SAN FRANCISCO — The conversation at AIDS 2020 is focusing not just on developing new technologies to fight HIV/AIDS — but also ensuring the tools that already exist realize their potential for impact.
As the world falls short of 2020 targets for progress on HIV/AIDS, global health experts are highlighting the need to make testing, prevention, and treatment affordable and accessible.
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Their insights on ways to close the gap between innovation and uptake for HIV/AIDS hold important lessons for a range of global health priorities where work on research and development is not paired with a plan for delivery, said Mitchell Warren, executive director at AVAC, a nonprofit focused on HIV prevention.
“We really need to talk about R&D&D,” he said, referencing a shorthand he often uses to capture research and development and delivery.
“Because if we only research and develop but don’t deliver, then frankly the greatest technologies are meaningless, and we see that. A safe and effective vaccine that sits on the shelf for polio is not safe or effective. But we put so much emphasis on new technology that we forget that we need as much if not more innovations in the delivery space. And that’s not for HIV only,” Warren said.
The global health community tends to think about access only after the phase 3 trial, the final stage of clinical research, Warren said. When these studies end early, the donors, implementers, and governments tasked with figuring out access to medicines are often caught unawares.
On Tuesday, the AIDS division at the National Institutes of Health announced the superior efficacy of cabotegravir, an investigative injectable drug under development for HIV prevention and treatment, over oral preexposure prophylaxis, or PrEP.
A study on safety and efficacy of cabotegravir in cisgender men who have sex with men and transgender women who have sex with men ended two years earlier than planned, after cabotegravir was found to be highly effective at preventing HIV in this population.
There was not a strong plan in place to roll out oral PrEP after it was approved following clinical trials in 2012. For cabotegravir, a range of partners came together with the support of the Bill & Melinda Gates Foundation to form the Biomedical Prevention Implementation Collaborative, or BioPIC, which has focused since 2018 on translating clinical trial results for HIV prevention into real public health impact.
At AIDS 2020, Helen McDowell, head of governmental affairs and global public health at Viiv Healthcare, presented what she described as “implementation research priorities to support product introduction.”
Some of the research priorities that will help these products reach the most vulnerable populations include evaluating new and existing delivery channels, working on cost-effectiveness, and integrating into test and treat programs.
“If we only research and develop but don’t deliver, then frankly the greatest technologies are meaningless.”— Mitchell Warren, executive director, AVAC
“No one group can support introduction and access on its own,” she said, emphasizing the importance of partnerships across sectors, from product development to budgeting to monitoring and evaluation, in order to ensure “affordable and sustainable access.”
When new drugs such as cabotegravir are introduced, the first question that arises is how much they will cost, said Linda-Gail Bekker, deputy director of the Desmond Tutu HIV Center at the University of Cape Town in South Africa.
“It’s always about the money!” she wrote in an email to Devex. “Once we can overcome that, we can overcome most of the other challenges.”
Other questions include who will administer the drugs and from where.
“If we can bypass health facilities or reduce the reliance on traditional health facilities we can increase utilization of a particular modality,” Bekker said. “I think we have seen this to an extent with contraception but even with this we haven’t gone far enough.”
Bekker said the global health community might learn from the fast-food industry: “Fast, decentralized, simple, not reliant on expertise, cheap, attractive to people who want it most, streamlined to eliminate wastage and tailored in delivery,” she said.
While an HIV cure remains elusive, it is needed most in resource-limited settings, said Thumbi Ndung'u, an HIV/AIDS researcher who heads the HIV Pathogenesis Programme at the University of KwaZulu-Natal, a province of South Africa.
“HIV cure research should be directed and focused on high-burden, low-income countries,” he said, noting the importance of cost and practicality of delivery, and directing AIDS 2020 attendees to an academic paper where he expanded on these points.
Ndung'u explained that experts working on the target product profile for an HIV cure, which state its intended use, target populations, and safety and efficacy targets, can begin with a north star in mind but must ask what is useful.
Many of the innovations to ensure the continuity of HIV/AIDS prevention and treatment in the context of the COVID-19 pandemic are not new, but have never been taken to such scale, said Shannon Hader, deputy director at UNAIDS, in the opening press conference of AIDS 2020.
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An example is differentiated service delivery, a client-centered approach that offers people convenient HIV services in ways that fit into their lives, which was endorsed in the 2016 World Health Organization guidelines, but recently scaled up in countries including Sierra Leone, Kenya, and South Africa.
COVID-19 is also accelerating the progress and adoption of a range of new technologies, ranging from self-testing to telemedicine.
Several conversations throughout the virtual forum this week are focused on the barriers that stand in the way of innovations working as intended, including stigma, discrimination, criminalization, and a failure to engage communities at the outset.
As the AIDS 2020 conference asks where the global health community is on the road to a cure and a vaccine for HIV/AIDS, there are unprecedented efforts to develop a vaccine for COVID-19. Companies and governments are making riskier investments far earlier in the process than they normally would.
“We’ve never seen that same risk tolerance in terms of an investment strategy in HIV or in anything else,” Warren said.
One of the big questions now is whether this change is unique to COVID-19, or whether this could translate into a more long-term change in the way the global health community thinks about product development and product delivery.
“If a COVID vaccine is shown to be effective a year from now, there will be a huge push for access,” he said. “We could have a COVID vaccine before an HIV vaccine, so let’s make sure we don’t have to re-adjudicate equitable access. Let’s do it once and for all and do it well.”