The purpose of the European AIDS Clinical Society's (EACS) meeting in January in Bucharest, Romania was to devise consistent, auditable standards of care for HIV, co-infection and co-morbidity treatment throughout Europe. See this report and this report for the meeting’s scene-setting presentations. This report summarises the discussion on standards.
Why auditable standards are needed
Although EACS has long produced an influential set of international treatment guidelines, notable for its publication in a pocket-sized booklet, it has not, unlike (for example) the British HIV Association (BHIVA), taken the further step of turning them into a formalised, auditable set of standards that can be used to measure the quality of care across the entire European region.
Two previous meetings in Rome in 2014 and Brussels in 2016 (see this report) went a long way towards formulating desirable standards but Europe’s extreme inequality of access to effective treatment and prevention, documented in the previous reports from the Bucharest meeting, has meant it has taken a long time to get to the point where there is enough good practice in common to establish standards that can be applied to all countries.
Auditable guidelines may make a difference, Romania’s Professor Adrian Streinu-Cercel told the meeting. In those European countries where immediate treatment on diagnosis had been incorporated into guidelines by 2016, 86% of people diagnosed with HIV are now on treatment. In countries that did not incorporate immediate treatment until last year, the proportion on treatment was 68%, and in the six yet to adopt it, it was even lower. This does not mean that adopting auditable standards causes improvements, of course – they may follow the improvements.
In Europe, the high proportion of people co-infected with HIV, viral hepatitis and TB is a factor in treatment failure and lack of access as people may not be diagnosed, linked to care or treated in a co-ordinated and efficient way that maximises their chances of health.
One project that has addressed this is Integrate, an EU-funded programme whose overall objective is to implement integrated activities related to earlier diagnosis and linkage to care of HIV, viral hepatitis, TB and STIs in partner countries. In Integrate, through a peer-review process, tools that work for particular disease areas have been identified. Integrate evaluates these tools’ generalisability across disease areas and gauges any adaptations they need to be applied to other areas, to identify the optimal mix of approaches.
Integrate’s co-ordinator, Dorthe Raben, told the meeting that it was encouraging that whereas in 2015 Integrate partner countries reported that single tests for HIV or for hepatitis were conducted in 62% of people being tested and only 38% were tested for both infections at the same time, by 2018 only 34% of people were being given single tests and 66% were being offered a test for hepatitis alongside HIV, and other conditions like TB and STIs too. This is an example of the difference that the adoption and auditing of guidelines can make.
Auditing in many different health settings
Auditable guidelines can create pressure to more consistently perform across a whole range of indicators. The meeting focused on three of these: testing and treating for hepatitis co-infection, testing and treating TB co-infection, and late presentation. Chloe Orkin, Chair of BHIVA, told the meeting: “An audit isn’t a piece of research, it’s a process. It’s an evaluation of clinical performance, not an outcome.” She introduced the BHIVA process whereby a specific topic has been chosen for audit each year since 2001. A relatively simple set of questions, based on BHIVA guidelines, and feasible for all HIV clinics in the UK to answer is sent, which asks whether clinics offer specific services and procedures – such as, for example, testing for viral hepatitis. Then a review of case notes for ten to 40 patients per clinic is done to find out if the clinic actually did these things in practice.
The task of deciding on auditable standards for a region with as many health systems as countries is considerably more complex.
Anastasia Pharris of the European Centre for Disease Control commented: “To say there is one model that will improve things is challenging. We have many different models of care; even within countries models differ between urban and rural settings and specialised and non-specialised settings. PrEP and harm reduction, for instance, may be delivered in many different ways. We need to be focusing on where we can get to in Europe, rather than on how to get there.”
Alex Schneider of EATG warned against audit benchmarks that were over-detailed or required doctors to ask for information that patients might feel reluctant to give.
“People testing for HIV or returning for treatment, if they are sexually active, should receive automatic STI tests,” he commented. “In Germany this gets done, but in Switzerland you have to ask, and also, because almost the whole country patient group is included in the Swiss HIV Cohort, doctors are required to ask patients about sexual risk behaviour and condom use. This is a potential disincentive for patients to come forward. We must not let the requirements of research inadvertently introduce stigma.”
Manuel Battegay, ex-EACS President and current chair of its guidelines committee, said the task of developing common standards was complicated in Europe, owing to the multiple morbidities and co-infections people might have. This was due to the ageing of the HIV-positive population, with the result that treatment choices became more difficult for physician and patient alike: it was no coincidence that in a recent study of how many other specialists people with HIV might interact with, nephrologists – kidney specialists most likely to be involved when drug interactions happen – were at the top of the list.
The inability of clumsy, vertically organised health services to deal with people with complex and varied needs is as much to blame as stigma when it comes to the failure to provide treatment to those who need it most. This failure cannot be allowed to continue, Elena Vovc of the World Health Organization told the meeting. In central Asia, 2018 figures show that about three-quarters of people with HIV are diagnosed, but only 42% start antiretroviral therapy (ART) and 27% are still on ART and virally suppressed a year later.
The proportions are worse in people who inject drugs: 27% start ART and 19% are virally suppressed – though this is better in people receiving harm-reduction services, with 60% in care and 40% on ART.
However, this is an improvement since a 2010 study which found that less than 1% of people who inject drugs in the region had started ART between 2004 and 2009. But it is clearly not enough and has allowed co-infections to thrive: the proportion of people with TB who have co-infection with HIV grew from 3.7% in 2004 to 12% in 2017.
Despite relatively high rates of testing, late diagnosis continued to be a factor too, with 50% of people with HIV in the region diagnosed late, and 66% of people aged over 50.
Current EACS President Jürgen Rockstroh said that guidelines could exert beneficial pressure to increase the use of specific therapies to prevent or reduce co-infection. It was a scandal, for instance, that TB prophylaxis with the drug isoniazid was taken by nearly a million people in Africa (400,000 in South Africa alone), but only about 60,000 in the whole of the rest of the world. In the Temprano study, isoniazid prophylaxis reduced mortality by nearly 40% even in people not taking ART, and 52% in people taking it. TB prophylaxis is a measure that could easily be extended to, for instance, prisoners with HIV in eastern Europe.
Another area where audited guidelines might exert pressure was direct-acting antivirals (DAAs) for hepatitis C. Several studies in western Europe have shown reductions in hepatitis C prevalence or new infections when DAAs were used as widely as possible. A programme in Iceland treating all injecting drug users has reduced prevalence in this population from 43% to 12% in just two years. This was facilitated by it being a small country with only one addiction centre, but similar reductions have been achieved in Switzerland in men who have sex with men, where in 2016 147 chronic and 31 new hepatitis C infections were diagnosed in gay men but only a year later 12 chronic and 16 new infections were seen. Similar reductions have been seen in Spain, where 82% of people with HIV/hepatitis C co-infection have taken DAAs.
Positive results like this can be used as benchmarks in audits to encourage similar practice.
Using physician expertise
Elena Vovc said that before deciding what should go into an audit, some basic questions had to be asked: Is the intervention available? What is its current coverage? Does its implementation meet basic quality standards? And is it effective or has changed practice? Britain’s Mike Youle concurred: “In a way, you have almost to decide what areas of practice need improving before you even audit them.”
Several guiding themes emerged that suggested answers to these questions. One was that HIV physicians should not underestimate their influence when it comes to interventions of proven efficacy such as harm reduction: “We may need to be even more explicit about our support for harm reduction,” was the comment of Jens Lungren, director of the European research collaboration CHIP.
Audit data can be used to educate specialists from other disciplines such as TB treatment and drug addiction, but the political situation in some countries is difficult, with Adrian Streinu-Cercel mentioning that the availability of opiate substitution treatment had actually declined in Romania since it joined the EU.
“It is a scandal across eastern Europe that we don’t have harm reduction implemented at scale,” commented Michel Kazatchkine, the former director of the Global Fund who is now the United Nations Special Envoy for HIV/AIDS in Eastern Europe and Central Asia. “When there is a conflict between legislation and public health, it is legislation that should be changed. The contribution of doctors is to say to others; ‘We can all reach this standard in Europe’”.
He criticised, to some extent, the World Health Organization for not being bold enough in its published standards for harm reduction, which have not had a major revision since 2012. “Where are there mentions of safe injecting rooms? Naloxone for overdoses? Heroin-assisted therapy?”
Health systems and insurance companies are often afraid that introducing new treatments such as hepatitis C DAAs and PrEP will cost too much. A number of European health systems, such as the Czech one, are resistant to the introduction of DAAs but even in Germany, Jürgen Rockstroh commented, “there have been strong worries from the insurance companies that suddenly everyone will get diagnosed and this would cost a lot.” There needs to be better education about the cost-effectiveness of interventions such as PrEP, the Iceland DAA programme and Portugal’s decriminalisation of drugs.
Sometimes local action within the workplace can be more quickly effective than slow political change. Chloe Orkin, reporting from the meeting’s workshop on late diagnoses, said: “If you see a patient who’s had a late diagnosis from another specialism, such as dermatology, then offer some teaching.”
Using community and patient expertise
Another theme that came through was the added value of working with the community. Alex Schneider said that civil society activism is a driver of change, and the difference an NGO can make was illustrated by the work of the website www.pereboi.ru, which, growing out of a web forum for people with HIV, allows people with HIV to report drug stockouts, denials of treatment, and so on. It asks patients to report if they have:
- Been refused a drug to treat HIV, tuberculosis, or hepatitis C
- Suddenly had a change in treatment regimen or formulation (eg syrup instead of pills)
- Had a fee demanded for tests for hepatitis/HIV
- Been issued drugs for a shorter time than usual
- Have not had tests for CD4 and viral load.
A total of 509 contacted the site with complaints in 2017 and 284 in 2018. “All problems were resolved in one way or another,” commented Alex, “and pressure from the website led to the introduction of sofosbuvir for hepatitis C.” However, he noted that out of 2634 HIV NGOs in the European region, only 263 were in eastern Europe and 259 in central Europe.
Dagmar Hedrich of the European Monitoring Centre for Drugs and Drug Addiction commented: “We should task-shift to peer workers close to the populations as this is the sole method that seems to reach new people and gets them linked to care.” Michel Kazatchkine praised the positive role of Peer Navigators (“patient Personal Assistants”), which had been proven in Africa.
Hedrich also commented: “We need to make prisons part of our strategy.” This was another theme that emerged during the meeting. The role of incarceration in the HIV epidemic in eastern Europe is probably even more important than it is in the US black community. On the one hand, prisons are both dumping grounds for many of the most vulnerable people with HIV, especially drug users, and also amplifiers of infection, especially of TB. On the other hand, prisons represent an opportunity to bring hard-to-access people into care and to audit performance, especially in longer-term inmates.
Towards formulating a Europe-wide audit tool
The meeting broke into three breakout workshops on hepatitis co-infection, TB co-infection, and late diagnosis to start formulating specific audit questions. The hepatitis workshop produced a detailed list of suggested questions both on clinic standards in general, such as availability of vaccines and drugs, whether they are reimbursed, criteria for receiving hepatitis C treatment and so on, and also more detailed questions for case note reviews – on, for instance, tenofovir for people with chronic hepatitis B, screening for hepatitis delta, and so on.
The TB workshop also listed suggested questions: was TB therapy terminated prematurely? Are antiretrovirals for HIV available in the same centre as TB treatment? Are there facilities for directly observed TB therapy?
The late presentation workshop suggested questions about, for instance, the HIV tests actually used, whether the testing protocol (e.g. insisting on a confirmatory Western Blot test) meant that people disappeared before infection was confirmed, and so on. However, it was recognised that late diagnosis was an area in which the clinical history that led to the late diagnosis might not be easily available to the HIV clinic and an audit on late diagnosis would be particularly focused on improving communications between, for instance, HIV and STI services, addiction, hepatitis and HIV services, primary and secondary care, and so on.
The next step is for EACS to set up an audit working group to generate a simple, non-technical list of audit questions in the three areas identified at this meeting – hepatitis co-infection, TB co-infection, and late presentation – and a forthcoming retreat by the organisation’s board will expedite the process of turning the EACS audit into a biennial, Europe-wide tool for bringing standards together and reducing the gross inequality of treatment and prevention available throughout the region.
The EACS 2019 Standard of Care meeting website is at www.eacsociety.org/conferences/standard-of-care-meeting/standard-of-care-2019.html, where you can find the programme and all presentations.