Transactional sex in MSM: How common is it? Who does it? What are the risk factors?

This presentation looked a cohort of MSM from Vancouver. Canada, to examine prevalence, trends and risk factors of transactional sex and ultimately if transactional sex constitutes an increased risk of HIV transmission.

The study design was a prospective cohort study with respondent driven sampling of approximately 700 MSM aged over 16 years. 201 participants were HIV positive. Participants used a computer assisted questionnaire with the main outcome was an exchange of money/drugs/goods or services for sex. The data was analyzed with a multivariate logistic regression model.

Transactional sex was found to be rare in this cohort (between 1-3%).

Transactional sex was more likely with the following factors:

1) partner was met online

2) a lower incomes

3) a lower level of education

4) identification as bisexual

5) having an older sexual partner and

6) having a partner who uses either crystal methamphetamine, GBL or GBH

Partner substance use was most strongly associated with transactional sex, No significant associations with HIV risk behaviour.

A late breaker poster was presented Tuesday showing the 48 weeks data comparing Bictegravir co-formulated with FTC/TDF in a fixed dose combination (B/F/TAF) vs. DTG/F/TAF in treatment naïve HIV-1 positive adults. The study is phase 3 multi-centered RCT with a primary endpoint of HIV-1 RNA < 50 copies /mL at 48 weeks, powered for non-inferiority.

B/F/TAF was safe, well tolerated and non-inferior to DTG/F/TAF in treatment naïve adults. Discontinuations due to adverse events were uncommon in both arms . There was no evidence of treatment-emergent resistance to study medication. Interestingly there was less of a decrease in the e GFR observed in the B/F/TAF participants. No difference observed in lipids.  

IAS2017 11 am Monday 14/7/2017

This session was about emerging therapies for HIV and new approaches to specific patient populations.  The topics covered in this session included immunodeficiency at the time of ART initiation and the use of various ART combinations in different settings such as advanced immunodeficiency, second-line ART resistance and the use of novel 2 and 3 drugs combinations in ART-naive individuals.

The first speaker, Nanina Anderegg showed that median CD4 count at ART initiation was <350 cells/µL, with >25% of individuals at CD4 count <200 cells/µL, in low, middle and high income countries in 2015.They analysed data from the International epidemiology Databases to Evaluate AIDS (IeDEA) in sub-Saharan Africa, Latin America, Asia-Pacific and North America regions and from the Collaboration of Observational HIV Epidemiological Research in Europe (COHERE). They included all HIV-positive adults (≥16 years) initiating cART between 2002 and 2015.  This demonstrated that a substantial number of individuals still initiated ART at advanced immunodeficiency. Additional efforts and resources are needed to improve testing coverage, linkage to care, and ART initiation globally.  There was a general trend to start ART at higher CD4 counts in the later years of the study though, which is encouraging.

Lelièvre found that the addition of maraviroc (MVC) to standard ART in advanced HIV infection had no impact on the risk of occurrence of infections, serious events and mortality, virological control or CD4 count recovery.  However, post hoc analysis showed a trend for a beneficial effect of the addition of MVC in the first 24 weeks in CD4 count recovery that disappeared thereafter.  Therefore miraviroc may be of some benefit in immune system reconstitution in early stages of therapy.

 Moh reported that in individuals failing second-line PI-based regimens, a phase of intense adherence reinforcement with HIV-RNA monitoring may help determine whether switching to a third-line regimen is required. 

 Joel Gallant showed that bictegravir/emtricitabine/tenofovir alafenamide was non-inferior to dolutegravir/abacavir/lamivudine in terms of virologic efficacy and was well tolerated. This was in treatment naïve subjects and their data extends to 48 weeks.  The single-tablet formulation bictegravir/emtricitabine/tenofovir alafenamide is potentially suited to the setting of same day/rapid ART initiation as it can be safe to start pending hepatitis B screening results, has high virological efficacy and favourable safety profile.  This study is ongoing.

In other treatment-naïve individuals, simplified combinations such as ritonavir-boosted darunavir/lamivudine was shown to be non-inferior to ritonavir-boosted darunavir/lamividuine/tenofovir in achieving HIV-RNA <400 copies/mL at week 24 as presented by Pedro Cahn.  Dolutegravir/lamivudine also demonstrated potent virologic efficacy at week 24 in individuals with entry HIV-RNA <500,000 copies/mL thanks to data presented by Babafemi Taiwo.  Early data suggest that simplified regimens consisting of ART with a high resistance barrier and lamivudine may be non-inferior in virologic control in treatment-naïve individuals. Data with larger sample sizes and longer follow-up are needed to confirm these findings.

On-demand oral TDF/FTC for PrEP: is it an option? 4 speakers put forward their argument for (and perhaps against) on demand PrEP. On-demand PrEP is an attractive and cost saving was of delivering PrEP but has only a limited number of studies to demonstrate its efficacy.

The first speaker presented strong evidence that both daily and multiple non-daily oral TDF/FTC were highly protective against the rectal and vaginal acquisition of SHIV in macaques. Various pre and post dose models were examined with “double” pre and post event dosing showing increased efficacy.

A pharmacologist followed up with a presentation demonstrating pharmacokinetic data that TDF/FTC reaches mucosal sites quickly, at appropriate concentrations and with a long enough “residence” to cover residual virus.

Bob Grant spoke following this about clinical experience of non-daily PrEP. Worldwide. Various non-daily PrEP studies (e.g. Holland, Montreal) show a significant cost saving as well as high patient satisfaction and preference. However, data from HPTN 067 showed fewer sex events were covered by non-daily PrEP use when compared with daily PrEP use.

The final speaker elaborated on the HPTN067 study. Non-daily PrEP regimens in this study were found to me more appropriate in participants who could adhere, had fewer sexual exposures and who could plan for sex.

There was a flavor of dual therapy around Mondays Plenary. An interesting study for Australian audience was the ACTG A5353 study which is a pilot study of Dolutegravir  + lamivudine for the initial treatment of HIV-1 infected individuals with viral loads of less than 500,000 copies/mL.  The 24 weeks data was presented using the FDA snapshot definition. There were 120 participants with no baseline resistance identified. There were no discontinuations. This regimen demonstrated potent virilogical efficacy at 24 weeks. 3 patients met the criteria for a protocol defined virilogical failure (PDVF), one had emergent M184V.

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The other interesting update was the 48 week data for Bictegravir(B)/F/TAF vs. ABC/DTG/3TC. This is a phase 3 RCT for treatment naïve adults. The primary endpoint HIV-1 RNA < 50 copies, powered for non-inferiority. B/F/TAF was non-inferior at 48 weeks. It was well tolerated and there were no adverse events leading to discontinuation. Nausea was significantly greater in patients taking ABC/DTG/3TC.  Gastrointestinal, Neuropsychiatric and sleep related problems were also more common in the ABC/DTG/3TC patients. Changes in BMD and renal function were comparable. The speaker felt that B/F/TAF was an “attractive” option for rapid commencement of antiretroviral therapy as no HLA status is needed and it could likely be commenced irrespective of Hepatitis B status and renal function.

This was an interesting presentation in that it gave the perspective of what is happening with wider access to PrEP throughout the world, which I think is highly relevant given the recent submission for PrEP to be listed on the PBS in Australia.  It started off with a taste of the WHO's PrEP implementation tool that will be officially launched at IAS 2017 and aims to provide a framework for implementation of PrEP on current evidence to a number of stakeholders, including clinicians, pharmacists, consumers and regulatory officials.

The talk then moved on to what is happening in France, home of the ipergay study which demonstrated that on demand PrEP was efficacious.  France has been successful in implementing access to PrEP within their state funded health system and as of early 2017 had almost 3,000 people on PrEP.  The main PrEP users in France are men who have sex with men (MSM), however a strong campaign is underway to ensure other target groups within France, namely migrant and transgender women are aware of PrEP and their access to it.

Moving on to South Africa and their implementation which has focussed on two main priority groups within their context – commercial sex workers (CSW) and MSM.  Between June 2016 to June 2017, over 30,000 CSW had HIV tests and almost 2,000 were initiated on PrEP.  For the same time period, over 1,000 MSM had HIV tests and over 200 were initiated on PrEP.  Both these groups demonstrated a fairly low overall uptake with CSW uptake around 7% and MSM uptake around 21%.  The uptake within the transgender community was reported to be very low.  Possible reasons for low uptake included stigma of ART medications, even if used as PrEP and inconvenience of clinic setting and to address the latter issue, the model of care has evolved into a nurse or peer led service with more convenient hours, locations and mobility.  What is great to see is in South Africa, of the people who do commence PrEP, about 75% are women and about 75% are between the ages of 19-34, which means that PrEP is getting to the groups that need it most, as in Africa the highest growing incidence is in women and young people.  Another great outcome is the sheer number of HIV tests that are being done – a step towards addressing the first 90.

Next stop on our world tour -  England, home of the PROUD study, famously interrupted due to the high 9% incidence of HIV in the delayed PrEP group.   There are currently an estimated 6,000 people on PrEP in England, the main source is via personal importation as the NHS were not willing to fund the addition of PrEP onto the national formulary, despite two court cases to compel them to do so.  Some funding for limited places has been made available recently.  Further compelling evidence for PrEP was presented in a 42% reduction of new HIV cases between 2015 and 2016, demonstrating that PrEP is benefiting both the individual and the greater MSM community. What is interesting is that the incidence of Chlamydia has been reported as stable when compared to the number of increased tests and that cases of Gonorrhoea have indeed decreased by 24% between 2015 and 2016.  No data for syphilis was presented at this talk.  The data for the bacterial STIs is encouraging as opponents of PrEP may use the rise in these STIs as an argument against widespread implementation.

Over to Australia and the achievement of the 90, 90, 90 targets was highlighted yet despite this, stable notifications of new infections and a significant proportion of new infections (70-80%) in MSM demonstrated that in the Australian context, meeting 90, 90, 90 is just not enough to make a population impact. Small PrEP demonstration projects in 2014 in New South Wales, Victoria and Queensland with combined numbers of around 500 participants demonstrated that high risk MSM (demonstrated by high rates of other STIs on enrolment) were willing to enrol and uptake PrEP with good adherence. The taxpayer funded health system in Australia calls for a cost effective and high impact upscaling and as such, high risk MSM remain the target population.  This upscaling was implemented in the EPIC trial in NSW which has over 6,000 paticipants in that state alone (other state trials only got a brief mention but an estimated further 6,000 places combined are available).  Data presented from EPIC demonstrates that the target group of MSM is being reached, that those under 20 years of age are under represented and that Gonorrhoea notifications are continuing an upwards trend, one that was already underway before the implementation of wider use of PrEP. It appears that new HIV infections have decreased with a reported 29% reduction in all diagnoses and a 43%reduction in early diagnoses in the first quarter of 2017, compared with the previous five year average, however more data over more time is required to ascertain if this is a significant trend as a result of PrEP.  Given these figures, there is great hope that PrEP will be PBS listed and the outcome of recent submissions to the PBAC will be known late August 2017.

Kenya presented next and identified their target populations as CSW, MSM and adolescent girls and young women (AGYW).  There have been significant milestones in Kenya’s upscaling since July 2016, including national guidelines, approval of generics and a national PrEP scale up launch in May 2017.  Further information presented revealed uptake in a number of groups beyond the initial three target groups, including partners of sex workers, men who have multiple female partners and serodiscordant couples.  A substantial media campaign was adopted to attempt to address the stigma with PrEP use in Kenya.

Last but not least was a presentation on the target group of adolescent girls and young women, an over represented group in Africa with some dramatic figures – 1000 young African women dying from HIV related illnesses every day in 2015, 90% of all new infections in 15-19 year olds in girls are in Southern Africa and only a 6% reduction in HIV in women 15-24 from 2010 to 2015.  HIV in pregnant women in South Africa was also startlingly high with an 11.5 % prevalence in women under 16 years attending for antenatal care all the way up to 51.9% in those over 25 years of age.  Given the high numbers in women and pregnancy, an assessment of PrEP in a sexual health and reproductive clinic seting has been commenced and between March 2016 and February 2017, 429 women were offered PrEP with a 61% uptake, a 67.8% retention rate with adherence being reported as 90% based on pill counts.  This demonstration project will hopefully inform how to roll out PrEP to South African women in sexual health and reproductive clinics in the very near future as it is desperately needed.

“PrEP for adolescent girls and young women in Africa is NOT a luxury we can afford to withold “ 

I attended this one hour punchy poster discussion session on Monday lunchtime. It covered a wide variety of topics including cardiovascular, renal, lipids and brain function, chronic pain and mental health in people living with HIV. It included an Australian presenter Dr Nicholas A. Medland who concluded that "Fanconi syndrome occurs at a late stage of antiretroviral treatment" and that it is "an uncommon but not rare" outcome. That "Ritonavir use increases the incidence by 5 times". And there was a memorable point to take away that monitoring is important and simple (once to twice a year urine dipstick test) even in long term patients who do not appear to be at increased risk.

Following this there was a talk by Dr Felicia Chow regarding higher HDL and improved brain function. There were 988 participants in the study and 80% were male. 27% were taking a statin medication and 36% an antihypertensive medication. I could relate to the frustration behind the questions from the audience regarding what can you actually do to increase HDL levels. As getting active, losing weight, healthy diet, reduce alcohol and stop smoking can be a slow process but it was a reminder once again to continue to encourage these lifestyle changes.

After this was an interesting talk regarding non pharmacological managment of chronic pain by Jordan E. Lake from the University of Texas. 55 participants who were aged fifty years or older and who were living with HIV. They had chronic pain for more than 3 months (mainly osteoarthritis and/ or peripheral neuropathy) and were randomly assigned to one of three twelve week treatment options. Either 1) Tai Chi (chosen for its ability to be used by even the frailest of patients) and Cognitive Behavioural Therapy and motivational mobile phone texts or 2) a support group or 3) no intervention. 

The conclusion was that substance use was reduced by both the support group and Tai Chi/CBT/SMS intervention and pain relief and physical function improved by the Tai Chi containing intervention. This reinforced the benefit of patients living with HIV having a chronic disease management plan and team care arrangement for easier access to an Exercise Physiologist and Psychologist from their General Practitioner.

I am reporting back from the IAS2017 session Mind the Gap: Filling knowledge gaps in Paediatric and Adolescent HIV for an AIDS free generation -- the first satellite session at 8 am on Sunday morning, well attended with standing room only.

This satellite, organised by the Elizabeth Glaser Pediatric AIDS Foundation will launch the research agendas and discuss considerations emerging from the process such as the use of observational data, optimising clinical trials design, the roles of basic and implementation science, and the role of community engagement, with a focus on the meaningful engagement of youth.

As a General Practitioner previously involved with youth sexual health screens in North Queensland where there is a relatively large proportion of teenage patients, I found this session quite useful. 

The most useful discussions were personal anecdotes by the speakers and from questions asked by the audience.

One question was asked to Carlo André Oliveras Rodriguez from Adolescent HIV Treatment Coalition (ATC), Puerto Rico, regarding the use of non-monetary incentives. He described using transport and internet access as alternatives.

I have myself seen the impact of using monetary incentives as impacting on future testing and treatment and it was great to get alternatives.

The delegate next to me, from the London School of Hygiene, said that ethics committees strongly restricted them to the use of food and drink or transport only for incentives. 

There was a flyer in my welcome pack for a program in the United States called the Undetectables which also touched on incentives for maintaining an undetectable viral load.

Visit the website: www.liveundetectable.org

The discussions were mainly in the context of research but I would like to transfer this knowledge to youth engagement in primary care such as a youth drop in clinic.

They also discussed barriers such intellectually disabled youth and hearing impaired such as youth officers trained with this in mind.

They talked about some young people preferring twice daily smaller pills rather than once daily larger sized pills. But also that the options for treatment of younger people with low body weight were a barrier due to limited single pill combinations.

The Elizabeth Glaser Pediatric AIDS Foundation host again another satellite session this afternoon with the goal of the satellite to raise awareness and facilitate discourse regarding adolescent-specific needs as a part of a comprehensive national HIV/AIDS care and treatment package.

See: Nonstop Journey: Delivering an Uninterrupted Continuum of HIV Services to Adolescents and Youth