7th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013)


SUSA04 Launch of the 2013 WHO Consolidated ARV Guidelines - What's the Evidence?
  Non-Commercial Satellite
Venue: Session Room 4
Time: 30.06.2013, 14:45 - 16:45
Co-Chairs: Andrew Ball (WHO), Switzerland
Nagalingeswaran Kumarasamy YRGCARE Medical Centre, India
Organiser: WHO HIV/AIDS Department
This satellite session launches the 2013 WHO Consolidated Guidelines on the Use of Antiretroviral Drugs for HIV Treating and Preventing HIV Infection. The Guidelines include recommendations along the continuum of HIV care, including recommendations on HIV testing and counseling, ART initiation and maintenance, patient monitoring, 2nd and 3rd line ART, management of co-infections and comorbidities and service delivery. New recommendations in the guidelines have been informed by 41 systematic reviews, modeling on costs and impact, surveys and country case studies. The satellite will present the science behind new key recommendations, including the rationale for deciding on when to initiate ART in different populations and the preferred regimens to use. After each presentation a small panel representing the perspectives of a national HIV program, civil society and a development agency, will comment on the presentation. These presentations will be followed by an opportunity for the audience to ask questions.

14:45

Powerpoint
Webcast
Welcome and introduction to speakers and discussants
A. Ball (WHO), Switzerland
N. Kumarasamy YRGCARE Medical Centre, India

14:50
Official Launch of the WHO 2013 Consolidated ARV Guidelines
H. Nakatani (WHO), Switzerland

14:55

Powerpoint
Webcast
Deriving public health recommendations from a systematic review of evidence
P. Easterbrook (WHO), Switzerland

15:10

Powerpoint
Webcast
Development Partners' Perspectives (Video Message)
M. Dybul (Global Fund), Switzerland
E. Goosby (PEPFAR), United States

15:20

Powerpoint
Webcast
Critical issues in adults with HIV
M. Doherty (WHO), WHO

15:35

Powerpoint
Webcast
Critical issues in pregnant women with HIV
N. Shaffer, Switzerland

15:50

Powerpoint
Webcast
Critical issues in children infected with HIV
T. Puthanakit Chulalongkorn University, Thailand

16:05

Powerpoint
Webcast
Critical issues in service delivery and decision making - Evidence review on service delivery, modelling of costs and impact, country experiences
Y. Pillay, South Africa

16:20

Powerpoint
Webcast
Panel discussion and perspectives from Civil Society and UNAIDS
S. Phurailatpam, Thailand
S. Kraus, UNAIDS

16:40

Webcast
Summary and concluding remarks
A. Ball (WHO), Switzerland
N. Kumarasamy YRGCARE Medical Centre, India

Powerpoints presentations
Welcome and introduction to speakers and discussants -

Deriving public health recommendations from a systematic review of evidence - Philippa Easterbrook (WHO)

Development Partners' Perspectives (Video Message) -

Critical issues in adults with HIV - Meg Doherty (WHO)

Critical issues in pregnant women with HIV - Nathan Shaffer

Critical issues in children infected with HIV - Thanyawee Puthanakit Chulalongkorn University

Critical issues in service delivery and decision making - Evidence review on service delivery, modelling of costs and impact, country experiences - Yogan Pillay

Panel discussion and perspectives from Civil Society and UNAIDS -



Rapporteur reports

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 in Asia.

- 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 recommendation. 

- 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 care workers.

- Adherence support needs to be there to support people and this is key to the community response to HIV. 

The implications 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,

We, the 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 following reasons:

1.    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

2.    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.

3.    Supply chain security is also a serious problem and interruption of medications will also lead to resistance.

4.    Development 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 weight.

5.    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 treatment.

6.    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.

We strongly 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 following:

1.    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 Guideline.

2.    Develop a 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.

3.    Ensure that 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.

4.    Strongly support countries in getting all children with HIV in care and those requiring treatment for HIV to be put on treatment immediately.

5.    Undertake a Values and Preferences Consultation with women living with HIV globally to provide guidance in rolling out this programme at the appropriate time.

6.     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.

Yours truly,

 

Challenging and supportive factors to starting and maintaining children on ART
Strategies to improve adherence to ART in children

Perceived preference of when to start ART and what ART regimen to start  in children
Health 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.

Specifically, regarding the challenges you have identified:

1)   Improved 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.

2)   Development 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.

3)   Supply 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.

4)   Development 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.

5)   Health 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 success.

6)   Clinical 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

4.    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 settings.

6.    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 AIDS.

Full involvement 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.

 

Sincerely Yours,

 

 

Dr. Gottfried Hirnschall

Director

WHO HIV Department

 

Dr. Meg Doherty

Coordinator, Treatment and Care

WHO HIV Department

 

Craig McClure

Chief, HIV/AIDS Section

Associate Director, Programmes

UNICEF

 

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 well.

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.

Best regards,

The group mobilized regarding the WHO Guidelines for Children

 


 

 

 

 




·       Organizational Signatories

·       Network of People Living with HIV and AIDS (REDBOL)

·       International Community of Women Living with HIV/AIDS, Global

·       ATHENA Network

·       Seres (Portugal)

·       Positive Women Inc., New Zealand

·       GESTOS/LACCSO

·       Women in Europe and Central Asia Regions +(WECARe+)

·       PozFem

·       Youth Voices Count

·       The African Young Positive network (AY+N)

·       ICW- Zimbabwe

·       Women of Asia Pacifc Plus (WAP+)

·       Fundacion para studio e Investigacion dela Mujer- FEIM

·       International AIDS Women Caucus-IAWC

·       HIV Young Leaders Fund

·       Namibian NWH

·       Sophia Forum

·       Salamander trust

·       African Health Promotion

·       Positively UK

 

 

 

 

 

 

·       Individual Signatories

·       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)

·       Martha Tholanah (Zimbabwe)

·       Yuan Wen Li (China)

·       Alice Welbourn

·       Isabel Nunes (Portugal)

·       Angelina Namiba (UK)

 

·       Jane Bruning ( New Zealand)

·       Sindi Fitriarti Putri ( Indonesia )

·       Wezi Thamm

·       Rukia Cornelius ( World AIDS Campaign)

·       Edward Low (MTAAG+ Positive Malaysian Treatment Access and Advocacy group)

·       Alessandra Nilo

·       Elisha Kor ( Positive Living Program PT Foundation, Malaysia)

·       Dini Andriani ( Indonesia)

·       Sophie Dilmitis

·       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 (Indonesia)

 

   

 

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.  

The 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.

 

 




   

    The organizers reserve the right to amend the programme.