Four babies with HIV enter remission after receiving experimental drug regimen during NIH-funded study - in potential breakthrough for hundreds of kids born to infected moms each year

Four HIV-positive babies were able to achieve remission for more than a year after doctors treated them with aggressive medication, giving hope to treatment and cure research.

From 2015 to 2017, scientists funded by the National Institutes of Health who had treated dozens of HIV-positive babies with one of two different treatment regimens since birth. About five years later, they chose six children to pause medication to test how long remission would last. 

In four of those six children, the levels of HIV in their blood were completely undetectable for 12 to 18 months before reaching levels that became detectable again. 

HIV can remain in the body but at levels so low the virus cannot be detected by blood tests, which also means it can't be spread to others. 

While the virus eventually returned in one of the toddlers, the sustained remission offered a glimmer of hope that scientists could soon uncover a way for children born with the potentially deadly autoimmune virus to live normal, healthy lives. 

The news comes just days after a 68-year-old California man with both HIV and cancer was cured of both diseases after doctors essentially replaced his immune system with that of another person who had a genetic mutation that made him immune to HIV.

Four children who acquired HIV in utero have remained free of detectable HIV for more than one year (Stock photo)

The four children who entered remission were not named, and countries of birth were not specified, though the authors said most of the babies included were from sub-Saharan Africa, where HIV rates are highest.

Doctors conducting the study, presented at a Denver virology conference, started out with 440 babies and separated them into two groups, or cohorts.

Cohort one consisted of babies born to HIV-positive mothers who were not receiving treatment for the disease. The second cohort included children born to HIV-positive mothers who were receiving antiviral treatment.

All of the babies initiated a preventative HIV treatment regimen known as antiretroviral therapy (ART) within 48 hours of being born - even before their HIV status was confirmed. 

ART is a treatment that prevents the replication of HIV in the body. It can also be taken by HIV-positive mothers to prevent the transmission of the virus to their baby during pregnancy, childbirth, or breastfeeding.   

If a mother with HIV takes the medicine throughout her pregnancy and the birth of her baby so that she has a suppressed amount of virus in her blood, and her newborn is given ART within hours of their birth, the chances of transmitting HIV to the baby are less than one percent.

Out of the study's babies, 54 babies - 34 from the first group and 20 from the second group had confirmed HIV when they were born. Thirty-three of them were females.

Six children were deemed eligible to stop taking their antiretroviral therapy regimen at around five years old as part of the study, based on certain criteria indicating that their HIV levels were under control and their immune systems were strong enough to withstand a hiatus from the medicine.

In four of those children, HIV stayed at undetectable levels for 48 weeks, 52 weeks, 64 weeks, and 80 weeks. 

The first three children are still in remission and being monitored for the study, while the fourth child’s HIV rebounded after 80 weeks.

Dr Ellen Chadwick, the lead researcher behind the study, said: ‘This remission was much longer than we had anticipated.

‘We’re not surprised or crestfallen if they rebound because that’s what usually happens when medications are stopped. If we can get the virus to such low levels that we might be able to use some newer, innovative treatments to keep them from needing medication every day, then we’re setting them up for success with long-term virologic control.’

The latest study comes on the back of a 2013 case report known as the ‘Mississippi baby,’ which described a baby girl born in Mississippi in 2010 to a mother with HIV and who had HIV herself. Doctors initiated treatment within 30 hours of her birth with a powerful combination of antiretroviral therapies.

When she was 18 months old, the family stopped the ART and she remained off the drugs for the next 27 months with undetectable levels of HIV in her blood.

It was encouraging for scientists, who have been working for decades on a means of saving children from a lifetime of being on the medicine. But the baby’s HIV rebounded when she was just about to turn four.

Dr Deborah Persaud, who reported the Mississippi case and co-led the latest study, said: ‘This is the first study to rigorously replicate and expand upon the outcomes observed in the Mississippi case report.

‘These results are groundbreaking for HIV remission and cure research, and they also point to the necessity of immediate neonatal testing and treatment initiation in health care settings for all infants potentially exposed to HIV in utero.’

HIV – human immunodeficiency virus – attacks the body’s own immune system, rendering it incapable to fighting off infections and diseases such as blood cancer.

Once a person has it, it stays in the body for life though levels of the virus in the blood can sink to so low that tests don’t detect it, which is the goal when being treated.

HIV is not equivalent to AIDS, which results from HIV going untreated. Not everyone with HIV will develop the full-blown disease thanks to advancements in prophylactic medicines in over the past three decades.

The resulting remissions among those children are not equivalent to a cure, but they indicate the medication is effectively suppressing the virus's replication, which in turn means a person is less likely to transmit it to sexual partners.

HIV is mainly transmitted via sex and sharing needles, but can also be passed from mother to child.  

Man is CURED of HIV: 'Düsseldorf patient' now virus-free 

The 53-year-old, known as the Dusseldorf Patient, is just the third person worldwide to be cured of HIV using a stem cell transplant. 

Dr Chadwick said: ‘We don't know precisely why they did so well, but we think it's because we reduced the reservoir to such a low level that the virus didn’t re-emerge in the same way it would in someone with a larger, more established reservoir,’ meaning, spots in the body for the virus to hide.

Reducing the reservoir – or limiting the number of available 'hiding spots' for the virus in the body – meant HIV had a harder time re-emerging and causing new infections or symptoms.

Roughly 1.2 million Americans and approximately 39 million people globally have HIV, and there is currently no cure, though scientists are zeroing in on the power of stem cells, which have the ability to develop into a myriad of different cell types in the body, including immune cells overtaken by HIV. 

Paul Edmonds, the 68-year-old California man who was cured of HIV and a type of blood cancer, was treated for the cancer with stem cell therapy.

This involves replacing stem cells damaged by chemotherapy with healthy ones from a donor - when doctors spotted a unique opportunity: to find a donor with a HIV-resistant genetic mutation. 

They found one, and transplanted stem cells that had two copies of a rare genetic mutation called CCR5 delta-3, which makes people resistant to HIV. Only one to two percent of the population have this mutation.

HIV uses the receptor CCR5 to attack the immune system, but the CCR5 delta-3 mutation blocks the virus from infecting the receptor. 

The transplant completely replaced Mr Edmond's bone marrow and blood stem cells with ones from the donor. 

Since the 2019 transplant, he has shown no signs of the cancer or HIV. 

Three other people have been in sustained remission from HIV from Berlin, London, and most recently Dusseldorf. That patient underwent a very similar transplant to Mr Edmond's. 

'Berlin Patient' Timothy Ray Brown was successfully cured of the HIV virus 16 years ago

Adam Castillejo, 40, was the second person in the world to be cured of HIV. Earlier this year he revealed he was the 'London patient'

The Dusseldorf patient underwent allogeneic hematopoietic stem cell transplantation (HSCT) in February 2013 after chemotherapy for his leukemia, overseen by an international research team, headed by doctors at Dusseldorf University Hospital.

It involved destroying the patient's unhealthy blood cells and replenishing them with those from a donor — who had the CCR5 mutation in their genes.

The patient continued to take anti-retroviral therapy after the transplant to stop HIV from replicating in the body.

The virus became undetectable in his blood, so he stopped taking daily drugs in November 2018 — six years after the stem cell transplant.

The team of doctors ruled the Dusseldorf Patient was in remission from HIV, adding his case provides 'strong evidence' that the transplant cured him of the virus.