Executive Summary

Consolidated ARV guidelines 2013, June 2013

These consolidated guidelines provide 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. They are structured along the continuum of HIV testing, care and treatment. Behavioural, structural and biomedical interventions that do not involve the use of ARV drugs are not covered in these guidelines.

The 2013 consolidation process combines and harmonizes recommendations from a range of WHO guidelines and other documents, including the following 2010 guidelines on using antiretroviral therapy (ART) for HIV infection in adults and adolescents, in infants and children and for treating pregnant women living with HIV and preventing HIV infection in infants. Comprehensive guidance is now provided on using ARV drugs across age groups and populations of adults, pregnant and breastfeeding women, adolescents, children and key populations. The guidelines also aim to consolidate and update clinical, service delivery and programmatic guidance.

The 2013 guidelines reflect important advances in HIV responses during the past three years. Since 2010, new technologies, including CD4 point-of-care testing, and new service delivery approaches allow HIV testing and treatment monitoring to be diversified and decentralized. Simple, safer, once-daily, single-pill ARV regimens that are suitable for use in most populations and age groups have become more affordable and more widely available in low- and middle-income countries. Countries are moving towards earlier initiation of triple-drug regimens and simplified programming for the prevention of mother-to-child transmission of HIV (PMTCT) that emphasizes the long-term health of pregnant women and mothers living with HIV and preventing HIV infection among their children.

The broader HIV prevention benefits of ARV drugs are being recognized: in addition to improving health and prolonging lives, ART prevents the sexual transmission of HIV, while pre-exposure prophylaxis of HIV with ARV drugs expands HIV prevention options and post-exposure prophylaxis of HIV continues to play an important role in managing HIV exposure in certain populations and settings, including for those who have been sexually assaulted. Although countries are at different stages of ART coverage and implementing the 2010 WHO guidelines, there is a consistent global trend towards initiating HIV treatment earlier.

Consistent with previous WHO guidelines, the 2013 guidelines are based on a public health approach to the further scaling up of ARV drugs for treatment and prevention that considers feasibility and effectiveness across a variety of resource-limited settings. The new clinical recommendations in these guidelines promote expanded eligibility for ART with a CD4 threshold for treatment initiation of 500 cells/mm3 or less for adults, adolescents and older children. Priority should be given to individuals with severe or advanced HIV disease and those with CD4 count of 350 cells/mm3 or less. ART is recommended to be initiated regardless of CD4 count for certain populations, including people with active tuberculosis (TB) disease who are living with HIV, people with both HIV and hepatitis B virus (HBV) infection with severe chronic liver disease, HIV-positive partners in serodiscordant couples, pregnant and breastfeeding women and children younger than five years of age. Harmonization of ART regimens for adults and children is recommended whenever possible, with a new, preferred first-line ART regimen. The need to phase out d4T in first-line ART regimens for adults and adolescents is being reinforced.

Viral load testing is now recommended as the preferred approach to monitoring ART success and diagnosing treatment failure, complementing clinical and immunological monitoring of people receiving ART.

The guidelines emphasize that ARV drugs should be used within a broad continuum of HIV care. Additional new recommendations provide guidance on community-based HIV testing and counselling and HIV testing of adolescents. Apart from new recommendations, summaries of and links to existing WHO guidance are provided for HIV testing and counselling, HIV prevention, general care for people living with HIV, the management of common coinfections and other comorbidities and monitoring and managing drug toxicities. Some existing recommendations need to be updated, and new recommendations will need to be reviewed in the next few years, as new evidence emerges.

Expanded eligibility for ART and a wider range of options for using ARV drugs provide new opportunities to save lives, improve clinical outcomes and reduce HIV incidence but also pose challenges to policy-makers and implementers in many countries. New operational guidance in 2013 provides recommendations for strengthening key aspects of the continuum of HIV care and improving linkages across the health system. This guidance focuses on strategies to improve retention in care and adherence to ART and on decentralizing the provision of ART to primary care, maternal and child health clinics, TB clinics and services to treat drug dependence. The operational guidance also addresses the implications of new clinical recommendations for laboratory services and supply systems for ARV drugs and other commodities.

Guidance specifically developed for HIV programme managers addresses decision-making and planning for the strategic use of ARV drugs in the context of national governance processes, HIV epidemiology, health systems capacity, available financial resources and ethical and human rights considerations. Implementation considerations especially relevant to programme managers are provided for major new recommendations. A concluding chapter on monitoring and evaluation provides preliminary guidance on monitoring the implementation of new recommendations.

The revision process for the 2013 guidelines was conducted in accordance with procedures established by the WHO Guidelines Review Committee. New clinical and operational recommendations in the guidelines are based on the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to reviewing evidence and decision-making. Modelling, expert consultations and country case studies have informed clinical, operational and programmatic guidance. The process has identified key gaps in knowledge that will guide the future research agenda. In addition to new recommendations based on the GRADE system, the guidelines summarize existing recommendations from other WHO guidelines. Most of these recommendations were developed using the GRADE system or a modification of the GRADE rating of the strength and quality of the evidence.

The primary audience for these guidelines is national HIV programme managers, especially in low- and middle-income countries. The guidelines are anticipated to guide country policy decisions and planning the scaling up of ART. They will also be a valuable resource for clinicians and informing the priorities of development agencies, international organizations, nongovernmental organizations and other implementing partners during the next few years.

The 2013 guidelines represent an important step towards achieving universal access to ARV drugs for treating and preventing HIV, increasing the efficiency, impact and long-term sustainability of ARV programmes and realizing the ultimate goal of ending the HIV epidemic.