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.

IAS2017 Tuesday 11 am 25/7/2017

 

This session provided updates from various oral, topical and long-acting injectable PrEP clinical trials.

 

Sheena McCormack presented long-term PROUD study data from 2-4 years post enrolment.  This indicated that reduction in HIV incidence was sustained, and confirmed high adherence and durable effectiveness of PrEP in the study population.  However, as suspected rectal chlamydia and gonorrhoea and syphilis diagnoses remained high re-iterating the need for structured regular followup of these high risk patients.

 

A qualitative analysis exploring PrEP perceptions among PROUD participants, found that most viewed PrEP as a temporary HIV prevention option. Participants described psychosocial benefits in terms of reducing fear and providing relief when taking PrEP.  They didn’t discuss some of the stigma that still persists in the community about people who take oral PrEP however.  Acceptability seems to be increasing however.

 

Guillemette Antoni presented data from a double-blind, randomised sub-study of IPERGAY which found a significant reduction in HIV infection risk with on-demand TDF/FTC vs. placebo, in MSM having infrequent sex.  Oral PrEP with tenofovir/emtricitabine is now subsidised in France.

 

Sharon Hillier presented data from the completed FAME study.  This study found that FGT and plasma drug levels of dapirivine were not affected by Lactobacillus or G. vaginalis microbiome.  Tenofovir levels in FGT and plasma however are adversely affected by vaginal disbiosis (bacterial vaginosis). The potential influence of vaginal microbiome on topical and plasma PrEP drug levels emphasises the need for HIV prevention products that work in women with vaginal dysbiosis.

 

Ian McGowan from the USA presented data from the MWRI-01 multi-dose Phase I study.  They found long-acting IM rilpivirine to be safe. Drug accumulation was significant in plasma, rectal, and female genital tract (FGT) tissue.

 

Finally, Raphael Landovitz presented data from HPTN077, a double-blind, randomised, placebo-controlled tolerability and pharmacokinetics trial.  They found LA cabotegravir was well tolerated at 800mg/600mg doses in HIV-uninfected low-risk males and females.

Normal 0 false false false EN-US JA X-NONE Updated safety, acceptability and pharmacokinetic data on LA IM rilpivirine and cabotegravir provides hope for the viability of long-acting injectable PrEP formulations and circumvention of the adherence challenges associated with oral or topical PrEP.

Tagged in: 2017 IAS Conference

 

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.

 

0 0 1 202 1155 Dr Chris Sherman 9 2 1355 14.0 Normal 0 false false false EN-US JA X-NONE

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.

Tagged in: 2017 IAS Conference

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 

 

 

 

Tagged in: 2017 IAS Conference

Dr Sinead Delany-Moretlwe presented a plenary regaring the implications of implementation of PrEP.

In November 2015 the World Health Organization recommended that PrEP be offered to high risk individuals. This was based on key evidence of 12 randomized controlled trials of oral PrEP effectiveness. PrEP was found to be effective at reducing HIV across age, gender or mode of HIV acquisition. The caveat to this was the effectiveness of PrEP depended on the level of adherence.

The greatest impact and cost effectiveness of PrEP will be in populations where HIV incidence is >3 per 1000 person years.

As a result of the WHO recommendations truvada as PrEP has been approved in more than 17 countries and just recently has been approved in Belgium, Portugal, Brazil and now the UK. US data of retail pharmacies has shown a dramatic increase in the rates of PrEP prescribing. There has been a 738% increase in prescribing since PrEP was recommended. UNAIDS has estimated that >160,000 people globally are currently on PrEP. However the targets set for those on PrEP by 2020 is 3 million people.

So what does PrEP offer for the patient? Decreased anxiety, increased disclosure amongst partners, increased intimacy and trust and increased self efficacy.

However there are significant barriers to PrEP use and these involve stigma surrounding its use. Other perceived barriers include:

1.) Safety in terms of side effects and effects on bone/renal health

2.) Resistance

3.) Longer term follow-up

4.) Development of safer drugs

5.) Potential effects in pregnancy and breast-feeding

6.) Cost especially if public funding is involved

The key questions to implementation include- how do you create demand? How do you supply demand? How do you support effective use?

Certainly many of the challenges can be seen as opportunities to strengthen and revitalize sexual health services for those most in need.

 

This session was delivered by Dr. Andrew Grulich (Kirby Institute, Australia).

Dr. Grulich began by stating that, 'We know PrEP works'. He presented some short soundbytes about lessons learned from PrEP trials in Australia.

-PrEP quickly attracts very high-risk gay men.

-There was high levels of adherance (proven by drug monitoring testing).

-This cohort has high levels of STI's (showing their relative HIV risk).

-No HIV seroconversions seen in about 500 person-years.

As Australia has a concentreated epidemic (~0.1% prevalence in general population v ≤15% in MSM in urban centres), the most impact that PrEP will make is to target high risk MSM. Andrew presented a model that showed that if the high risk MSM group were saturated with PrEP users, it would result in much lower incidences of HIV plus it would have a herd immmunity effect on those in the same sexual networks but not exhibiting as high risk taking behaviour.

Andrew discussed the EPIC study. He discussed how some clinics workloads were much increased due to the amount of MSM on PrEP attending their clinics. This showed that innovation was required to ensure the services continued whilst under great pressure.Thes innovations included:

-Peer led education pre-consent sessions.

-Same day PrEP precriptions.

-Nurse led dispensing/care requiriung only once or twice yearly medical review.

Dr. Grulich asked the question, 'Will PrEP end HIV?' His answer was that whilst safer sex practices and TasP has resulted in stable HIV prevalnce in NSW, it hasnt showed a reduction. He displayed a slide that showed that since the PrEP study was rolled out, HIV prevalnce has REDUCED by 23% in the second half of 2016 in NSW. He did warn that it is too early yet to say PrEP is the reason. More data and time past is required.

He concluded by saying that should PrEP be rolled out as a national startegy, federal government subsidy would be required. The cost may not be as high as first thought as the PBS is considering an application for generic Truvada to be added as a PrEP treatment.

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Tagged in: APACC 2017