The “Mississippi baby,” born with HIV, treated early and aggressively, lost to treatment at 18 months only to return to care with no signs of virus, showed detectable viral levels in a clinic visit earlier this month, the National Institutes of Health announced today. Tests also showed a drop in the now four-year-old child’s immune cell count, as well as antibodies to HIV.
It is a disappointing turn in a case that encouraged hope worldwide that immediate and intensive treatment could, perhaps, change the course of the epidemic by proving it was possible to eliminate the virus in infants. Researchers have stressed they were not quick to conclude that had occurred in this case, and had sought repeated confirmations that the child had been infected with HIV in the first place and was in fact clear of the virus. Their findings had spurred physicians treating other babies to take a similar approach to immediate treatment with the same combination of antiretroviral medicines, with promising results from several infants including one in California, reported at the 2014 Conference on Retroviruses and Opportunistic Infections. The case also inspired the launch of the P1115 trial, supported by the IMPAACT (International Maternal Pediatric Adolescent AIDS Clinical Trials) Network, that opened last month, a multi-center study to explore the effects of early intensive antiretroviral therapy on achieving HIV remission in newborns. “The study is still in play,” National Institute of Allergies and Infectious Diseases director Dr. Anthony Fauci said in a news briefing Thursday, adding that it has not yet enlisted participants, and that it is being re-examined, including for amendments to the informed consent materials given to trial participants. The study retains the goal of seeking to determine information on optimal treatment for newborns.
Dr. Fauci acknowledged disappointment while reiterating commitment to cure research, and saying “What has happened in this case is really quite important.” Among the questions it has raised, he said, is how the virus was suppressed without a detectable immune response — antibodies — being discovered in the child. Dr. Deborah Persaud, who has led analsyis of the child’s case, and who has announced and updated news of the case at the last two CROIs, said that the length of time that the child remained without antiretroviral treatment and without signs of the virus was unprecedented. “Typically,” she said, “when treatment is stopped, HIV levels rebound in weeks, not years.” The rebound of the virus also has yielded information, including further proof that the child was infected, and with the same virus with which the mother was infected. And she said, the child’s case supports that early treatment can reduce the size of the viral reservoir.
Dr. Hannah Gay, who has cared for the child since its birth, said the development “felt very much like a punch in the gut.”
Analysis of the child’s case began when she was returned to care after five months without treatment in apparent good health. The child had been born to an HIV-infected mother who had received no prenatal care, and was started on three drug antiretroviral treatment 30 hours after she was born, which continued for the next 18 months. After the child returned to care showing no signs of the virus without treatment, she was closely monitored, Dr. Gay said today, with clinical visits every 6-to-8 weeks. It was at one of those visits last month that, while the child appeared well, tests showed the rebound of the virus and its effects on the child’s immune cell count. The child is once again on antiretroviral treatment and is responding well to it, her viral load once again dropping and immune cell count increasing.