GUIDELINES

Consolidated guidelines on

the Use of Antiretroviral

Drugs for Treating and
Preventing HIV Infection
Summary of key features and recommendations

JUNE 2013

HIV/AIDS Programme

Consolidated guidelines on

the Use of Antiretroviral

Drugs for Treating and
Preventing HIV Infection
Summary of key features and recommendations

JUNE 2013

HIV/AIDS Programme

Consolidated guidelines on the use of antiretroviral drugs for

treating and preventing HIV infection: summary of key features and recommendations
I.World Health Organization
WHO/HIV/2013.7
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CONTENTS
1. What are the key features of the 2013 consolidated guidelines? 6
2. What are the new recommendations? 7
3. Components of the consolidated guidelines 8
4. What is the expected impact of the guidelines? 9
5. Summary of new recommendations 10

Acronyms
3TC lamivudine

HIV human immunodeficiency virus

ABC abacavir

LPV/r lopinavir/ritonavir

AIDS acquired immunodeficiency syndrome

NNRTI non-nucleoside reverse transcriptase inhibitor

ART antiretroviral therapy

NRTI nucleoside reverse transcriptase inhibitor

ARV antiretroviral (drug)

NVP nevirapine

ATV/r atazanavir/ritonavir

PI protease inhibitor

AZT azidothymidine (also known as zidovudine)

PMTCT prevention of mother-to-child transmission of HIV

DRV darunavir

RAL raltegravir

EFV efavirenz

RTV ritonavir

FTC emtricitabine

TB tuberculosis

HBV hepatitis B virus

TDF tenofovir disoproxil fumarate

HCV hepatitis C virus

WHO World Health Organization

6
The 2013 World Health
Organization (WHO)
Consolidated guidelines on
the use of antiretroviral drugs
for treating and preventing
HIV infection provide new
guidance on the diagnosis
of human immunodeficiency
virus (HIV) infection, the care
of people living with HIV
and the use of antiretroviral
(ARV) drugs for treating and
preventing HIV infection.
This document provides a
summary of the key features
and main recommendations
of the new guidelines.
The full guideline document
is available at:
www.who.int/hiv/pub/
guidelines/arv2013

1. What are the key features

of the 2013 consolidated
guidelines?
They respond to new
science and emerging
practice since 2010
N ew and easy-to-use HIV testing
technologies and approaches
enable more people, especially
those who are most vulnerable
and marginalized, to learn their
HIV status.
Simpler, safer, once-daily, single-pill
treatments that are suitable for use
in most populations and age groups
have become more affordable and
more widely available in resourcelimited countries.

Programmes for preventing motherto-child transmission of HIV (PMTCT)

are promoting earlier and simpler
treatments to improve the health of
pregnant women and mothers living
with HIV and to prevent HIV infection
among their children and partners.
In addition to improving health and
prolonging lives, clear evidence
indicates that antiretroviral
therapy (ART) prevents the sexual
transmission of HIV and that the
use of ARV drugs by uninfected
individuals can protect them from
becoming infected.
There is a trend towards starting
treatment earlier among people with
HIV to protect their own health and
prevent HIV transmission to others.

Guidance is provided
on ARV use along the
continuum of care

WHO/Viktor Suvorov

Retention
HIV TESTING
AND
counselling

LINKAGE
to
care

Enrolment
in Care

G eneral HIV care

HIV prevention
Managing coinfections
and comorbidities
P reparing people
for ART

ART
Initiation
(First Line
art)

For the first time, the 2013 guidelines

combine recommendations across
the continuum of HIV care, including
recommendations on HIV testing and
counselling, using ARV drugs for HIV
prevention, linking individuals to HIV
treatment and care services, providing
general HIV care, initiating and maintaining
ART and monitoring treatment. Guidance
is provided on using ARV drugs across
all age groups and populations of adults,

Retention and
Adherence

 onitoring ART
M
response
Monitoring ARV
toxicity

Second and
third line
ART

WHO

pregnant and breastfeeding women,

adolescents, children and key populations.
The guidelines provide advice on the
clinical management of people living with
HIV, make recommendations on how to
improve the efficiency and effectiveness of
HIV services and give guidance on how to
plan HIV programmes and use resources
most efficiently.

They combine new and

existing recommendations
WHO has been producing guidance
on the use of ARV drugs since 2002,
producing a range of guidelines on
various aspects of HIV diagnosis,
treatment and care. The 2013 guidelines
aim to combine and harmonize new
and existing recommendations,
including updated recommendations
from the 2010 guidelines on ART for
adults, adolescents and children and
ARV treatment and prophylaxis for
pregnant and breastfeeding women
living with HIV. They also include
existing WHO guidance on HIV testing
and counselling, HIV prevention,
general care for people living with HIV,
managing common coinfections and
other comorbidities and monitoring and
managing drug toxicities.

2. What are the new

recommendations?
New clinical
recommendations for
treating people with HIV
The 2013 guidelines are based on
a public health approach to further
expanding the use of ARV drugs for
HIV treatment and prevention, with
a particular focus on resource-limited
settings. The new clinical recommendations
in the guidelines include:
t reating adults, adolescents and
older children earlier starting ART
in all individuals with a CD4 cell
count of 500 cells/mm3 or less and
giving priority to individuals with
severe or advanced HIV disease and
those with a CD4 cell count of 350
cells/mm3 or less;
starting ART at any CD4 count
for certain populations with HIV,
including people with active TB
disease, people with hepatitis B virus
(HBV) coinfection with severe chronic

liver disease, HIV-positive partners in

serodiscordant couples, pregnant and
breastfeeding women and children
younger than five years of age;
a new, preferred first-line ART regimen
harmonized for adults, pregnant and
breastfeeding women and children
aged three years and older;
support to actively accelerate the
phasing out of stavudine (d4T) in
first-line ART regimens for adults
and adolescents;
the use of viral load testing as the
preferred approach to monitoring
the success of ART and diagnosing
treatment failure in addition to
clinical and CD4 monitoring of
people receiving ART; and
community-based HIV testing and
counselling and HIV testing of
adolescents to diagnose people
with HIV earlier and link them to
care and treatment.

New operational guidance

and recommendations
Expanding the use of ARV drugs
provides new opportunities to save
lives, improve the health of people
living with HIV and reduce the number
of people becoming newly infected
with HIV. With these opportunities
come challenges policy-makers and
implementers need to determine how
best to implement the recommendations
to achieve greatest impact. Guidance
is provided on enhancing the efficiency
and effectiveness of HIV interventions,
strengthening the continuum of HIV
care and improving linkages across the
health system. This guidance focuses on:
strategies to improve retention in
HIV care and adherence to ART;
t ask-shifting to address human
resource gaps;

decentralizing delivery of ART to

primary health care and integrating
ART services within maternal and
child health clinics, tuberculosis (TB)
clinics and drug dependence treatment
services; and
the implications of new clinical
recommendations for laboratory
services and procurement and
supply systems for ARV drugs and
other commodities.

New guidance for

programme managers
The document aims to assist
countries in decision-making and
programme planning, to adapt the
recommendations for their epidemic
and health systems contexts. The
guidance developed for HIV programme
managers outlines fair, inclusive and

transparent decision-making processes

at the country level on the strategic use
of ARV drugs. Consideration is given
to national planning processes, HIV
epidemiology, health system capacity,
available financial resources and ethical
and human rights considerations.
Tools for costing and planning are
also suggested. Implementation
considerations especially relevant to
programme managers are provided for
all major new recommendations.

New guidance on
monitoring and evaluation
Guidance is provided on monitoring the
implementation of new recommendations,
including potential indicators for monitoring
the performance of programmes
across the continuum of care.

3. components of the consolidated guidelines

What to do

How to do it

HIV testing and counseling

Adherence to ART

Prevention based on
ARV drugs

Retention in care

General HIV care

Clinical

Operational

When to start ART

(first-line ART)
What ART to start with
How to monitor
(ART response and toxicity)

Programmatic

Innovative models of service

delivery (integration,
decentralization and task
shifting)
Human resources
L aboratory and diagnostic
services
Procurement and supply
management systems

What ART to switch to

(second-line ART)
Management of coinfections
and comorbidities

How to decide what to do,

where and when
Decision-making (process, data required
and key parameters)
Implementation considerations
Useful tools for costing and planning

Monitoring and evaluation

Monitoring implications of new recommendations
Monitoring outputs and outcomes of scaling up ARV access
Other monitoring considerations (HIV drug resistance and
ARV toxicity monitoring)
Strengthening monitoring and evaluation systems

4. what is the expected impact of the guidelines?

Globally, an estimated 26 million
people living with HIV in low- and
middle-income countries will be
eligible for ARV drugs under the
new guidelines compared with the
previous close to 17 million people
eligible for them in accordance with
the 2010 guidelines. Progressive full
implementation of the guidelines
could avert as many as 3 million

AIDS-related deaths and 3.5 million

new HIV infections between 2013 and
2025 over and above those averted
by implementing the 2010 WHO
treatment guidelines. Realizing these
benefits will require an estimated
10% increase in the total annual
investment in the global HIV response.

WHO/Andr Francois/ImageMagica

10

5. summary of new recommendations

The tables below summarizes the new WHO recommendations formulated for the 2013 guidelines. The table is not
comprehensive and does not include recommendations drawn from other existing WHO guidelines.

HIV testing and counselling

Topic and population
Community-based testing

Recommendations

In generalized HIV epidemics, community-based HIV testing and counselling with linkage to prevention,
care and treatment services is recommended, in addition to provider-initiated testing and counselling
(strong recommendation, low-quality evidence).


In all HIV epidemic settings, community-based HIV testing and counselling for key populations,
with linkage to prevention, care and treatment services is recommended, in addition to providerinitiated testing and counselling (strong recommendation, low-quality evidence).
HIV testing and
counselling of adolescentsa


HIV testing and counselling, with linkages to prevention, treatment and care,
is recommended for adolescents from key populations in all settings (generalized,
low and concentrated epidemics) (strong recommendation, very-low-quality evidence).


HIV testing and counselling with linkage to prevention, treatment and care is recommended for all
adolescents in generalized epidemics (strong recommendation, very-low-quality evidence).

We suggest that HIV testing and counselling with linkage to prevention, treatment and care be
accessible to all adolescents in low and concentrated epidemics (conditional recommendation,
very-low-quality evidence).

We suggest that adolescents be counselled about the potential benefits and risks of disclosure of
their HIV status and empowered and supported to determine if, when, how and to whom to disclose
(conditional recommendation, very-low-quality evidence).

WHO/Jerry Redfern

11

When to start ART in people living with HIV

Topic and population

Recommendations

When to start ART in

adults and adolescents a


A s a priority, ART should be initiated in all individuals with severe or advanced HIV clinical
disease (WHO clinical stage 3 or 4) and individuals with CD4 count 350 cells/mm3
(strong recommendation, moderate-quality evidence).


ART should be initiated in all individuals with HIV with CD4 count >350 cells/mm and 500 cells/mm3
regardless of WHO clinical stage (strong recommendation, moderate-quality evidence).

ART should be initiated in all individuals with HIV regardless of WHO clinical stage or CD4 count
in the following situations:
Individuals

with HIV and active TB disease (strong recommendation, low-quality evidence).
Individuals

coinfected with HIV and HBV with evidence of severe chronic liver disease

(strong recommendation, low-quality evidence).



Partners

with HIV in serodiscordant couples should be offered ART to reduce HIV

transmission to uninfected partners (strong recommendation, high-quality evidence).

When to start ART
in pregnant and
breastfeeding women


A ll pregnant and breastfeeding women with HIV should initiate triple ARVs (ART), which
should be maintained at least for the duration of mother-to-child transmission risk. Women
meeting treatment eligibility criteria should continue lifelong ART (strong recommendation,
moderate-quality evidence).


For programmatic and operational reasons, particularly in generalized epidemics, all pregnant
and breastfeeding women with HIV should initiate ART as lifelong treatment (conditional
recommendation, low-quality evidence).

In some countries, for women who are not eligible for ART for their own health, consideration
can be given to stopping the ARV regimen after the period of mother-to-child transmission risk
has ceased (conditional recommendation, low-quality evidence) .
ARVs and duration
of breastfeeding

The key principles and recommendations established in 2010 remain, including:

National or subnational health authorities should decide whether health services will mainly
counsel and support mothers known to be infected with HIV to either breastfeed and receive ARV
interventions or avoid all breastfeeding given their particular context.
In settings where national authorities have decided that maternal and child health services will mainly
promote and support breastfeeding and ARV interventions as the strategy that will most likely give
infants born to mothers known to be infected with HIV the greatest chance of HIV-free survival:


Mothers known to be infected with HIV (and whose infants are HIV uninfected or of unknown
HIV status) should exclusively breastfeed their infants for the first 6 months of life, introducing
appropriate complementary foods thereafter, and continue breastfeeding for the first 12 months
of life. Breastfeeding should then only stop once a nutritionally adequate and safe diet without
breast-milk can be provided (strong recommendation, high-quality evidence for the first
6 months; low-quality evidence for the recommendation of 12 months).
When to start ART in
children


A RT should be initiated in all children infected with HIV below five years of age,
regardless of WHO clinical stage or CD4 count.
I nfants diagnosed in the first year of life
(strong recommendation, moderate-quality evidence)
Children infected with HIV one year to less than five years of age
(conditional recommendation, very-low-quality evidence).

A RT should be initiated in all children infected with HIV five years of age and older with
CD4 cell count 500 cells/mm 3, regardless of WHO clinical stage.
C D4 count 350 cells/mm 3
(strong recommendation, moderate-quality evidence)
C D4 count between 350 and 500 cells/mm 3
(conditional recommendation, very-low-quality evidence).

A RT should be initiated in all children infected with HIV with severe or advanced
symptomatic disease (WHO clinical stage 3 or 4) regardless of age and CD4 count (strong
recommendation, moderate-quality evidence).

A RT should be initiated in any child younger than 18 months of age who has been given
a presumptive clinical diagnosis of HIV infection (strong recommendation, low-quality evidence).

An adolescent is a person aged 10 to 19 years inclusive.

12

What ART regimens to start

Topic and population

Recommendations

First-line ART regimens

for adults


F irst-line ART should consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus
a non-nucleoside reverse-transcriptase inhibitor (NNRTI).
TDF

+ 3TC (or FTC) + EFV as a fixed-dose combination is recommended as the preferred option

to initiate ART (strong recommendation, moderate-quality evidence).

If
 TDF + 3TC (or FTC) + EFV is contraindicated or not available, one of the following

options is recommended:
AZT

+ 3TC + EFV
AZT

+ 3TC + NVP
TDF

+ 3TC (or FTC) + NVP

(strong recommendation, moderate-quality evidence).


Countries should discontinue d4T use in first-line regimens because of its well-recognized metabolic
toxicities (strong recommendation, moderate-quality evidence).
First-line ART for pregnant
and breastfeeding women
and their infants


A once-daily fixed-dose combination of TDF + 3TC (or FTC) + EFV is recommended as first-line
ART in pregnant and breastfeeding women, including pregnant women in the first trimester of
pregnancy and women of childbearing age. The recommendation applies both to lifelong treatment
and to ART initiated for PMTCT and then stopped (strong recommendation, low- to moderatequality evidence: moderate-quality evidence for adults in general but low-quality evidence for the
specific population of pregnant and breastfeeding women and infants).


Infants of mothers who are receiving ART and are breastfeeding should receive six weeks of
infant prophylaxis with daily NVP. If infants are receiving replacement feeding, they should
be given four to six weeks of infant prophylaxis with daily NVP (or twice-daily AZT).
Infant prophylaxis should begin at birth or when HIV exposure is recognized postpartum
(strong recommendation, moderate-quality evidence for breastfeeding infants; strong
recommendation, low-quality evidence for infants receiving only replacement feeding).
First-line ART for children
younger than 3 years
of age


A LPV/r-based regimen should be used as first-line ART for all children infected with HIV
younger than three years (36 months) of age, regardless of NNRTI exposure. If LPV/r is not
feasible, treatment should be initiated with an NVP-based regimen (strong recommendation,
moderate-quality evidence).


W here viral load monitoring is available, consideration can be given to substituting LPV/r with
an NNRTI after virological suppression is sustained (conditional recommendation, low-quality
evidence).

F or infants and children younger than three years infected with HIV, ABC + 3TC + AZT is
recommended as an option for children who develop TB while on an ART regimen containing
NVP or LPV/r. Once TB therapy has been completed, this regimen should be stopped and the
initial regimen should be restarted (strong recommendation, moderate-quality evidence).


For infants and children younger than three years infected with HIV, the NRTI backbone for an ART
regimen should be ABC + 3TC or AZT + 3TC (strong recommendation, low-quality evidence).
First-line ART for children
3 years of age and older

For children infected with HIV three years of age and older (including adolescents), EFV is the
preferred NNRTI for first-line treatment and NVP is the alternative (strong recommendation,
low-quality evidence).

(including adolescents)


For children infected with HIV three years to less than 10 years old (and adolescents weighing

less than 35 kg), the NRTI backbone for an ART regimen should be one of the following,
in preferential order:
ABC + 3TC
AZT or TDF + 3TC (or FTC)
(conditional recommendation, low-quality evidence).


F or adolescents infected with HIV (10 to 19 years old) weighing 35 kg or more, the NRTI

backbone for an ART regimen should align with that of adults and be one of the following, in
preferential order:
TDF + 3TC (or FTC)
AZT + 3TC
ABC + 3TC
(strong recommendation, low-quality evidence).

13

Monitoring ART response and diagnosis of treatment failure

Topic and population
All populations

Recommendations

V iral load is recommended as the preferred monitoring approach to diagnose and confirm
ARV treatment failure (strong recommendation, low-quality evidence).

If viral load is not routinely available, CD4 count and clinical monitoring should be used to
diagnose treatment failure (strong recommendation, moderate-quality evidence).

Second-line ART: what ARV regimen to switch to

Topic and population
What ARV regimen to
switch to in adults and
adolescents

(includes pregnant and

breastfeeding women)

Recommendations

S econd-line ART for adults should consist of two nucleoside reverse-transcriptase
inhibitors (NRTIs) + a ritonavir-boosted protease inhibitor (PI).
The

following sequence of second-line NRTI options is recommended:
After

failure on a TDF + 3TC (or FTC)-based first-line regimen, use AZT + 3TC

as the NRTI backbone in second-line regimens.

After

failure on an AZT or d4T + 3TC-based first-line regimen, use TDF + 3TC

(or FTC) as the NRTI backbone in second-line regimens.

Use

of NRTI backbones as a fixed-dose combination is recommended as the

preferred approach (strong recommendation, moderate-quality evidence).


H eat-stable fixed-dose combinations ATV/r and LPV/r are the preferred boosted
PI options for second-line ART (strong recommendation, moderate-quality evidence).
What ARV regimen to
switch to in children

(including adolescents)


A fter failure of a first-line NNRTI-based regimen, a boosted PI plus two NRTIs
are recommended for second-line ART; LPV/r is the preferred boosted PI (strong
recommendation, moderate-quality evidence).

A fter failure of a first-line LPV/r-based regimen, children younger than 3 years should
remain on their first-line regimen, and measures to improve adherence should be
undertaken (conditional recommendation, very-low-quality evidence).


A fter failure of a first-line LPV/r-based regimen, children 3 years or older should switch to
a second-line regimen containing an NNRTI plus two NRTIs; EFV is the preferred NNRTI
(conditional recommendation, low-quality evidence).


A fter failure of a first-line regimen of ABC or TDF + 3TC (or FTC), the preferred NRTI
backbone option for second-line ART is AZT + 3TC (strong recommendation, low-quality
evidence).

A fter failure of a first-line regimen containing AZT or d4T + 3TC (or FTC) the preferred
NRTI backbone option for second-line ART is ABC or TDF + 3TC (or FTC) (strong
recommendation, low-quality evidence).

14

Third-line ART
Topic and population
All populations

Recommendations

N ational programmes should develop policies for third-line ART (conditional
recommendation, low-quality evidence).

T hird-line regimens should include new drugs with minimal risk of cross-resistance to
previously used regimens, such as integrase inhibitors and second-generation NNRTIs and
PIs (conditional recommendation, low-quality evidence).


Patients on a failing second-line regimen with no new ARV options should continue with
a tolerated regimen (conditional recommendation, very low-quality evidence).
Special considerations
for children

Strategies that balance the benefits and risks for children need to be explored when second-line
treatment fails. For older children and adolescents who have more therapeutic options available
to them, constructing third-line ARV regimens with novel drugs used in treating adults such as
ETV, DRV and RAL may be possible. Children on a second-line regimen that is failing with no
new ARV drug options should continue with a tolerated regimen. If ART is stopped, opportunistic
infections still need to be prevented, symptoms relieved and pain managed.

Operations and service delivery

Topic

Recommendations

Interventions to optimize
adherence to ART


M obile phone text messages could be considered as a reminder tool for

Service integration
and linkage


I n generalized epidemic settings, ART should be initiated and maintained in eligible

promoting adherence to ART as part of a package of adherence interventions

(strong recommendation, moderate-quality evidence).

pregnant and postpartum women and in infants at maternal and child health care
settings, with linkage and referral to ongoing HIV care and ART, where appropriate
(strong recommendation, very-low-quality evidence).


I n settings with a high burden of HIV and TB, ART should be initiated for an individual
living with HIV in TB treatment settings, with linkage to ongoing HIV care and ART
(strong recommendation, very-low-quality evidence).


I n settings with a high burden of HIV and TB, TB treatment may be provided for an
individual living with HIV in HIV care settings where TB diagnosis has also been made
(strong recommendation, very-low-quality evidence).


A RT should be initiated and maintained in eligible people living with HIV at care
settings where opioid substitution therapy (OST) is provided (strong recommendation,
very-low-quality evidence).
Decentralization of
treatment and care

The following options should be considered for decentralization of ART initiation

and maintenance.


I nitiation of ART in hospitals with maintenance of ART in peripheral health facilities
(strong recommendation, low-quality evidence).

I nitiation and maintenance of ART in peripheral health facilities (strong recommendation,
low-quality evidence).

I nitiation of ART at peripheral health facilities with maintenance at the community level
(that is, outside health facilities in settings such as outreach sites, health posts, homebased services or community-based organizations) between regular clinical visits
(strong recommendation, moderate-quality evidence).
Task-shifting


Trained non-physician clinicians, midwives and nurses can initiate first-line ART
(strong recommendation, moderate-quality evidence).

Trained non-physician clinicians, midwives and nurses can maintain ART
(strong recommendation, moderate-quality evidence).

Trained and supervised community health workers can dispense ART between regular
clinical visits (strong recommendation, moderate-quality evidence).

15

Guidance for programme managers

Topic

Guidance

Guidance for
programme managers

For deciding on the implementation of the clinical and operational recommendations,

it is recommended that:

T he national authorities do so using a transparent, open and informed process.
This process should have broad stakeholder engagement, including meaningful
participation from the affected communities, and take into account the specifics
of the recommendations under discussion.

T he decision-making process take into account data on the national and local HIV
epidemiology, current ART programme performance and the socioeconomic, policy and
legal context, including the budgetary, human resource requirements and other health
system implications. The latter would identify which inputs and systems are currently
available and which areas require additional investment.

T he decision-making process take into account the ethics, equity and human rights, the
impact and cost-effectiveness and the opportunity and risk dimensions of alternative
implementation options.

WHO/AndrFrancois/ImageMagica

For more information, contact:

World Health Organization
Department of HIV/AIDS
20, avenue Appia
1211 Geneva 27
Switzerland
E-mail: hiv-aids@who.int
www.who.int/hiv

WHO/HIV/2013.7