Community Advisory Group report by Kevin Nicholas Baker
This important session saw the launch of the new
consolidated ARV guidelines from WHO.
These guidelines were consolidated across a continuum of HIV care, all ages
and populations and seek to provide clinical, operational and programmatic
guidance on the use of ARVs in one place.
Key new recommendations included:
- Earlier ARV initiation is recommended at CD4 less than
or equal to 500, an increase from 350.
The community response is that we must think about when people are being
presenting for testing, as often it is still very late with the average is 100
- A single, preferred 1st line regimen (FDC) is
recommended. The community raised
the issue of sustainability and cost implications in relation to drug options
and choices in certain countries.
- Lifelong ARV for pregnant and breastfeeding women is
also recommended in the guidelines.
- Immediate ART for all children under 5 years old and while
the community welcome this hopes that ART will be available for all children
- The guidelines recommend a move to viral load
monitoring. The community welcomed
this but recognized the situation currently on the ground – e.g. In Nepal there
is only 1 viral load machine in the whole country.
- The integration of ART into other services is also a
- Provision of ARV to zero-discordant couples – the scope
of this needs to be clearly defined to support the implementation process. The
community felt that it should not just mean married couples.
- Decentralisation and task-shifting is also a welcome recommendation
– ART can be provided in local settings and by many different types of health
- Adherence support needs to be there to support people and
this is key to the community response to HIV.
and impact to 2015 include and additional 3 million HIV-related deaths averted, an additional 3.5 new HIV infections averted and the need for an additional 10% of total resource needs.
The community welcomed the guidelines broadly but
highlighted the overall need for all constituents to work together to ensure
this and the other recommendations are implemented on the ground. One element of this that was
highlighted was the need for clear definitions – e.g. in relation to the
populations concerned and health care workers involved. Also the guidelines should
include Hep C issues also but it is not – will be issued separately next year. We must continue to be political – the review
of the MDGs is just 2 years away and AIDS needs to be kept in the discussion.
We all must ensure that ARV financing is sustainable and work
together to ensure cost effective access to ARVs – e.g the implications of future trade
agreements being key.
Below are copies of the petition from community, WHO's subsequent reply, and a community response to WHO.
Dear Ms. Doherty
and Mr. McClure,
undersigned, are writing to you with regard to the World Health Organization Treatment
Guideline changes for children under 5 years old effective June 30, 2013. We
understand that the UNICEF strongly supports the Guideline changes. In effect ,
these changes recommend that all children under 5 years of age (previously 2
years of age) living with HIV immediately be put on antiretroviral treatment
regardless of CD4 count or health status.
We are strongly
in support of care for all children living with HIV. As mothers ourselves and
those supporting them, we have an abiding concern for the health and welfare of
our children. We also strongly support the aims of the Guidelines. Our concern
is that there are a number of barriers to the universally successful
implementation of these Guidelines at the present time which must be removed
prior to the implementation.
We draw on the
recent presentation by Kate Gilmore, Deputy Executive Director of UNFPA as a
framework for these concerns. In her recent speech at the women Deliver Conference
she reflected on the role of those in authority in governments and
international organizations as duty bearers in relation to human rights aspects
and implications of their recommendations on the world stage. Specifically, she
cited the International Covenant on Economic, Social and Cultural Rights (ICESCR)
General Comment No.14 which state that four elements, being: availability, accessibility, acceptability
and quality are essential to the enjoyment of the right to health by all.
Regrettably, the Guidelines proposed will not meet this fourfold test for the
Adherence is serious
issue for young children. Ritonavir liquid is unpalatable and children do not
want to take it. Because it is so hard to get them to swallow it and they spit
it out it is impossible to tell if they are getting a therapeutic dose. If not,
they will build resistance to the drug. In addition, it requires refrigeration
to remain stable and refrigeration is not often available. Efavirenz resistance
builds with only one resistance mutation and therefore resistance to it builds
rapidly if children are not adherent. There are also still concerns about its
safe use in children
Since there are
not second and third line drugs universally available children may well still
become ill if they develop resistance to the first line treatments.
security is also a serious problem and interruption of medications will also
lead to resistance.
issues also impact the success of treatments. In many countries adequate food
and water is not available consistently in all regions to ensure that treatments
will be properly metabolized by children. Nutrition becomes a huge issue
because the delivery of antiretroviral drugs to children is dependent on their
The health care
systems that are rolling out this programme are not fully developed in all
locations, particularly where local clinics are rolling out the treatments.
Health care providers have not been adequately educated in all cases about how
to help mothers provide these treatments to young children so that lack of
adherence and resistance is minimized. They are also often overworked and do
not have the time to assist women in a manner that ensures continued encouragement
for women and their children to continue to attend the clinic for care and
The trials to
date have not supported the proposed Guidelines. We appreciate that we do not
want to wait until children are very ill to treat them but on the other hand we
do not want to treat children earlier than necessary since these medications
are difficult for children to take and there is no strong evidence that
prolonged treatment on antiretrovirals in their formative years does not have
an impact on bone and other growth factors in children as they become
adolescents. Balance is necessary.
support the right of all children living with HIV to have access to treatments
when required. We also strongly support the necessity to have all children
living with HIV in care. Support for their parents and other caregivers is also
urgently needed by health care providers and vibrant fully functioning health
care and development systems. To achieve these we strongly recommend the
Implement a pilot
project in two appropriate locations to determine the optimal manner to roll
out this programme universally and to determine how to overcome barriers to
optimal implementation and rollout prior to a full implementation of this
multi-pillared education programme for health care providers including all relevant
clinical information as well as advice on how to assist mothers and other
caregivers of children living with HIV in a respectful, cooperative manner
within a human rights framework, as described by Kate Gilmore.
palatable, safe, practical treatment formulae are developed for all drugs in use
for children, living with HIV meeting the human rights test of availability,
accessibility, acceptability and quality. Strongly support countries to get an
effective supply chain and effective health care and development systems that
will support implementation.
countries in getting all children with HIV in care and those requiring
treatment for HIV to be put on treatment immediately.
Values and Preferences Consultation with women living with HIV globally to
provide guidance in rolling out this programme at the appropriate time.
Women living with HIV should be involved
in all aspects of implementation including operationalizing the Guidelines, creating
service demands, providing knowledge transfer, exchange and education,
providing technical assistance and monitoring and evaluation, to ensure the
success of the roll out.
We submit that
undertaking these recommendations will meet both the spirit and the letter of
the human rights framework set out by Kate Gilmore and respected in numerous
international Conventions including the Convention on the Elimination of All
Forms of Discrimination against Women, the Convention on the Rights of the
Child and the UN Convention on the Rights of Persons with Disabilities. It will
also surely provide a solid framework to ensure the universal success of these
Guidelines. Countries respect WHO and UNICEF and look to them for guidance to
provide the optimal advice in implementing successful treatment programmes.
May we please
hear back from you at your earliest convenience.
and supportive factors to starting and maintaining children on ART
to improve adherence to ART in children
preference of when to start ART and what ART regimen to start in children
workers who provide treatment to children living with HIV were surveyed on issues related
to treatment initiation, formulation and adherence.
Through these consultations and the review of the available evidence,
programmatic data and the values and preferences expressed by the community who
participated in our process, there was consensus to recommend: 1) all children below 5 years should initiate ART regardless of CD4 count
as a conditional recommendation, and
2) children less than 3 years of age should start with a first-line therapy
which contains lopinavir/ritonavir (LPV/r) as a strong recommendation.
regarding the challenges you have identified:
ARV formulations for children under 3-years of age to facilitate improved
adherence - We are working with partners, namely the Drugs for
Neglected Disease initiative (DNDi) to support pilot projects of the newly
developed LPV/r sprinkles and fixed dose combination (FDC) regimens for infants
and children. We have not made a
recommendation to use efavirenz (EFV) in children less than 3 years despite the
USA FDA approval of EFV sprinkles for young children. We will be following the dosing data closely prior to making
any recommendation. Improved delivery and FDCs will improve
adherence and ease the difficulty this poses to the caretaker.
of Resistance – You are correct that children with previous
exposure (from the mother or given to the infant during the breastfeeding
period) to non-nucleoside reverse transcriptase inhibitors (NNRTIs) like
nevirapine (NVP) or EFV may lead to the development of NNRTI resistant virus in
the child – though this is not universal.
Nevertheless, it is for that reason that LPV/r is now part of the
preferred first-line regimen for children less than 3 years. We recognise that by using a protease
inhibitor (PI) as part of the first line treatment, there are currently fewer
second line options. However, we
are advocating with industry and forecasting needs to bring both more potent PIs
(darunavir/ritonavir) and integrase inhibitors to resource limited settings in
the near future so that future options will be available for these
children. The goal, however, is to
limit failure and the development of resistance by supporting better adherence
programmes and community-based ART delivery systems.
Chain – it is true that interruption of the supply chain
could lead to inadvertent interruption of treatment and possible development of
resistance. However, WHO is
working with the supply chain programmes to address this globally. Using a PI-based ARV regimen will
provide greater flexibility and less risk of development of resistance and
failure should there be an interruption.
issues – We agree that safe and available food and water are
key to successful ARV programmes.
This is a challenge for countries to address and WHO and UNICEF, among
other UN agencies, support these additional development goals, but this must be
addressed through a country owned, multi-sectorial approach and should not delay
global recommendations on ARV use.
care systems – Again we agree that these systems are weak
in many low- and middle-income countries. Part of the operational and service
delivery recommendations in the new guidelines address several evidenced-based
approaches to health systems strengthening for optimal HIV programmatic
trial evidence to support the recommendations – Regarding the evidence for initiation of children
less than 5 years old, a causal
modelling study was undertaken using prospective data collected by the
IeDEA-Southern Africa network on 5732 ART-naive children 24–59 months old
(median age 3.3 years) who had CD4 counts above the 2010 eligibility thresholds
of 25% or 750 cells/mm3. The study did not show any survival benefit from early treatment in this
population, but a large proportion of children in this age range would
rapidly become eligible under the existing criteria, since most children with
CD4 count of 750 cells/mm3
or higher at enrolment into care reached the CD4 treatment threshold within
three years. More specifically, 32% of this subset of the cohort fell below the
thresholds for eligibility after one year and 60% after two years. Programmatic
data shows that retention to care is better once children start ART and some
studies suggest that children may benefit from a reduction in opportunistic
infections and other HIV comorbidities when started earlier. Despite the lower
risk of progression in children 2–5 years old compared with children younger
than two years, the MCH Guidelines Development Group emphasized the operational
and programmatic advantages of removing the CD4 barrier to treatment for
children under 5 years of age. Treating all children younger than 5 years of
age is expected to simplify approaches to paediatric treatment and facilitate
an expansion of ART coverage for young children.
We are aware of
the challenges of implementing the WHO 2013 recommendations for infants and
children. WHO and UNICEF are currently working to overcome the identified
challenges through the following mechanisms:
1. Collaborating with DNDi and others
to support the pilot project of innovative drug formulations including
palatable, heat stable LPV/r and fixed dose combinations as per WHO 2013
recommendations for ART in children.
2. Development of a five-pillar pediatric
framework, within the Treatment 2.0 framework, to innovate, expand and sustain
care for HIV exposed infants and children. This framework will address service
provision, family centered care, health provider training, HIV-case
identification and inclusion of communities in designing and implementing
policies for the care of HIV exposed children.
3. Organization of the Pediatric
Conference on Antiretroviral Drugs Optimization (Pediatric-CADO) where innovative
aspects on drugs formulations, second line treatments, as well as operational
issues, including supply chain management, will be addressed
Convening a consultation on new
strategies in infant diagnosis, including operational issues.
5. Advancing closer linkages between
identification of HIV-exposed infants through broader child health programmes
outside of the traditional PMTCT services, including routine immunization and
community- and facility-based platforms for sick infants in high HIV burden
Working through the Coalition of
Children Affected by AIDS (CCABA) to strengthen care and support for children
and their families through NGOs and CBOs, including provision of treatment
adherence, nutrition, social, and economic support for families affected by
of communities, including networks of people living with HIV is essential to the
success of these new guidelines. We
will continue to have open dialogue with all members of civil society and
appreciate the opportunity to communicate with ICW and the community
organization and individual signatories of the letter. We will be strongly engaged in
operational research in the context of implementation of the guidelines and
evaluations of barriers and challenges to implementation with the goal of
overcoming these challenges.
We will be happy
to arrange a follow-up conference call to see how best to operationalize your
suggested recommendations and how best to assure ongoing input and support from
civil society. We invite you to
work with us in the next phase of these guidelines including partnering with others who are developing training programmes and assisting
countries as they discuss adaptation and adoption of these global guidelines
for their own countries and contexts.
Dr. Meg Doherty
Treatment and Care
Chief, HIV/AIDS Section
Associate Director, Programmes
Our response to WHO:
Dear Dr. Hirnschall, Dr. Doherty and Mr. McClure,
June 30, 2012
On behalf of the organizational signators, I thank you very much for the
comprehensive, informative and productive response to the letter we wrote to you
on June 28th regarding the new WHO Treatment Guidelines for children
under 5 years of age.
We will respond to your letter point by point.
Please be assured that our group recognizes and lauds the ongoing work
of both UNICEF and WHO in its work with children including children living with
HIV and their families and in no way doubts the total commitment of both
organizations to championing this cause.
As with all complex and sensitive global health and development issues,
we know that you share our recognition of the value of input from all of the parties impacted.
Clearly, the views of mothers, caregivers and young people living with HIV who
have firsthand experience of HIV treatments as children, are invaluable
additions to ensure that good health policy can also become good health
practice. It is from this perspective that we have brought the implementation
concerns that we foresee to your attention. Thank you very much for validation
of our concerns. We recognize that they are complicated to resolve and require
the leadership and accountability of many partners including those in
leadership positions in other parts of the international health community and
at country level.
That being said, we look to you for leadership as well. Both of your
organizations are global leaders and other partners look to what you say as the
litmus test for their activities.
As regards the ARV formulation issue, we applaud your decision not to
recommend use of efavirenz in this population; to collaborate with DND and
others to support the pilot project of innovative drug formulations and and the
organization of the Paediatric Conference on Antiretroviral Drugs Optimization.
We would have wished that the formulation issue was resolved, however, before
the Guidelines were changed, not after.
As regards resistance , we are pleased that you are advocating with
industry to bring more potent PIs and integrase inhibitors to the resource
limited settings. This cannot happen soon enough and we offer our full support
in joining those advocacy efforts.
As regards supply chain issues, we are glad to learn that WHO is working
with the supply chain programmes but we consider this to be a major impediment
to the immediate successful implementation of this Guideline.
Development issues and health issues have been siloed throughout this
epidemic in a way that is extremely counterproductive to the successful
implementation of ARV programmes generally, including this one. We recognize
that WHO and UNICEF cannot solve this problem alone by any means but are
working with CCABA on these issues, however, children cannot access drugs
without the full – and fully supported- agency of their primary carers-who are
primarily also women living with HIV . This is why we offer our support as
Health care systems are also at the heart of the success of your
Guidelines. We are gratified to read that WHO and UNICEF are involved i the
development of a five pillar paediatric framework; is convening a consultation
on new diagnosis strategies in infant diagnosis and advancing closer linkages
between identification of HIV-exposed children infants and children through
broader child health programmes outside the traditional PMTCT settings. As you
know, one very strong concern we continue to have is the profound need for
comprehensive education of health care providers not only about clinical
information but also the human rights framework within which their work must be
done. We sincerely believe that, without this, no programme will be successful.
I have sent you a copy of the Stepping Stones video about gender-based violence
in health care settings made in Malawi, Dr. Doherty, and would appreciate it if
you would share it with your UNICEF colleagues. It clearly exemplifies the
problem in stark terms. We would like to have seen these community support
programmes in place before the Guidelines were changed and continue to be
doubtful about the success of your programmes until they are.
Clinical trial evidence is, of course, very important. We have been
clear that we strongly advocate that all children living with HIV be in care at
all times. We do not, however, support treating children who do not require
treatment given the difficult of adherence, the potential for resistance, the
lack of second line drugs and the lack of education for health care providers.
In our view, we iterate therefore that it seems highly unlikely that you will
have any greater success in keeping children in care or getting children into
care by changing the game from 2 to 5 years old unless and until the system
barriers that are keeping children out of care now are resolved.
We welcome your invitation to have a follow up teleconference to see how
best to operationalize our recommendations and accept it without reservation.
We are pleased to accept the invitation to work with you on the next phase of
the guidelines, including the development of training programmes and assisting
countries as they discuss adaptation and adoption of these global guidelines.
Because we are a collection of groups with members all around the world we will
be able to assist wherever needed.
Once again, thank you for this clear, comprehensive and meaningful
dialogue. While we continue to consider that the launch of these Guidelines is
, to coin a phrase, putting the proverbial “cart before the horse” and ask you
to reconsider it, we will certainly work with you to make the best of this
situation going forward.
The group mobilized regarding the WHO Guidelines for Children
Network of People Living
with HIV and AIDS (REDBOL)
of Women Living with HIV/AIDS, Global
Positive Women Inc., New
Women in Europe and
Central Asia Regions +(WECARe+)
Youth Voices Count
The African Young
Positive network (AY+N)
Women of Asia Pacifc Plus
Fundacion para studio e
Investigacion dela Mujer- FEIM
International AIDS Women
HIV Young Leaders Fund
African Health Promotion
Violeta Ross (Bolivia)
Jessica Whitbread (Canada
Louise Binder (Canada )
Holly M Benavides (USA)
Tung Nui ( Vietnam)
Kath Khangpiboon (
Thailand, Thai Transgender Aliance , Bangkok)
L’Orangelis Thomas Negron
( Puerto Rico)
E.Tyler Crone ( USA)
Rebecca Matheson (Australia)
Yuan Wen Li (China)
Isabel Nunes (Portugal)
Angelina Namiba (UK)
Jane Bruning ( New
Sindi Fitriarti Putri (
Rukia Cornelius ( World
Edward Low (MTAAG+ Positive
Malaysian Treatment Access and Advocacy group)
Elisha Kor ( Positive
Living Program PT Foundation, Malaysia)
Dini Andriani (
Luisa Orza (Co-chair, UK
Consortium Gender Working Group)
Felicity Daly ( Co-chair,
UK Consortium Gender Working Group)
Susan Paxton (Australia)
Oyelakin Oladayo Taiwo
Emmy Lucy Smith
Dear Ms. Louise
Binder and the Organizational Signators:
Thank you very
much for your letter and the expression of concern regarding the development of
the 2013 WHO ‘Consolidated guidelines on the use of antiretroviral drugs for treating
and preventing HIV Infection’, and in particular, the guideline changes for
when to start anti-retroviral therapy (ART) among children.
We share the
same goal of providing the best care to the greatest number of HIV-exposed and
HIV infected children, and their families. We also are sympathetic to the
implementation concerns you highlight in your letter and hope to adequately respond
by outlining our approach to both improve and reduce these barriers.
As you are acutely aware, ART coverage for children lags behind that of
adults and in 2012 it is reported to have increased from 16% in 2009 to 34%
among the 21 Global Plan priority countries. However, this coverage remains in stark contrast to that of
adult ART coverage at 68% of those eligible and in need of treatment in the 21 priority
countries in 2012.
Globally, we have attained great successes in scaling up treatment to adults;
yet children have been left behind leading to tens of thousands of potentially
avoidable deaths. Children are left behind for many
reasons but most notably due to the poor follow up of HIV-exposed children and
the failure to identify and initiate infected children under 2 years of age on
treatment (recommended since 2010), low coverage of
early infant diagnosis (EID) (35% globally in 2011), the failure to
implement provider initiated testing of sick infants in high HIV burden countries,
the relative complexity of delivering ARVs to children, the dosing and poor
taste of the medications, the lack of true simplification of ARV regimens, the lack of investment in developing and producing
acceptable and affordable paediatric formulations, the lack of
decentralized training and care for paediatric ART programmes, the shortage in skilled health workers for paediatric HIV care and the lack
of clear policies in many countries recommending task-shifting to enable
non-physician health providers to test, initiate and monitor treatment of
children, resulting in a weak case identification and linking to care, the
scarcity of integrated, family-centered care for the majority of children with
HIV, and ultimately,
the extra burden this places on the family and caretakers.
2013 consolidated guidelines provide recommendations based on the best evidence
available and based upon the discussions surrounding feasibility,
acceptability, values and preferences, ethics (rights based care), and costs. These guidelines are in part aspirational, recommending the best
public health approach, but acknowledging that not everything is immediately
implementable (e.g. viral load monitoring). The Maternal and Child Health Guidelines
Development Group reviewed the research, evidence and community consultations
in detail prior to making the recommendations reflected in the current
guidelines. Extensive community
consultations were conducted during the guideline process, the results of which
we have outlined and shared in a previous document (annexed here). In brief, WHO commissioned the International HIV/AIDS
Alliance to conduct a community consultation to establish values and
preferences and specific recommendations related to the priority areas of the
new guidelines, including questions related to ‘Option B+’ and paediatric
treatment. WHO also commissioned GNP+ in partnership with ICW to assess the
perspectives and experiences of women living with HIV regarding:
Track D report by Nancy Czaicki
This session outlined the updated 2013 WHO Treatment Guidelines and the evidence base for the update. The 2013 guidelines also included a new section on operational aspects of the response or the “how to do it” part. Dr. Yogan Pillay, the Deputy Director General, National Department of Health, South Africa who also served as the co-chair for the operational and service delivery guidelines group, outlined the recommendations in this new section and their challenges.
Recommendations began with expanding HIV testing. First, WHO recommends community based testing as well as facility-based and testing (with linkage) in all settings with generalized epidemics. In settings with concentrated epidemics, community based testing for key populations are recommended.
The new guidelines also suggested optimizing adherence to ART by using FDC, nutritional support, minimizing out of pocket costs, and strengthening the drug supply system. One new formal recommendation was made, and this was to considering using mobile phone text messages as reminders. These should be incorporated as appropriate as part of a package of adherence interventions.
New recommendations were also made regarding service integration with a focus on integration of ART with other health services such as TB care, maternal and child health, antenatal care, and opiate substitution therapy.
Decentralization of treatment and care in order to bring services closer to patients was a topic of new recommendations. For example, it is now recommended that ART initiation can be carried out at peripheral health facilities with maintenance at the community level. Complementary recommendations regarding task shifting now support using nurses and non-physician clinicians to initiate first-line ART. Furthermore, community health workers can dispense ART between clinic visits. It was noted that there must be mentorship and support in addition to training for task shifting to be successful as it has been in Rwanda.
Finally, guidance for program managers emphasizes that national authorities consider their local epidemiology, social and economic conditions, and policy context while using a transparent process to decide on the implementation of clinical and operational recommendations in their country.
The reaction from the audience and panel highlighted the importance of further research on implementation in order to carry out these recommendations. Discussion questions included access to drugs, intellectual property, how to include private sector health providers, and managing choice and human rights in guideline implementation. Dr. Kumarasamy, Chief Medical Officer at YRGCARE and session moderator, ended the talk with a call to carry out implementation science to understand the best way forward so that these recommendations can be realized in real world health care settings.
Track B report by Jürgen Rockstroh
Launch ofthe 2013 consolidated ARV guidelines
The last WHO guidelines on ART in HIV were released in 2010. In this early afternoon packed Sunday session the updated 2013 new WHO ARV guidelines were launched, deriving from the need to translate experience and advances in science/technology from the last years into updated ARV guidelines. Overall, more than 1500 individualsand organizations contributed to the new guidelines. The WHO 2013 consolidated guidelines provide for the first time not only the usual clinical guidance along the continuum of care – the what to do (such as when to start and whatregimens to use), but also operational guidance on how to deliver HIV services as well as guidance for programme managers in the field as to how to implement the recommendations. Overall, 50 new recommendations are provided. Major changes are the raise in the CD4 threshold for starting HIV treatment in HIV-infected adults to ≤500/µl but maintaining a priority for treating patientswith a CD4-count ≤350/µl as well as a streamlined and simplified first-line antiretroviral treatment recommendation with TDF+3TC (or FTC)+EFV preferably as a single-tablet regime. With regard to monitoring, viral load it is now recommended as the preferred monitoring approach to diagnose and confirm ARV treatment failure. All pregnant and breastfeeding women infected with HIV should imitate triple ARVs, which should be maintained at least for the duration of mother-to-child transmission risk. Women meeting treatment eligibility criteria should continue lifelong ART. The updated pediatric ARV treatment recommendations recommend treatment for all children younger than 5y; for children above 5 years of age the guidelines are harmonized with the adult recommendations starting HIV therapy in all children with a CD4-count ≤500/µl. Challenges in the implementation of the new ARV recommendations into clinical practice were outlined. Retention and treatment adherence were highlighted as necessary prerequisites to achieve sustained viral suppression, and minimize risks of transmission. Indeed multipleinterventions are likely to be needed to support treatment adherence. Finally more resources will be needed to successfully implement the new guidelines.
The new WHO guidelines are clearly a great step forward in attempting to increase and facilitate access to ARVs throughout the world as well as increase harmonization between guidelines in different income areas worldwide.