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WHO early 2016 guidelines expand ART to all HIV-infected patients
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WHO issued an early release of the organization’s 2016 guidelines, recommending that all patients with HIV should immediately initiate ART regardless of their CD4 cell counts and that all patients at high risk for HIV should receive daily pre-exposure prophylaxis.
The updated guidelines reflect recent findings from the START trial and the HPTN 052 study. START trial results indicated that patients undergoing early ART had a 57% reduction in non-AIDS–related events and AIDS-related events, including tuberculosis and AIDS-defining cancers. The HPTN 052 study demonstrated that early ART reduced the risk for HIV transmission by 93%.
“The two recommendations are being made available on an early-release basis because of their potential to significantly reduce the number of people acquiring HIV infection and dying from HIV-related causes and significantly impact global public health,” the guidelines stated.
The guidelines were updated using the GRADE approach by a clinical guideline development group assembled by WHO officials. The guidelines are primarily targeted to HIV program managers who are responsible for implementing recommendations at the country level.
“By publishing these recommendations as soon as possible, WHO aims to help countries to anticipate their implications in a timely fashion and begin the dialogues necessary to ensure that national standards of HIV prevention and treatment are keeping pace with important scientific developments,” the guidelines stated.
According to the updated recommendations, WHO strongly advises that:
- all patients living with HIV should receive ART at any CD4 cell count;
- all women with HIV who are pregnant or breast-feeding should receive ART regardless of CD4 count; and
- all high-risk patients, including men who have sex with men, transgender women and those with multiple partners, should receive daily oral pre-exposure prophylaxis (PrEP) that contains Viread (tenofovir disoproxil fumarate, Gilead Sciences).
Under two newly developed conditional guidelines, ART should be further expanded to all adolescents, aged 10 to 19 years, and children, aged 1 to younger than 10 years, with HIV, regardless of CD4 count.
Based on cohort and national program data, officials predicted a 35% increase in ART. UNAIDS estimated that expanding ART to all infected patients will prevent 21 million AIDS-related deaths and 28 million new infections by 2030, according to the guidelines. However, the cost implications at the country level warrant further investigation.
The feasibility, acceptability, cost-effectiveness and impact of treatment will be explored in the SEARCH and MaxART studies; results are not expected before 2017 or 2018. Three randomized control studies assessing the population effect of early ART on HIV incidence and mortality are expected to produce results in 2018 or 2019, the guidelines said.