Proclaiming that at least 5.2 million people with HIV were now receiving antiretroviral therapy (ART) in low and middle-income countries, the World Health Organisation (WHO) formally launched the 2010 guidelines on Antiretroviral therapy for HIV infection in adults and adolescents, during a press conference at AIDS2010 in Vienna.
The guidance, with its emphasis on earlier treatment, will dramatically increase the number of people with HIV who qualify for treatment, from an estimated 10 million to an estimated 15 million. WHO assembled a panel of experts to discuss what these guidelines will mean, how acceptable they are to the community and what will it take to implement them.
“Earlier treatment” [will translate] to longer lives, healthier lives, and fewer infections,” said Dr Gottfried Hirnschall, WHO Director of HIV/AIDS. Though recommending earlier treatment has been criticized by some who say it will be too increase costs to programmes at a point when the recession is threatening the dream of universal access, Dr Hirnschall said “we have enough evidence that these investments will however play out in a positive sense with health cost savings in a few years, and we really think we are in a win-win situation.”
WHO got the roll-out rolling
WHO has long argued that ART could be efficiently delivered to millions of people living with HIV in resource-limited settings by using a public health approach. In 2003, WHO launched the historic “3 by 5” initiative to provide access to HIV treatment to 3 million people living in low- and middle-income countries by the end of 2005. WHO’s approach to scaling up treatment has generally been simpler and more cost-conscious than many of ART programmes that were subsequently implemented.
The 3x5 goal wasn’t quite reached, but it was important to set the target.
“When we started the 3X5 initiative in 2003, many people were sceptical, but now we have put 5.2 million people on treatment,” said Dr Hiroki Nakatani, WHO Assistant Director-General for HIV, Tuberculosis, Malaria and Neglected Tropical Diseases who opened the press conference. Indeed, since 2003, the number of people receiving HIV treatment has increased 12-fold. “The additional 1.2 million were gained in 2009, which is the largest increase in people accessing treatment in a single year.”
The new guidelines
The new guidance, which had an advance-release towards the end of last year, contains four key changes.
- It promotes earlier treatment, recommending starting HIV treatment at 350 cells or below.
- It recommends moving to more patient-friendly and less toxic regimens, phasing out stavudine (d4T), which is more toxic than initially thought
- It recommends starting coinfected people with TB (or hepatitis B if it requires treatment) on ART earlier, regardless of the CD4 count
- It acknowledges the prevention benefits of treatment.
“The big additional benefit is the prevention benefit of scaling up treatment. In a way we are stating the obvious, that somebody who is on treatment who has less virus is less infectious and less likely to transmit the virus. But now we have sufficient scientific evidence so that we can formally incorporate this into the recommendation,” said Dr Hirnschall.
“We believe that with this reduction of mortality of up to 20% in the next five years, important reductions in TB related mortality as well, and the additional prevention benefit, this is quite a revolution,” Dr Hirnschall added.
According to Dr Kevin Moody of the Global Network of People Living with HIV/AIDS (GNP+), the guidelines are welcomed by people living with HIV around the world
“We think it will help to improve people’s quality of life, and people will have better health outcomes. We are also interested in the fact that earlier treatment may have prevention benefits,” he said.
Notably, WHO consulted extensively with communities of people living with HIV in different parts of the world before drafting the guidelines.
“HIV positive people are mothers, fathers and children. We aren’t a special group demanding special treatment. All we want is our right to health, which includes the right to treatment,” he added.
Kenya quick to adopt new guidelines
However, it will be up to the countries whether or not to implement the guidelines — and there will be some challenges putting them into operation on the ground. But said Dr Peter Cherutich of the Kenyan National AIDS & STI Control Programme, these challenges are not insurmountable.
“Implementing these guidelines at country level is not necessarily going to be easy, but we see this as a challenge not a barrier. These are challenges we can find solutions to,” he said. “These guidelines are feasible in Africa, and we in Kenya will try to provide leadership demonstrating this.”
Kenya has about 1.4 million people with HIV infection. About 350,000 qualified for treatment under the old guidelines, and this has now increased to 600,000. But the prevention benefits of treatment have been a powerful incentive to the programme.
“Our overriding goal in adopting this is that our HIV incidence is too high, and so we are adopting these guidelines in part to reduce transmission of HIV,” said Cherutich.
However in order to reap the prevention benefits of treatment, it will be necessary to identify the people who need treatment.
“With these new guidelines the paradigm of testing has to shift to identify people earlier in infection,” said Cherutich.
The country has implemented provider-initiated testing and counselling, and has also done pioneering work demonstrating high rates of acceptance of door-to-door testing of the general population, and targeted testing of the partners and other family members of people living with HIV.
“We’ve expanded efforts, including testing in the home and testing couples. We need to move to more proactive, human rights based, provider-initiated testing. We’ve seen it is possible and it is happening in Kenya where more than half now know HIV status,” he said.
“It’s important that people know their status,” said Dr Moody. “We also hope that through promotion of the guidelines, people will be more likely to get tested.”
He also believes that the community of people living with HIV need to be more involved in testing campaigns working in collaboration with the formal health sector, for example by training people with HIV to test and counsel others.
Concerns about resistance, increased sexual risk taking behaviour, and costs
Some audience members posed questions to the panel about whether earlier treatment (and the notion that it might work as prevention) could have some negative consequences, including an increase in resistance, disinhibition of sexual risk taking behaviour, and significant and unsustainable costs to health systems at a time of global recession.
“We are working with about 15 countries on resistance in RLS, but in most countries, the development of resistance has been less than expected, less than 5%,” said Dr Hirnschall. “In the south, people said that there wouldn’t be enough support for adherence, but the experience has been otherwise.”
“Adherence rates in Africa are comparable to the rest of the world,” agreed Dr Cherutich. “We need to use the resources we’ve developing of counselling people to take their treatment, adherence support. But we also need to plan a process for breakthroughs, and have a surveillance program for resistance in place.”
“Pretty much the only risk is that people don’t take the drugs regularly. Side effects are one of the reasons for this, but these guidelines switch to less toxic drugs and so should help with adherence,” said Dr Bernard Schwartlander, Director, Evidence, Strategy and Results, UNAIDS.
The biggest question in everyone’s minds was how to pay for putting more people on sometimes more expensive treatment. Looking at the annual cost over the next five years, the additional cost will be US$2 billion. Clearly this issue had Dr Cherutich concerned.
“Of course, the issue of cost is big challenge to us,” he said that Kenya has been contributing a minimum level which has gone up from US$ 7 to 13 million. “But that’s a drop in bucket of what is needed, so we need partnerships… We’ve been looking at the private sector, and we have an expectation that PEPFAR and the Global Fund will help us meet our commitments.
Dr Schwartlander stressed that the increased upfront costs would be offset by savings over time.
"The investments we make today can not only save millions of lives but millions of dollars tomorrow,” said Dr Bernhard Schwartlander, Director, Evidence, Strategy and Results, UNAIDS. " But the big problem is that people have been coming forward too late, and treating people who are very sick is very costly."
Treating people earlier would prevent the eventual costs of hospital care. In addition, he said that much of the cost of treatment actually comes from treatment delivery monitoring, which may be offset somewhat by using safer drugs. Finally, prevent more infections “will have huge returns, which will return on our investment as we move forward,” he said.
“We shouldn’t exaggerate or overestimate what the additional costs are,” said Dr Hirnschall. He pointed out that the new guidelines essentially means that an HIV-positive person, who will probably be on treatment for up to 30 years, will only go onto treatment two year earlier.
Even so, Dr Moody pointed out that the guidelines have come at an alarming time when funders are cutting back support, the G8 has broken their promises, and it is difficult to get funding even to meet old guidelines. Nevertheless, he stressed that people living with HIV, are committed to advocate that countries meet their funding commitments.
“We need to continue to make the case and sustain commitment to universal access and say it loud and clear,” said Dr Hirnschall. But in addition, programmes do have to look at how they operate, and make strategic linkages and use resources more efficiency (including the community).
“We have to look at what we have and try to use in optimal way. We still need to find ways to simplify what we are doing now and to reduce costs. For example, there’s no way that we can accept that second line drugs still cost what they cost,” he said.
Moving forward, he said WHO would work very closely with countries to try to identify operational bottlenecks, and funding gaps along the way. But “double standards regarding treatment should not exist between north and south… these guidelines should be applicable in any part of the world,” he said.
Ultimately, the question of cost should not be what dictates WHO policy, according to Dr Nakatani.
“Guidelines should be evidence-based, and should be applicable to anyone rich or poor,” he said in closing.