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Of Guidelines Targets, and Resources -- Documents that Defined AIDS 2014

If there was a phrase that defined the 20th International AIDS Conference last week in Melbourne -- one that surfaced in every few presentations and kept turning up in documents -- it was "key affected populations." New World Health Organization (WHO) guidelines released in conjunction with AIDS 2014 recommend pre-exposure prophylaxis (PrEP) as an option for gay men at risk for HIV infection and naloxone to prevent overdoses among people who inject drugs (PWID).

[Produced in collaboration with Aidsmap]

The World Health Organization (WHO) actually released its new Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations on July 11, more than a week before the conference started.

The primary attention it garnered then was a couple of inaccurate reports in The Age (since corrected) and Time asserting that the WHO was saying that "all men who have sex with men should take antiretroviral drugs."

In fact, WHO says something a lot more cautious and tentative, namely that the evidence suggests quite strongly that, for men who have sex with men (MSM), "PrEP is recommended as an additional HIV prevention choice within a comprehensive HIV prevention package." (This also does not say that the comprehensive package must include a recommendation to use PrEP only with condoms, as has also been alleged.)

The change from the previous guidelines is that the earlier version suggested that PrEP should only be offered as part of the ongoing research program on this still new and hardly-used method of HIV prevention. Now WHO is suggesting, quite radically, that the evidence is sufficient for the world to consider how it could move to enabling gay men to take PrEP. (The guidance also says that PrEP should be considered for the negative partner in couples of different HIV status, but this is not a new recommendation.)

Brazilian HIV and STI health director Fabio Mesquita was in charge of the re-evaluation of the evidence for PrEP that found its way into the new guidelines. He told a press conference at Melbourne: "The question no longer is whether PrEP works, but whether we can make it available."

Barriers to Achieving the End of AIDS

As the conference proceeded and the new guidelines found their way into numerous presentations and debates, it became apparent that their radicalism covered a lot more than PrEP.  

WHO had issued its Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection only last year, and they were structured in a way that has become familiar over the last few years: around the "HIV care cascade," the sequence of targets that have to be hit -- proportion of people tested, proportion in care, proportion on treatment, proportion virally suppressed -- in order for enough people living with HIV to become essentially non-infectious and turn the epidemic around.

These guidelines in themselves made new recommendations -- that HIV testing in the community and at home was as good as provider-initiated testing, for instance -- and increased the CD4 cell threshold for treating HIV to 500 cells/mm³. But they were still written as an essentially "top-down" approach to ending the epidemic: if we get our programs right, test enough people, fund enough treatment, and get as many as we can on antiretroviral therapy (ART), then the epidemic will end.

During the ensuing year several events and some evidence suggested it might not be so simple. Notoriously, anti-gay legislation was enacted -- or rather intensified -- in Uganda, Russia, and Nigeria, at least one HIV clinic was raided, and at the Global Forum for MSM and HIV (MSMGF) meeting before the main conference evidence was presented showing that this was already leading to MSM staying away from healthcare facilities.

Evidence was also presented at the Vancouver treatment-as-prevention meeting WHEN that the forcible detention of people who inject drugs in south-east Asia was also having negative effects on HIV prevention there.

The Melbourne conference also heard yet more evidence of rising HIV epidemics among MSM in various parts of the world -- including one from Bangkok showing that 45% of young gay men who used condoms inconsistently, and 20% who tried to use condoms consistently, would have HIV within five years of starting sex.

Fascinating evidence was also presented at the conference revealing that HIV stigma and barriers to disclosure in some communities were such that simply providing ART to people with HIV without counselling that supported disclosure within their relationship might lead to very poor adherence and suppression rates. This evidence came from heterosexual couples, but may apply equally if not more powerfully to populations that are more stigmatized and between whom talk of HV status is more fraught with problems such as criminalization. 

Guidelines that Meet the Needs of Communities

Such events and evidence led WHO to be concerned that "without addressing the needs of key populations, a sustainable response to HIV will not be achieved."

Not only that: "To date, however, in most countries with generalized HIV epidemics, the response has focused almost exclusively on the general population. Even countries recognizing that HIV epidemics are concentrated in key populations often are reluctant to implement adequate interventions that reach those most in need."

Furthermore: "In many settings HIV incidence in the general population has stabilized or fallen. However, globally, key populations continue to experience significant HIV burden" -- and yet "health data, including HIV prevalence data, are less robust for key populations...due to complexities in sampling...legal concerns and issues of stigma and discrimination. Laws criminalizing the behavior of key populations make it difficult to collect representative data."

In other words, not only do key populations bear a disproportionate burden of HIV, we do not even know what that burden is because it affects people afraid to be counted.

Therefore, although they have issued separate guidelines in the past on key populations such as MSM, people who inject drugs, prisoners, sex workers, and transgender people, WHO decided to make addressing the needs of key populations the main focus of their 2014 document.

Key Populations, Vulnerable Populations

WHO makes a very clear distinction between key populations and vulnerable populations -- one that was missed in some responses to the document, which asked why groups such as adolescents and women were not included.

WHO defines key populations as people who "due to specific higher-risk behaviors are at increased risk of HIV irrespective of the epidemic type or local context" [WHO’s emphasis]. In other words, they are at extra risk of HIV simply by being who they are and doing what they do.

Vulnerable populations are people who "are particularly vulnerable to HIV infection in certain situations or contexts [WHO’s emphasis], such as adolescents (particularly adolescent girls in sub-Saharan Africa), orphans, street children, people with disabilities, and migrant and mobile workers. These populations are not affected by HIV uniformly across all countries and epidemics." However, WHO adds, many of the new guidelines recommendations apply to vulnerable groups as well.

WHO adds that it is not sufficient to address the needs of key populations --"They also are essential partners in an effective response to the epidemic."

Thus, Gottfried Hirnschall, WHO’s Director of HIV, told the Melbourne conference that in terms of specific changes to recommendations, there were not a lot of new ones in the new guidelines. The difference was that for the first time the guidelines had been shared by a large and comprehensive consultation exercise that had taken into account "the values and preferences of the communities."

Preventing Overdose: Naloxone Packs

In fact, there is only one other specific recommendation that is brand new in the guidelines other than the one on PrEP for MSM. WHO recommends, as it has done before, that people who inject drugs should have access to needle and syringe programs and opiate substitution therapy. But it adds a new recommendation that PWID should be provided with emergency packs of the heroin antidote naloxone for use by friends or by the users themselves in case of accidental overdose.

WHO's Philip Read told the conference that more PWID now die of heroin overdoses than of AIDS, and that 60% of overdoses occur in front of another person. Almost all the PWID interviewed by WHO in its research had at some time witnessed an overdose, and in the first year of a trial of naloxone packs, 20% of them had been used. This provision of "PEP for overdose" could lead to substantial saved lives, he said.

Dismantling the Critical Disablers

Needless to say, such specific recommendations will not be sufficient to save lives unless the structures that oppress key affected populations are also dismantled. The first of the "critical enablers" that will be necessary to implement prevention for key affected populations is that "Laws, policies, and practices should be reviewed and, where necessary, revised by policymakers and government leaders, with meaningful engagement of stakeholders from key population groups, to allow and support the implementation and scale-up of health-care services for key populations." The others tackle violence, discrimination, and other barriers to accessing care.

Rachel Baggaley, who was in charge of collating the evidence that led to the recommendation on PrEP, said that healthcare worker attitudes were also an important disincentive for key affected populations to come forward for care. This had led to a wasteful situation where there were parallel healthcare systems in many countries: the government one, and one run by community-based organizations funded by non-government money that did not get consulted by the public servants in charge of the country’s HIV strategy. This was often necessary to deliver any services at all, but resulted in a blindness of governments to the key affected populations in their midst and contributed to denial of their existence or needs.

WHO, then, this year issued guidelines informed by a more "bottom-up" consultancy process whereby the needs and opinions of the community informed what HIV programs should do. However, WHO representatives were asked at a press conference about the new guidelines, did this mean that WHO had abandoned the idea of "universal test and treat" altogether, and were they ever going to recommend that all people with HIV were offered treatment on diagnosis?

90/90/90: Can We Finally Treat Our Way Out of the Epidemic?

Another document issued at the conference took a hopefully complementary approach towards solving the HIV epidemic. UNAIDS issued for public consultancy -- meaning it is not yet in its finalized form -- a discussion paper entitled Ambitious treatment targets: writing the final chapter of the AIDS epidemic, which proposes the next aspirational target the agency wants to set for the world to meet.

This would be the 90/90/90 target, meaning that by 2020, 90% of all people living with HIV would know their status, 90% of those would be on treatment, and 90% of those would be virally suppressed. This would mean that 72.9% of the entire world population of people with HIV would have an undetectable viral load by 2020. If they did, then models predict the end of HIV as an epidemic disease by 2030.

At first sight, this looks incredibly ambitious. Currently, only 37% of people with HIV in the world receive antiretroviral therapy -- fewer in some areas such as eastern Europe (21%). And, as UNAIDS itself explained, previous targets such as "15 by 15" (15 million people on ART by 2015) do not capture the multistage cascade of achievements that need to happen in order to achieve such a figure.

And yet it looks as if the 15 by 15 target will be achieved. "Targets promote accountability," according to UNAIDS. The organization’s Chief of Special Initiatives, Badara Samb, said: "This is the kind of document that will land in a health minister’s in-tray. Targets get remembered by politicians."

Besides which, UNAIDS says, targets "demonstrate that AIDS is a winnable fight." In other words, we will only end AIDS if we believe we can.

What May Be Possible

UNAIDS believes the evidence suggests that it is possible to end AIDS. For instance, there are a few countries in Africa -- Ethiopia and Malawi for instance -- where already over two-thirds of adults have tested for HIV at least once, and one country, Rwanda, where over 80% have done so. In Latin America, an average of 70% of people with HIV know their status -- though this varies widely from 43% in Colombia to 80% in Brazil and 90% in Cuba.

One of the important ways to achieve this goal is to incorporate HIV in multi-disease health campaigns, UNAIDS says, and such campaigns in Kenya have led to 86% knowing their HIV status.

Retaining people on treatment has proved to be a challenge in some areas, but in Latin America and the Caribbean it is estimated that of those who start on treatment, an average of 80% are still on it 2 years later. (There are a couple of glaring exceptions -- the small nations of the Bahamas and Belize, where half of those put on treatment have dropped out within a year; these exceptions are useful as sources of information on how to do it better.)

As for the third target, viral suppression, there is again a wide spread of achievement in different countries. The 83% of people on treatment who are virally suppressed in Rwanda shows what is possible. The less than 45% cited by one researcher for Zambia shows what can happen without proper support. Similarly, although viral suppression rates for people on ART in Brazil and Mexico are 80%, in other countries such as Venezuela and Cuba that claim very high rates of retention in care, they hover around 50%. This exemplifies how the "treatment cascade" approach can expose weaknesses in a system that has strengths in other places.

Hurdles to Overcome

Achieving the 90/90/90 goal will be a huge challenge. In sub-Saharan Africa, for instance, only 29% of people living with HIV are currently virally suppressed. One of the problems is that measuring viral suppression itself is going to be one of the challenges: studies have shown that switching treatment on the basis of CD4 counts or clinical symptoms can result in switching either too soon (so wastes still-effective drugs) or far too late (so maintains people on therapies that aren't working, creating sickness and drug resistance). But viral load testing technology is still too expensive for the low-income world, and UNAIDS admits there will still not be enough viral load testing by 2020.

Another challenge is children: fewer children who need ART get it than adults, and only 10 of 29 currently available HIV medicines are approved for pediatric use.

There are a number of "elephants in the room" in the UNAIDS discussion paper. Glaringly absent is data from Russia and central Asia, the Middle East, and indeed some of the upper-income countries that are failing to treat their key affected populations, notably the U.S.  And some HIV campaigners believe that there are structural problems ahead that may prevent UNAIDS from getting anywhere near its goal.

One final question: there is an inherent contradiction between "stretch targets" and "evidence-based recommendations," and some WHO personnel expressed reservations to this reporter that the UNAIDS targets might be too far removed from the latter. Evidence-based guidelines say: "Let’s do what we know works, and only that," while the former uses what we know works as a springboard for what might work. It's great to have ambitions, but it's important to adapt them if the evidence suggests they should be different.

The Perils of Pushiness

The activist group the International Treatment Preparedness Coalition (ITPC), for instance, have released their own report on progress towards the 2013 WHO guidelines that finds patchy progress in different areas and, in particular, drug stock-outs and regulations that bar certain people from treatment on a micro level.

But Christine Stegling, IPC’s regional director, is concerned not so much with what has been happening as with what may happen.

"Some of the rhetoric about AIDS simply doesn't match the reality of what's on the ground," she says. "Not only are people not getting what they're entitled to, they're not aware of what they should be getting because treatment literacy is so low. There is very little grassroots awareness of the WHO treatment guidelines and, of course, very few non-discriminatory services tailored to the needs of key affected populations."

"We all like 'stretch targets,' but you need to put them in context," she continued. "One of the biggest threats, ironically, is the economic progress some countries are making: by 2020, 70% of the priority countries targeted by providers like the Global Fund and PEPFAR will be in the middle-income bracket which, according to current agreements, will deprive them of cheap generic drugs. One of the big problems here is that the HIV activist community has such low awareness of intellectual property rights and how we can work trade agreements like TRIPS to our advantage. Generics won't necessarily be cheaply available: many generic companies have been bought by the big pharmaceutical companies whose motto seems to be 'If you can’t beat them, buy them'."

"We welcome the general aim of the UNAIDS targets, but we need to ensure they are not insensitive and 'pushy'," she concluded. What is achievable for a pregnant women in Uganda may not be achievable for a gay man there, and even in majority populations we are seeing really bad retention and drug resistance in some programs."

Stepping Up to the Plate: Will Governments Fund their Own HIV Programs?

One answer to the "middle-income" problem, of course, is to tell the governments of such countries to step up to the plate and pay for treating HIV themselves. Although some countries with wealth like Nigeria are not only failing to do this, but actively persecuting their key populations, UNAIDS shows in its discussion paper a very promising graphic that plots Asian countries' per-capita GDPs with the proportion of their spending on AIDS that is domestic.  

In the main, the correlation is very strong. Thus, in the poorest Asian countries like Nepal (per capita GDP US$690 per year) and Bangladesh ($752 per year), the proportion of AIDS funding contributed by the country's own government is only 1% and 8%, respectively. In contrast, in well-off Malaysia (per capita GDP $10,432 per year), 97% of AIDS funding comes from the Malaysian government.

Where countries' AIDS spending is out of line, it tends to be in the direction of over- rather than under-spending: in Thailand (per capita GDP $5480 per year), 85% of AIDS spending is domestic, and the figure is very similar for China. India ($1503 per year), with a domestic proportion of AIDS spending of 10%, falls slightly below the line, but that country has numerically the biggest HIV burden in the region and also has a number of exceptionally well-financed HIV programs that are transitioning towards government funding.

In other words -- in general, and with many exceptions -- the world seems to be meeting the financial challenge of AIDS. The question is: will it meet the political and cultural challenges too?

7/29/14

Sources

World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. July 2014. www.who.int/hiv/pub/guidelines/keypopulations/en/.

UNAIDS. Ambitious Treatment Targets: writing the final chapter of the AIDS epidemic. www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2014/JC2670_UNAIDS_Treatment_Targets_en.pdf.

International Treatment Preparedness Coalition. Global Policy, Local Disconnects: a look into the implementation of the 2013 HIV treatment guidelines. www.itpcglobal.org/atomic-documents/11057/20005/WHO%20Report_web.pdf.