New WHO Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection

By Dr Lisa Nelson, Medical Officer and Dr Gottfried Hirnschall, Director (HIV/AIDS Department, WHO, Geneva)

On June 30 2013, WHO released updated HIV guidelines on the diagnosis of HIV, the care of people living with HIV and the use of antiretroviral (ARV) drugs for treating and preventing HIV infection.  These guidelines were launched during the 7^th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013) held in Kuala Lumpur, Malaysia from 30 June to 3 July 2013.

The document was developed in consultation with country policy makers and programme planners, implementers, researchers, clinicians, and affected communities. These guidelines are novel in several ways by:

1. harmonizing guidance and treatment regimens across populations, as well as along the continuum of care;
2. providing guidance on how to improve service delivery and to make decisions on optimal resource allocation; and
3. consolidating existing and new recommendations into a single document using a public health approach.  

Key data that prompted this update include evidence of the individual and population-level benefit of earlier treatment [1], more effective and simplified treatment approaches, new knowledge on effective service delivery models and new technologies such as point-of-care CD4 testing.

The new clinical recommendations in these guidelines promote early initiation of antiretroviral therapy (ART) at a CD4 threshold of 500 cells/mm3 or less for adults, adolescents and older children. Priority should be given to persons with severe or advanced HIV disease and those with CD4 count of 350 cells/mm3 or less. ART is recommended 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) 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, pregnant women and children is recommended whenever possible, with a new, preferred first-line ART regimen of tenofovir/lamivudine or emtricitabine/efavirenz (TDF/XTC/EFV) as a fixed-dose combination tablet once daily. 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.

“These new guidelines have the potential to transform HIV responses in countries and to boost efforts to achieve ‘Universal Access’ targets, towards and beyond 15 million people on antiretroviral therapy in low- and middle-income countries by 2015.” Dr Gottfried Hirnschall 

For pregnant and breastfeeding women and children under age five living with HIV, the routine offer of ART irrespective of CD4 count or clinical stage will improve treatment access.  Current treatment coverage is unacceptably low for these groups.  Simplified approaches such as using a common regimen of TDF/XTC/EFV for all those eligible should also improve uptake.

The guidelines emphasize that ARV drugs should be used within a broad continuum of HIV care.  Additional new recommendations range from community-based HIV testing and counseling, to HIV testing of adolescents, and the use of post-exposure prophylaxis after sexual assault. Summaries 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 co-infections and other comorbidities, and monitoring and managing drug toxicities.

Data on service delivery models were reviewed and a number of new evidence-based recommendations were developed including a recommendation to initiate ART in maternal and child health and tuberculosis treatment facilities in high burden settings.  ART should also be offered in care settings where opioid substitution therapy (OST) is provided.  Decentralization of services provides an opportunity to offer ART to more people closer to where they live.  Trained non-physician clinicians, midwives and nurses can initiate and maintain first-line ART (task shifting) and supervised community health workers can dispense ART between regular clinical visits.

These guidelines aim to assist countries in decision-making and programme planning, to adapt the recommendations for their epidemic, health systems and resource context.  The document outlines fair, inclusive, transparent and equitable decision-making processes at the country level on the strategic use of ARV drugs.

The implementation of these guidelines will expand the pool of persons eligible for ART and will require additional investments in the near and medium term.  However, modelling clearly demonstrates that earlier treatment initiation will reduce new infections over the medium to long term as HIV transmission is reduced, and will be a major step forward towards reducing the global burden of HIV.

The full guidelines and accompanying annexes are available at: http://www.who.int/hiv/pub/guidelines/arv2013/download/en/index.html

References

1.     Cohen MS et al. Prevention of HIV-1 infection with early antiretroviral therapy. New England Journal of Medicine, 2011, 365:493–505.

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