WHO Issues Guidelines To Push HIV Epidemic Into “Irreversible Decline”

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The World Health Organization (WHO) has issued new recommendations that call for earlier HIV treatment with antiretroviral therapy (ART) in an effort to keep HIV patients healthier for a longer period of time.

The new recommendations are included in WHO’s latest update to the Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection, last published in 2010.

In a news release, WHO Director-General Margaret Chan stated, “with nearly 10 million people now on antiretroviral therapy, we see that such prospects – unthinkable just a few years ago – can now fuel the momentum needed to push the HIV epidemic into irreversible decline.”

The new recommendations were released by WHO on 30 June, the opening day of the 2013 International AIDS Society Conference in Kuala Lampur, Malaysia.

The full guideline document is available at: www.who.in/hiv/pub/guidelines/arv2013

New Recommendations

For the first time, the new guidelines bring together clinical, service delivery and programmatic guidance for low and middle income countries across all age ranges (adults, adolescents, children and pregnant women). They combine recommendations along the entire continuum of HIV care, including testing and counselling; using ARV treatment as prevention; linking individuals to HIV treatment and care services; providing general HIV care; initiating and maintaining ART; and monitoring treatment.

Earlier initiation of treatment is one of the important changes to the WHO recommendations. Previously, a CD4 cell count of 350 cells/mm3 or less was the threshold to begin ART, but this has been raised to 500 cells/mm3 or less. At the 500 CD4 level, the patient’s immune system is still considered strong. CD4 cell count marks the density of CD4 cells in the blood, an indicator of immune status.

WHO based the recommendation on evidence that earlier treatment can keep patients healthy and the viral load low, ultimately reducing the risk of transmission. WHO states that ninety per cent of all countries have adopted the 2010 recommendation of 350 CD4 count, but a few countries such as Argentina, Algeria, and Brazil have already begun offering ART at the 500 level.

All children under five, pregnant and breastfeeding women with HIV, as well as all HIV-positive partners where one partner in the relationship is uninfected (discordant couples) are now to receive ART, irrespective of CD4 count.

WHO now recommends a single fixed-dose combination pill as the first line of treatment, because it is easier to take and safer compared to other treatment combinations that were previously recommended. The guidelines support accelerated phasing-out of stavudine (d4T), to be replaced by the preferred first-line regimen, which is a combination of three ARV drugs (Tenofovir + Lamivudine (or Emtricitabine) + Efavirenz) in a single pill. The single fixed-dose pill is recommended for adults, pregnant women, adolescents, and older children, but not for children younger than three years old. Children younger than three are recommended to be given the regimen that includes Lopinavir/ritonavir (LPV/r).

New clinical recommendations also include the use of viral load testing, in addition to clinical and CD4 monitoring of people receiving ART, as the preferred approach to monitoring the success of ART and diagnosing treatment failure. Community-based testing and counselling for adolescents will also help diagnose people earlier and link them to appropriate treatment and care.

Widespread Approval

Many donor agencies, non-governmental organisations (NGOs), and members of civil society have lauded the new guidelines. Mark Dybul, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, said, “The new WHO guidelines are very timely in view of the rapid progress we have made in expanding programs for prevention and treatment. This is an example of how the Global Fund and the WHO work together to support countries as we move towards removing HIV as a threat to public health.”

Médecins Sans Frontières (MSF, Doctors without Borders) also welcomed the new guidelines, but called for action to carry them out. “Early HIV treatment makes a major difference – it keeps people healthier and also helps prevent the virus from spreading within communities, but we need the political and financial support to see these recommendations rolled out rapidly,” said Unni Karunakara, international president of MSF.

Challenges Ahead

WHO has said that the global target, set by United Nations member states, of providing ART to 15 million people by the end of 2015 (referred to as the “15 by 15” target) can be reached if the positive dynamic in scale-up of HIV treatment programs can be maintained. This scale-up means that some 26 million additional people in low and middle income countries will be eligible for treatment.

Gundo Weiler, coordinator for the HIV/AIDS department at WHO, said in a press briefing for the launch of the new guidelines that reaching those 26 million people will require “a number of years, investments, and it will take a lot of innovation.”

Another issue warranting immediate attention is the gap between treating young children and older patients. Currently, the preferred single fixed-dose pill can only be given to patients three years or older.

The director of HIV/AIDS department at WHO, Gottfried Hirnschall, said that treating children is still not as simple as treating adults, in part due to the complexity and lack of “palatable” regimen for young children. He said that system issues need to be addressed to include more and better training of non-pediatricians as well as non-physicians and the development of better drugs.

The under-three age group has been overlooked so far in the majority of HIV programmes, often overshadowed by what has been an extremely successful effort to reduce mother-to-child transmission. One of the top priorities for WHO over the next year is to focus on better and earlier diagnosis of children, better drugs, and major investment into service delivery to redress what Hirnschall described as an “unacceptable inequity.”

Mariangela Simao, director of Rights, Gender, Prevention, and Community Mobilization at UNAIDS, said in the briefing that these new guidelines “push the agenda forward.” Simao also touched on the topic of pricing issues, when it comes to access to treatment.

“As we put more people on treatment, there is also a need to address issues on pricing, intellectual property,” she said Simao spoke about the need to address the drug prices in upper-middle income countries that have high prevalence of HIV.

Financing the scale up of HIV treatment and prevention in accordance with the new recommended guidelines will require not only international investment, but also a significant contribution by domestic governments to ensure that individual countries have the political and monetary support to sustain momentum. WHO officials estimated US$ 22-24 billion annually for a fully funded response, which would include treatment, prevention, and structural interventions.

The Medicines Patent Pool issued a statement [pdf], saying that, “Priority medicines under the new WHO guidelines are covered by agreements made through the Medicines Patent Pool, which will help ensure better access to these medicines in developing countries.”

Brittany Ngo is currently completing her Master’s in Health Policy and Global Health at the Yale School of Public Health and previously obtained a Bachelor’s of Arts in Economics from Georgetown University. Through her studies she has developed an interest in health-related intellectual property issues. She is a summer intern at Intellectual Property Watch.

Brittany Ngo may be reached at info@ip-watch.ch.

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