Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
Questions and answers
1. Why do we need these consolidated guidelines?
- 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 released several ARV-related guidelines, most recently in 2010. But different guidelines have been developed for different populations and to address different aspects of HIV infection.
- 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.
- Earlier treatment, with suppressed viral load, is also 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 technologies and approaches to expand and diversify HIV testing, treatment and monitoring, and analysis of country experiences.
- 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 to enable them achieve universal access and universal health coverage targets in efficient and sustainable manner.
2. What are the new recommendations?
- Key new recommendations promote the earlier initiation on antiretroviral therapy (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.
- 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 (prevention of mother-to-child transmission (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. What are the potential implications and impact of implementing the Guidelines?
- Implementation of the guidelines can save an additional 3 million lives and prevent an additional 3.5 million infections over the next 12 years, while adding only 10% increase 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%.
- 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 least-developed 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.
4. 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 headquarters’ (HQ) offices.
- WHO (HQ, regional and country-level) staff will work with partner organizations in countries to 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.
- Intensified technical support and financial assistance is likely to be required by individual countries where ARV needs are great and 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 is 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.