New report shows steady progress in research and development for HIV vaccines

Recent breakthroughs in HIV prevention research have confirmed the promise of new options to help end the AIDS epidemic and highlight the urgent need for ongoing research to develop additional prevention options and support rapid rollout of proven ones. However, continued progress requires a broader base of funders committed to sustained support according to the new report From Research to Reality: Investing in HIV Prevention Research in a Challenging Environment released today at 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013) in Kuala Lumpur.

Steady progress in research and development for HIV vaccines, pre-exposure prophylaxis using antiretroviral drugs (PrEP), and treatment as prevention have confirmed the critical role science has to play in providing solutions to end the AIDS epidemic, yet the ninth annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group shows that funding has essentially plateaued.

In 2012, funders invested a total of US $1.31 billion across R&D for six key prevention areas: preventive HIV vaccines, microbicides, PrEP (pre-exposure prophylaxis) using antiretroviral drugs, treatment as prevention, operations research related to voluntary medical male circumcision and prevention of vertical transmission. This is a six percent increase over funding in 2011. However, a significant portion of this increase is likely due to improved reporting by several donors.

"Science has a critical role to play in ending the AIDS epidemic," said Luiz Loures, Deputy Executive Director, Programme, UNAIDS. "The potential returns on investments are hugely important and I strongly urge donors to make funding for research and development a top priority."  

This report comes as new guidelines are being released from the World Health Organization (WHO) on when to start taking antiretroviral therapy (ART) for HIV. These new guidelines recognize recent advances made in HIV prevention R&D and will help countries maximize the impact of antiretroviral therapy on keeping people alive and well ad helping prevent new infections.  It is too early to tell what additional resources will be needed to support countries and programs in adopting the new WHO guidelines and effectively rolling out these proven prevention options, which represents an investment opportunity for countries heavily impacted by HIV, particularly emerging economies.

According to the report, the United States remained the largest public sector funder of HIV prevention research, spending a total of US$925 million in 2012—70 percent of the total investment in HIV prevention R&D—and underscoring the importance of fostering broader commitments by additional global partners.

"As the report highlights, the HIV vaccine field has been a leader in catalyzing innovative partnerships across the public, private, philanthropic and academic sectors. Such partnerships can help integrate new funders and help enhance the information exchange and collaboration that is required as we tackle remaining critical questions in immunology as we move forward to develop even more effective prevention options," said Margaret McGlynn, President and CEO of the International AIDS Vaccine Initiative, IAVI.

For the first time this year, the report includes the critical investment made by HIV prevention research trial participants. In 2012, there were 99,931 participants in HIV prevention research trials, primarily based in sites with high HIV burden in South Africa, Uganda and the United States. As more efficacy trials are planned, tens of thousands more women and men in the communities hardest hit by HIV will take time from their daily lives to participate in clinical trials and to help end the epidemic, representing a significant, ongoing investment in prevention R&D.

Following the scientific breakthroughs of 2011, during which preventive HIV vaccines, PrEP, and treatment as prevention all advanced faster and further along the scientific path, 2012 was largely a year of follow-up research seeking to confirm results of past studies, move forward with new clinical research and roll out proven new prevention modalities. Even though 2012 brought steady progress, it also brought results that have both challenged the resiliency of the HIV prevention research field and raised new questions that the field is compelled to answer.

• Additional data from the RV144 vaccine trial in Thailand has provided new clues about why and how the vaccine worked and has helped to pave the way for trials set to begin in Thailand and South Africa in 2016. At the same time, researchers are developing other vaccine candidates and also learning more about broadly neutralizing antibodies, which may form the basis of future clinical trials.
• 2012 saw intensified focus on faster rollout of adult male circumcision for maximum prevention impact. Funding for R&D and operations research increased, with an emphasis on research that would better inform delivery and demand and enhance understanding of current constraints.
• Planning for demonstration projects of daily oral PrEP among a range of populations moved forward in 2012, following the US Federal Drug Administration (FDA) approval of Gilead Science Inc.'s daily oral TDF/FTC as PrEP and World Health Organization (WHO) guidance for PrEP demonstration research trials.
• Large-scale trials of treatment as prevention are now taking place in more than 40 countries around the world, demonstrating a global commitment to explore the potential of this intervention. At the same time, implementers and normative agencies continued their efforts to add treatment as prevention to HIV prevention agendas and the national strategies.
• Following flat results from the VOICE (MTN 003), which was testing daily oral tenofovir, daily oral TDF/FTC and daily 1% tenofovir gel, data from the trial are being examined, and preliminary results suggest that too few women in the trial adhered to prescribed use of the trial products to allow for evaluation of their effectiveness. The ongoing FACTS trial of 1% tenofovir gel as well as microbicide ring trials are working to incorporate lessons learned from the VOICE trial around understanding and supporting participant adherence.

"There is a growing consensus that we can begin to end the AIDS epidemic if we develop and deploy the right tools," said Mitchell Warren, executive director of AVAC. "But we won't be able to make a sustained impact on the cycle of new infections without aggressive roll out of new prevention options – voluntary medical male circumcision, PrEP, treatment as prevention, microbicides and eventually vaccines. We need sustained and flexible funding to ensure that we efficiently deliver what we know works, demonstrate how proven options can be rolled out, and develop new options."