WHO CONSOLIDATED GUIDELINES ON THE USE OF ANTIRETROVIRAL DRUGS FOR TREATING AND PREVENTING HIV INFECTION Background: INTERNAL QUESTIONS AND ANSWERS DRAFT At the end of 2012, 9.7 million people were receiving antiretroviral therapy (ART) in low- and middleincome countries, representing an additional 1.6 million people on ART as compared with the end of 2011. These new figures will be the main message of the Global HIV Treatment Report, which is being launched on the same day as the guidelines. ART scale-up continues in some of the most challenging settings and poorest communities, despite the global financial crisis, with the most substantial expansion of treatment occurring in sub-saharan Africa, which is also the region with the greatest need. Despite this impressive public health response, huge gaps and disparities in access to ART exist in all regions, particularly affecting children and marginalized populations. Implementation of the 2013 ARV guidelines will make 26 million people living with HIV eligible for ART, leaving a treatment gap of 16 million people. If countries are to close the treatment gap and to achieve the global goal of having 15 million people on ART by 2015 it will be necessary to accelerate ART scale-up efforts, improve the quality of treatment and retain people in care. At the same time there is a need to improve the efficiency and effectiveness of ART services if they are to be sustainable in the long term. Universal coverage of ART cannot be achieved overnight health systems will need to be strengthened to deliver treatment and maintain people in care. The progressive strengthening of systems will enable countries to move beyond the 2015 target to move towards universal coverage. HIV infection has become a chronic, treatable health condition, which requires long-term care, integrated into broader health systems. 1. Why do we need these consolidated guidelines? The new 2013 guidelines aim to translate new evidence and country experiences into clinical, operational and programmatic guidance that can transform the way in which countries use ARVs and enable them to achieve universal access targets, and to achieve universal health coverage efficiently and sustainably. WHO first produced global guidelines on the use of antiretroviral drugs (ARVs) for HIV treatment in 2002, followed by guidelines on the use of ARVs for preventing mother-to-child transmission of HIV (PMTCT) in 2004. Since then WHO has produced various ARV-related guidelines with updates every two to three years, most recently in 2010. But different guidelines have been developed for different populations and to address different aspects of HIV infection, risking confusion and conflicting guidance. 1
Since 2010 there has been increasing evidence on both individual clinical benefits and population benefits of earlier ART. People who initiate ARVs between CD4 cell count of 350-500 cells/mm³ and maintain a suppressed viral load, should have improved survival, reduction in HIV associated illnesses, reduced exposure to the inflammatory properties of HIV replication (that is associated with HIVassociated and non-hiv associated cancers, ischaemic heart disease, dementia, premature ageing and other non-communicable diseases). Earlier treatment, with suppressed viral load, is associated with a reduction of onward transmission of HIV to others and can benefit the community and public health in general. Since 2010 there has been substantial new developments, with generation of new evidence on the treatment and prevention benefits of ARVs, emergence of new technologies and approaches to expand and diversify HIV testing, treatment and monitoring, and analysis of country experiences. Of particular note has been increasing evidence of the benefits of starting ART earlier (at a CD4 cell count of 500 cells/mm³ as compared with 300 cells/mm³), with the potential for reducing HIV-related morbidity and mortality and preventing onward transmission of HIV. There is increasing awareness of the association of HIV infection with a broad range of other health conditions, including various noncommunicable diseases and coinfections (such as viral hepatitis), that alert to the need to better integrate and link programmes to leverage broader health outcomes. 2. What is new, what is different? The new guidelines aim to consolidate existing and new guidance from different, fragmented sources, into one document that covers all aspects of the use of ARVs for HIV treatment and prevention, for different populations, age groups and settings. The guidelines consolidate guidance across a number of dimensions: Age groups and populations: The guidelines address the use of ARV drugs for all age groups and populations. Previous, separate WHO guidelines on using ART among adults and adolescents have now been combined with those for children and for PMTCT, harmonizing ARV regimens and treatment approaches to the extent possible across age groups and populations. Continuum of HIV prevention, diagnosis, care and treatment: Guidance on using ARV drugs is presented within the context of the continuum of HIV-related prevention, treatment and care. In addition to providing recommendations on the clinical use of ARV drugs for treatment, the guidelines address other major aspects of HIV-related care. New and existing guidance: Consolidation has allowed for new recommendations to be harmonized with relevant, existing WHO guidance such that this document provides a one stop information source for HIV programme managers and policy makers. Different health services: Consolidation promotes the consistency of approaches and linkage between settings. Consolidated recommendations help to facilitate linkage and promote consistency of approaches across the various settings in which ARV drugs and related services 2
may be provided, including specialized HIV care, primary care, community-based care, maternal and child health services, TB services and services for people who use drugs. Clinical, operational and programmatic guidance: Consolidation brings together clinical recommendations (what to do) with operational recommendations (how to deliver services) and programmatic guidance (how to decide what, where and how to implement and making allocative decisions) A more systematic approach to guidelines review and development will enable updates to be more timely and comprehensive in the future. Clinical, operational and programmatic implications of new science and emerging country practices will be monitored and reviewed every two years to inform global updates. 3. What are the new recommendations? (refer to Attachments 1 and 2) Key new recommendations promote the earlier initiation on ART, the further simplification of ART regimens, with a single preferred first line regimen for adults, pregnant women, adolescents and older children, which is available in a once-a-day fixed-dose combination pill, and improved monitoring of people on ART. They also promote immediate ART for all children under the age of 5 years and pregnant and breastfeeding women. Key new clinical recommendations include: Earlier initiation of ART for all populations (CD4 500 cells/mm³); Immediate ART for children below 5 years of age; Immediate ART for all pregnant and breastfeeding women (PMTCT options): ART for all pregnant and breastfeeding women with the option to discontinue treatment after the MTCT risk period has ceased for women who do not meet the eligibility criteria (Option B) or lifelong ART in all pregnant and breastfeeding women (Option B+); Harmonization of ART across populations (e.g., adults and pregnant women, B/B+) and age groups (adults, adolescents and older children); and A single, preferred, safer first-line ART regimen (TDF/XTC/EFV) Key operational recommendations include: Use of fixed-dose combination formulations, enabling one-pill a day treatment which is well tolerated and affordable; Improved patient monitoring to support better adherence and detect earlier treatment failure through increased use of viral load monitoring; Strategies to promote ART adherence within different settings and populations; Innovative approaches to service delivery through decentralization and integration of services; Improved use of human resources through task-shifting; and Expansion of HIV testing and counselling approaches through community based testing. 3
4. What are the challenges on the ground to implement these guidelines? Implementation of the new guidelines will increase the numbers of people eligible for ART, put more demands on health systems and initially increase costs with the transition to more costly ART regimens and patient monitoring approaches. However, the guidelines make recommendations for simplifying ART and improving the efficiency and effectiveness of ARV services to build stronger health and community systems. Increased investments now will guarantee major cost-savings in the future. Increased ART eligibility will mean increased patient numbers and demands on the health system. Human resources: the recommendations to decentralize, integrate and task-shift will require adjustments in the organization of services and changes in human resource policies and investments Procurement and supply chain management: regimen changes will have to be planned to avoid stock-out and bottlenecks to ensure the secure supply of recommended ARVs and diagnostics Innovation in diagnostics, specifically point-of-care technologies for CD4 and viral load testing, will have to proactively pursued and made available in countries. Additional financial investment may need to be made, as patients are moved to more expensive but safer and more effective ART regimens and treatment monitoring approaches. These changes will improve treatment adherence, retain more people in care and minimize the ARV toxicities and emergence of HIV drug resistance all contributing to better patient outcomes and greater impact on HIV mortality and transmission. Increasing ART eligibility poses challenges for ensuring equitable access to treatment. The guidelines prioritize the provision of ART to those individuals who are in greatest need of ART for their own health and promote approaches to reaching those populations most marginalized and underserved. 5. What are the potential implications and impact of implementing the Guidelines? Implementation of the guidelines will save an additional 3 million lives and prevent an additional 3.5 million infections over the next 12 years, while adding only 10% to the overall costs of the HIV response. The 2013 WHO ARV guidelines will increase the potential number of people eligible for ART to an estimated 26 million in 2013 (9 million more people than were eligible under the previous 2010 WHO treatment guidelines). The overall cost for a comprehensive global HIV response has been estimated to be around US$ 22-24 billion in 2015 including prevention and treatment programmes. Changing from the 2010 to 2013 guidelines will increase the overall annual cost by around 10%. 4
This additional investment can be deemed very cost effective according to global criteria one HIV infection averted costs around US$ 6 000 (which is considered cost effective even in leastdeveloped countries in Africa). Switching from 2010 to 2013 guidelines and initiating ART earlier will help to save many more lives, and prevent many more HIV infections: between now and 2025 providing ART according to the 2010 guidelines would avert a cumulative total of 9 million deaths, while implementing the 2013 guidelines would avert 12 million deaths, saving an additional 3 million lives, or a 33% increase in deaths prevented. Fully implementing the 2010 ART guidelines would prevent 15.5 million new HIV infections between now and 2015, while implementation of the 2013 recommendations would prevent 19 million new infections, preventing an additional 3.5 million new HIV infections. 6. What will WHO do to support countries in implementing the guidelines? WHO has developed a strategy for disseminating the guidelines to all key partners and to support adaptation and implementation at country level, which involves support provided through WHO country, regional and HQ offices. WHO (HQ, regional and country-level) staff will help countries interpret, adapt, disseminate and implement the new guidelines. Regional workshops and other capacity building activities will be undertaken to ensure rapid dissemination of the guidelines through all regions, bringing together clinicians, national programme managers, implementers and development partners. Materials are being developed, including slide-sets and other training materials, to assist with capacity building efforts, that can be used by different groups. Intensified technical support and financial assistance is likely to be required by individual countries where ARV needs are great and treatment coverage is low. Opportunities for new or reprogrammed funding can be identified through WHO s financing dialogue with external funders (e.g. the Global Fund or PEPFAR) or through domestic budgets. WHO can facilitate national HIV programme reviews or revisions of national ARV guidelines. WHO will be working with key partners to ensure that the new guidelines are adopted into their programmes, harmonizing approaches across different development partners and technical agencies. For example, WHO has already providing briefings to Global fund staff and the Technical Review Panel, capacity building events are being planned with PEPFAR agencies and opportunities are being identified to disseminate and implement the guidelines through a wide range of civil society networks. The guidelines will be regularly updated to ensure recommendations are most current and meet countries needs and will enable countries to plan for regular programme reviews. 5