clinic daily or weekly and use of webster packs to keep things simple and accessible again were effective changes.

In total, DNA rates were halved, patients were happy and were no longer discharged by the service and quality care was given to the patients. The take home message was that we make small tweaks ourselves to make things work becuase patients less likely to do so. Hahaha, so true.

Thanks for following me and looking forward to the second part of the day.

 

 

Divergent rates of HIV in Aboriginal and Torre Strait Islander

Dr James Ward gave us a thought provoking opening speech outlining the recent increase (i.e. divergence) of HIV infection rates among Aboriginal and Torres Strait Islanders compared with the general population.  Here are the take home messages from the talk:

 

  • initially rates of HIV infection were similar between Indigenous and TSI, but numbers are now increasing
  • 2015 marked the highest rate of new diagnoses (n=38)
  • new diagnoses of HIV are occurring in rural and remote areas, which has never been seen before
  • why?
    • background: young, more mobile, more regional
    • risks: injecting equipment, high background of STIs
    • success in non-indigenous diagnosis
    • failure to engage with community
  • how to improve?
    • increasing workforce rather than downsizing
    • timely surveillance data (absurd that we deal with 2015 data in Nov 2016)
    • implementation of a national KPIs reportable for STIs by Aboriginal PHC
    • change to AHC, make STI/BBV checks more mandatory
    • Medicare items specific to BBV/STIs
    • improved testing strategies
      • only 32% of people with a positive STI screen had an HIV test within 30 days

 

I found the session a real eye opener and saw that there were plenty of areas that we could improve in. Simply increasing the rigor at which we conduct testing would seemingly make a big difference.

The Treatment Evolution: New Drugs, New Reality session on Thursday afternoon was the most important session so far at the conference from the point of view of therapeutics.  Of great interest was the 48 week data for injectable cabotegravir + rilpivirine.

 

At this session the 48 week results for the Cabotegravir + rilpivirine as long-acting maintenance therapy: LATTE‑2 week 48 results’ were presented by David Margolis (THAB0206LB).    This phase 2b study compared 4 week and 8 week injections vs oral therapy (CAB + ABC/3TC) to maintain viral suppression of HIV-1.

 309 patients ART-naïve HIV infected adults were treated during the 20 week induction period to reach a RNA< 50 c/mL with daily oral CAB 30 mg + ABC/3TC then were  randomized 2:2:1 to IM CAB LA + RPV LA every 4 weeks (Q4W), every 8 weeks (Q8W), or oral CAB + ABC/3TC (PO) in the Maintenance Period (MP).

 Key findings from this study were 

-          At Week 48, 92% (Q8W), 91% (Q4W), and 89% (PO) remained suppressed (ITT).  

-          More patients on Q8W (5%) than Q4W (< 1%) and PO (0%) had HIV-1 RNA >50 c/mL at Week 48. 

-          There were more discontinuations in Q8W (8%) and PO (9%) arms versus Q4W arm (1%).   

-          Injection sited reactions were common but resulted in < 1% withdrawal.  

-          Three subjects met criteria for viral failure during maintenance, one Q8W subject with emergent RPV and CAB resistance

 Q4W dosing resulted in lower rates of virologic non-response than Q8W so was selected for progression into phase 3 studies.  This treatment appears to be very effective and safe.   Questions remain about the acceptability of monthly injections in various clinical settings but this is a potentially the beginning of a whole new approach to HIV therapy.

 

Catherine Orrell  presented ‘Superior efficacy of dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) compared with ritonavir (RTV) boosted atazanavir (ATV) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naïve women with HIV-1 infection (ARIA Study)’.   (THAB0205LB) DTG/ABC/3TC was superior to ATV+RTV+FTC/TDF, with 82% and 71%, respectively, achieving HIV-1 RNA < 50 c/mL at Week 48.

Differences were driven by lower rates of both discontinuations due to adverse events (AEs) and virologic failures in the DTG/ABC/3TC group.  Of six DTG/ABC/3TC subjects who met protocol-defined virologic withdrawal criteria, none had resistance mutations, compared with 4 ATV+RTV+TDF/FTC subjects who met virologic withdrawal criteria of which one had an NRTI mutation, M184M/I/V. This study was very important in that it showed superiority and was female only.

 

 

 

Jean-Michel Molina  presented ‘Who benefited most from immediate treatment in START? A subgroup analysis’ (THAB0201).  In asymptomatic ART-naïve adults with >500 CD4 cells/mm3, immediate ART was superior to deferral across all subgroups.  People > 50, higher plasma HIV RNA level, lower baseline CD4 count, and higher Framingham risk had the greatest benefit.

 

Alejandro Arenas-Pinto presented ‘Increased risk of suicidal behaviour with use of efavirenz: results from the START trial’ (THAB0202). These findings suggest that participants using EFV in the immediate ART group had an increased risk of suicidal behaviour compared to ART-naïve controls. A prior psychiatric diagnosis increased the risk.

 

Michael Aboud  presented ‘STRIIVING: switching to abacavir/dolutegravir/lamivudine fixed dose combination (ABC/DTG/3TC FDC) from a PI, INI or NNRTI based regimen maintains HIV suppression at week 48’ (THAB0203).  Treatment experienced patients were randomized to continue current ART on Day 1 or switched to ABC/DTG/3TC.  The current treatment arm then switched at week 24.   In this switch arm 92% maintained viral suppression at 48 weeks (note the 24 week data has previously been presented).

 

 

 

Of the plenary session today what really stood out was Anton Pozniaks session ‘TB and Co-infections: the long game.  During the session he reminded us that TB is now the leading cause of death for people living with HIV.  He detailed steps to disease elimination for TB, hepatitis B and C – a very long game indeed.

In ‘The Living with HIV: Long-Term Effects’ Amanda Mocroft (PDB0101) examined renal function in patients in the START study.  eGFR was significantly lower in the deferred arm versus the immediate treatment arm. This finding reached significance in the non-adjusted analysis despite the use of potentially nephrotoxic drugs such as tenofovir.  Yet another reason to start ART early.

PrEP has been a major theme at this conference.  More good news was provided by Jean-Michel Molinain the extension arm of the Ipergay study  (WEAC0102).   This study used intermittent PrEP and previously reported the high efficacy of PrEP with TDF/FTC taken ‘on demand’ in high risk MSM – an 86% relative reduction in HIV-incidence in the TDF/FTC arm vs Placebo (95% CI: 40-98, P=0.002).  All participants were offered open-label TDF/FTC.  During 515 person-years only 1 HIV infection occurred giving a risk of HIV of 0.19 (0.01-1.08) per 100 per year.  This patient reported that he had ceased PrEP.

 Also continuing good news for HIV/HCV co-infection.  In the ‘Bad Bugs’ session Norbert Bräu  (WEAB0301) presented the results of the ASTRAL-5 study Sofosbuvir/velpatasvir was given for 12 weeks to 106 patients.  The genotype distribution was 62% GT1a, 11% GT1b, 10% GT2, 11% GT3, and 5% GT4. No patient experienced confirmed HIV virologic rebound (HIV-1 RNA ≥400 copies/mL).  SVR rates were 95% overall, and 100% with cirrhosis and 97% the previously treated.

As this combination will be widely used in Australia the next session was very relevant. AnnieLuetkemeyer (WEAB0302)  presented ‘Drug-drug interactions studies between HCV antivirals sofosbuvir/velpatasvir and HIV antiretrovirals’.  This was a Phase 1 study conducted in healthy volunteers to evaluate potential drug-drug interactions (DDIs) between SOF/VEL and HIV antiretroviral (ARV).

-       Increased TFV exposure (~40%) was observed with SOF/VEL when administered as TDF

-       Decreased velpatasvir (53%) when given with efavirenz

The author concluded that all study combinations could be used except efavirenz-containing ART.  This is an important finding given the number of patients taking Atripla.

And for the rare patients who does not achieve SVR with DAA therapy with sofosbuvir/ledipasvir (Harvoni)?  Well they can be retreated with…. Harvoni for 6 months combined with ribavirin.   Annie Luetkemeyer  (WEPEB060) presented data on 9 HIV/HCV who had not cleared with 12 weeks of Harvoni who were then retreated with 8/9 achieving a SVR.

 

 

 

 

 

Day 1 plenaries continued the themes from the opening ceremony with great presentations on the epidemiology of the HIV pandemic from Steffanie Strathdee.  Alex Coutinho presented data on Universal Access, the stage beyond the 90:90:90 target set by WHO.  Some countries in Africa appear to be close to passing these benchmarks include Rwanda and Swaziland.  There were few dry eyes at the conference as Edwin Cameron, a South African judge described his life living openly as a HIV positive gay man since 1986.  He introduced his godson who has been living with HIV since his birth 22 years.

 

A Clinical highlight of the morning was the PrEP:New Drugs session.  Robert Grant (TUAC01) reviewed the risk of drug resistance versus the benefit of HIV prevention across 6 randomized clinical trials and one demonstration project. This study was of great interest to those doctors involved in PrEP studies in Australia so the take home messages are:

 

1)    FTC resistance occurred in 10 who received FTC/TDF PrEP, including 33% (5/15) with acute infection when starting PrEP, and in 3% (5/157) with established infection. 98 infections were prevented giving 10 (98/10) infections prevented for every FTC resistant infection.

2)    Tenofovir resistance occurred in 1 who received TDF PrEP, including 10% (1/10) with acute infection when starting PrEP, and none (of 90) with established infection. 53 infections were prevented by TDF PrEP giving 1 (53/1) infection prevented for every tenofovir resistant infection

3)    A screen for acute viral symptoms in PrEP assessments led to deferral of PrEP among 30 of 1603 (1.9%) of whom 2 (6.7%) were found to have acute HIV.  No acute infections were missed using this screen.

 

At the Late Breaker session K Rawlings presented data on the uptake of PrEP in the USA with almost 80 000 people started PrEP in the USA to end of 2915, 76% are men.  No data was available on longer term use of PrEP.

 

The highlight of the ‘Cancer and HIV’ program was a presentation by Andrew Grulich from Kirby Anal cancer in people with HIV  (TUSY0803).

To summarise.  Historically anal cancer is the third most common cancer in HIV +ve males after KS and lymphoma. In heterosexual males it is 10 x more common, in gay males it is 50 X more common than the general population with an incidence of up to 100 / 100  000. Following ART and CD4 recovery there has been a rapid decline in KS and lymphoma but only a slight decline in anal cancer incidence which remains high even with normal CD4.

In terms of primary prevention HPV vaccination results in a 75% reduction in high grade disease in young gay men but preliminary data did not show that it was effective in males older than 26 although further studies are needed.

In terms of secondary prevention – screening and treatment is complicated by the 75% prevalence of high risk virus with 30 – 40% high grade disease but there appears to be less progression to cancer compared with cervical disease.   Treatment pathways are currently uncertain. In comparison to colposcopy anosocpy requires much more training.

In terms of tertiary prevention detection of anal cancer remains controversial with some recommendations to perform annual PR examinations

In the epidemiology session Alison Rodger presented results from the PARTNER (TUAC0206).  This prospective, observational study enrolled 1166 HIV sero-discordant couples who reported condomless sex and HIV-1 RNA load suppressed to less than 200 copies/mL.  1166 enrolled couples, 548 heterosexual and 340 MSM provided had a median follow-up of 1.3 years. No HIV transmissions occurred within the studied couples.  11 infections occurred from ‘unlinked’ partners. This gave rate of within-couple HIV transmission of zero with upper 95% confidence limit of 0.30/100 couple-years, and for condomless anal sex 95% CI of 0.71 per 100 couple-years of follow-up. These results are very encouraging in terms of the tremendous value of treatment as prevention.

 

This paper reviewed the increase in viral suppression and sustained viral suppression in USA adults on ART between 2009 and 2013.

Viral suppression increased in a linear fashion from 72 - 80% a significant 2% rise year on year. Sustained virological response followed a similar trajectory from 58% - 68% over the same time. This was not explained simply by an increase in number of people on therapy.

Women, 18-29 year old's, 30-39 year old's, African Americans all had a greater benefit than the overall. MSM were higher than the average at all time points.  There were two Guidelines introduced during the study period which actively promoted treatment and barriers and delays to accessing AIDS drugs. All suggesting that policy change is having impacts.

This is Oral paper number 53, in session O-5, if you want to have a look when the presentations go on-line. http://www.croiconference.org/

Sydney Rosen presented this SA randomised trial. Patients in South Africa were randomised to start ART on first visit or delay to standard guidelines (which require CD4 testing and behavioural visits, which can take up to 4-6 visits). Three quarters in the RapIT arm started on the first visit (TB was the main cause for delay in the RapIT arm). The RapIT arm had improved outcomes. It saw greater effect for young people, in primary care clinics and loss to follow up was very low.

The presentations should be on line shortly http://www.croiconference.org/ this one is #28 in Session Oral-2

Panel Discussion on Stigma, Trauma and Stress: Considerations for HIV Research and Programs

Monday 22nd Feb

Session MD – Panel Discussion on Stigma, Trauma and Stress: Considerations for HIV Research and Programs.

Moderator: Morenike Ukpong-Folayan (Nigeria)

Diversity in panelists: Laurel Sprague, Sethembiso Mthembu and Keith Green.

 

Speaker 1

Laurel Sprague: Limits and Complexity Research on Stigma and HIV. (Milford, PA, USA)

Complex topic for discussion and opening panelist Laurel Sprague opened with Stigma, fear, and anxiety around disease is just as important as the focus on reaching undetectable viral loads.

She continued to highlight that HIV positive people surveyed actually want not disclosing ones HIV status to be decriminalised, and it is the ongoing impact of the possibility for incarceration that is continuing HIV stigma within the US.

Discussion around the Stigma Index Questionnaire within the US and globally. http://www.stigmaindex.org

 

Speaker 2

Sethembiso Mthembu: Women’s Rights and Decision Making in Hormonal Contraception. (Durban, South Africa)

Presented on how there are overriding political issues that continue to impact on the provision of care for women, different contraception is offered in northern regions to southern regions, and based on religion and race.

Increasing awareness into the effects of hormonal contraception – in particular depo provera injection has on vaginal pH levels and thus is actually increasing the risk of HIV transmission for African women, as well as an increased link with higher rates of cervical cancer.

ECHO Study is currently looking at the direct links between administration of hormonal contraception and increased rates of HIV.

http://echo-consortium.com

Current government programs push hormonal contraception onto African women with little education or communication of possible side effects, in HIV positive females, provision of ARVs is withheld until the person can prove they have had their depo provera injection

Ongoing provisions of care complications are highlighted with African women being provided with ‘contraception only’ clinics, which will not and do not address any other complex care needs of women’s health.

We can all argue how effect depo provera is as a form of contraception that is discreet, effective and economically accessible around the world. The point raised by Sethembiso is that we need to consider and understand the impact however such hormonal contraception is being pushed in Africa not as an option but with forced prescription and the impact in relation to HIV risk.

 

Speaker 3

Keith Green: Engaging Young Men of Color in Community HIV Prevention Studies. (Chicago, USA)

Emphasis on multi-disciplinary approach and peer lead and consumer inclusion into study development and implantation.

He notes a major aspect of barriers in engaging youth consumers and participants into new studies and trials is not due to just their own stigma concerns but rather also the fact that youth inherently rebels and does not like to follow set orders or rules, and is just part of their nature as humans.

Keith also highlighted that we should not be so quick at labelling and using terms as MSM to communicate with young people, in todays day and age the better options is to ask the person how they wish the be identified and then use that term.

He has raised some interesting points, but also it does seem that it is increasingly difficult to allow interactions across all politically correct and non judgmental levels without making the research less valid, or repeatable in other settings, if allowing too many broad topics, and individual approaches helps gain numbers of consumers to participate will it then also indirectly make the research less scientifically valid?

The use of facebook and twitter proved valuable to their team in engaging and maintaining participation from youth consumers. The importance of privacy and sensitivity was highlighted but most participants were very happy to communicate via social media rather than phones. In considering the youth of today, mobile numbers change frequently, however very few will ever change their facebook or their email. Putting privacy and internet safety of information aside and assuming all was protected, one would think that this approach could not only benefit in youth interactions but also for all consumer/ client groups that are often lost to follow-up, low retention of care populations and indigenous and/or remote populations within geographically diverse Australia.

Keith repeatedly emphasis the importance of health provision to always remain culturally competent and relevant. This is of course a huge challenge in any community and country around the world especially as technology and communication avenues evolve so rapidly.

 

Open Q&A - Discussion:

The open discussion highlighted some global issues on the topic and some interesting specific examples were given. To summarize the main points of the discussion;

-       HIV prevention and control act implemented in Uganda has actually increased stigma, trauma and stress with the implantation of heavy fines on HIV positive people.

-       Is incarceration as punishment actually discrimination? In South Africa women are targeting for testing drives esp in antenatal screening – however if testing positive are indirectly persecuted, hence promoting fear towards testing.

-       Is the threat of incarceration a why in which governments globally can still impose authority.

-       Fears for women was further highlighted by the following scenario: If a man rapes a women in South Africa he is charged with rape and undergoes mandatory HIV testing, if positive he is then also charged with infecting people. On the flip side, the women raped is also tested, and if she is found to be the source, then she goes from being the rape victim to potentially facing a charge for HIV transmission to the rapist!

-       Do HIV, MSM and Sex worker clinics promote health care and reduce stigma or do they promote isolation and less integration and public understanding by segregation.

-       How can we reduced the distrust between consumer populations and research communities. Is it by educating, training and giving voice in positions to consumer/ peers. Would a society then specifically place aside allocated funding and positions for consumers/ peers to enter the industry and become researchers. In the Australian context how would this be rolled out? Similar to indigenous program models and would this encounter any population bias or speculation, helping reduce stigma or increasing it?

 

Session OS  - Opening Session - Fighting AIDS with Style 

On an additional note the final speaker of the day at the opening session was a special event guest, designer Kenneth Cole, now chairman of amfAR. He has dedicated his social and influential career in the fashion industry since 1985 to helping reduce stigma by being an individual public voice. From his efforts to not live in the dark or silence and instead pushing controversial AIDs and HIV issues into the public light.  https://www.kennethcole.com/lgfg-making-aids-history.html

It is something about the concept of stigma, trauma and stress in relation to HIV in all aspects including research barriers that should be challenged by more people speaking out and making it an acceptable public topic for discussion. When society is forced to fell comfortable about what is actually going on around it and within it, it is then that ignorance and bigotry can be overcome and help reduce stigma and hence promote public health.

This morning we saw a series of presentations from the Monopoly Study, which is a national Australian study that looked at how gay and bisexual men think about and conduct their relationships. They looked at whether gay men have explicit relationship agreements with their regular partners, particularly around issues like monogamy. They also presented finding around why and when couples change their relationship agreements from monogamous to open and vice versa.

Some interesting points included:

  • There is inconsistent classification of sexual partners in the literature. Generally in Australia partners are classified as either "regular" or "casual", but the definition of these categories is inconsistent. Particularly, they highlighted that "fuckbuddies" can be placed in either the regular or casual partner category, and perhaps clinicians and data collectors need to consider this group of partners as separate to either regular or casual partners.
  • Young men have shorter relationships than their older counterparts.
  • Young men tend to assume that being in a relationship means that the relationship is monogamous, so they don't tend to have explicit relationship agreements. There was some discussion on why this may be so. One thought was that these days young gay men tend to have more heterosexual friends than in previous generations, and hence they tend to have views on relationships that mirror their heterosexual counterparts. I think that perhaps this may also underlie the change in relationships amongst young heterosexuals, where it seems that young heterosexual couples now more often make explicit agreements around monogamy vs having an open relationship. Another possible contributor to the lack of relationship agreements among young gay couples is the ongoing marriage equality campaign. I think it's fair to say that the marriage equality campaign in Australia tends to promote monogamous gay relationships as being "the norm", and tend to ignore the many other possible types of gay relationships. Such campaigns may have altered the perception of young gay men on what is expected in a gay relationship, and hence they don't feel the need to have an explicit agreement.
  • Older men tend to have explicit relationship agreements. The explanation offered was that many gay men over time come to the realisation that relationships are complex, and that the supposed "rules" dictated by social norms are not concrete. As such, they feel that it's important to discuss the needs of both partners, and that an agreement is reached, which is may subsequently be revised when the couple's needs change.

So what does all of this mean for clinicians?

  1. It may be useful to ask patients about fuckbuddies when talking about their relationships, and to ask what agreements people have with their fuckbuddies. In the "casual" vs "regular" linguistic dichotomy, fuckbuddies may get lumped in the "casual" category, and thus not get the attention they deserve.
  2. We must ask young gay guys whether they have explicit relationship agreements with their regular partners and fuckbuddies, as this data shows that they often assume that their relationships are monogamous. The assumption of monogamy may place them at increased risk of HIV and STIs.

The afternoon session: O21 - HIV and co-morbidity started with two speakers who complemented each others presentations very well.  

Dr Paddy Mallon provided an excellent overview of the cardiovascular risk factors associated not only with HIV itself, but the ART used in its management - especially abacavir.

Importantly he provided an overview on the potential role of increased platelet activity and their role in increasing the risk of vascular events and thrombosis. He concluded with reference to a current trial of pitavastatin to assess its potential in reducing hyperlypidaemic risk.  

Dr Janine Trevillyan followed on with an excellent overview of why HIV patients are at increased risk of CVD including dyslipidaemias, immune activation, platelet activity and other risk factors such as a higher incidence of smoking and diabetes.  

Janine then provided an overview of her current research activities on platelet derived soluble glycoprotein VI (sGPVI), where she described the observation that sGPVI levels are reduced in the month preceding a cardiac event in HIV positive patients and may have an important role in promoting cardiovascular disease in this population.  It was postulated that this reduction in levels may be linked to a pathological process leading to MI, or sign of an unstable plaque.

This stream covered quite a range of issues in regards to PrEP and it's use.

Dr Zablotska told us that community surveys show informal prep is currently being used in AustraliaPrEP was being accessed were through state based PrEP demonstration projects or through self importation. It was important to know the likely eligibility and demand for PrEP in the community. Based on the highest risk group ie MSM and using national statistics, self reported data and guidelines - conservatively it was estimated that eligibility and demand for PrEP ranged from 2500 to 6000 cases.

Dr John de Wit presented data on the change in sexual behaviours and risk reduction in men who are on PrEP. Using baseline and 3 month questionnaires from VicPREP - nothing changed in subjects with regular partners, in either frequency of sex or risk reduction practices. In subjects with casual partners - there was no change either BUT there is a moderate reduction in condom use in casual partners, specifically an increase in 'never used a condom' and a decrease in 'most of the time' in the last 3 months.

This was definitely a difference between trials/extension projects vs demo projects. It is possible that there was a selective change in risk reduction practices, based on informed decision making to balance risk and pleasure. A focus on 'real world' use of PrEP would have to be on sustained education and support on sexual risk reduction strategies, including condom use. This would especially be important for other STIs. This was my take home message from these sessions.

Dr de Wit then spoke about the early experience of men using PrEP in the VicPREP demonstration project. Although 53.9% of subjects reported missing ANY prep doses, the median number of doses missed was 1 dose. This didn't alter the effectiveness of PrEP. The main reason? Forgetfulness!

 
Six men reported interrupting the use of PrEP for 2 days or more. the reasons? They were myriad but included travel, perceiving that they were not going to have sex or actually not having sex, waiting for pills to arrive, depression, and other unrelated minor ill health issues.
 
Significantly there were changes in the perception of sex inline with views espoused by Dr Grant at the PrEP forum. The use of PrEP was associated with empowerment of the individual, healing of trauma, mitigation of fear and generally was received well by partners/contacts.

Presented by Dr Phillip Read, Sexual Health Physician and the Acting Director of the Kirketon Road Centre in Sydney’s Kings Cross who spoke about the rising rates of Syphilis and co- infection in HIV+ve men. There are increasing rates of syphilis notifications in the MSM cohort, with more than 50% of notifications in this group. In Canada, there is a 300x increase in rates of syphilis associated with HIV infection. In OECD countries, there are increases evident in the male to female ratio of syphilis infections. 

 
Other points that were discussed included 'PrEP' for syphilis in a proof of concept study which used doxycycline 100mg daily. It demonstrated a 73% reduction in infections, with minimal side effects.
 
Also, a study that showed that 2 weeks of doxycycline showed no difference in cure rates of syphilis when compared to a single benzathine dose. That's reassuring for myself when I've had to use that regimen for those who can't use penicillin. Interestingly, another study showed that a 3gm dose of amoxicillin had a 95% cure rate for syphilis. 
 
The take home message for me was about treatment of syphilis in HIV+ve individuals. Time to come clean... I have to admit that I have always been in the '3 is better than 1' boat however a study in the U.S. Military Cohort showed no difference between 1 dose and 3 for cure. Interestingly, 40% of syphilis treatment in Australia was with enhanced therapy (ie 3 injections) vs guidelines for acute/early syphilis. So there are many in my boat, but I think it's time to jump ship.

HIV and Women's Health was the topic of Wednesday morning's stream. Much interesting and varied work was presented. I will attempt to summarise below.

Damian Jeremia presented his work entitled Prevalence and Factors Associated with Modern Contraceptive use among HIV-positive women aged 15-49 years in Kilimanjaro region, Northern Tanzania.

Women's responses to a questionnaire and interview in Swahili language were aggregated. Results showed that only 54% of these women were using a form of modern contraception. Male condoms were the most common contraceptive method (25.4%). He cited lack of contraception information and lack of combined reproductive health and HIV services being the main barriers in contraception use. 

Dr Lisa Noguchi presented on some complex findings from women participating in the S African-based VOICE trial. The VOICE trial is a Phase 2B trial of women using tenofavir as HIV prevention, and one of the eligibilty criteria required having effective contraception.  Lisa's secondary analysis of the data looked at injectable Progestin contraception and acquisition of HSV2 Infection. Injectable progestins are the most common contraceptives used in S Africa. Whilst some data suggests hormonal contraception may increase HIV-1 risk for women, recent studies have suggested there are differences in this risk between the 2 commonly available progestin injectables - DMPA and NET-EN. Retrospective analysis of the VOICE data showed HIV-1 was higher for users of DMPA vs. NET-EN (aHR 1.41, 95% CI 1.06-1.89) p=0.02.   However, the risk of HSV-2 acquisition  between the 2 types of injectables turned out to be not significantly different.     She noted that the data was extracted from the VOICE study retrospectively, which was originally designed to demonstrate different data and results could therefore be prone to bias.

 

Shaun Barnabas presented longditudinal cohort data on genital symptoms and STIs in just under 300 women aged 16-22 years in different cities of S Africa. The Cape Town cohort was more risky in behaviour with a high prevalence in STIs vs. Johannesburg, specifically a higher prevalence of chlamdyia, gonorrhoea and HSV-2. There were low rates of symptoms reported across the board,with "normal vaginal discharge" being the most common symptom (58%) and "abnormal discharge" 8% at baseline.There was little correlation between symptoms and STIs. This is an issue as S African guidelines are based on syndromic management, thus potential for under treatment is significant. 

His final question was "Is it time for the SA government to move away from syndromic management?"  The resounding answer from the audience response was "Yes!".

 

Alison Norris educated us about the gender differences in HIV testing and knowledge in Rural Malawi, one of the poorest per capita countries in the world. There were encouragingly very high rates of HIV testing in both sexes. Most powerful predictor in whether someone of either sex had ever had an HIV test was knowing the partner had received a test. Ultimately their prediction that there would be significant differences between testing and knowledge between men and women was unfounded.

 

A/Prof Sheona Mitchell talked on uptake of cervical cancer screening among HIV positive women participating in a pilot RCT in Uganda: the ASPIRE project (a collaborative study between Canada and Uganda).  The aim of the ASPIRE project is to inform policy makers about cervical screening programs in resource poor areas.

They studied 500 women in an urban community in Kampala. Usual cervical screening involves visual pelvic speculum exam with acetic acid application.ie invasive. The potential for a less invasive test such as a self-collected swab detecting high-risk HPV strains is a novel, attractive approach for low-resource settings. HIV positive and negative women were randomised to speculum visual exam or self-collected swab. 

Self collection of swabs had a high uptake in both HIV pos and neg women. It was found to highly acceptable, improved access and had high rates of retention going forward to further exam and treatment (compared to visual exam alone).  She was hopeful of future POCT for the HPV swab to further reduce barriers to cervical screening uptake. 

 

Elizabeth Fearon then finished up the session by presenting interesting data on a method to estimate the national prevalence of HIV among female sex workers in Zimbabwe by pooling data from Multiple Sampling Surveys and Programme Consultations.

My take home message from all of the above presentations is that there is much great innovative research going on in some of the most resource-stretched places on Earth.   Many small steps are being made towards improving access to screening, testing, support and treatment for women (both HIV positive and negative) from these difficult to reach populations and places.  But there is still a long way to go.

 

PrEP Community Forum (aka Are you PrEPing for the future?)

What a privilege to attend this forum which featured amongst others Dr Robert Grant, named one of Time magazine’s most influential people in 2012 for being the father of “treatment as prevention.” Dr Grant highlighted the observation that PrEP use in San Francisco had reached a positive tipping point in the last few years, with increasing use of PrEP. How have they come to this point?

It's been driven by:
1) PrEP research and demonstration projects being run in San Francisco
2) The FDA approval for Truvada use in PrEP, and
3) Word of mouth and the use of social media

Dr Grant also reiterated that by using an intention to treat analysis, PrEP is efficacious - the analysis shows that in order to prevent 1 HIV infection, 13 to 18 people were required to be treated. The recommendation for PrEP is for daily dosing although the data shows that if users were taking PrEP 4 times or more per week, the benefits were maximised. Daily dosing provides for a high level of protection and is forgiving of the occasional missed dose. The exciting takeaway message I took was that currently, there are Phase 2 Trials in long acting injectable PrEP, which may come to fruition around 2020.

Dr Darren Russell spoke about PrEP in Australia and the current 'lay of the land'. Importantly, he announced that the HIV Foundation Queensland was in planning to roll out an affordable access program for low-income individuals via the Foundation, to counter the social and ethical inequities of access to PrEP in Queensland. Dr Russell also 'hypothesised' that Truvada for PrEP may obtain TGA approval in the first quarter of 2016 and hopefully PBS approval in the latter half of 2017 (all going well). Watch this space!

Most importantly, this forum highlighted the social science and personal impacts of PrEP - it's ability to mitigate the fear of HIV, the empowerment of users, the circumvention of condom difficulties to prevent HIV infection. We heard both from Chris Williams an early adopter and PrEP advocate and Dr Fiona Bisshop, a PrEP prescriber at Holdsworth House Medical Brisbane.

The final word? If you are not PrEP'd for the future, you better get with the program.

Tuesday mornings Oral Abstract session was titled PreP: Demonstration for Implementation presented the initial findings from at least four studies into issues such as adherence and uptake. The studies examined some key affected populations. 

 

Of particular interest was an abstract from the U.S about PreP in Young MSM (YMSM) and transgendered women by the adolescent trials network (ATN) study 110. YMSM are at particularly high risk of HIV acquisition and remain relatively understudied with respect to PreP.

 

The ATN 110 study has some locally relevant points. 

 

ATN 110 was an open label study or once daily TDF/FTC across 12 U.S cities of men aged between 18-22. 

 

The primary objectives were to 

 

  • provide additional safety data on FTC/TDF use in YMSM
  • to examine the acceptability, patterns of use, rates of adherence and drug levels when YMSM are provided open label Truvada and 
  • to examine patterns of sexual behaviour when YMSM are provided PreP

 

The 200 enrolled participants had self-reported high sexual risk in the last 6 months and were HIV negative. 

 

The mean age of participants was 20 years, 78% identified as gay, more than 80% reported condoles anal intercourse in the last six months, almost 60% receptive anal intercourse and 22% were positive for an STI at screening. More then 50% were black.

 

There were very few adverse events but 25 discontinued primarily due to personal choice or a self perceived change in their sexual risk.

 

Study participants were incentivised $25 per visit and had study visits at weeks 4,8,12; then three monthly. 

 

There were 4 seroconversions by week 48. All four had undetectable levels of Truvada, None of them had drug resistant virus.

 

Generally, participants reporting higher sexual risk had higher levels of Truvada. This remained consistent though to week 48. The mean number of parterns and condomless sex acts was mostly unchanged. STI rates remained as high as there were at baseline.

 

Notably, adherence decreased for all participants over the 48 weeks. Adherence appeared to decrease as the study visits decreased in frequency. Some qualitative research will be done some time in the future. This could infer that YMSM may need more rigorous follow up or an ‘enhanced visit schedule’

 

 

Wednesday’s Plenary will further examine PreP

There has been a theme running through the conference, and I believe through the UK and Europe about where is the best place to provide HIV care. The Australian concept of the highly trained and experienced General Practitioner or Primary Care physician seems to be missing. This is interesting given the very regulated structure of general practice in the UK. But also perhaps understandable because of the existence of GUM clinics.

Yesterday morning's symposium Making Health Care Resources Count: What is the Optimal Way of Managing HIV? gave a number of perspectives. Andrew Briggs gave an interesting and informative introduction to health economics and particularly focused on the concept of driving cost down while minimising any associated reduction in health benefit. This is basically the exact opposite of introducing new drugs or approaches, which have demonstrable benefits but come with commensurate increases in cost.

This theme was continued by Nathan Clumeck who looked at task shifting to minimise cost without compromising outcomes. I think many of us are familiar with this in the developing country setting. But diminishing health budgets are making the discussion of these issues more prominent in the developed setting. WHO has recently published approaches to task shifting in resource limited settings.

Jens Lungren introduced an additional concept to the cost benefit analysis, that of the additional contributory benefit of prevention and reduced transmission, gained by achieving durable suppressive therapy. In his cost benefit analysis a slightly lower benefit for some patients, might be traded for greater population benefit. For example having more people on adequate suppressive therapy, might have a better cost profile than less people on very high cost suppressive therapy, and some people getting no therapy at all.

Alain Volny-Anne presented an interesting patients' perspective reflecting that decentralised care and community care could mean that people living with HIV now needed to access multiple care providers if they were no longer having all their care needs provided by a specialist HIV facility. He referred to this as the "go away" trend. One of the Australian HIV Community S100 prescribers indicated that in Australia she would be able to provide the majority of that care in the general practice setting.

The outcomes from this session were that prevention is cheaper than treatment, no matter how treatment is delivered. Tasks can be shifted provided that there is adequate training, with supervision and support when required. Nathan Clumeck described a model which involved generalists, physicians assistants, nurses and peers in the delivery of routine care, with second and third line care being restricted to specialist physicians.

Additional Abstracts

Two additional abstracts were presented in this symposium. They related to regimen changes as a way of reducing drug costs in the UK. It has to be recognised that there were abstracts added to the symposium and not papers developed for the symposium. They both suggested considerable cost reductions:

  • Hill by switching from brand name co-formulations to generic single drugs multi-pill regimens, and
  • Walker by switching from triple-therapy to PI monotherapy

Questions and comments from the floor and subsequent discussions were mixed about the point of even considering these options. It was pointed out that the introduction of generics may result in people having their regimen dictated by their capacity to pay as well as by purchasing and discounting arrangements used by Foundation Trusts negotiating prices.

Two posters on the related themes of where best to provide care:

P139 A comparison or routine and targeted testing strategies Perez et. al. from Spain, Found that routine testing was ALWAYS better in primary care. Targeted testing was lower than routine, testing only 50% of the population. But the best result were found in routine targeted testing in Primary Care.

P160 Late diagnosis among our aging HIV population Mensforth et. al. UK. Found that 27 people over 50 with a HIV indicator condition were not tested for HIV in acute medical unit.

 

 

In Prof Greg Dore’s exciting presentation on Friday at the 9th Viral Hepatitis Conference, Expanding access to hepatitis C treatment through primary care: Challenges and opportunities, he spoke about the HCV disease burden in Australia and the opportunities for increased involvement of GP prescribing whilst acknowledging some of the current barriers.

Despite an expanding burden of progressive liver disease, treatment numbers remain low at around 1%. Australia needs to increase numbers of people receiving antiviral therapy to around 6% as the numbers of people with cirrhosis are projected to reach over 37,500. Increased efficacy of future treatment alone will not significantly reduce the burden of disease. Greg noted the number of prescribers is a key determinant of treatment uptake.

GPs already manage very complicated patients with multiple chronic diseases, including HIV, and many are involved in addiction medicine. Data from recent studies, such as ETHOS and the ASHM GP Treatment Initiation Pilot, was presented and demonstrated HCV treatment can be provided successfully in primary care settings with efficacy rates comparable to tertiary centres. Greg acknowledged current barriers exist in expanding HCV treatment in primary care, such as the Highly Specialised Drugs regulations, existing HCV treatments are complex (but that these will change soon), that interferon-free direct acting antiviral therapy will likely have initial s100 restrictions and that there is still some conservatism among specialists. The need for primary care incentives was also highlighted.

Greg proposed strategies to increase assessment and treatment uptake which included changes to s100 regulations and antiviral therapy access through public health advocacy; simpler treatment assessment, treatment regimens and delivery; increased education and involvement of health care professionals.

In closing, Greg said it was time to move forward and not to pit one model of care against the other (e.g. GP prescribing vs nurse-led models), as there is a role for multiple models in order to increase the number of prescribers to treat the 10,000-15,000 people that is needed to reduce the burden of HCV in Australia. A person with a fibrosis stage F0 to F2 will not require ongoing monitoring once cured of their HCV, so the burden of HCV disease will decrease as more are treated.

It is exciting times in hepatitis C – what other chronic disease can offer a cure? Let’s work together and get as many treated as we can.

The 9th Australasian Viral Hepatitis Conference has offered up a variety of lessons learnt from trials and piloted services. The question is, which model/s will be taken on if we are to massively scale up our response to hepatitis B (HBV)?

During the proffered papers session on Clinical Care for HBV, Thursday, 18 September, Tracey Cabrie addressed the topic of improving quality of care for people living with HBV in primary care, with some preliminary data from the Integrated Hepatitis B Service, run out of the Royal Melbourne Hospital. Tracey works as a Hepatitis B Integrated Care Nurse in the Service, a role which is shared, and funded for 0.8 FTE.

The Integrated Hepatitis B Service provides support to high case load GP clinics, through capacity building, developing clinical pathways, and supporting the increase in testing and vaccination. Through the Hepatitis B Integrated Care Nurse, the service has engaged 45 primary care professionals within 5 primary care clinics in 2 years. Within these clinics, 830 patient records have been audited, with 328 patients identified as having chronic hepatitis B (CHB).

Cabrie’s team collected baseline and follow up data at 18 months at 2 clinics. Of patients with CHB, the majority were in the immune control phase. At follow up, the majority were managed by their GP, compared to the majority at baseline being managed by a specialist. There were improvements in rates of annual LFTs and DNA in both clinics at follow up. Between 20-30% improvements in liver ultrasounds for HCC (in line with the guideline) at follow up.

Lessons learnt?

Relationship building with the clinicians was essential to capacity building

Patient-centred care is vital, and therefore service delivery should be varied, as each practice is different, and each patient's needs are different

The audit of patient records supported the idea of developing systems, and the need to provide or link in training and resources

Guideline-based CHB management is achievable in a primary care setting

In short, it seems there’s “no such thing as a model of care” – real quality care needs to be flexible, responsive and appropriately resourced. CHB management is complex and therefore requires a nuanced and multi-faceted intervention. 

Please join us for a memorial event celebrating the life of one of Australia’s leading HIV advocates, Levinia Crook… https://t.co/N7dof5xaGa

ASHM ASHM