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WHO New Guidelines: start ART at any CD4;
PrEP recommended for all at substantial risk
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"......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."
Press Release
http://www.who.int/mediacentre/news/releases/2015/hiv-treat-all-recommendation/en/
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Treat all people living with HIV, offer antiretrovirals as additional prevention choice for people at "substantial" risk
New policies could help avert more than 21 million deaths and 28 million new infections by 2030
News release
30 SEPTEMBER 2015 GENEVA - Anyone infected with HIV should begin antiretroviral treatment as soon after diagnosis as possible, WHO announced Wednesday. With its "treat-all" recommendation, WHO removes all limitations on eligibility for antiretroviral therapy (ART) among people living with HIV; all populations and age groups are now eligible for treatment.
The expanded use of antiretroviral treatment is supported by recent findings from clinical trials confirming that early use of ART keeps people living with HIV alive, healthier and reduces the risk of transmitting the virus to partners.
WHO now also recommends that people at "substantial" risk of HIV should be offered preventive antiretroviral treatment. This new recommendation builds on 2014 WHO guidance to offer a combination of antiretroviral drugs to prevent HIV acquisition, pre-exposure prophylaxis (PrEP), for men who have sex with men. Following further evidence of the effectiveness and acceptability of PrEP, WHO has now broadened this recommendation to support the offer of PrEP to other population groups at significant HIV risk. PrEP should be seen as an additional prevention choice based on a comprehensive package of services, including HIV testing, counselling and support, and access to condoms and safe injection equipment.
New recommendations on early use of ART and expanded offer of PrEP are contained in WHO's "Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV." The new guideline stresses 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 those undergoing treatment are supported to adhere to recommended regimens and are retained in care.
The recommendations were developed as part of a comprehensive update of the "WHO consolidated guidelines on the use of antiretroviral drugs for preventing and treating HIV infection". This early release guideline is shared ahead of the full publication, slated for release later this year, because of their potential for public health impact.
Based on the new recommendations, the number of people eligible for antiretroviral treatment increases from 28 million to all 37 million people who currently live with HIV globally. Expanding access to treatment is at the heart of a new set of targets for 2020 with the aim to end the AIDS epidemic by 2030. These targets include 90% of people living with HIV being aware of their HIV infection, 90% of those receiving antiretroviral treatment, and 90% of people on ART having no detectable virus in their blood.
According to UNAIDS estimates, expanding ART to all people living with HIV and expanding prevention choices can help avert 21 million AIDS-related deaths and 28 million new infections by 2030.
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Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV
Publication date: September 2015
Overview
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 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.
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.
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