Will HIV Cure Research Finally Bring Urgency to “Test and Treat” for Infants?

As a health advocate, I rely on evidence and research to help shape policy recommendations. Because HIV research is often complicated and takes several years to complete, moments where research results drive immediate policy changes and programmatic action don’t come along as frequently as we advocates would like. But something out of the ordinary happened last week.

At the Conference on Retroviruses and Opportunistic Infections (CROI), Dr. Deborah Persaud and the IMPAACT P1115 study team announced that four children initiated on antiretroviral treatment (ART) within 48 hours of birth were found to be free of detectable HIV for more than one year after pausing their ART.

In most cases, HIV treatment interruption gives the virus a chance to re-establish itself in the body, and within weeks adult and pediatric patients see elevated amounts of HIV in their blood. This is because a small bit of HIV (known as the “HIV reservoir”) hides in the body, ready to awaken and go back to work as soon ARVs are out of the way. But these four children told us something different.

Dr. Persaud’s research, including her earlier research with the “Mississippi baby”, provides a clear signal that infant immune systems may be able to use very early ART initiation to limit the establishment of the HIV reservoir, giving us a glimpse into what genuine potential for HIV remission could look like.

Revealing that four children are living ART-free with no detectable HIV in their blood is certainly the headline, but what also grabbed my attention was something Dr. Persaud said during an interview on the research findings. She said: “It’s on us with this finding to really push implementation science towards having newborns and infants having access to point of care testing so they can be diagnosed early and put on treatment. Even if that’s not for remission or cure, we know that early treatment of children is lifesaving.”

Dr. Persaud expressed something that I knew the minute I read the NIH announcement: this research doesn’t just give us hope for a future HIV-cure; this research reinforces the necessity of the work happening now. Early infant diagnosis, rapid optimal treatment initiation, and viral load monitoring serve as the building blocks for possible ART-free remission while ensuring every child has the opportunity to survive and thrive today.

The Urgency of Early Diagnosis

The standard of practice for diagnosing adults with HIV is a rapid test that returns results in less than an hour. Unfortunately, rapid tests used on adults cannot be used on infants for several reasons, so other testing methods must be used. And most of the HIV testing techniques utilized for infants are painfully slow and only return results to the clinic after several weeks if not months – impacting not only the opportunity for HIV remission but also survival since peak mortality for infants with untreated HIV infection is between 2 to 3 months old.

The game changer here should be scale-up of point-of-care early infant diagnosis (POC EID). Point-of-care testing allows infant samples to be run at a location in or near the clinic almost instantaneously after collection rather than having to transport samples miles away to a conventional lab. Elizabeth Glaser Pediatric AIDS Foundation research funded by Unitaid published in the Lancet in April 2019 established that point-of-care testing was highly effective, reducing the turnaround time from sample collection to return of test results down from almost two months down to less than two days – and in most places, down to only a few hours.

Despite compelling evidence on POC EID developed by EGPAF and other partners, policymakers have been cautious and uncertain about how much to invest in the promise of rapid test-and-treat for infants. One potential sign of progress: PEPFAR recently updated its EID policy to remove barriers to testing HIV-exposed children at birth, even instructing country teams to prioritize POC testing when doing such tests. But scale-up of this technology remains disappointingly low, with many national programs continuing to rely on conventional lab-based testing rather than moving to point-of-care.

The Urgency of Treatment Options for Infants

The IMPAACT research relies on having antiretroviral drugs available that are safe and effective for use in children within 48 hours of birth.

While it is remarkable to see four infants achieve drug-free remission, these children started in a cohort of 54 infants. Only six of the 54 reached and maintained the viral suppression threshold needed to stop ART. Sadly, its common to see low pediatric viral suppression rates, especially as compared to adults: in 2022, only 46% of children living with HIV were virally suppressed.

In my opinion, these statistics should be viewed as an indictment of the current standard of care for children. More optimal drug regimens, such as pediatric dolutegravir, have improved pediatric treatment and care, and initiatives like the Global Accelerator For Paediatric Formulations (Gap-f) – of which EGPAF is a founding partner – are helping national HIV programs accelerate introduction and roll out of much-needed fixed dose ARV formulations proven to be safe in this youngest patient group. But more needs to be done to not only develop drug formulations that meet the unique medical needs of children but also ensure that children down the youngest age ranges can access those drugs.

It is on all of us to ensure every infant – not just those enrolled in a research trial – has access to timely HIV testing and the most effective treatment available to ensure their own viral suppression and increase their chances of having long, healthy lives.