Doctors say they have cured an infant born with HIV for the first time by giving her a cocktail of drugs shortly after birth, a result that could point the way toward saving the lives of thousands more infected children.
The baby’s treatment combined lamivudine and zidovudine, both sold by GlaxoSmithKline’s (NYSE: GSK) joint venture with Pfizer Inc., ViiV Healthcare, and Abbott Laboratories’ Kaletra.
Note: This story is being offered free of charge for a limited time. WRALTechWire Insiders will have access to exclusive, selected content like this soon.
ViiV focuses on HIV. The company was formed by GSK and Pfizer in 2009 with the goal advancing treatment and care for people living with HIV. Japan-based Shionogi joined ViiV Healthcare in 2012 as an investor.
“Our aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and then take a new approach to deliver effective and new HIV medicines as well as support communities affected by HIV,” ViiV says.
“We are in the era now where we need to shift the goal towards an HIV cure,” said Deborah Persaud, an associate professor of infectious disease at Johns Hopkins Children’s Center in Baltimore, Maryland. “Where our goal was prevention, now our goal can be a cure and that is a major shift in the field of HIV.”
The baby, whose identity has been kept anonymous, began a regimen of AIDS drugs about 30 hours after she was born at a rural Mississippi hospital, doctors said Sunday at a medical meeting in Atlanta. At 18 months, the mother took the child off the medication. With no signs of the virus for 10 months, the infant was deemed “functionally cured,” researchers said.
There’s no guarantee the child will remain healthy, although sophisticated testing uncovered just traces of the virus’ genetic material still lingering. If so, it would mark only the world’s second reported cure.
“You could call this about as close to a cure, if not a cure, that we’ve seen,” Dr. Anthony Fauci of the National Institutes of Health, who is familiar with the findings, told The Associated Press.
A doctor gave this baby faster and stronger treatment than is usual, starting a three-drug infusion within 30 hours of birth. That was before tests confirmed the infant was infected and not just at risk from a mother whose HIV wasn’t diagnosed until she was in labor.
“I just felt like this baby was at higher-than-normal risk, and deserved our best shot,” Dr. Hannah Gay, a pediatric HIV specialist at the University of Mississippi, said in an interview.
HIV treatments can hold the disease at bay, though stopping the drugs can be a death sentence since it allows infected cells secreted within the immune system to re-emerge, spreading the virus anew. Administering the mix of drugs right after birth may have stopped the virus from forming hidden reservoirs. If confirmed in further studies, the approach could help cure some of the 300,000 children infected each year with the AIDS virus.
“Some babies here in the U.S. and Western Europe, and an awful lot of babies in the developing world don’t have the opportunity for prevention,” said Hannah Gay, who treated the infant at the University of Mississippi in Jackson. “There would be scores of babies that would benefit if we can find a strategy for intervention that allows us to make this happen in other babies.”
Doctors reported the result at the Conference on Retroviruses and Opportunistic Infections, an annual gathering of more than 4,000 infectious disease researchers.
The development comes at a time when researchers are ramping up efforts to find a cure for AIDS. Drugmakers, including Merck & Co., Johnson & Johnson and Gilead Sciences Inc., are all studying medicines that could completely flush out the virus from infected patients.
Researchers at the meeting said they will continue studying a drug by Merck for a rare type of cancer after it showed early signs of clearing the hidden deposits of HIV, and Gilead announced plans last year to test a cancer drug called Istodax in a small group of HIV patients.
So far, there is only one person on record who has ever been cured of HIV, Timothy Ray Brown — the so-called Berlin Patient. His HIV was wiped out after getting a bone marrow transplant in 2007 for leukemia.
The donor had a rare gene mutation that made the new white blood cells resistant to infection with the AIDS virus. Bone marrow transplants carry severe side effects and can be deadly, ruling them out as a practical solution for curing HIV for the masses. There have been some reports of infants who were cured, though none of the cases are well documented and verified by researchers.
The number of children infected with HIV has tumbled over the past decade after researchers found that giving AIDS treatments to pregnant women could prevent 98 percent of them from passing the virus to their children. In 2011, 330,000 children worldwide were infected with HIV, a 40 percent drop since 2001, according to the United Nations. In the U.S., about 100 children are infected each year, according to the Centers for Disease Control and Prevention.
In the case of the Mississippi baby, the mother didn’t know she was HIV positive during her pregnancy so she hadn’t taken any of the medications that could have prevented her from spreading the virus to the fetus. She first found out she was infected when she showed up at the rural hospital in labor. The infant was unable to immediately receive a preventative drug that can greatly reduce the risk of infection from the mother because the liquid pediatric formulation wasn’t available at that the hospital, said Gay.
The baby was transferred to the University of Mississippi Medical Center in Jackson where she got the first dose of AIDS medication 30 hours after birth. By that time, the baby was already showing signs of the virus in her blood and was diagnosed as being HIV positive by a series of tests. Gay said she believes the child was likely infected while still in the womb because of the high level of virus she had at just a few days old.
For the next 18 months doctors regularly saw the baby and gave her a standard regimen of drugs approved by the Food and Drug Administration for infants. The baby’s viral load started to go down after a week on the drugs and was eventually undetectable.
The mother then stopped bringing the baby in for the regular office visits and doctors lost all contact. By the time the child returned to the doctor, the mother said that it had been five months since she had given her the virus-suppressing medication.
Gay assumed that the virus had resurfaced and began replicating again without the medication to suppress it. She said she was shocked when tests came back showing the baby was HIV negative. She assumed it must be an error and did more tests that continued coming back with no signs of the virus. That’s when she contacted researchers at the University of Massachusetts and Johns Hopkins Children’s Center to conduct a more sensitive analysis. Those researchers also were unable to find any trace of the virus, prompting them to determine the baby had essentially been cured.
Typically, newborns with infected mothers are put on a preventative treatment in the first several hours of birth to try to prevent the virus from taking hold. If that prophylaxis fails, they are then switched to a three-drug treatment regimen. Because the Mississippi baby wasn’t able to get the preventative at the rural hospital where she was born and was already showing signs of the virus at 30 hours of age, she was given the standard three-drug cocktail sooner than other children.
The child, now two-and-a-half years old, is still HIV free.
Persaud said AIDS experts are trying to develop an ethical way to test whether more infants can be cured. The main challenge would be when or whether babies should be taken off medication since there’s a risk of the virus resurfacing and mutating.
A record 34.2 million people worldwide are living with HIV, according to UNAIDS, the United Nation’s division devoted to treating and preventing the disease. It remains a killer disease globally, with about 4,000 deaths a day attributed to it last year alone, the data shows.
Just last week, ViiV announced it had struck a patent dealthat will lead to lower costs for HIV drugs in countries where patients are least able to afford them.
Last month, ViiV also secured fast-track review from the U.S. FDA for a new AIDS drug.
GSK, which operates its U.S. headquarters in RTP, recently said it had no plans to sell ViiV.
[GSKARCHIVE: Check out more than a decade of GSK stories as reported in WRAL Tech Wire.]