We CAN End the AIDS Epidemic
To sign on to the statement as an individual or on behalf of your organization, click here.For the first time in the 30 years of the AIDS epidemic, there is now conclusive evidence showing that earlier initiation of highly active combination antiretroviral therapy (ART) at 350-550 CD4 cells/mm3 is a highly powerful tool for preventing transmission to sexual partners and has clinical benefit for HIV-positive people.
The evidence comes from the HPTN 052 trial, which released its results in May 2011.1 HPTN 052 compared clinical outcomes and rates of transmission within predominantly heterosexual couples in which one partner is HIV-positive and the other is HIV-negative (serodiscordant couples). HIV-positive individuals with CD4 cell counts between 350 and 550 were randomly assigned to receive immediate ART or to delay initiation until clinical or laboratory guidelines (usually CD4 cell count below 250) were met. The randomized comparison between immediate and delayed ART initiation was stopped four years ahead of schedule due to evidence of overwhelming benefit. Specifically, the trial found that immediate initiation of ART in HIV-positive individuals with CD4 cell counts between 350 and 550 reduced the transmission risk to the HIV-negative partner by 96 percent, while at the same time significantly reducing cases of extrapulmonary tuberculosis in the HIV-positive partner.
These extraordinary data signal a paradigm shift in the global AIDS response. HPTN 052 shows conclusively that treatment is prevention. Now is the time to change the approach to the epidemic. Funding needs to be directed to evidence-based strategies with ART as a cornerstone of the set of proven strategies we have to prevent and treat HIV. These also include male and female condoms, male circumcision, prevention of vertical transmission, behavior change programs that target social norms as well as individual risk, and activities addressing key populations including sex workers, gay men and other men who have sex with men, transgender women, and harm reduction programs for injecting drug users.2 Funds that are not aligned with these core activities need to be justified and, where applicable, reprogrammed.
These biomedical, structural and behavioral interventions need to be delivered in the context of a community-centered mobilization for health and rights. Emerging and experimental strategies such as AIDS vaccines, microbicides, pre-exposure prophylaxis, and eradication strategies may provide additional tools for reducing incidence in the future.
Earlier initiation of ART at CD4 cell counts of 350—and possibly higher as suggested by HPTN 052—is a powerful, potentially cost-saving tool that can help end the AIDS epidemic. Provision of these medications also fulfills the right to health for all people living with HIV. Resources must be made available for scaling up voluntary HIV testing and case finding, clinical and laboratory monitoring, diagnostic testing and adherence-support services. Stakeholder groups—including health care workers, implementers and civil society—need to develop integrated approaches to, and competency with, treatment and prevention messages and interventions. While some of these essential investments can be supported by reprogrammed funds that are already available, there is also a need to identify new resources in order to achieve high coverage of ART, which is necessary for a population-level impact. The price tag for these programs must be seen in context: They will secure two-fold benefits (clinical and prevention) for a single cost.
The data from HPTN 052 make it more urgent than ever that all nations accelerate efforts to diagnose, counsel, support and offer early treatment to all people living with HIV, including the many millions who do not yet know their status. While we acknowledge that countries are still trying to reach universal access to treatment under current WHO treatment guidelines criterion (CD4 cell count less than 350), and that more data on individual and population-level impacts of initiating treatment at a CD4 cell count less than 5003 are needed, particularly in resource-poor settings, the existing data suggest that every person living with an HIV CD4 cell count less than 500 who is not offered ART may potentially represent a missed opportunity both to avert AIDS-defining illness, especially TB, and to prevent new infections. The obligation to protect human rights and public health require that we act with urgency to translate the HPTN 052 data into practice. Donors, implementers, civil society and other partners must now mobilize new and available financial and human resources to realize:
- A world that supports and protects the human rights and dignity of every individual, and in which everyone living with HIV has the opportunity to receive an early diagnosis and is offered access to free or affordable ART and the services needed to help them adhere to their treatment.
- A world in which protecting public health and promoting affordable access to medicines for all takes priority over private intellectual property.4
- A world in which people living with and at risk of HIV have unfettered access to the full complement of evidence-based prevention methods, including male circumcision, syringe exchange, male and female condoms, and early initiation of ART in HIV-positive individuals, along with other new prevention options when they become available.5
- A world in which the structural and human rights-related barriers to HIV diagnosis and treatment—such as punitive laws criminalizing people living with HIV and marginalized populations, stigmatizing policies and practices, stigma and discrimination—are removed once and for all.
To achieve these goals:
- Countries and implementing partners, such as the US PEPFAR program, need to implement ART initiation at a CD4 cell count less than 350 (current WHO guidelines) while modeling and additional data are obtained on individual and population-level benefits of initiating ART at a CD4 cell count between 350 and 500.
- Governments must ensure the availability of appropriate ART at the lowest possible cost in all countries, including unfettered use of TRIPS flexibilities to ensure generic production of more affordable versions of patented products, as appropriate.
- WHO should review available data and release timely guidance on clinical and prevention benefits of earlier ART initiation at a CD4 cell count greater than 500 for different contexts, such as serodiscordant couples, concentrated and high-prevalence epidemics. This may include generating further modeling and providing guidance on addressing evidence gaps through additional research.
- UNAIDS should coordinate a multi-stakeholder effort to assess the impact, cost-effectiveness, population-level benefits and cost tradeoffs of initiating ART at a CD4 cell count less than 500 versus a CD4 cell count less than 350, proactively determine how existing financial resources can be better spent and new ones marshaled to support full implementation of earlier initiation between now and 2015.
- National governments’ strategic plans should include milestones for collecting and assessing data including impact, cost-effectiveness and population-level benefits of ART, as well as barriers and facilitators to ART uptake, adherence and retention at higher CD4 cell counts on whether to increase the treatment initiation threshold to CD4 cell count greater than 500.
- The Global Fund to Fight AIDS, TB, and Malaria (GFATM) should include data from HPTN 052 in its call for proposal guidance for Round 11 and encourage ambitious proposals based on the treatment and prevention benefit.
- PEPFAR, GFATM and other donors and governments should consider creating a "step-up" fund for hyper-endemic countries to raise the ART initiation threshold in order to manage the co-epidemics of TB and HIV.
- Financing for prevention programs must be allocated to evidence-based programs, with a focus on ART, male and female condoms, male circumcision, prevention of vertical transmission, syringe exchange and coverage targets to maximize impact, all in the context of addressing critical enablers.6
- UN Member States should support a treatment coverage target of 15 million people on ART by 2015.
- Governments, NGOs and the pharmaceutical industry should collaborate to increase HIV treatment and prevention competency at the community level by strengthening treatment literacy programs and promoting cross-training among the prevention and treatment stakeholders.
- Donors, communities, implementers, industry and researchers should map and execute an implementation research agenda for ART as part of combination prevention strategies. This would include:
- Implementation research on best practices for programs addressing the full range of issues affecting adherence, particularly earlier treatment initiation, including protections for human rights and the right to health.
- Research on how to extend the prevention benefit of HPTN 052 beyond heterosexual serodiscordant couples to all individuals living with HIV including those who are marginalized and criminalized (e.g., gay men and other men who have sex with men, transgender women, sex workers and injecting drug users).
- Research on how to counsel individuals and couples at risk of HIV regarding the relative risks and benefits of ARV-based prevention.
- Pharmaceutical industry prioritization of research and development into new drugs and combinations or adapted formulations of existing drugs to specifically address the needs of people in most affected countries and facilitate the scale-up of ART and treatment compliance.
- Swift, ethical research on and implementation of new strategies that could be part of combination prevention, such as AIDS vaccines, microbicides and pre-exposure prophylaxis.
Non-integrated, artificially separated approaches to funding and delivering treatment and prevention services must be replaced with integrated approaches linking newly diagnosed HIV-positive people to comprehensive support and care programs, including ART. This will optimize the benefits to individual health and to public health. These programs must be used as a platform for linking HIV-negative individuals to the full range of evidence-based prevention methods.
The global response to AIDS is at a turning point. On the eve of the 2011 United Nations High-Level Meeting on AIDS, we call all governments, donors, international agencies, researchers, implementers and civil society to act on this evidence and end the AIDS epidemic now. We can, and we must.
A PDF of this document is available here.
2Schwartländer et al. “Towards an improved investment approach for an effective response to HIV/AIDS.” The Lancet. Published online June 3, 2011. DOI:10.1016/S0140-6736(11)60702-2.
3The US Department of Health and Human Services guidelines currently recommend initiation at CD4 cell count less than 500. Emerging and anticipated data including HPTN 052 may support a higher CD4 cell count threshold for initiation. Such data must be tracked and used to guide policy without delay.
4World Trade Organization. Declaration on the TRIPS agreement and public health. Doha WTO Ministerial 2001. Adopted on 14 November 2001.
6UNAIDS states that critical enablers include (but are not limited to) (i) activities to generate more demand; (ii) activities to create a conducive environment for a sound AIDS response; and (iii) activities to support and improve performance of key interventions. The specific mix of critical enablers will depend on national and local circumstances.