The World Health Organisation (WHO) has issued sweeping new guidelines that could put millions more people on HIV drugs than are now getting them. The New York Times reports that health officials say the recommendations could go a long way toward halting the epidemic but would cost untold billions of dollars not yet committed. HIV patients should be put on an antiretroviral therapy of three drugs immediately after diagnosis, the agency said, and everyone at risk of becoming infected should be offered protective doses of similar drugs.
Immediate treatment has become the standard of care in America and much of the developed world, but the agency’s new HIV treatment and prevention guidelines increase by 9m the number of infected people who should get it worldwide. The health agency did not estimate how many at-risk people would benefit from its new prevention guidelines, but UNAids, the UN Aids fighting agency, made a back-of-the-envelope calculation that 10m could be helped, including many women and girls in Africa not previously covered.
Dr Mark Dybul, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, said the new recommendations were “critically important to moving us toward fast-track treatment and prevention goals.” Numerous recent studies have shown that people taking so-called triple therapy every day not only live longer, but also have so little circulating virus that they are highly unlikely to infect others even through unprotected sex. Studies using Truvada, a two-drug combination taken preventively, have shown that those taking the drugs every day have near-total protection against infection.
The recommendations underscored the difference in options available to patients in industrialized countries and those in the developing world, and public health advocates acknowledged that it was unclear where the money would come from to turn the new guidelines into reality. Donor contributions for Aids have been essentially flat since 2009.
The report says although the WHO issues guidelines, each country sets its own policy. Inevitably, when treatment starts depends on how many citizens the country’s health budget can afford to treat – 15m people are on treatment now, fewer than half of the 37m people infected worldwide. But advocates noted that the situation has appeared hopeless before; a generation ago, the idea of treating anyone in poor countries with $15,000 medications looked impossible. Now, with generic drugs and the generosity of wealthy nations, the number of people getting treatment in Africa, Asia and Latin America has been rising by about a million a year.
The new guidelines represent an acknowledgment that no vaccine is on the horizon, and that the long-touted “ABC” strategy – abstain, be faithful, use a condom – has not worked. And yet there is hope the epidemic can be ended, or at least greatly shrunken, with tools now at hand. “We can make the impossible possible,” said Dr Deborah L Birx, the US global Aids coordinator and head of the President’s Emergency Plan for AIDS Relief. “If we can demonstrate that this would break the back of the epidemic, I think people will step up.”
The report says the WHO last issued new treatment guidelines in 2013, when it advocated immediate treatment for some groups, including children, pregnant women and people with tuberculosis. But for most others it recommended treatment only when their CD4 counts – a measure of immune system strength – fell below 500. Under those guidelines, about 28m were eligible for treatment.
Although that meant starting before serious immune breakdown began – 500 is considered the lower limit of a healthy level – some advocates have argued for immediate treatment for all. Failing to provide it meant losing patients and spreading the disease, they argued. The medical charity Doctors Without Borders said that a third of people who got HIV diagnoses in its clinics but were not put on drugs because they were not yet eligible never returned, presumably getting sicker and infecting others.
Many advocates have argued that groups not previously covered by treatment guidelines – particularly women and girls in those African countries where more than 1 percent of the adult population is infected – should be covered. The WHO’s previous guidelines recommended preventive doses for some gay men, transgender women, people with infected partners and others. Risk guidelines must be determined individually, experts explained. Not all gay men need PrEP, for example; those in monogamous relationships with HIV-negative partners do not, while those having unsafe sex with strangers do. Poor women and girls in countries with high infection rates are considered at risk both from rape and from pressure to have sex without condoms with infected men in return for money, favours, grades, job promotions and so on.
Most African countries that depend on donors use a CD4 count of 500 – the old guideline – as the treatment starting point, as do India and China. Russia, Eastern Europe, Indonesia and some Southeast Asian countries use an even older WHO guideline, waiting until patients fall below 350. Mexico, Brazil and a few other middle-income countries have already adopted test-and-treat protocols for everyone.
The report says estimating a price tag for the guidelines is difficult. The health organization did not do so in issuing them, other than acknowledging that countries would have to set priorities. Almost $22bn is currently spent on Aids in poor and middle-income countries, half of it contributed by donors, according to UNAids. Even before the new guidelines, that was predicted to rise to $32bn by 2020.
The guidelines come as an early surprise, according to a Health-e News report. Many, including South Africa’s own National Department of Health deputy director general Yogan Pillay, had anticipated that the WHO would issue the groundbreaking call in December, the report says.
Globally, many countries including South Africa take a cue from the WHO when drafting their own guidelines. New WHO guidelines do not mean that South Africa will automatically adopt the test and treat model, but it may be an added push for the country, which has already begun to mull the move over.
“South Africa is considering the test and treat strategy and, in principle, we will be moving towards test and treat,” said CEO of the South African HIV non-profit the Right to Care, Dr Ian Sanne. “The idea is that we would require less laboratory monitoring (of CD4 counts)… there would be an overall simplification of the programme to being more people onto treatment quickly.” Sanne added that ARVs remain one of the best options for HIV prevention.
“ARVs have proven to be the only intervention that really reduces HIV transmission,” he is quoted in the report as saying. “(They) are still better than any other prevention intervention undertaken, this includes microbicides, and they are better than condom use.”
Speaking at a recent Mpumalanga Provincial AIDS Council meeting, South African National AIDS Council HIV Counselling and Testing advisor Rev Zwoitwaho Nevhutalu called for the country to rethink HIV testing in the run up to adopting the test and treat model. Nevhutalu also advocated that the Department of Health consider promoting HIV self-testing to increase HIV diagnoses.
If the WHO’s recommendations are implemented in South Africa, it would mean about 3m more South Africans would be eligible for ARVs. If the world adopted test and treat, an additional nine million people would be started on the life-saving medication.
South Africa’s Department of Health is weighing up the practical and financial implications of expanding HIV treatment to more people. South Africa’s guidelines state that patients should start treatment when their CD4 count falls below 500 cells per mm³ and that pregnant HIV-positive women should start lifelong treatment and Business Day reports that since only about half of the 6.4m people infected with HIV in SA are on treatment, the WHO’s guidelines might, at first sight, suggest that the country is destined to double the number of patients taking antiretrovirals.
But both government sources and independent experts said that they did not anticipate a massive surge in demand, as previous policy changes had not triggered large spikes in the numbers of those receiving treatment. Instead, the number of people on HIV treatment had steadily risen over the past few years.
Moving to the “test and treat” regimen recommended by the WHO would expand the pool of eligible patients, but exactly how many would elect to start treatment immediately was unclear, Pillay said. “There are both operational and financial issues to consider. I will be convening a series of meetings, and will then make recommendations to the (health) minister,” he said.
The report says the Treasury has made provision in its medium-term expenditure framework for steadily expanding HIV treatment, with the HIV/Aids conditional grant rising from R13.7bn this fiscal year to R15.4bn in 2016-17, and R17.4bn in 2017-18. The Health Department has historically under-spent this grant, suggesting weaknesses in the health system rather than lack of finances may be the biggest impediment to expanding treatment, the report says.
University of Cape Town researcher Leigh Johnson said changing the eligibility criteria was unlikely to make a huge difference to the number of people on treatment in South Africa. In 2012, the guidelines recommended starting treatment when patients’ CD4 count fell below 350, yet only a third (415,000) of the 1.23m patients who had been diagnosed with HIV and met the treatment criteria were taking antiretrovirals, he said.
Pillay acknowledged that Gilead Sciences’ Truvada, which the WHO recommends for pre-exposure prophylaxis, was not yet registered in SA, but said tenofovir was a good alternative. Truvada combines tenofovir and emtricitabine.
The new guidelines recommend that specific combinations of ARVs are given to anyone who is at high risk of contracting HIV. According to a Mail & Guardian report, several studies have shown that when HIV negative people take these combinations of ARVs, they drastically reduce their chances of contracting the virus.
President of the Southern African HIV Clinicians Society, Francesca Conradie has welcomed “the addition of pre-exposure prophylaxis (preventative treatment) to those who are at substantial risk of HIV”. But, the report says, she warned that the ARVs, TDF and FTC, that are used for preventative treatment, are not yet registered for this purpose in South Africa. “We would urge the regulatory authorities to expedite the registration,” she said.
Pillay, however, said the registration should be through by November. “We would start with the most vulnerable groups in South Africa – female sex workers, men who have sex with men, discordant couples (couples where one person is HIV positive and the other HIV negative) and young women between the ages of 15 and 24,” Pillay said. “That’s what the WHO recommends.”