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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Central Demand of "Access Equity/Rights Now" Vocalised on Opening Day of AIDS2016 Durban

The IAS AIDS2016 Conference in Durban, officially opened Monday night local time, however multiple pre-conference meetings had already taken place in the days running up that, including the first MSM Global Forum to be held in Africa; the 1st IAS HIV Cure Symposium, TB, HIV/HCV co-infection, paediatric HIV sessions as well as funder meetings, and political activism, along with cultural and community events in the Global Village. It is 16 years since the conference was held in South Africa, in Durban and the current meeting's theme is "Access Equity/Rights Now" – a central demand is the need for world leaders to meet global goals they need to continue to support HIV treatment and prevention and stick to their funding commitments and goals as well as a call  to combat inappropriate criminalisation of HIV transmission (and recognising the current evidence base of very low HIV transmission risks in a treatment era) – something ASHM is working on through a Consensus Statement with expert stakeholders nationally.

 

MSM Global Forum points out critical issues

Chris Beyrer, President of the IAS opened the MSM Global Forum pre-conference day meeting, pointing out that the recent UNAIDS High Level Meeting on HIV/AIDS struggled to keep key populations on the agenda including MSM, and stigma remains a critical issue intersecting with very low funding (2% of global funding which is out of proportion to the burden of new infections among MSM), violence and criminalisation. An interesting angle taken by the Forum was considering the national economic costs of homophobia, based on a premise that if political leaders and decision makers do not listen to rights based arguments then the ‘dollar value’ impact of the consequences of homophobia on their respective government wallets might work better. Legal reform indicators need also to be included in UNAIDS global indicators.

 

"Know your epidemic means know your HIVDR"

At a well-attended pre-conference meeting, a WHO organised session on HIV Drug Resistance found speakers addressing an inherent potential paradox of a universal access or ‘Treat All’ global response and indeed PrEP scale up and the increased risk therefore of HIV drug resistance (HIVDR).  This session therefore focused on how to prevent the emergence and transmission of HIV DR and consequent risk of treatment failure, increase in drug costs, higher treatment complexity and lowered durability of 1st line regimens (i.e. if people need to switch to more expensive 2nd or even 3rd line regimens due to DR). Fast tracking of global treatment goals need to include the issue of HIV DR risk and this should be an integral part of delivering quality HIV services and be part of routine program management in terms of VL suppression across all the UNAIDS 90-90-90 goals. Presentations focused on strengthening surveillance with the inclusion of a new zero draft WHO Global Action Plan on Early Warning Indicators (EWI) for HIV DR.  This plan is intended to complement national HIV DR surveillance through for example indicators of possible emergence of DR such as monitoring ART prescribing practices, loss to follow-up at 12 months, retention on ART at 12 months, on-time pill pick up, on time appointment keeping, drug stock outs and their relation to VL suppression. VL monitoring is obviously also critically needed (as a proxy for possible patient HIV DR) but still unavailable in too many country contexts. Clinic level data from  55 countries have indicated high levels of appropriate prescribing but sub-optimal levels of loss to follow-up at 12 months, retention at 12 months on time ARV drug pick up and ARV stock outs – which could indicate emergence of HIV DR.

 

WHO seeks online public consultation on Global Action Plan on HIV Drug Resistance

WHO is consulting with global and regional stakeholders to inform the Global Action Plan  on HIV DR – of note to the region is a WHO Western Pacific/South-east Asia regional consultation in Bangkok, August 8th – 12th, 2016 with a plan finalised by end 2016 and full launch in early 2017.

We came to this meeting in part to hold a round table discussion about the role of DBS sample collection. Excitingly for us, further exploration of DBS, including through multi-centre collaborations made it onto the list of 4 priorities coming from the meeting.

Dry Blood Spots are a simple way to collect a biological sample for analysis in the laboratory. You use a lancet to pierce the finger-tip and drip blood onto one or more target sites on a sheet of blotting paper. This sample is then dried, sent to the lab (through the mail or easily transported at room temperature) and then analysed in the lab. The spot is punched out of the blotting paper and eluted The lab can test for any number of things including the presence of antibody, molecular, and serological tests. Labs can use their own tests or test which are marketed through diagnostics companies using a variety of analysers.

In order to be approved (and rebated), a DBS claim needs to be made by a producer/supplier when the product is registered. This has been something which has held back DBS sample collection for some time. As tests became more sophisticated and analysers more mechanised, the operator-involved steps in processing a DBS sample probably seemed overwhelming.

But there are many factors which place a DBS sample in good light. Transportablity, durability and stability are all excellent in remote, hard to reach or poorly serviced areas. They also appear to provide an alternative for people who are, for whatever reason, avoiding testing through conventional means.

Two posters which also looked at DBS, both its use in one of the larger format analysers, and as an acceptable sample collection technique for consumers are below.

Validation of the GEN-PROBE® APTIMA® HIV-1 RNA Qualitative Assay for use with Dried Blood Spots.pdf

Diminishing Return on Increasing DBS Sample Quantity.pdf

 

 

The presentations from the HIV Diagnostics Conference have now been put on line. They are accessible at

http://hivtestingconference.org/2016-hiv-diagnostics-conference/oral-presentations/

You can access the full program from this link and simply click on the desired presentations.

Those who pay much attention to the HIV testing landscape in the USA will be aware that there was a long period where the testing algorithm was debated, discussed and reviewed, resulting in the 'New' algorithm coming into effect in 2014. At this conference it was suggested a number of times that the new algorithm should now be redrafted.

Largely the reason for this is the shift in treatment guidelines and the relationship between testing and treatment. The 'new' guideline was written against a background of selective CD4 and viral load based decisions about when to start treatment. Now, with the emphasis being on starting people on treatment as soon as feasible after diagnosis, the need for repeat testing was questioned. This is an important shift, where one can see treatment and clinical practice driving precursor testing. These issues are discussed in 

Session C: CDC/APHL Laboratory Testing Algorithm and 

Session D: CDC/APHL Laboratory Testing Algorithm (Part 2)

There was a very good round table discussion on Wednesday morning which looked at matching testing approaches to the HIV cascade. Joanne Steckler raised the issue about the large differential between people tested and people lost to follow-up. This comes from work in Washington state, where a great many people who were thought to be lost to follow-up were in fact legitimately in care somewhere else, often no longer in the county or state.  

At the same time, rapid tests, which have been widely used in the USA for many years as part of the testing strategy, particularly in community settings, but also in more remote areas (Alaska, Midwestern and north states) where laboratory access is limited, are becoming less popular.

One of the major reasons driving this is the problems associated with false negatives. As always there was some discussion about the amount of transmission associated with very early infection, and it was interesting that there was a greater linkage between efforts to get people to test, particularly very early after infection, and recognising the limitation of point of care or rapid tests in these contexts. 

Session F: Performance of CLIA-Waived HIV Tests and the session immediately before this examined some of these issues.

Testing was very much seen as the vehicle facilitating the linkage of patients to care. A presentation from Eugene Martin, New Jersey, demonstrated that high level linkage could occur with timely intervention.

The laboratory instrument providers also attend this conference. It seems that many of the analysts have the capacity to perform multiple tests (concurrently, but not yet necessarily all the tests we would like to see in the one run). But this really did seem the next step where the largest leap could be made. This particularly emphasised the need to link HIV testing with related testing in the STI and viral hepatitis areas.

The closing remark gives a good coverage of the scope of the meeting. It was thought there was ongoing need for the meeting and that it would have to, in the context of HIV PrEP, include STI in its agenda. 

 

 

The Conference opened with a broad based plenary looking at the new landscape in HIV, often referred to as the HIV Testing 101 Workshop. This is a two hour session which will be on line shortly and really is an excellent overview. It starts out with a glossary of terms and then moves through technology; performance; programs; surveillance and the relationship between laboratory and strategy.

I strongly recommend that anyone setting out into the world of testing watch this session. The slides will all be up on the website some time after the conference and we will advise when this happens.

The USA has recently introduced a change algorithm for HIV diagnostic testing. This raises practical issues for laboratories. But an equally important issue for this conference is how laboratories support initiatives to increase testing (and timeliness of testing) and improve the care continuum.

Details can be found on the website http://hivtestingconference.org  

Key HIV Testing Issues

Key issues in this meeting are how to get testing done early enough and also how to use the best test on an early-after-exposure sample. This will likely play out over the next few days. Clearly the cognitive distance between the laboratory and the clinic is narrowing here. Labs are trying to play a role in the clinical improvements that are sought in reducing the time between exposure and testing. Yet with the increase of self testing, and large scale community clinics with the capacity to perform more complex tests, the laboratory is coming much closer to the community.

With this comes the big question for me: How does one get this information to the person needing testing, at the time that they need it? The Achilles heal in any algorithm would seem to be the differentiation of the population upon which it is performed.

Joanne Stekler (Seattle) discussed this in the breakfast session today. Indicating that the greatest variation between yield on different tests is how differentiated the sample is.  Population-based screening is low yield in low prevalence settings and yield rises dramatically when more targeted testing is performed.

Increased infectivity during seroconversion and early in infection mean it is vitally important to get people to test during this period. Though this has not been discussed here yet, the role of PEP in this context should be reconsidered.