Lessons from ATRAS
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This presentation on the findings of the AHOD Temporary Residents Access Study (ATRAS) was given by Aaron Cogle, NAPWHA Executive Director, at the AFAO Members Forum - May 2015.
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Lessons from ATRAS
- 1. AFAO Members Forum Aaron Cogle 16 May 2015 Lessons from ATRAS
- 3. ‘Medicare Ineligible’ • In Australia legally • No Access to PBS subsidised ARVs • Existing provisions for this group vary significantly across jurisdictions • Only 60% of HIV+ people who need treatment are getting it • 31% are on sub-optimal combinations
- 4. Aims • To describe the population of HIV+ temporary residents • To describe the HIV disease status of this group • To model HIV transmission rates • To provide compassionate ARV access for up to 4 years (ends Nov 2015)
- 5. The Sample • Recruited 180 people from 21 sites • 74% male, 26% female • 46% SE Asia, 19% SS Africa, 11% S America, 11% S Pacific, 9% Europe, 6% N America • 31% Student visa, 33% Working visa, 14% Bridging visa, 13% Spousal Visa, 13% other visa • Route of transmission; 49% MSM, 39% Heterosexual contact, 12% Other
- 6. HIV Characteristics at Enrolment • The average CD4 cell count was 376 cells • 63% of recruits were receiving ART • Only 47% had an UDVL • 46% of those on treatment changed their regimen after enrolment into ATRAS
- 7. Changes in CD4 count Baseline Month 12 Month 24 No. Mean SD No. Mean SD No. Mean SD Total 161 376 227 151 475 198 106 534 235 Female 42 350 187 37 444 190 22 524 188 Male 119 385 239 114 485 201 84 536 247 Bridging 24 436 273 24 532 216 21 554 242 Other 21 357 296 15 430 191 11 465 157 Spouse 13 391 193 12 432 184 4 435 259 Student 56 328 162 56 479 195 42 511 182 Working 47 405 238 44 464 199 28 593 311 Asia/SE Asia 76 341 214 73 458 198 56 508 208 Europe 14 422 247 13 541 234 10 702 434 North America 9 526 318 7 449 160 5 506 254 South America 18 371 149 18 556 201 13 629 197 South Pacific 14 437 164 15 512 148 9 488 88 Sub-Saharan Africa 30 371 268 25 414 199 13 461 187
- 8. Changes in UDVL Baseline Month 12 Month 24 N % N % N % Total 76 47.2 126 88.7 99 94.3 Female 21 50.0 28 80.0 21 100.0 Male 55 46.2 98 91.6 78 92.9 Asia/SE Asia 32 42.7 63 91.3 52 94.5 Europe 7 50.0 12 100.0 11 100.0 North America 5 55.6 4 57.1 4 80.0 South America 5 27.8 16 100.0 12 92.3 South Pacific 8 57.1 10 76.9 8 100.0 Sub-Saharan Africa 19 61.3 21 84.0 12 92.3 Bridging 14 58.3 22 91.7 20 95.2 Other 12 60.0 13 81.3 11 100.0 Spouse 6 40.0 10 83.3 3 75.0 Student 21 38.9 45 93.8 38 95.0 Working 23 47.9 36 85.7 27 93.1
- 9. HIV transmission 53% detectable at baseline After 12months (12% detectable) • 77.4% reduction in detectable viral load and who have a substantial risk of onward transmission After 24 months (6% detectable) • 93% reduction in the risk of onwards transmission
- 10. Transition to Medicare Eligibility • At July 2013 – 39 patients had left ATRAS • At July 2014 – 79 patients had left ATRAS • By November 2015 – 110 (estimated) patients will have left ATRAS Nearly two thirds of people return to C.O.O. or become eligible within 4 years.
- 11. Modelling • Estimated 450 Medicare Ineligible people in Australia at any time. • Treatment cost estimated at $29,642,230 (discounted cost $26,354,092) • Potential to avert a median 81 new infections over 5 years. • Equivalent to a lifetime cost saving of $69,412,098 (discounted cost $17,982,044) Broadly cost-neutral
- 12. Lessons • Providing access to ARVs to PLHIV yields better health outcomes and a reduction in the risk of onward transmission • Medicare ineligible people are receiving significantly poorer treatment and care. • Treating Medicare ineligible people is cost neutral • Most Medicare ineligible become eligible quickly. • We can avert 81 new infections every 5 years. • Treatment of this group would be consistent with Australia’s commitments, internationally and domestically.
- 13. Challenges Politically unpopular subject and there is no permanent solution on the horizon. The National Strategy targets require treatment access for Medicare ineligible PLHIV Medicare ineligible people are not identified as a key population This means ‘measured progress’ could be misleading Variation across States and the Commonwealth
- 14. Future ATRAS ends in November 2015: 70 people still on study Working with states to provide ongoing access for study participants Further reports imminent No agreement for Medicare ineligible people not on the study Further work around policies in each state
Editor's Notes
- Today I have been asked to talk about the ATRAS study and some of the things we have learnt from it It’s a joint project of NAPWHA and The Kirby Institute and its supported by the Australian HIV Observational Database (AHOD) clinical sites and the seven pharmaceutical companies who provide HIV antiretroviral drugs in Australia. It’s designed to help us get a better understanding of ARV treatment and access for people living with HIV who are ineligible for Medicare in Australia. Before we get started;
- ATRAS stands for the AHOD Temporary Residents Access Study and AHOD, as I’ve just said, is the Australian HIV Observational Database.
- Medicare Ineligible people are in Australia, perfectly legally, on various temporary student, business or employer sponsored visas that don’t allow access to Australia’s Medicare scheme SO they don’t have access to subsidised drugs through the PBS. For HIV positive people in this situation this means; Delaying or stopping treatment Finding a compassionate access schemes or a clinical study – but this won’t always guarantee an optimal regime. Sourcing Drug from the internet or from country of origin – but this has availability and quality problems. OR paying the full unsubsidised price in Australia BUT the unsubsidised cost of something like Atripla is $12,500 per year which is prohibitive for most. There are SOME provisions made for this group at the State and Territory level but it varies significantly between jurisdictions. Some states have formal state-wide arrangements, others don’t. In some states it comes down to the individual clinic or health area. This is problematic because it wastes time and costs money for health professionals to spend hours trying to arrange compassionate access on a case by case basis. The result is a costly patchwork system of unpredictable access that falls short of the standard of ‘care and treatment’ that’s given to Australian citizens and permanent residents. Only an estimated 60% of Medicare Ineligible people who needed treatment were getting it in 2007. Around 31% of those were receiving a sub-optimal combination because that is all that was available.
- The ATRAS study was established to describe this population of HIV positive temporary residents To understand the disease status of that group To model HIV transmission rates. And it was also a mechanism by which we could supply appropriate ARV access for up to four years - to a population that is being denied the same access as the rest of us
- Between November 2011 and June 2012 we recruited 180 people from 21 AHOD sites – About half of those came from Sexual Health Clinics (46%), a quarter from General Practices (27%), and another quarter from Tertiary Referral Centres (27%). Three quarters were male (74%), and one quarter were female (26%) Most came from SE Asia (46%), then Sub-Saharan Africa (19%), then South America and the Pacific (11%), Europe (9%) and North America (6%). The most common visas were student visas (31%) and working visas (33%), with lesser numbers on Bridging visas (14%), Spousal Visas (13%) and other visas (13%). The most common mode of transmission was sex between men, then heterosexual sex then ‘other’. Less than 2% of people reported Injecting Drug Use as a mode of transmission.
- The average CD4 cell count at enrolment was 376 cells per microliter (of blood). There were differences in CD4 cell counts related to country of origin; with people from lower income countries having generally lower CD4 counts. 63% of recruits were on treatment before enrolment in the study - about half were accessing their treatment from overseas (47%), About a quarter were on compassionate access programs (22%) and about 11% were on clinical trials. Only 47% had an UDVL 46% changed their regimen as soon as they were enrolled because they were not on combinations consistent with those recommended under the Australian ARV treatment guidelines.
- So, here are the results in relation to CD4 cell counts; There were positive changes in CD4 cell counts after one year of treatment and then again after 2 years. There were improvements in all categories; across gender, visa status and region of origin. The average CD4 cell count increased from 376 at baseline to 475 after one year and then to 534 after two years.
- These are the results in relation to UDVL; The proportion of people with an undetectable viral load increased from 47% at baseline to 89% after one year and then 94% after two years Again there were improvements observed in most of the sub-categories as well.
- Just to emphasise that point; From 53% detectable at baseline there was a 77.4% reduction in detectable viral load after 12 months and a 93% reduction in detectable viral load after 24 months. With a corresponding reduction in the risk of onward transmission.
- Also important to note is that a substantial percentage of people who are Medicare ineligible either return to their country of origin at the end of their temporary visa, or they transition to a Visa which allows Medicare access… and this happens relatively quickly. At July 2013 39 patients were no longer receiving ART from ATRAS. 4 of those had left the country and 2 were lost to follow up so 33 of those had transitioned to Medicare Eligibility. By July 2014 79 patients were no longer receiving treatment And by November 2015 we predict that there will only be about 70 people left on the study. That means nearly two thirds of people either transition to Medicare Eligibility or return to their country of origin within four years. That has a couple of implications that I think are worth mentioning; First it means that supplying cost free drug to this group is not an extra lifelong financial burden that Medicare must shoulder – rather, it is capped to a relatively small group of people for a limited time - following which they will be able to access Medicare anyway. AND secondly it means that complications caused by delays in treatment commencement, treatment cessation or sub-optimal treatment combinations will, in the most part, will also end up having to be resolved by the Medicare system in the end. Early treatment of this group therefore holds the potential for cost savings in the long run. AND in point of fact, that was exactly what our modelling suggested.
- As part of the most recent report some cost modelling was undertaken. Two surveys were completed; one in July 2013 and a second in October 2014 and we established that at any one time there are about 450 Medicare ineligible people living in Australia. Using that figure it was calculated that providing ARV treatment for that group would cost about $29 million over 5 years with the potential to avert 81 new infections over that same period. Avoiding these new 81 infections would result in a lifetime cost saving of about $69 million. Now I know that seems like we save an enormous amount but there is a fair bit of mathematical alchemy that went into these figures which I won’t pretend to understand. However what the health economists assure me is that these figures show that providing free access to ARV meds for Ineligible HIV positive people is broadly cost neural over five years AND there are additional cost savings after that period.
- So, what did we learn? Providing ARV access to PLHIV yields better health outcomes and a reduction in the risk of onward transmission Medicare ineligible people are receiving significantly poorer treatment and care than the general population - and many are on sub-optimal combinations. Providing free drug to this group is cost neutral Two thirds will become eligible within 4 years. We can avert 81 new infections every 5 years. Treatment of this group would be consistent with Australia's commitment to ‘universal access’ under the UN Political Declaration on AIDS as well as our domestic commitments in the National HIV strategy, the AIDS 2014 legacy statement and so forth.
- However, we still don’t have a solution to this problem AND we face some substantial challenges. Politically, it is a very unpopular subject. The last meeting of the reference group was really quite despondent. The ATRAS study was meant to buy some time to allow governments to organise a solution. Unfortunately we are still discussing many of the same issues as we were four years ago and we have not really advanced from where we where when we started. The targets in the strategy demand that we treat Medicare ineligible people. They count for maybe about 1 and a half percent of all PLHIV in Australia. So, if we are to increase treatment up take to 90% then this group are a crucial sub-population that we need to address. Further, the ability to avert 81 new infections every 5 years, is equally necessary if we are to reduce sexual transmission by 50%. AND of course ignoring this group will compromise the goal of virtually eliminating HIV by 2020. However, Medicare ineligible people are not identified in the strategy (or the implementation plan) as a priority population. They make up a part of the other Priority populations but they are not singled out. So, they are easy to ignore. As we measure our progress we must ensure that this group doesn’t slip through the net. The implementation of the strategy has to recognise the diversity and breadth of the entire PLHIV population in Australia. We also face great political variation across the states; with some states, and the commonwealth, being more or less able to commit to a solution at the moment.
- Right so what does the future hold? Well, ATRAS officially ends in November this year and there will be 70 people still in need of ARV’s. The good news is we have a loose agreement from the States and Territories that the remaining study participants will be able to continue to access ARV’s, after November, through existing mechanisms at the State or Territory level. AND we are working with the State and Territory Health Representatives through BBVSS to ensure a smooth transition to the new systems. There will be at least one further ATRAS report that will follow health outcomes for the 70 remaining patients. This will allow us to keep the pressure on at BBVSS for a solution to the broader issues of those 450 Ineligible people who are in Australia but not on this study. There will also be some further work around identifying and documenting the treatment access policies that are in place across the different jurisdiction. Finally I would just note that I am really pleased with how the ATRAS study continues to amass overwhelming evidence as to the benefits of treating this group of PLHIV. And it is really frustrating to see how difficult it is for our political and bureaucratic systems to act quickly and decisively in this space.