Science has been the backbone of the HIV response. Daily antiviral therapy has changed an HIV diagnosis from a death sentence, and today those infected can expect to have a nearly normal life span. The science also propelled an unprecedented global response. In 2005, President George W. Bush launched
the President's Emergency Plan for AIDS Relief (PEPFAR) which continues to provide $6 billion a year to deliver antiviral drugs in low- and middle-income countries. At the time the largest international health initiative
in history, PEPFAR has enjoyed strong bipartisan support for more than 15 years. The world came together to create the Global Fund
to fight AIDS, tuberculosis and malaria. Together, these two programs have supported countries to save the lives of more than 20 million people living with HIV.
However, more than 30 years into the HIV pandemic, over 13 million people
still do not have access to the antiretroviral therapy (ART) and treatment they need daily. Factors ranging from new infections, limited access to health care, stigma, discrimination, persistent myths, fears about treatment and supply chain limitations have all contributed to preventing full control of -- and access to treatment for -- HIV.
It's time then to more firmly plant the need for an HIV cure on the policy agenda. While interventions that lead to a meaningful cure -- allowing for people to safely stop antiviral drugs -- are at least decades away, we must begin planning for it sooner than later. Once available, we must ensure a cure can be successfully delivered to those countries most burdened by the disease and delivery must come at speed.
Infectious disease expert Dr. Anthony Fauci recently remarked
about the three promising new Covid-19 vaccines that the hardest part of any medical advance is getting a product that works to as many people as possible. Consider the case of pre-exposure prophylaxis, or PrEP, a daily tablet that provides near complete protection against HIV when taken daily. The scale-up of oral PrEP has been slow, despite receiving FDA approval in 2012. An estimated 350,000 individuals have used PrEP, with two-thirds of these in the United States -- a far cry from the United Nations goal of three million users by 2020. Some of the barriers to scaling up PrEP have included who covers the cost, low awareness of its efficacy and where to get it and challenges to stay on PrEP for prolonged periods.
The lesson here? Start planning for delivery when research looks promising. Do not wait for a product to be approved.
Why now? In addition to the lack of global access to lifesaving treatment, treatment is not perfect and people living with HIV still suffer from stigma and discrimination -- issues that will take time to overcome.
There's also the cost.
Over a 16-year period, the world spent approximately $560 billion
on HIV. With 1.7 million new infections per year
and every person living with HIV needing lifelong treatment, sustaining such massive investments is challenging.
An HIV cure, in contrast, would mitigate the long-term health and economic consequences of the virus and eventually replace daily treatment. This would facilitate cost savings that could free health resources for other priority diseases. It could also catalyze pandemic control. In other words, by changing treatment from lifelong ART to a fixed finite period of ART, there will be greater motivation for PWH to access and adhere to ART.
Most importantly, the scientific case for an HIV cure has become increasingly stronger over the past decade. We know that a cure is possible thanks to the case reports of two men, Timothy Brown and Adam Castillejo, who were cured of HIV
following a stem cell transplant.
Additionally, combined interventions
that stimulate the immune system have led to cures in monkeys. Given the high bar for safety, evaluation of many interventions is now complete, allowing for clinical trials of combination cure strategies that are now underway.
If an HIV cure is to have maximal impact, it must be affordable, deliverable, and acceptable in all countries hit hard by the virus. We are therefore proposing steps to plan for an HIV cure now, including defining a target product profile
(TPP) and establishing the HIV Cure Africa Acceleration Partnership (HCAAP)
, a multidisciplinary public-private partnership to catalyze and promote HIV cure research through diverse stakeholder engagement. TPPs are an integral feature of any drug development process, to align interested parties, including pharmaceutical companies, product development partnerships, regulators, end users, donors, and civil society around a clear set of goals or requirements for a potential product.
HCAAP will convene stakeholders, including people living with HIV, at an early stage to accelerate the design, socialization, and rapid adoption of HIV cure products.
This last point is critical: to maximize the likelihood that they will be used, it is essential that input from communities themselves help drive both research and product development. As Bill Foege details in his book
The House on Fire: The Fight to Eradicate Smallpox, the vaccine delivery mechanism originally developed resembled a gun, resulting in low rates of acceptance in some cultures. By changing the shape of the tool, a barrier to eliminating the disease was overcome.
With continued scientific advances, researchers have acknowledged that there will be successive generations of interventions leading to an HIV cure, starting with combined interventions to bolster the immune system and to reduce the pool of residual virus, and possibly even extending to genetic therapies in the future. Those solutions, though now looking promising, are still some way off. But that is precisely the reason why planning for an HIV cure begins now.