Today on World AIDS Day, we reflect both on the remarkable progress that has been made against HIV as well as the considerable challenges that remain. We now have highly effective HIV treatment and prevention methods, and work is underway to address the remaining challenges in delivering these tools to the people who need them most, as well as to develop new interventions. The National Institutes of Health continues to advance rigorous, innovative research to prevent new HIV transmissions and improve the health of people with HIV worldwide.
This year the coronavirus disease 2019 (COVID-19) pandemic is creating great concern and uncertainty for people everywhere, including those affected by HIV. Notably, lessons we learned from involving affected communities in HIV research planning and implementation are informing our response to this new pandemic. NIH also is leveraging its HIV research infrastructure and expertise to conduct critical clinical trials evaluating investigational vaccines and monoclonal antibodies for COVID-19 prevention, as well as a variety of potential COVID-19 therapeutics.
In the face of the challenges posed by COVID-19, our work to address HIV has not slowed, reflecting the U.S. Government theme for this year’s World AIDS Day—Ending the HIV Epidemic: Resilience and Impac and the theme for NIH’s observance — Science and Community: Working Together to Prepare for the Unexpected. We applaud the resilience of the HIV clinical trial participants, researchers, health care professionals, advocates and other members of the global community who are continuing their work to advance HIV research.
If current HIV treatment and prevention methods could be optimally implemented, an end to the HIV epidemic is feasible. This year, NIH awarded approximately $10 million to support implementation science research to advance the goals of the Ending the HIV Epidemic: A Plan for America initiative, which aims to reduce new HIV diagnoses in the United States by at least 90% by 2030.
Achieving a durable end to the HIV pandemic also will require continued development of new and improved HIV prevention and treatment tools that are safe, effective, scalable and desirable to diverse global populations. In a landmark advance this year, two large-scale clinical trials found that a long-acting form of the antiretroviral drug cabotegravir injected once every eight weeks was safe and more effective than daily oral pre-exposure prophylaxis at preventing HIV acquisition among cisgender women and cisgender men and transgender women who have sex with men. These results mark the first time a systemic, long-acting form of HIV prevention has been conclusively demonstrated to be highly effective.
Other forms of long-acting HIV prevention modalities under investigation include intravaginal rings, implants and antibodies. The adoption of a positive scientific opinion on the dapivirine vaginal ring by the European Medicines Agency this year and subsequent prequalification by the World Health Organization marked pivotal steps toward expanding HIV prevention choices for women. If approved by regulatory agencies, the monthly ring would provide women in developing countries with a discreet long-acting HIV prevention option that they control.
The development of a safe and effective HIV vaccine remains a top priority, and notably, certain platforms used to develop COVID-19 vaccine candidates employed the structural biology techniques used in HIV vaccinology. Two ongoing clinical trials for HIV vaccines, Imbokodo and Mosaico, are evaluating an experimental HIV vaccine regimen designed to protect against a wide variety of global HIV strains. Results expected soon from two other clinical trials, evaluating intravenous infusions of a broadly neutralizing antibody for HIV prevention, will provide key insights for further development of antibody-based HIV prevention tools and ultimately a vaccine.
Thanks to extraordinary advances in antiretroviral therapy, many people with HIV can control the virus by taking just one pill each day. However, adhering to daily pills can be challenging. Researchers therefore are pursuing long-acting treatments that would allow a person with HIV to keep the virus suppressed without daily medication, as well as strategies to completely eradicate HIV from the body.
A few exceptional clinical scenarios have provided proof that HIV can be cured, including that of Timothy Ray Brown. Brown was widely recognized as the first person cured of HIV and for inspiring and advocating for scientists and communities worldwide to advance HIV cure research. Sadly, he died of leukemia in September 2020; however, his legacy lives on in the robust HIV cure agenda that researchers are pursuing today.
Even when HIV is well-controlled with treatment, people living with the virus are at heightened risk for co-infections and comorbidities. Tuberculosis remains the leading cause of death globally for people with HIV. Researchers recently reported that a new four-month treatment regimen is as safe and effective as the standard six-month regimen for drug-susceptible tuberculosis, a finding that has the potential to offer an additional tuberculosis treatment option that may be more convenient.
People with HIV also are more likely to experience noninfectious comorbidities such as heart disease, kidney disease and certain cancers. In order to successfully address these comorbidities, a robust research agenda is required to better understand how these conditions develop and to evaluate appropriate treatments. In this regard, the global REPRIEVE clinical trial that is focused on HIV and heart disease is teaching us about the many long-term health effects of HIV. The trial recently began gathering data to assess the impact of COVID-19 on people with HIV.
As we reflect today on our progress, we also look forward to new HIV research advances. To guide these efforts, NIH, through the Office of AIDS Research, recently released a 5-year strategic plan for HIV and HIV-related research. Yesterday, NIAID named the four HIV clinical trials networks that will conduct innovative clinical research in the United States and internationally over the next seven years to accelerate progress against the pandemic.
It is essential to work closely with communities and advocates to develop HIV prevention and treatment strategies that suit the diverse needs, preferences and desires of people with or at risk for HIV worldwide. It also is critical that we continue efforts to nurture the next generation of HIV investigators and ensure that diverse voices are represented. Together, we can identify the optimal strategies to improve the health of those with HIV, prevent new cases, and ultimately, end the pandemic.
We would also like to remind everyone of the U=U Concept: The Undetectable Equal Untransmittable Concept was established by the NIAID and published in JAMA as being scientifically sound based on bodies of clinical evidence. It means that those living with HIV that have achieved and maintained an undetectable viral load of HIV in the blood by taking and adhering to antiretroviral therapy as prescribed will not sexually transmit the virus to others. This validates HIV treatment as a prevention strategy and has several behavioral, social, and legal implications, including helping to reduce the stigma that many living with HIV face, to create environments in which all people, no matter their cultural background or risk profile, will feel welcome for prevention and treatment services.
