ATLANTA -- Researchers reported here that a child born with HIV infection and treated in infancy with antiretroviral therapy has achieved a 'functional cure' -- no longer having detectable virus and off medications for more than 6 months.
The premature infant underwent antiretroviral therapy at 30 hours of life after hospital tests showed HIV viral loads of 20,000 copies/ml in early samples, said Deborah Persaud, MD, associate professor of pediatric infectious diseases at Johns Hopkins University School of Medicine.
Five additional blood tests showed presence of the virus, but the test at day 29 showed that treatment had suppressed the virus to undetectable levels, Persaud said at a press briefing at the Conference on Retroviruses and Opportunistic Infections.
The child continued on medication and had undetectable virus until 18 months old. "At that time the child was lost to follow-up and re-presented at 23 months," she said. "At that time the caretaker reported that the antiretroviral drug treatment had been discontinued."
Tests determined that viral loads were undetectable using a 20 copy/ml assay, and then further ultrasensitive assays were also employed but no copies of replication-competent virus could be detected.
"The child (now 30 months old) remains off antiretroviral therapy and remains well," Persaud said. "We believe that perhaps the introduction of very early antiretroviral drugs prevented the establishment of later reservoirs of HIV and sets the stage for cure."
Over the years, numerous studies have been published indicating that the phenomenon known as seroconversion has occurred in children first thought to be HIV-positive and later found to not have infections, including a 1995 New England Journal of Medicine study authored by Yvonne Bryson, MD, of UCLA. "Over the years we have seen reports of 42 cases of these seroconversions," Persaud told Ƶ, "but 99% of them including Dr. Bryson's report have later been found to involve laboratory errors or contamination."
"It would be a very, very, very rare outcome for the virus to clear from the child without antiretroviral therapy," she said.
In response to a volley of questions from media outlets, Persaud explained that the term 'functional cure' is used because ultimate outcome with the child is not yet known. She also noted that trace amounts of virus can still be detected in peripheral blood using highly sensitive testing.
She said her case study may be unique because usually blood is drawn from a child and there is a delay in reporting the results. When those results are analyzed, an appointment is made and the results are reconfirmed and then treatment may begin -- often 6 weeks after birth. "What was different about this case was that the child was slightly premature so it was in the hospital for the first few weeks," she explained. When the first results came back showing HIV in the blood, treatment was immediately initiated.
"We have found that all the previous cases of seroconversion appear to be laboratory errors or misinterpretation of data," Scott Hammer, MD, professor of medicine at Columbia University, New York, and moderator of the press briefing, told Ƶ.
"I think the study by Dr. Persaud is intriguing," he said. "The questions raised in the press briefing are appropriate questions. I don't think this is a question of laboratory error. Dr. Persaud and her laboratory are extremely careful. I don't think they would be making these statements unless they had gone all the way in figuring this out. We pay attention to single case reports, if the science is there.
"I think we have to let this play out. Appropriate caution is needed here rather than the banner: Children cured," he said.
Disclosures
Persaud had no disclosures. Hammer disclosed commercial relationships with Bristol-Myers Squibb.
Primary Source
Conference on Retroviruses and Opportunistic Infections
Source Reference: Persaud D et al, "Functional HIV cure after very early ART of an infected infant" CROI 2013; 48LB: 89.