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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This was an interesting oral abstract session regarding community knowledge and approaches to pre-exposure prophylaxis.  PrEP was discussed in detail and covered topics like barriers to uptake of PrEP, preferences for prevention technologies, measuring adherence in PrEP users and how the health system and study designs of PrEP trials can facilitate rapid enrolment of those at high risk of HIV acquisition.

The first speaker was Adeline Bernier from France.  Although PrEP is already available in Norway and France through government subsidised programmes it has not been widely taken up in the rest of Europe.  She presented results from The Flash! PrEP in Europe (FPIE) online survey.  This was a community-based research study aiming to assess interest in and barriers to PrEP uptake amongst respondents from 11 European countries.  They found low knowledge of PrEP amongst at-risk groups, high interest in PrEP but low uptake.  Most commonly cited barrier to taking PrEP was fear of side effects.

Darrell Tan presented results from an MSM survey conducted with those undergoing routine HIV testing.  They asked questions regarding preferred method of PrEP delivery (oral, injectable, topical) and whether the reliability of different technologies would influence their decision on which method to use.   The results were many and varied.  Further analysis is required to understand what influences each individual’s preference for PrEP.

James Ayieko from Kenya presented results from the ongoing SEARCH trial, 18% of 4,064 participants took up the offer of PrEP within 30 days.  Participants’ perception of own risk did not always match that from a risk score.  This indicates further community-based education regarding risk is required for those considering PrEP.

Edwina Wright presented data from the Melbourne cohort of the PREPX trial. Recruitment to the PrEP trial was facilitated by a high community PrEP awareness and involvement of GPs and Pharmacists who were remunerated for their services.The high PrEP awareness in Australia contributed to the high enrolment of the ongoing PrEP study.

Rupa Patel presented data from a US study which found a good correlation between adherence measured by 3-month MPR (medication possession ratio) and 7-day self-report with TFV-DP (tenofovir diphosphate) blood levels in DBS (dried blood spot) of MSM taking daily oral PrEP.  The good correlation of the 3-month MPR and 7-day self-report with biological measures of adherence in PrEP users suggests that this could be ideal for measuring adherence in the clinic setting.

Hanne Zimmermann from the Netherlands presented data from a longitudinal semi-structured interview in MSM using PrEP.  This revealed that MSM switched between daily and event-driven PrEP use or even stopped PrEP based on their personal situation and risk exposure.  Individuals made decisions on PrEP use based on perception of their own risk.  The authors concluded that in order to successfully support future PrEP users, a tailored approach, addressing choices for PrEP regimens as a continuum of flexible and changeable choices, is essential.  Appropriate education would be an essential part of this strategy.

Quick update on a presentation by John McAllister

 

  • if source VL is undetectable, then PEP is no longer recommended
    • however, do need to discuss the reliability of the history of undetectable VL
  • Truvada should be used for PEP
    • avoid tenofovir and lamivudine (although cheaper)
  • 3-drug PEP
    • if 3 drugs are needed, then stick with dolutegravir (ALT increases by 22%), raltegravir or rilpiravine

 

All things PrEP (courtesy of Prof Jared Baeten)

I haven't come across PrEP before - it is not easily accessible in Western Australia, although a few patients have obtained it through personal importation.  Hence, the sessions on PrEP were of particular importance to me as I'm sure they will be filtering through to WA very soon.  In particular I enjoyed the summary by Prof Jared Baeten, and I've tried to summarise my learning points below.  I've combined two of his talks into one.

 

Firstly, I love this quote that he put up (forgotten who said it though): all truth goes through three phases: it is ridiculed, violently opposed, and then accepted as self-evident.

 

  • PrEP works: those who had tenofovir in their system had a >90% reduction in HIV transmission
  • PrEP works for high risk patients
  • a single agent may work as well as dual agents (e.g. TDF only = 85%, TDF/FTC = 93%)
  • adherers adhere
    • not everyone used PrEP, but those who did use it tended to be consistent users
    • non-adherers rarely started adhering
    • there wasn't much change in behaviour after 1 month
  • surprisingly, real world effectiveness was better than efficacy in the studies
    • ?adherence was better in real life than in the trials
  • PrEP  has several additional benefits
    • decreased anxiety
    • increased communication and trust
    • increased sexual pleasure and intimacy
  • chance of developing eGRF <70 while on PrEP if your baseline is >90 is extremely small
  • rising STI rates in the US have been happening for a while, even before the introduction of PrEP
  • PrEP works even when STIs are present

 

Most of the informal feedback I've heard before today has been that PrEP is associated with an increase in STIs but if the data above is applicable to Australia, then perhaps that isn't quite true.  I think the evidence if favour of PrEP is mounting, and the major obstacle in Australia is probably the cost-benefit ratio...

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.

We have just heard from 7 speakers on the status of PrEP across Euro and North America. There is considerable support for PrEP and incredible consistency across the regions in both trends and challenges a s well as interest.

Clearly there is no debate about the efficacy of PrEP, thought there remain differences in choice about daily or on demand PrEP. There seems to be considerable comfort in the level of resistance, side-effects and toxicities, while these may be appearing they are at such low levels as to no impact support for PrEP.

There is also a very generalised concern about cost of PrEP, but a growing confidence that cost issues will be addressed. How to implement PrEP is where the differences are most striking. Many people are indicating that PrEP must be resourced by cutting back in other areas. Cost effectiveness remains linked to the cost of the drug ad the level of risk, but a number of speakers also introduced location or background prevalence into that assessment.

PrEP access, at least in a number of settings, does not match HIV transmission risk. One presenter gave a detailed account of where PrEP is accessed and by whom. Overwhelmingly PrEP access in the USA favours white MSM, yet black and hispanic MSM and women are at much greater risk. This is s strong take home message. We will need to make sure that PrEP can be assessed by at risk populations and communities at greater vulnerability.

 

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Glasgow HIV 2016 has just opened.

It was interesting to hear new-comers to this meeting reflect on the three excellent presentations in the opening: Clarity, different perspectives, and reflections mixed with predictions. The sessions will be up on the Conference website shortly.

Tony Fauci, giving the Joep Lange and Jacqueline van Tongeren Memorial Lecture. Ending the HIV/AIDS pandemic: follow the science, reflected on the changes that have come about since he entered the field in 1981, following the publication of seminal articles in the MMRW. Fauci indicated that this is when he decided to change his career trajectory and concentrate on the, as then un-named, phenomenon which would become HIV.

Fauci sprinted through 30 years of HIV to focus on the more recent research which has redefined ending HIV. Namely the recognition that treatment reduces virus which in turn reduces transmission and that knowing ones status allows for interventions. But he did not stop there. He went on to cast and eye to the horizon and identified two areas where science has significant contributions to make.

HIV persistence, or stopping persistence, is a holy grail. This comes in two forms, eradicating HIV where HIV is made dormant while treatment is administered, yet re-emerges when treatment is stopped or controlling rebound, where interference at binding or replication sites reduces proliferation. This individualised therapy has shown to be useful in this strategy in cancer treatment and it has potential in HIV.

HIV vaccines, whether therapeutic or preventative are of course what everyone is hoping for. Fauci presented some realistic steps which are being made to transition vaccines from 32% effective to more like 50% effective, a point which he suggested could make significant inroads in reducing transmission, particularly in endemic settings and in combination with other strategies. He also discussed a number of new vaccine initiatives.

He ended with neat summary of why vaccinologists have not yet been rewarded. This I thought was a poignant rationale for continuing with vaccine development in the absence of any hitherto prizes. Most vaccines mimic the actual process of disease and immune response. That is not the case in HIV, so the vaccinologist needs not to copy the virus, but be much smarter than it.

 

Andrew Hill

Spoke about the potential to improve treatment access through the greater use of generic drugs. I can’t help thinking every time I hear Andrew talk that he is simplifying something in the greater economics and practicalities of capitalism or financial markets. But his arguments are very compelling.

Interestingly Andrew inserted discussion about Australia’s funding for hepatitis C treatment. Having just come from the USA where I was asked about details of the same, it seems to me that there are very different mechanisms in place in different countries which can result in very different approaches to price setting.

Two years ago at this meeting Andrew suggested it might be in the interests of the NHS budget to make a two pill (rather than single pill) regimen available to the UK public through the NHS. This brought criticism from at least one senior Australian clinician and commentator who thought that it would be unacceptable to expect patients to take a less convenient regimen.

Linda-Gail Bekker

As always presented clearly and passionately about the current experience of HIV in Africa and was able to compare and contrast this to other global settings. She is able to mix population and locational differences and introduce a third dimension of how these interact.

Adolescents were for a long time not a priority in HIV prevention. Key affected populations, are largely characterised as being “the-non-majority population”. While recognising this, she introduced an emerged KAP in Africa and that is adolescent women.

Linda-Gail was able to focus on trends which demonstrated changes for the good. It was very interesting to see a map where Australia was pink (on a blue to red scale) for increasing or sustained new infections. While our numbers might not be big they seem to be somewhat intransigent. Many African states have seen dramatic improvements. While more developed settings seem to be finding it difficult to make changes to address persistent, comparatively low-level, new infections. Something which Fauci also recognised in the USA. It would be interesting to see Andrew Hill’s economic assessment of the cost of these different interventions.

A great opening session which augers well for the coming days.

Levinia

 

 

Anthony Fauci from the National Institute of Allergy and Infectious Diseases (NIAID) & National Institute of Health (NIH), Bethesda, USA, presented an excellent keynote lecture on ending the HIV/AIDS pandemic.

He started by taking us through a timeline of HIV infection. Starting in the 1980s, when the mean life expectancy of a newly diagnosed 20 year old (not on ART) was ~12 years. We followed the science through time and today, over 35 years later, the mean life expectancy of a newly diagnosed 20 year old (on ART) is ~53 years.

What we've learned since the 1980's regarding the etiology, virology, pathogenesis, treatment and prevention have given us a better understanding on how all these advances should continue to be used in conjunction in order to end the HIV/AIDS epidemic.

We've discussed treatment as prevention (TasP) and looked at a traid of pivotal ART studies regarding the treatment of individuals with HIV infection:

  • The SMART study showed that episodic ART is inferior to continuous ART
  • The HPTN 052 study showed that early ART reduces HIV transmission to uninfected sexual partners by 93%
  • The START study showed that early ART reduces serious illness or death by 57%

 

We are all aware of the continuum of care when our patients have a positive HIV test results, but we should also be very proactive in the continuum of prevention in those who test negative.

Despite our 90/90/90 targets, the numbers of newly diagnosed HIV infection have plateaued globally since 2009.

Continuing to improve access to ART and HIV prevention strategies, such as pre-exposure prophylaxis (PrEP) could dramatically decrease HIV-related deaths and the rate of new HIV infections.

The efficacy of PrEP has been proven in multiple studies and most recently the San Francisco Strut PrEP program showed no new HIV infections in >1200 men on PrEP in nurse-lead intervention over nearly 1.5 years. There were 82 new infection at that clinic among men not enrolled in the PrEP program.

The two main remaining scientific challenges for HIV identified are:

  • Addressing HIV persistence
    • eradicate the reservoir - classic "cure"
    • control viral rebound - sustained virologic remission
  • Development of a safe and effective preventative HIV vaccine 

Towards a HIV vaccine:

  • The first signal of efficacy (31%) in a HIV vaccine clinical trail - RV144, was seen in: Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. S Rerks-Ngarm, et al. For the MOPH-TAVEG investigators. N Engl J Med 2009; 361:2209-2220. Dec 3, 2009
  • Additional work since this study has lead to a large-scale HIV vaccine trial that will launch in November 2016 in South Africa: HVTN 702 modifeid RV144 prime-boost regime
  • More work is also being done on Neutrolising Monoclonal Antibodies, discovered since 2009.

 

Conclusion:

Treatment + non-vaccine prevention + vaccine = durable end of the HIV/AIDS pandemic