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Friday, July 11, 2014

Expert QA: NIH’s Anthony Fauci on “Mississippi Baby”

viral load

News reports in 2013 touted that a baby infected with HIV given a potent cocktail of anti-HIV drugs 30 hours after birth had been “functionally cured” of the infection.

But after 27 months during which HIV was undetectable in the child’s blood, the virus was discovered during a routine checkup this month, the National Institute of Allergy and Infectious Diseases (NIAID) announced Thursday.

Relatively few U.S. babies are born with HIV, because infected pregnant women are usually treated with antiretroviral drugs to prevent transmission. But this child’s mother received no prenatal care or antiretroviral drugs when she delivered in July 2010 in Mississippi. Because of the great likelihood that the baby was infected, doctors decided to start the child on three antiretroviral drugs less than 2 days after birth. By the baby’s 29th day of life, HIV was nearly undetectable in the child’s blood.

Writer Rita Rubin talked to HIV/AIDS expert Anthony Fauci, MD, executive director of the NIAID, about what this new development with the un-named “Mississippi baby” means for future research:

Q. Would you call the reappearance of HIV in this child a scientific setback?

A. “It’s clearly disappointing for the patient, the patient’s family, and the researchers,” Fauci says. “People ask me, ‘Is this a major setback?’ I certainly don’t think it’s an advance, but I don’t think it’s a setback.”

“Some very important things did happen,” Fauci continues. Going 27 months with no detectable virus or HIV antibodies was an “important accomplishment” that raised many questions, he says. “What was it that was suppressing the virus if there was no detectable immune response during those 27 months?”

Q. Back in 2013, you talked about how this child could provide “a promising lead for additional research toward curing other children.” Does this relapse suggest you were wrong?

A. “I generally tend to be reserved and academically conservative,” Fauci says. “The whole arena of ‘cure’ is still in the very early discovery phase. We know in science that when you’re in the discovery phase, you lose more than you win. You get it wrong more than you get it right.”

Q. This child is infected with the same HIV strain as the mother, so it’s the same infection the child was born with. Where was it during the 27 months it was undetectable?

A. “This tells us in a very cold and sobering way that our assays (to track HIV in infected individuals) … are woefully inadequate. Clearly, it was there, because it rebounded. It took 27 months to rebound.”

Q. Would this child have been better off or worse off if the antiretroviral therapy had continued uninterrupted since birth?

A. Fauci emphasizes that the child went off therapy because the mother stopped bringing her baby in for care, not because doctors decided to stop the drugs. But “taking medicines from the time you’re born throughout life has consequences,” he says. That’s why even a temporary hiatus from therapy in infected children without detectable virus would be desirable, Fauci says. According to the NIAID, the child is back on retroviral therapy, which has decreased HIV levels without any side effects.

Q. What does this mean for the planned trial designed to see whether children born infected with HIV could eventually stop treatment?

A. No babies have yet been enrolled in the study, which is supposed to be done at multiple sites in the United States and in Africa, Fauci says. “It was getting set to be launched.”

Now, he says, “we have to look at the ethical considerations.” HIV-positive mothers with eligible babies — namely, those who did not receive antiretroviral therapy while pregnant — must fully understand that the premise of the trial is the possibility of a prolonged remission, not a cure, Fauci says. If researchers don’t make that point perfectly clear, he says, women might enroll their children because they mistakenly think, “Wow, that baby was cured. I’m going to get my baby cured.”

Another aspect of the trial that needs to be reconsidered is “how long do you want the person on therapy before you stop it?” Fauci says. Clearly, children in the trial will have to be monitored much more closely than originally thought, he says, not just every few months or so. Hannah Gay, MD, the University of Mississippi Medical Center pediatric HIV specialist who has been involved in the child’s care since birth, detected the reappearance of HIV “as soon as the virus blipped up,” Fauci says.

Posted by: WebMD Blogs at 2:38 pm

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