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.

Delinkage of the cost of research and development from drug prices

James Love, Director of Knowledge Ecology International

This was a fascinating talk that proposed an alternative model for R+D of new drugs that would reduce the cost of new drugs and improve access for all.

Love outlines how the current drug patent and monopoly for funding the R+D of new drugs has many challenges. Pharmaceutical companies invariably set prices for maximum profitability and costs have risen dramatically even over the past 10 years. The current trajectory means that high and middle-income countries will likely limit access and impose restrictions on those who receive these treatments, and resource-limited settings will face further inequities.

Love proposes an alternative model that funds R+D by “delinkage” of the cost or R+D of new drugs, from the final price of the product.  Alternative funding models for R+D have been proposed; drug research grants and contracts, R+D subsidies, incentives and innovation prize funds.

Some of the above initiatives already exist. There are NIH and EU framework grants, R+D subsidies such as the Orphan Drug tax-credits which are funds available for R+D on drugs for rare diseases (apparently 47% of new US drug approvals in 2015 fell under this model).

Love proposes expansion of current incentives, and progressively switching from the current system of monopolies to alternative models of funding. Progressive delinkage mechanisms could be introduced by governments over time that sequentially move prices closer to the marginal cost of production of the drug.

Love talked about the $15 billion spent on HIV drugs in the US annually with the return of on average one new HIV drug per year. Recently Bernie Sanders in his US election campaign proposed that $3 billion of this money be set aside to fund R+D for new HIV drugs and at the same time eliminate monopolies. He also advocated setting aside funds to reward scientists and researchers who contributed to the development of a drug via open source platforms. 

There seems to be growing support for Love’s model with many seeing the current system as unfair and ridiculously expensive. Apparently several members of the European parliament have expressed interest in the delinkage model, the Human Rights Council has asked states to support the principles of delinkage, India and the World Health Assembly have endorsed the model, the CEO of GSK has endorsed the delinkage model in the context of expensive drugs for rare diseases and several companies have endorsed it for the development of new antibiotics.

This issue has repercussions the world over, and is pertinent at a conference being hosted in sub-Saharan Africa that addresses the HIV and viral Hepatitis epidemics. While we come from a relatively privileged position in Australia, we do face shortages in provision of access to many of the new cancer medications, and one wonders how our health budget will fund the escalating pharmaceutical costs in the future.  This talk outlined an elegant alternative model of funding R+D that would be more equitable and allow universal access to new drugs for all.

Combating HIV drug resistance

 

With the rapid scale up of access to ART and with countries working towards the 90-90-90 and 2030 targets, this session seemed very pertinent in addressing the final tier of the cascade – that 90% of those on treatment should have an undetectable viral load. Meg Doherty from WHO discussed that this is particularly important in settings where access to viral load and drug resistance testing is limited.

Several low and middle income countries have reported levels of HIVDR at or above 10% in ART naive patients and up to 37% in those restarting ART with prior exposure to ART. *

The WHO speaker cautioned that a “one size fits all approach” would be a mistake and this was certainly evidence by presentations from certain countries with varying resistance rates. However access to viral load, not to mind genotypic resistance testing is lacking in many low and middle income resource countries and each country needs to collect this data to guide and tailor its own response.

Modeling suggests that the cost of inaction is a costly price to pay with increased morbidity and mortality, increased transmitted resistance, increased program costs with second and third line ARVs and increases in new infection rates.

WHO recommends that each country should have a HIVDR surveillance strategy that is based on 1) Early Warning Indicators which essentially reflect the quality of care of the program and include data on prescribing practices, loss to follow-up, ARV supply continuity, viral load etc, 2) National surveys of pre-treatment resistance, 3) National surveys of acquired drug resistance, and 4) Nationally representative surveys that measure drug resistance in <18month olds.

Other interesting comments from panel members at the session emphasised the importance of monitoring drug resistance in pregnant women returning to care with PMTCT option B+ and also in children and adolescents who have lower viral load suppression rates than with adults.

The Global Fund panelist talked about the important implications of HIVDR rates in reaching other targets such as 90% of people who have need of PrEP having access to it, and HIVDR rates being important for effective PrEP.

Dr Anna Flavia presented some of the drug resistant data from Brazil where pre-treatment Efavirenz resistance rates are 7%. This has prompted discussions about whether the national program should recommend routine resistance testing prior to ART initiation, or whether the country simply switch to including Dolutegravir in the first line regimen. All cost benefit analyses favour the switch to Dolutegravir rather than performing resistance testing on all commencing treatment.

The take home message from this presentation was that drug resistance is rising and if the target of ending AIDS by 2030 is to be achieved, then monitoring and responding to HIVDR will be a critical element and that each country is called to act and collect more and better data in order to tailor their response in terms of thinking about switching ART regimens and quality improvements to their HIV programs.

*The WHO draft of the Global Action Plan on Drug Resistance (2017-2021)

HIV and Migration: All is NOT fair in Love and War

Slightly belated report back from Friday morning's session.

President of AFAO, Dr Bridget Haire opened this session - in the absence of Dr John-Paul Sanggaran, the former Medical Officer, Christmas Island, Queensland. Bridget read extracts from a moving letter Dr John penned to highlight to governing bodies the multiple inadequacies in health management of HIV testing and treatment on Christmas island.

In it he pointed out that often an HIV test result takes at least 1-2 weeks due to logistical factors, by which time the patient has usually been "processed" and moved on to another island and so they will not receive their result in time.  If the HIV result is positive then there are further problems once the patient has been tracked down, as they have been transferred to places such as Nauru where treatment access and roll-out is sub-optimal.  He then described how HIV positive refugees on the island had often been placed in the "White Building" - usually reserved for people with behavioural difficulties.  His experiences really highlighted the challenges faced by clinicians and patients alike, in difficult health care settings, in stark contrast to my own, well resourced Sexual Health Clinic in Sydney.

Then in the second session Dr Kathy Petoumenos presented findings from the ATRAS Study Group: The Australian HIV Observational Database Temporary Residence Access Study, of which several patients from my clinic have been gladly enrolled.

The NAPWHA group engaged various pharma companies to provide free ART to 180 medicare-ineligible patients for up to 4 years.

This study aimed to determine reasons for Medicare ineligibility, time to become eligible for HIV treatment on Medicare, and assess their long-term clinical outcomes once on ARTs. Enrolment was from 2011 - 2012. Results from the 24 month findings were presented.

Interesting results from baseline showed that 73% were male, most common visa status was Student Visa (34%) and 63% of the cohort had experienced prior ARTs (either as self-funded, trial participant, origin country or compassionate access).

Encouragingly over the period of the study, the mean CD4 count increased from a baseline of 376 to 534 at 24 months. Even more pleasing was that the percentage of patients with an undetectable viral load increased from 47% at the start of the study to a fantastic 94% at 24 months, with 100% of females achieving undetectable viral load.

So far 74% of participants have dropped out as they became Medicare Eligible, 17% have gone overseas and 9% were lost to follow up. Students were least likely to have stopped requiring ATRAS medications.

In the 2nd part of the presentation the group attempted to estimate cost benefit of expanding ARTS to all medicare-ineligible patients. The survey findings estimates there are approximately 450 medicare-ineligble HIV clients in Australia.  After 2 years patients with a detectable viral load reduced from 53% to 6%.  i.e. a 93% risk reduction in onward transmission of the infection.  Thus 81 new infections would be averted/ 5 years. 

Mathematical modelling using these figures shows that expanding ARTS access and treating all the temporary resident HIV+ population was determined to be at least cost-neutral - i.e. it saves as much as it costs.   Of course, the public health benefit and the benefits to the HIV-supressed individuals alike is so much more than that.

Aaron Cogle (Exective Director for NAPWHA) pointed out that medicare-ineligible people are not recognised as a priority population nationally, this and other federal and state barriers to ART access need to be tackled imminently.   If universal test-and-treat policy is to be realised then this population needs to be included.

Atras Ceases Nov 2015.

Sadly I was unable to attend the last presentations in this session as I had to catch my flight.

What a great conference, see you all in Adelaide (and Rio) and thanks to all or any who managed to read this far into my blog!!

 

You could almost - almost - be forgiven for feeling like the biomedical developments in HIV have come to their hump-day.  Vaccines research hasn't been as successful as we had hoped, microbicides are good but not great. New drugs are refinements (and handy combinations) rather than truly novel compounds. Cure still seems so painfully far away - although there certainly has been progress announced this week - see https://theconversation.com/cancer-drug-promises-to-break-down-barrier-to-hiv-cure-47558 for some discussion.

We have excellent treatments, which we now know without doubt are good for patients, good for partners and good for the population. In Wednesday's morning plenary session, Mike Cohen emphasised his belief that there is now no justification for delaying therapy.  Long live test and treat.  Prevention studies continue to add weight to arguments for Treatment as Prevention and Pre-Exposure Prophylaxis. 

The Wednesday afternoon plenary session and Friday's session on migration were reminders to step back, and consider how lucky we are in Australasia, but that this is not universal.  HIV is a global disease; our 27,000 Australians living with HIV are but a tiny fraction of the 40 million people infected worldwide.  People in low and middle income countries are not only living with HIV, they are still dying from it.

 

Clearly this isn't because there aren't treatments as our local experience shows.

People are dying because of lack of access.

 

In the developed world, we have has some success in fighting legal discrimination against people with HIV;  this is not the case everywhere.  Laws criminalising homosexuality or injecting drug use can only act as a barrier to Test and Treat.  Thursday's session on Criminalisation highlighted the dangers posed by laws such as these. The HIV sector can stand tall for their efforts in fighting these laws - to improve health and to remove stigma.

An area of advocacy that, as a group, we often don't consider, however, is intellectual property and global trade.  Charles Chauvel from the United Nations Development Project gave an excellent talk on the risks of IP laws for global access to medication.

Antivirals are expensive; and rather than becoming cheaper, there is a very good chance that these IP laws, coming into effect as part of free trade agreements, will limit the development and availability of generic antivirals, which are so crucial the low and middle income countries.

 

Australia is a world-leader in HIV research. While we look to a cure, tantalising us on the horizon, we should all remember to pause and look back, so we can make sure that no one is left behind.

 

Tagged in: HIVAIDS2015

A fascinating and compelling presentation from Charles Chauvel from the a Global Comission on HIV and the Law and UNDP.

Charles spoke of the higher HIV prevalence in countries where sex work, injecting drug use and MSM are criminalised activities. He showed some graphs which clearly showed the relationship between reduction in harm reduction programs and increasing HIV. Charles gave the example of the Philippines where harm reduction services for PWID were dramatically reduced and HIV prevalence in PWID increased from 1% to over 40% in just 6 years. Although there are likely other factors at play here it is still a staggering increase.

It seems that attitudes are changing at a global level and hopefully we will see an end to the 'war on drugs' as this can hamper our efforts to reduce HIV incidence as well as access to those at risk who may need testing and treatment. We need more of a focus on drug use as a health issue and also the social issues which can contribute to problematic use.  

As Charles stated in his presentation, law reform is an effective way to reduce HIV transmissions and its free!

Tagged in: HIVAIDS2015

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

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