WHO GUIDELINE ON WHEN TO START ANTIRETROVIRAL THERAPY AND ON PRE-EXPOSURE PROPHYLAXIS FOR HIV
SEPTEMBER 2015

EXECUTIVE SUMMARY
In 2013, WHO published the first consolidated guidelines on the use of antiretroviral (ARV) drugs for HIV treatment and prevention across all age groups and populations. A comprehensive revision of these guidelines based on new scientific evidence and lessons from implementation is being undertaken in 2015.

This early-release guideline makes available two key recommendations that were developed during the revision process in 2015.

First, antiretroviral therapy (ART) should be initiated in everyone living with HIV at any CD4 cell count.

Second, the use of daily oral pre-exposure prophylaxis (PrEP) is recommended as a prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches.

The first of these recommendations is based on evidence from clinical trials and observational studies released since 2013 showing that earlier use of ART results in better clinical outcomes for people living with HIV compared with delayed treatment.
The second recommendation is based on clinical trial results confirming the efficacy of the ARV drug tenofovir for use as PrEP to prevent people from acquiring HIV in a wide variety of settings and populations.

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. By publishing these recommendations as soon as possible, WHO aims to help countries to anticipate their implications in a timely fashion and begin the dialogue necessary to ensure that national standards of HIV prevention and treatment are keeping pace with important scientific developments.

The target audience for this guideline is primarily national HIV programme managers, who will be responsible for adapting the new recommendations at country level. The guideline will also be of interest to a wide range of other stakeholders, including national TB programme managers and civil society organizations, as well as domestic and international funders of HIV programmes.

The recommendations in this guideline will form part of the revised consolidated guidelines on the use of ARV drugs for treating and preventing HIV infection to be published by WHO in 2016. The full update of the guidelines will consist of comprehensive clinical recommendations together with revised operational and service delivery guidance to support implementation.

A Clinical Guideline Development Group convened by WHO developed the recommendations in this guideline based on systematic reviews that summarized the evidence available up to June 2015. The GRADE approach was used to determine the quality of the evidence and the strength of the recommendation.

The ambitious UNAIDS Fast-Track targets for 2020, including achieving major reductions in HIV-related mortality and new HIV infections and the 90–90–90 targets, will require countries to further accelerate their HIV responses in the coming years. Much greater effort is also needed to ensure that key and vulnerable populations and adolescents gain access to essential HIV treatment and prevention services.

Implementation of the recommendations in this guideline will contribute to achieving these goals and to ultimately ending the AIDS epidemic as a major public health threat by 2030.

G Mohan.