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HIV & AIDS: A Crisis on Pause.

IN THIS SECOND INSTALLMENT, JOHN CALLAGHAN continues his investigation of global efforts to combat HIV & AIDS. Here, John digs deep into the policy battles and their consequences on the ground in countries where infection rates are decreasing and those where the disease remains epidemic. What policy decisions and cultural factors create such disparity?

During his keynote address at the World AIDS Conference in Amsterdam last year, former US president Bill Clinton, with his seemingly effortless charm, told thousands of the world's leading HIV & AIDS advocates:
   One of the first things I did after what
   was for me a heartbreaking election
   in 2016, within 48 hours T called
   President George W. Bush and I
   asked him, I told him, I said, "The best
   thing you did was PEPPFAR, and they will
   come after it. And you can save it if you
   get the commitments now before
   anybody is thinking about it." So, I know
   that a lot of you would like more money
   put into PEPFAR, I would, too. But the
   fact that PEPFAR is still being funded
   at the level it is--that's something you
   owe him.


Bush established PEPFAR, the President's Emergency Plan for AIDS Relief, in 2003, under the rubric of compassionate conservativism. Tens of billions of US taxpayer dollars invested over 15 years has had an enormous and deep-reaching impact. The numbers are impressive: 14 million people on anti-retroviral therapy (art), 85 million tested for HIV, 15 million voluntary male circumcisions, two million babies born inv-free to infected mothers, 6.5 million orphans and vulnerable children receiving support. Male circumcision can significantly reduce female-to-male transmission, as the epithelial cells in the foreskin are vulnerable to the virus.

According to its own numbers, PEPFAR has saved more than 17 million lives since its inception in more than 50 countries. But--despite Clinton's encomium--PEPFAR is under threat. These threats are not just funding related, but also due to the imposition of ideological constraints than can only serve to limit PEPFAR's effectiveness. The religious fundamentalism pervading the Trump administration also hinders domestic HIV & AIDS prevention.

A SUCCESS STORY

The favored global approach to combatting the HIV & AIDS epidemic has changed in recent years. The changing dynamics of the disease and the many lessons learned along the way have shifted the focus of the coordinated World Health Organization/Joint United Nations Program on inv and AIDS (WHO/UNAIDS) response. Deep-pocket funding from PEPFAR, along with funding from other national governments and big name foundations, and the advent of low-cost, generic anti-retroviral therapies have resulted in a highly focused strategy--treatment as prevention (TasP). Adding to the existing armory of prevention approaches that include neonatal treatment, male circumcision, focused key population education and training campaigns, and most recently, pre-exposure prophylaxis (PrEP), TasP focuses on suppressing the virus in those infected, thereby stopping its spread.

Low-cost HIV drugs (like the highly effective first-line treatment dolute-gravir) have become widely and immediately available, thereby having a significant positive impact on the epidemic. Generic art can be provided for as little as $75 per person, per year. Health administrators and epidemiologists are cautiously optimistic that we can reverse the negative trajectory of the disease and effectively contain it within the next 10 years.

The new narrative, test and treat, is conceived of as a treatment cascade with three aggressive targets, summarized as 90-90-90 targets. Each of these targets has an associated set of challenges that must be recognized, understood and addressed.

Testing Goal: By 2020, 90 percent of people living with HIV will know their status. The core challenge here is getting people to take an HIV test. Low-cost testing has become more available in increasingly diverse social settings, but some key groups still resist testing. Today, an estimated 25 percent of people living with HIV do not know their status; in other words, 75 percent know their status. Getting to 90 percent is a daunting challenge.

Treatment Goal: By 2020, 90percent of people diagnosed with HIV will receive sustained ART. Rapid transition to treatment is at the core of the new model. In the past, various thresholds were used to initiate treatment. For example, t-cell counts below 300 or 500 were standard protocols for initiating art. Clinical evidence clearly supports the idea that people with undetectable viral loads cannot infect others. Suppressing the virus quickly is an incredibly effective means of limiting its spread, with rapid movement to treatment being the most cost-effective strategy. The challenge here, however, is providing strong linkage to care. And this can be incredibly expensive. Making art available to the estimated 40 million, and growing, HIV-positive people, for the rest of their lives, is a serious long-term commitment.

Retention Goal: By 2020, 90percent of all people receiving ART will have viral suppression. Even with HIV drugs available at low or no cost from local clinics or health centers, it will be difficult to get people to stay in treatment. In some respects, this is the hardest target to hit because it's the least responsive to having money thrown at it. Many of those with HIV are young and have never gotten sick from a disease. Many also are poorly educated, and convincing them that the virus is dormant in their body reservoirs and will become active if they stop taking the pills every day is not an easy sell. Retention in care is a challenge, as is tracking those who become "lost to care."

UNAIDS and PEPFAR assert that reaching these targets remains within reach, and their models suggest that the epidemic will be brought under control by 2030. The core of the narrative is that while we do not yet have a cure for HIV, we have developed the tools and techniques to contain it. We simply need to increase our efforts to achieve 90-90-90. They have produced an ambitious fast-track proposal to push for the targets and point out that, in some locations, success is tantalizingly close, and in a few cases, may have already been reached.

The success is remarkable. Policymakers generally agree that PEPFAR, despite some early missteps, has been unprecedented in its effectiveness and approach. (Early iterations of PEPFAR required a significant portion of funds be allocated to promote abstinence as a treatment, and at one time, partner organizations were required to sign an anti-prostitution pledge). The laser focus on treating and preventing HIV & AIDS--sometimes referred to as AIDS exceptionalism--in partnership with local community NGOS has become a model for global health partnership. And it may be on the verge of turning the HIV & AIDS epidemic around, an unprecedented historic achievement.

A DARKER NARRATIVE

However, a counternarrative is also emerging, with a much more ominous and menacing tone. The International AIDS Society (IAS)--Lancet Commission, a prestigious group of global experts, published a report in 2018 that found "the HIV epidemic is not on track to end and that existing tools are insufficient." The report states, "Although art has transformed the HIV response by averting deaths, improving quality of life, and preventing new infections, HIV treatment alone will not end the epidemic." The Commission points out that--despite significant progress in extending the life span of people with HIV--no real progress has been made in reducing new infections in the last decade. They highlight the example of Botswana, where it is likely the UNAIDS 90-90-90 targets have already been reached, but the rate at which new HIV infections is falling is not nearly enough to curtail the epidemic.

Almost two million new HIV cases per year lead to a growing pool of infection as people live longer. According to the IAS--Lancet Commission, "Without further reductions in HIV incidence, a resurgence of the epidemic is inevitable, as the largest ever generation of young people age into adolescence and adulthood." In other words, this large and growing population of people carrying the virus for decades into the future is an epidemiological time bomb.

The Commission believes that not only is the 90-90-90 strategy flawed, but the overall conditions in which HIV & AIDS is to be managed have deteriorated. Democracy is in retreat globally, and the role of civil society is under threat with the emergence of nationalist ideologies and conservative politics. These political trends can lead to an upswing in stigma around HIV & AIDS and xenophobia, which can leave vulnerable populations like migrants at risk of being neglected in care. Nowhere is this more evident than in Russia, where the epidemic is on the rise, the rate of new infections increasing by 10-15 percent per year. Only 35 percent of HIV-positive people in Russia are on art--a long way from the 90 percent UNAIDS target. It has one of the lowest treatment rates on the world. Russia's HIV epidemic is concentrated among people who inject drugs (PWID), and heterosexual transmission accounts for almost half of new infections. Socially conservative legislation under the Putin regime heavily stigmatizes key populations and leads to underreporting of numbers generally and those for gay men in particular.

The problem of regressive legislation is not confined to Russia. According to UNAIDS, around 73 countries have laws that criminalize HIV non-disclosure, exposure or transmission, and 39 countries have applied other criminal law provisions in similar cases. Yet, the Oslo Declaration released in 2012 points out that "A growing body of evidence suggests that the criminalization of HIV non-disclosure, potential exposure and non-intentional transmission is doing more harm than good in terms of its impact on public health and human rights." It also undermines the UNAIDS 90-90-90 targets for treatment as prevention.

Ongoing debates about cutting PEPFAR funding also threatens progress. The Trump administration's proposed budget cuts (despite Bush's early intervention at Clinton's prompting) in 2018 were unsuccessful because of strong bipartisan opposition, but few doubt that the Office of Management and Budget has PEPFAR firmly in its sight. This at a time when who and UNAIDS are calling for a significant increase in funding to push forward with the 90-90-90 targets and bring the epidemic under control.

The current administration was also more successful in limiting PEPFAR's scope of engagement by extending the Mexico City gag rule. The Mexico City policy is a requirement imposed by Republican presidents (and lifted by Democrats) that US foreign aid money cannot be given to foreign organizations or government agencies that speak about, refer or counsel patients about abortion care options. President George W. Bush made a specific exclusion for PEPFAR in recognition of the magnitude of the problem and the urgency of the global situation. This sense of pragmatism has been lost as the Trump administration plays to its core, fundamentalist base.

The full impact of the Mexico City ruling has not been fully assessed, but the effect will certainly be negative. Jennifer Kates of the Kaiser Family Foundation, speaking at the World AIDS Conference in Amsterdam last year, reported on a study of PEPFAR-funded NGOS for a recent three-year period to estimate the scale of the problem. Almost 500 foreign NGOS managing about $900 million could be affected by the ruling. An additional 264 US NGOS are not directly impacted by the policy, but pass an estimated $5 billion in funding on to local providers that would be impacted. These funds flow to 61 countries, in 36 of which legal access to abortion is available.

NGOS and health providers will be forced to choose between continuing to provide the full range of care, including referring or counseling on abortion, or to muzzle themselves and deny their patients critical information in order to continue to receive PEPFAR funding. This ultimatum clearly impacts medical ethics and questions of sovereignty. The real impact on the ground will not be fully understood for some time.

On the domestic front, too, the Trump administration is adding administrative and procedural hurdles that make it more difficult for people with HIV to access their drugs. The HIV-positive population skews poorer, and large numbers rely on Medicare for their art (estimates hover around 40 percent). The administration is trying to introduce a cost-cutting measure that will limit the selection of medications available and force patients to use less-effective therapies.

The US government has also encouraged the introduction of "limited-duration" health insurance plans. These plans, ostensibly a low-cost alternative for the uninsured, sidestep the core requirements of the Affordable Care Act to treat HIV & AIDS. They will not ensure people with HIV & AIDS at all and do not cover PrEP, the drugs that prevent key at-risk individuals from catching the disease. This is, in effect, a return to the "existing pre-condition" exclusion that denied people with HIV & AIDS access to medical care in the past and is a dangerous and ugly precedent.

But one of the more mundane aspects of the emerging negative narrative on HIV & AIDS treatment is the growth in complacency. With success comes a growing sense that society no longer needs to pay so much attention to the disease; a feeling that we have figured out how to manage the epidemic and we can now shift focus to other problems. Bill Clinton, in his address explained:
   The thing I'm most worried about is that
   there are too many people in too many
   places who are so comfortable they think
   the battle is over--where they live. And,
   so there's not enough testing and not
   enough basic public health preventions.
   Even in the wealthiest settings, people
   think it's over. There are too many young
   people who are not used to living with
   the imminent threat of death, so they
   think it's over. There is political debate all
   over the world today, falling out of this
   tribal separatism that seems to have
   captured the imagination of so many
   people that they think, "Well, we got to
   cut this, because we got to give our
   people a tax cut or this-that-or-the-other-thing,
   so we got back off or certainly
   don't give any more money."


And, critically, progress towards a preventative vaccine and functional cure has slowed as the urgency behind the epidemic has waned. Federal funding allocated to domestic AIDS research--most of which goes to the National Institutes of Health (NIH)--has remained flat at approximately $2.7 billion since 2012. This means an inflation-adjusted drop in funding for the search for a real, sustainable way to contain the disease.

SOUTH AFRICA: THE FRONTLINE

The scale of the HIV & AIDS epidemic in South Africa is staggering. An estimated 7.5 million South Africans are infected with HIV. That's almost one in five of the adult population aged 15 to 49. Officials project that 270,000 new HIV infections will occur next year, and 110,000 people will die from AIDS-related causes, mostly tuberculosis (TB) co-infection. As the most economically developed of the sub-Saharan countries, South Africa battles the epidemic within the same key populations where the disease is focused in rich Western countries: men who have sex with men (MSM), people who inject drugs and sex workers. But it also has high rates of transmission within the general population of straight men and women. And young women and girls are especially vulnerable. Male-to-female transmission from unprotected vaginal sex is the most common mode of transmission. Poverty, women's lower social status and the prevalence of gender-based violence mean that almost 40 percent of new infections now occur in young women aged 15-24 years.

There are many medical, social, economic and cultural factors used to explain how the disease got such a foothold in southern Africa. Biological factors include the high incidence of untreated STDS, especially those that produce genital ulcers, and the low rate of male circumcision. Behavioral factors come into play from the culture of polygamy and sexual networking, tacitly accepted, especially among men. Economic contributors include migrant labor (men leaving families at home to work in mining or construction projects and availing of sex workers) and poverty. Add to this a culture of traditional medicine and a distrust of Western, or "foreign" medicine.

By most measures, South Africa has responded extremely well to the crisis. The country has the largest art program in the world (4.5 million people on anti-retrovirals) and perfectly represents the huge successes made in recent years with the expansion in test-and-treat programs. Progress towards the 90-90-90 targets is impressive: 86 percent of HIV-positive people know their status; 68 percent of those who know their status have access to ART; 78 percent of those ON ART are fully virally suppressed. The country also distributed about 850 million free condoms in 2018.

The ANOVA Health Institute, based in Johannesburg, operates on the frontlines of prevention. Partnering with the city's health clinics, ANOVA receives PEPFAR funding to support a broad range of HIV prevention and treatment initiatives targeting key populations. However, due to current trends, about 80 percent of its activity is now focused on the general population, especially straight men and young women. Young women and girls are particularly vulnerable, as Tanja Bencun-Roberts from ANOVA explains, because of the culturally embedded idea of men giving small gifts, or "blessings," to young women in return for sex. It's not considered sex work, but it still places an obligation on the girl to have unprotected sex because "He's my blesser, because he gives me (cell phone) air-time, or he buys me perfume or fancy clothes."

Bencun-Roberts described some of the challenges in getting straight men to test. So much HIV messaging in the past focused on gay men and other key populations that straight men did not identify as being at risk. Making test facilities available when and where straight men find them convenient and reconfiguring them to be welcoming to straight men is a recent ANOVA initiative. They recently provided pop-up testing sites for men and found infection rates of around 10 percent, most of who transitioned to treatment. Another ANOVA program called FAITH works with various churches and religious communities, including traditional healers, to address issues of stigma and encourage men to test.

South Africa also exemplifies many of the warnings sounded by those who caution against complacency and an overreliance on treatment as prevention. The very human limitations of long-term art treatment are evidenced at the Tapologo HIV & AIDS project in the mining town of Rustenburg, a couple of hours drive from Johannesburg.

Tapologo was founded by Bishop Kevin Dowling and has been providing ART to the people of Freedom Park since 2014, with funding from PEPFAR. Freedom Park, a shantytown pushed up against the world's largest platinum mine, has one of the highest infection rates ever recorded--some think as high as 70 percent. Stephen Blakeman, Tapologo's CEO, has witnessed an important shift in perceptions over the past 15 years. "Once we had the medications and people who were dramatically sick started becoming well, this had a net positive effect, because you actually had peer conditions within the community, and you could start to advocate from within." But the drugs didn't end the stigma. Today, the government is pushing hard to get people on treatment, but they are no longer dramatically ill. Blakeman adds, "We are putting people on medication who don't feel sick, who are not presenting with symptoms. And there are many reasons then that they don't feel they have to adhere. And to go onto a lifetime medication when you don't actually feel sick is quite difficult." Not enough attention is being paid to the "loss to follow-ups." Figures from the South African government show adherence rates ranging from 35 percent to 70 percent.

Blakeman's concern is not just for the welfare of the individual or around the fact that individuals will quickly become infectious again once the viral levels rebound if they stop taking the medication. He also worries that non-adherence allows drug-resistant strains of the virus to develop, and points to the new multi-drug resistant (MDR) strains of TB that are now the biggest killers in South Africa. They are the most common co-infections killing people with compromised immune systems from HIV. He believes health administrators once had TB under control using a direct observed treatment (dot) model, but now we are witnessing an escalating curve of infection.

STAKES ARE HIGH

Stephen Blakeman is not alone in his concern that a large and growing population of outwardly healthy people moving in and out of treatment for decades into the future represents a serious danger. The possibility of a major drug-resistant strain of HIV evolving only increases with time, and with the number of HIV-positive people in whom the virus is not fully suppressed. The 90-90-90 targets aim to reduce that population, but they will not eliminate it. Only a vaccine and functional cure will do that.

In other words, the epidemic is on pause. Countervailing forces--on the one hand, increasing availability of low-cost testing and treatment, and on the other, a young, healthy and growing population living with the virus for years to come--seem to have stalled the progress of the virus, but not stopped it.

An upsurge in the HIV & AIDS epidemic would be disastrous. In addition to the very immediate human cost of the sickness, and death of those infected, AIDS leaves communities hollowed out by attacking the young, fertile and economically most-productive members. Families, villages, cities and nations can be impoverished economically as well as socially by the disease. And, historically, economic instability increases global instability--something the Trump administration's America First boosters should bear in mind before advocating funding cuts or further restrictions on PEPFAR.

A rebound in HIV & AIDS will have a huge impact on morale within the global health community. The massive mobilization of resources to combat HIV & AIDS, the globally coordinated response and the huge strides made in extending generic treatments to millions of people have been unprecedented. Success feels within reach. And as the IAS-Lancet Commission says, "A refusal to follow through to achieve long-term control of the epidemic would merely repeat a longstanding pattern in global health, when failure to sustain a surge in global interest in combating particular health threats allows these epidemics to return in force ... At a moment when the means to improve human health are greater than ever, allowing a resurgence of HIV through neglect and apathy could deal a blow from which the broader cause of global health could need decades to recover."

So, how do we avoid a reversal? The fight against HIV & AIDS will continue for many years to come and will require increased levels of funding from a broad range of sources. When funded well, the global health community responds effectively, and treatment can work at containing the disease. But it's important to recognize that treatment alone is not enough. Preventing new infections is essential, and there are many approaches. Ante-natal treatment, voluntary circumcision, condoms, education and information, needle exchange programs and PrEP will all continue to have a role to play in the future. More-targeted prevention strategies for straight men, women and girls--now seen as a key risk group--are needed to effectively impact their behavior. And we need to pay attention to newly emerging outbreaks of the disease, like the pockets of infection now popping up along the major opium trafficking routes from Afghanistan into Russia.

FOCUSED INTERVENTION

We must address the problem of stagnation and complacency not just in government policy and in public opinion, but also within the structures of the HIV global bureaucracy. Recent reports paint a picture of UNAIDS in a crisis state itself, with defective leadership, a culture of impunity and a toxic work environment. Amid widely publicized allegations of sexual harassment, bullying and abuse of power, the executive director, Michael Sidibe, has rejected calls for his resignation. UNAIDS cannot be effective in its mission without accountability and transparency. There must also be an organizational refresh within the major global institutions charged with managing the crisis. Twenty-five years after UNAIDS' founding, it's time to shake things up.

To truly move the HIV & AIDS epidemic towards an endgame, we need to focus more time, money and effort into developing a vaccine. The biomedical nature of the virus poses many challenges to the development of a preventative vaccine. The challenges are significant, and limited real progress has been made to date. We have learned a lot about what doesn't work in developing a vaccine, but there are no particularly strong candidate vaccines currently undergoing trial. It is worth pointing out the economic disincentives for big pharmaceutical companies to be successful in this endeavor. Not only would a vaccine significantly reduce the market for their highly lucrative art medications, but it also is likely that governments and NGOS would very quickly source generic formulations of a vaccine as they did with ART. As a result, realistically, any vaccine breakthrough will likely need to come from publicly funded research institutions.

We also need more moral pragmatism--the type of moral pragmatism President Bush showed when he exempted PEPFAR from the Mexico City policy. The moral pragmatism Bishop Kevin Dowling, the founder of Tapologo, showed in response to the suffering in Freedom Park. He spoke out against church dogma and supported the use of condoms because his sense of compassion for the people living with the reality of AIDS outweighed his sense of obligation to an abstract dogma that banned condoms.

We will also need to see greater moral pragmatism on the part of churches, especially the Catholic church, if we are to turn the tide on AIDS. The US Protestant fundamentalist movement cheered Trump's extension of the Mexico City gag rule to include PEPFAR. And the Catholic hierarchy seems to be locked in an internal battle for the soul of the church. Pope Francis and the reformers fight a battle to bring enlightenment to a deeply conservative theological establishment, while the institution itself is mired in child and nun sex-abuse scandals that point to a deeply dysfunctional culture that cannot seem to come to grips with sex and sexuality matters. The crisis within the church renders its prohibition on the use of condoms to prevent AIDS almost farcical. It would be funny, if it were not such a betrayal of its responsibility to Catholics across the world. We deserve better.

JOHN CALLAGHAN is an occasional writer, a lifelong learner and an inveterate do-gooder who lives with his husband and his cat. He has HIV.

Caption: Members of AIDS activist group act up (AIDS Coalition to Unleash Power) protest at FDA headquarters on October 11, 1988.

Caption: ACT UP New York protests in Times Square ahead of World AIDS Day. November 29, 2017.
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Author:Callaghan, John
Publication:Conscience
Geographic Code:6SOUT
Date:Mar 22, 2019
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