Antibody added to infant HIV therapy appears safe in early trial
A randomized trial found VRC01 was well tolerated in infants with HIV, but did not significantly reduce viral DNA overall when added to standard drugs.
By Tom Brennan · Health & Medicine Correspondent
3 min read
An international clinical trial found that an experimental anti-HIV antibody could be given safely to very young infants alongside standard antiretroviral treatment. The result matters because babies born with HIV face lifelong drug therapy, and researchers are looking for ways to shrink the viral reservoir that makes a cure difficult.
The study, led by Dr. Alka Khaitan of Indiana University School of Medicine and published in Science Translational Medicine, tested a broadly neutralizing antibody known as VRC01 in infants younger than 12 weeks who were living with HIV. Khaitan and colleagues reported that the antibody was well tolerated, though it did not produce a significant overall drop in HIV DNA compared with antiretroviral therapy alone.
Khaitan’s team noted that, despite progress in preventing HIV transmission around birth, 130,000 infants acquire HIV each year and 1.5 million children worldwide live with the virus. The researchers said a major barrier to cure is HIV’s ability to settle quickly into resting CD4 T cells, where it can persist as a reservoir.
How the antibody was tested
The trial enrolled 61 infants across sites in North America, Africa and Asia, according to the study. Thirty-one infants received antiretroviral therapy alone, while 30 received antiretroviral therapy plus subcutaneous injections of VRC01 within 14 days of starting standard treatment.
VRC01 belongs to a class of broadly neutralizing antibodies, or bNAbs, that are designed to recognize parts of HIV that vary less across strains. The study focused on an antibody that targets gp120, a viral glycoprotein HIV uses during entry into human cells.
Researchers have studied bNAbs more extensively in adults, but Khaitan’s team said far less is known about their use in infants. The trial was designed to see whether adding the antibody at the start of early HIV treatment could help clear infected cells and reduce the size of the viral reservoir.
Safety signal, limited overall effect
After 14 weeks, investigators found no significant difference in the decline of HIV DNA between the two treatment groups, according to the study. The trial did not identify safety concerns tied to VRC01, and the researchers said infants tolerated the antibody treatment.
The team’s additional analysis pointed to possible reasons for the limited effect. Many infants carried HIV strains that were already resistant to VRC01, and blood levels of the antibody were often lower than researchers had expected, according to Khaitan and colleagues.
Even so, the study found that infants with higher VRC01 concentrations tended to have larger reductions in HIV DNA. The researchers said that pattern suggests stronger antibodies, higher effective concentrations or antibody combinations may have more impact than VRC01 alone.
Khaitan’s team concluded that findings from adult antibody trials cannot be assumed to apply directly to infants. They said further studies using more potent broadly neutralizing antibodies, or combinations of several antibodies, will be needed to assess whether the approach can become a useful addition to infant HIV treatment.
This story draws on original reporting from Medical Xpress.