Functional Cure for HIV-Infected Infant After Very Early Treatment

A 26-month-old infant girl born in Mississippi has been functionally cured of HIV, according to results presented at CROI 2013 in Atlanta.

According to lead author Deborah Persaud, M.D., the infant was treated very early, within 31 hours of life, with zidovudine/lamivudine (AZT/3TC, Combivir) and nevirapine (Viramune). After a week, the nevirapine was switched out for lopinavir/ritonavir (Kaletra).

While HIV testing and prenatal treatment is standard for pregnant women in the U.S., the infant's mother was not in care during her pregnancy.

The mother, who was unaware of her HIV status, was confirmed infected using standard rapid tests during labor and delivery. Within 30 hours, the baby was transferred to the University of Mississippi Medical Center, where Hannah Gay, M.D., administered two separate HIV tests: a nucleic acid test at 30 hours and a viral load test at 31 hours.

The test results didn't come back until days later, but based on the mother's prior lack of HIV care, Gay decided the risk of mother-to-child HIV transmission was too great, and made the highly unusual decision to start the child on a full antiretroviral regimen immediately.

Within a week, the nucleic acid test came back positive and the viral load test revealed the child had a viral load of about 20,000 copies/mL. Persaud noted that the two positive tests are the standard definition of HIV infection in a perinatally exposed child and therefore justified the decision to start the infant on HIV treatment.

Within a month, the baby's viral load had lowered to undetectable levels. After 18 months of treatment, the mother decided to take the child off treatment. Despite this treatment discontinuation, the infant has continued to have an undetectable viral load through 26 months of age. Although HIV DNA fragments have been found in the baby's blood in extremely small amounts, there has been no sign of any actively replicating virus.

"Plasma viral load, PBMC (peripheral blood mononuclear cells) DNA, and HIV-specific antibodies remained undetectable with standard clinical assays, confirming a state of functional HIV cure," the researchers state in the study abstract. They theorize that very early treatment could have stopped the virus from forming reservoirs that cannot be eliminated with existing antiretrovirals; the existence of those reservoirs has thus far proven to be the primary roadblock to HIV eradication in chronically HIV-infected patients.

Dr. Persaud noted that this case appeared to be different from post-exposure prophylaxis (PEP) because the infant showed detectable levels of virus prior to treatment initiation, thus suggesting she was probably infected in the womb rather than during delivery.

For thoughtful analyses of the importance of this study and its significance for the HIV community, read this reaction article by Paul Sax, M.D., as well as this op-ed by Jim Merrell of the HIV Prevention Justice Alliance on the questions this story raises about the U.S. health care system.