Where Will the New WHO Guidelines Take HIV Treatment?

Where Will the New WHO Guidelines Take HIV Treatment?

{Photo credit: Reavis/MSH, Malawi}Photo credit: Reavis/MSH, Malawi

The World Health Organization (WHO) made waves at the International AIDS Society conference in Kuala Lumpur when it issued revised guidelines for HIV treatment. The new guidelines—WHO’s first major update since 2010—recommend an earlier start to treatment, from a CD4 threshold of 350 cells/mm3 to 500 cells/mm3. While most patients don’t show symptoms of disease at these higher CD4 counts (a measure of immune system strength), the new guidelines responded to evidence that an earlier start improves long-term clinical outcomes and that ARV treatment dramatically reduces patients’ likelihood of transmitting the virus to sexual partners.

The guidelines received a mixed welcome. Under the old WHO guidelines, around 17 million people worldwide were eligible for antiretroviral therapy (ART). Under the new guidelines, 26 million of the world’s 34 million HIV positive people are eligible—three out of four. That’s a substantial jump, but doesn’t go all the way to a “test and treat” model offering ART to anyone who tests HIV positive. While Thai government officials balked at the size of the increase, some activists decried the move as “absolute bare minimum steps” from “stingy donors and U.N. technocrats and national governments in the global south.”

WHO guidelines always face the tension between clinically optimal, evidence-based recommendations and the reality in which donors and host countries struggle to afford and implement HIV treatment programs. If these guidelines were too far divorced from reality, they would be ineffective as an accountability mechanism; yet setting the bar too low would reinforce a double standard between developed and developing countries for potentially life-saving interventions.

The pressure on WHO is to address a core question in global health: what should the international community expect from HIV programs in high-burden, low-resource countries?

Countries Lead

Surprise: countries have been bucking low expectations, pushing ahead of WHO, and setting high standards that work for them. Under previous guidelines, WHO suggested two options for preventing mother-to-child transmission (PMTCT): Option A and Option B. Each option determined the treatment for an HIV-positive pregnant woman depending on whether her CD4 was below 350 (making her eligible for lifelong ART) or above. Above 350, each option provided a short-term regimen which she’d only receive through the end of breastfeeding.

In 2010, the Malawi Ministry of Health (with technical consultation from MSH) looked at these options and its infrastructure, and saw that CD4 testing resources weren’t available widely enough to implement either Option A or B. Women in Malawi have a high fertility rate, so a woman would likely become pregnant again within a few years, and stopping and starting ART repeatedly is unhealthy. Plus, the evidence had already emerged that an earlier start is better for patients and their partners. So Malawi decided to skip the CD4 counts and put every HIV-positive pregnant woman on lifelong ART, calling it Option B+. It’s effectively “test and treat” for pregnant women, bringing the developed world standard to a developing country.

A few years later, the idea has caught on. A half dozen countries in sub-Saharan Africa have committed to provide Option B+ (including Uganda), another half dozen are on the verge, and many more look likely to follow.

And the 2013 WHO guidelines? They drop Option A and acknowledge that in settings like Malawi, “the benefits…are clear” for Option B+.

Harmonizing Efforts

Showing awareness of programmatic considerations, the new WHO guidelines recommend a move towards universal use of a single first-line ARV regimen. The once-daily, single-pill regimen (containing tenofovir, lamivudine/emtricitabine, and efavirenz) is safe and easy to use. Even better for health systems, standardizing and harmonizing around a single regimen will simplify supply chain management and streamline processes like provider training. There are five manufacturers creating price competition, and bulk purchasing around a single regimen should continue the considerable price reductions that have made expanded treatment possible.

For WHO to push a public health approach—emphasizing earlier treatment for better health and expanded prevention—is a major step. Still, the room for improvement in global HIV practice is immense. While WHO guidelines can provide standards and accountability for slower-moving governments and donors, ambitious countries will continue their own leadership towards better care.

We wouldn’t be surprised to hear a high-burden, low-income country announce tomorrow that it will fulfill the new WHO guidelines. Or implement “test and treat” for certain high-risk populations (along the lines of Global Fund Executive Director Mark Dybul’s “hot spots” philosophy). Or roll out “test and treat” for the whole population.

If there’s one thing we can expect under the new WHO guidelines, it’s that country leaders will keep finding innovative ways to solve their own problems.

Scott Kellerman, MD, MPH, is global technical lead on HIV & AIDS at MSH. Jonathan Jay, JD, MA, is a senior writer at MSH.

Comments

A. Frederick Hartman, Jr.
Thank you Scott and Jay. The current guidelines are clearly a compromise between those who want to move towards "test and treat" (the norm in the USA and Europe), and those who still want some limits on how many people receive ART. In our work in comprehensive HIV & AIDS programs in Ethiopia, earlier analyses on eligibility for initiating treatment at 350 helped stimulate the Ethiopia FMOH to adopt 350 as the approved policy, and to initiate option B+ for PMTCT programs in February, 2013. We are heavily involved in the FMOH TWGs that address these issues, and this TWG is now willing to discuss the new guidelines of initiating ART at a CD4 count of 500. Thus, we have completed an analysis showing that the vast majority of HIV+ individuals in Ethiopia presenting for evaluation will fall under the CD4 count of 500 threshold. If the GOE decides to accept that guideline, moving to "test and treat" will only increase costs by 16%, a comfortable cost-benefit analysis given the overall cost savings from reduced partner transmission and reduced hospitalizations from AIDS-defining illnesses. My sense is that we are witnessing the slow but logical progression to a "test and treat" approach in high HIV burden, low resource countries that will be beneficial to all. Let us keep up the dialogue and exchange of information.
YOKA P.L..
I agree with Frederick regarding the cost effectiveness of the "test and treat" option which seems to cause a cost increase increase of about 15% in a short term period, but which is going to reduce dramatically the overall cost from the spread of the infection and AIDS related illnesses. Country leaders particularly those from limited resources countries will be accountable for the commitment to this option while drawing their strategic plan to contain the pandemic for the next decades.
Gerald Mentoor
Whilst it is good and well to 'up' the treatment, shouldn't we first look at whether the support systems to implement this 'new and improved' treatment are in place? In this I refer to those medical practitioners that are to implement and oversee that the 'new' treatment indeed gets dispensed to the patients. Too often we find that we do not have adequate systems to first of all track those that are in need of follow-up treatments and are 'lost'. There is thus no 'tracking systems' in place to find those individuals. The RSA government is still in its very infant stage of implementing or rolling out its National Health Insurance (NHI) programme that purports to re-engineer Primary Health Care that is 'Taking services to the people'. Fundamentally it struggles with Health professionals, computerised systems and a variety of other challenges. Whilst all this is going on the HIV and AIDS programme is already running for a few years. Can we say as a country that we have indeed reached our targets that is those with the CD 4 count below/above 350 as we intended to at least reduce the no's as was announced? Shouldn't we first analyse as to why the targets were not achieved and address those challenges? It could be that more resources of whatever nature should be first put in place....with this it is not necessarily meant more money, but maybe training and re-training professionals to aptly deal with the 'bigger' influx if the CD count will now be for those with a 500 count? Should we not have a credible computerised system in place to enable the tracking of patients once the database has been certified to be credible? My concerns might not seem 'that relevant' now, but one has too often seen in the past that 'new' initiatives are introduced without looking at the past ones. We do not look at the reasons for it not having had the desired outcomes it was supposed to have had. Then we all hear there is a new product/method available and we all 'jump' to it thinking it will solve our problems, only to find that we have created for ourselves an unmanageable problem.

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