WHO ART guideline: Treat all with HIV, offer PrEP to those at “substantial risk”

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“We have no excuses,” says U.S. Global AIDS Coordinator Ambassador Deborah Birx

They cost pennies to manufacture, and research has proven that accessing them upon diagnosis of HIV is life-saving, averts serious illnesses, and prevents transmission of the virus. But until today, international HIV treatment guidelines recommended delaying access to antiretroviral medicines for most people while waiting for signs of illness to appear. That changed this morning with the early release of updated guidelines from the World Health Organization, recommending that all people diagnosed with HIV receive treatment.

WHOGuidelineIt is the most recent in a series of guideline updates over the years, that originally focused on the number of immune, or CD4, cells found in blood testing. The new guideline greatly widens the pool of people worldwide who the international agency says should be able to access antiretroviral treatment. At the same time, by eliminating the need to measure immune system damage before providing medicine, and the need to retain individuals in care without treatment for repeated testing, following the guideline also would greatly simplifiy the process of initiating treatment for HIV. Currently an estimated 37 million people live with the virus, 15 million of whom were receiving treatment as of March 2015.

Treatment upon diagnosis of HIV has long been the standard of care in the United States, Brazil, British Columbia and a handful of other countries. While most of those have been relatively high-income countries, among the exceptions is Malawi, a low-income country that recently announced it would adopt a policy of HIV treatment for all in April 2016. Still, a significant number of countries worldwide, many home to large numbers of people living with the virus continue to follow earlier WHO eligibility guidelines for treatment initiation, issued prior to updates in 2010, 2013, according to HIV Policy Watch, an interactive site launched by IAPAC — the International Association of Providers of AIDS Care.

The new guidelines say that implementation of its recommendations “should be informed by local context, including HIV epidemiology, availability of resources, the organization and capacity of the health system and anticipated cost–effectiveness.” At the same time a mounting body of research, which WHO noted prompted the early release of its update, have highlighted the costs of delayed treatment. Studies that include HPTN 052, the START trial and the TEMPRANO trial showing that early treatment more than halves risks of serious illness and death, and almost entirely eliminates risks of transmitting the virus. In addition, previous accelerations of treatment scale-up have led to economies of scale and practice, with negotiations for lower drug prices and health system task shifting helping to offset costs.

The updated guideline also greatly expands the numbers of people recommended to be eligible for PrEP — pre-exposure prophylactic antiretroviral medicine as a preventive measure against becoming infected. While WHO recommended in 2014 that people in “key populations” including men who have sex with men, people earning income through sex work, and people who inject drugs have access to daily oral PrEP, today’s release recommends PrEP be offered to people at “substantial risk,” which the document defines as HIV incidence of greater than 3 percent, that can include in addition to previously cited situations of risk, heterosexual men and women who have sexual partners with undiagnosed or untreated HIV infection. The update notes that HIV incidence greater than 2 percent was among criteria for offering oral PrEP in the recommendations issued by the International Antiviral Society USA panel in 2014. The guideline also notes that some studies have demonstrated offering PrEP was cost effective, while others have not. Today’s release also promises a “comprehensive implementation guidance for PrEP in 2016.”

Among responses to the guidelines also released by WHO today, were calls for wide implementation, and discussion of potential results.

“It will enable more people with HIV live [to] live better quality lives, drastically reduce TB episodes and save many lives,” a statement from Kenly Sikwese, Coordinator at the African Community Advisory Board (AFROCAB), said.

 “We have no excuses,” a statement from U.S. Global AIDS Coordinator Ambassador Deborah Birx, said, “it is up to us to seize this moment and chart a bold course together to end AIDS as a public health threat.”

“In Brazil, we adopted treatment for all from December 2013 and since then we’ve included people sooner in treatment, benefitting our community with the strategic use of ART,” a statement from Brazil Ministry of Health AIDS program director Fabio Mequita said. “That is why we encourage all countries to adopt the new directions . . .”

The IDSA Education and Research Foundation Center for Global Health Policy, which produces this blog, released a statement today, hailing the guidelines as “an important
step toward control of the HIV pandemic,” and encouraging world leaders and donors to put them into practice.

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