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New WHO Guidelines Recommend HIV Treatment for All and PrEP for Those at Risk


The World Health Organization (WHO) has released updated guidelines calling for universal antiretroviral therapy for everyone diagnosed with HIV, regardless of CD4 T-cell count, and pre-exposure prophylaxis (PrEP) for people at substantial risk of infection. The organization estimates that the recommendations, if widely adopted, could avert 21 million deaths and prevent 28 million new infections worldwide by 2030.

"These new recommendations will have tremendous impact on peoples’ lives, if rapidly implemented," saidGottfried Hirnschall, director of WHO's Department of HIV/AIDS. "So we must work together to support countries to translate them into action and results."

The new guidelines put WHO's global recommendations in line with U.S. treatment recommendations. San Francisco was first city to offer treatment for everyone diagnosed with HIV, starting in early 2010. The Department of Health and Human Services federal treatment guidelines followed suit in 2012. In May 2014 the Centers for Disease Control and Prevention recommended that people at substantial risk should consider PrEP to prevent HIV infection.

"These timely recommendations will make it easier for the poorest and most vulnerable populations everywhere to access the best treatment and services that modern science can provide and that are already available in the world’s richest countries,” added UNITAID executive director Lelio Marmora.

HIV Treatment For All

Hirnschall and others gave a preview of the new recommendations and explained the process behind them at the 8th International AIDS Society Conference in Vancouver this past July. This week's early release of the guidelines was done ahead of a full release expected later this year due to of its public health importance.

The new WHO guidelines state that, "Antiretroviral therapy should be initiated in all adults living with HIV at any CD4 cell count." The same recommendation applies to infants, children, adolescents, and pregnant women. People with advanced immune suppression or clinical symptoms of AIDS should be prioritized for treatment.

The recommendation for universal treatment for everyone who tests HIV-positive was informed by the large START trial, which showed the benefits of early antiretroviral therapy. The WHO guidelines team had advance access to these study findings after a data monitoring committee stopped the trial ahead of schedule because there was enough evidence to show an advantage og early treatment.

At the IAS meeting, Jens Lundgren from the University of Copenhagenreported that people with high CD4 counts (>500 cells/mm3)who were randomly assigned to start treatment immediately had a 57% reduction in serious AIDS-related events, non-AIDS events, or death, compared with people who delayed therapy until their CD4 count fell below 350 cells/mm3 or they developed AIDS symptoms.

Another presentation at the conference confirmed previous results from a study of heterosexual couples in Africa (HPTN 052), showing that HIV-positive people who start treatment immediately instead of waiting until their CD4 count drops had a 93% lower risk of transmitting HIV to their partners. When transmission did occur, it was usually soon after starting treatment before viral load became undetectable.

"[START] clearly indicates that antiretroviral therapy should be provided for everyone regardless of CD4 count," Lundgren told in Vancouver. "Now we have evidence that aligns individual benefit and prevention benefit without evidence of harm."

PrEP for People at Risk

The new WHO guidelines state that, "Oral PrEP (containing [tenofovir disoproxil fumarate]) should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches."

The WHO does not specify a particular PrEP regimen. Gilead Sciences' Truvada (tenofovir plus emtricitabine) has been most extensively studied for PrEP and is the only PrEP option approved by the U.S. Food and Drug Administration. Tenofovir alone was also evaluated in some PrEP trials. Generic versions of tenofovir and emtricitabine -- as well as the older off-patent drug lamivudine (3TC), which is similar to emtricitabine -- are available in many countries.

The large international iPrEx trial showed that once-daily Truvada reduced the risk of HIV infection for men who have sex with men by 92% among participants with blood drug levels indicating regular use. More recently, the UK PROUD and French Ipergay studies both found that Truvada PrEP -- daily in PROUD, "on demand" before and after sex in Ipergay -- lowered the risk of infection for gay men by 86%.

The updated WHO guidelines reaffirm an earlier recommendation, released prior to the 2014 International AIDS Conference in Melbourne, that PrEP could be used as part of a "comprehensive prevention package" for at-risk men who have sex with men. WHO did not then -- and does not now -- recommend that all gay men should take antiretrovirals for HIV prevention.

The new revision extends this recommendation to all population groups. While WHO broadly defines "substantial risk" as an HIV incidence greater than 3 per 100 person-years -- alevel of risk been seen in some groups of gay and bisexual men, transgender women, and heterosexual men and women with untreated HIV-positive partners -- it acknowledges that individual risk varies within groups.

"The new recommendation will enable a wider range of populations to benefit from this additional prevention option," according to the guidelines. "It also allows the offer of PrEP to be based on individual assessment, rather than risk group, and is intended to foster implementation that is informed by local epidemiological evidence regarding risk factors for acquiring HIV."

Ensuring Access

Under the new recommendation, the number of people eligible for treatment will increase from 28 million to 37 million worldwide, according to WHO. UNAIDS estimated that 15 million people were on treatmentas of March 2015, representing 41% of adults and 32% of children living with HIV.

The new guidelines stress that in order to effectively implement the recommendations, countries will need to ensure that testing and treatment for HIV infection are readily available and that people on treatment are given support to stay in care and maintain good adherence.

Expanded access to treatment and PrEP are key tools to reach the UNAIDS 90-90-90 targets, which include 90% of people living with HIV being aware of their status, 90% of those receiving antiretroviral therapy, and 90% of those having undetectable viral load.

"Everybody living with HIV has the right to life-saving treatment," said UNAIDS executive director Michel Sidibé. "The new guidelines are a very important step towards ensuring that all people living with HIV have immediate access to antiretroviral treatment."

"Providing antiretroviral treatment upon diagnosis is the best way to preserve the health of people living with HIV and PrEP ensures prevention equity for all," added International AIDS Society president Chris Beyrer. "This sends a signal that I hope will inspire governments, funders, and the international community to act now."

But others caution that people with HIV should not be compelled or coerced to start antiretroviral therapy before they area ready.

"[I]t is imperative that access to care is offered without coercion, upholding the rights and dignity of people living with HIV," said Global Network of People Living with HIV (GNP+) executive director Suzette Moses-Burton."We call upon governments to ensure that the freedom to make choices about treatment and prevention is upheld as they revise their national guidelines and programs."



World Health Organization. Guideline on When to Start Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV. September 2015.

World Health Organization. Treat all people living with HIV, offer antiretrovirals as additional prevention choice for people at "substantial" risk. Press release. September 30, 2015.

World Health Organization. Partner agencies support new guideline on antiretrovirals. Press release. September 30, 2015.

UNITAID. UNITAID Welcomes New WHO Guidelines for anti-retrovirals and preexposure prophylaxis. Press release. September 30, 2015.