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.