A Baby Alleged to Have been “HIV Infected” is “Deemed Cured”–But Where is the Proof?

The New York Times front page article, “In Medical First, Baby With HIV Is Reported Cured, ” in its sub-heading acknowledges,

“Some Skepticism Voiced.”

Furthermore, the Times report states: “doctors announced…that a baby had been cured of an HIV infection for the first time….”
but the report also notes that the claimed “cure” has not been confirmed, published, or even peer reviewed.

Indeed, The Times notes that “Dr. Persaud and other researchers spoke in advance of a presentation of the findings at a Conference on Retroviruses and Opportunistic Infections.”

“If the report is confirmed, the child born in Mississippi would be only the second well-documented case of a cure in the world.”

Well documented?

Unless independently verifiable documented evidence  is presented for confirmation, this story appears to be propaganda.

The announcement is calculated to persuade health policy officials to divert scarce healthcare dollars for expensive AIDS drug cocktails to be forced on newborn babies born to poor, uninformed young women.

The Times quotes Dr. Deborah Persaud of Johns Hopkins stating: “It’s proof of principle that we can cure HIV infection if we can replicate this case.”

Proof in principle is NOT proof of cure!

“Some outside experts, who have not yet heard all the details, said they needed convincing that the baby had truly been infected. If not, this would be a case of prevention, something already done for babies born to infected mothers.”

Dr. Daniel R. Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston is quoted stating:

“The one uncertainty is really definitive evidence that the child was indeed infected.”

The Times reports: “The mother arrived at a rural hospital in the fall of 2010 already in labor and gave birth prematurely. She had not seen a doctor during the pregnancy and did not know she had H.I.V. When a test showed the mother might be infected, the hospital transferred the baby to the University of Mississippi Medical Center, where it arrived at about 30 hours old.”

“Typically a newborn with an infected mother would be given one or two drugs as a prophylactic measure. But Dr. Gay said that based on her experience, she almost immediately used a three-drug regimen aimed at treatment, not prophylaxis, not even waiting for the test results confirming infection. “

“Without test results confirming infection…” It is very troubling that aggressive treatments are being applied to seemingly healthy babies who are merely “suspected” of being HIV-infected–even as the treating doctors believe there is no cure.  How can doctors justify aggressive treatments before they are even certain that a disease is present? Does this not constitute medical malpractice?

“Virus levels rapidly declined with treatment and were undetectable by the time the baby was a month old. That remained the case until the baby was 18 months old, after which the mother stopped coming to the hospital and stopped giving the drugs.When the mother and child returned five months later, Dr. Gay expected to see high viral loads in the baby. But the tests were negative. ”

“Suspecting a laboratory error, she ordered more tests. “To my greater surprise, all of these came back negative,” Dr. Gay said. ”

“There have been scattered cases reported in the past, including one in The New England Journal of Medicine in 1995, of babies clearing the virus, even without treatment. “

The Times report suggests the tenuous reliability of the announced “miracle”  “One hypothesis is that the drugs killed off the virus before it could establish a hidden reservoir in the baby. One reason people cannot be cured now is that the virus hides in a dormant state, out of reach of existing drugs. When drug therapy is stopped, the virus can emerge from hiding.”

“In the United States, transmission from mother to child is rare — several experts said there are only about 200 cases a year or even fewer — because infected mothers are generally treated during their pregnancies. “

“Dr. Bryson, who was not involved in the Mississippi work, said she was certain the baby had been infected and called the finding “one of the most exciting things I’ve heard in a long time.”

Does any of this sound like proven scientific findings???

By Monday afternoon the story was no longer on the Times’ website front page .

The Washington Post
reported: “Even if the report proves true, aggressive HIV treatment starting at birth has no obvious relevance to adults, who are by far the biggest age group infected each year. Even in newborns it may be of little practical use, as nearly all mother-to-child infections can be prevented by a simpler strategy that isn’t yet fully implemented around the world.”

Below the Wall Street Journal reports:

Dr. Gay summoned health-department and child-protection workers, who found [the mother] last August, and she returned to the clinic. The baby had been off therapy for at least five months.”

Before resuming treatment, Dr. Gay ordered a test to make sure the baby’s virus hadn’t developed resistance to any of the drugs. To her astonishment, technicians couldn’t find any virus to test.” “At first, Dr. Gay worried that she had been treating an uninfected baby for more than a year.”

How often, one wonders, have doctors like Dr. Gay, treated uninfected, healthy babies with retroviral drugs?

This statement, coupled with the acknowledgement that there are some reported cases of “babies clearing the virus, even without treatment” raises serious concern about why doctors are only focusing on aggressive prescribing of multiple drugs at ever higher doses.

Since there are very few cases in the US of infants being infected–in 2010 there were 174–the aggressive prescribing practices have most likely lead to subjecting many uninfected babies to very powerful retroviral drugs that have serious adverse side-effects.

As a rule, the practice of “cowboy medicine” has caused serious harm. It’s the reason for the Hippocratic Oath, which admonishes physicians to adhere to the precautionary principle in medicine: “First, Do No Harm.” 

Furthermore, it is of great concern that doctors summon “child protection workers” to coerce individuals to submit their babies to possibly unnecessary aggressive treatment.  Indeed, had the mother of the “cured” baby not disobeyed the docotrs by withdrawing the aggressive drug regimen from her infant, that baby would have been condemned to be on those drugs for life!

This front-page story was likely planted so as to obscure the under-reported findings of a FAILED, SCIENTIFIC study that tested three different retreoviral drugs and vaginal gel in more than 5,000 HIV-negative women in Uganda, South Africa and Zimbabwe.

Medscapre reports: “A large study to determine if pre-exposure prophylaxis could prevent HIV transmission among high-risk women failed to show any significant differences between those who took oral medication or vaginal gel or placebo medications in protection against acquiring infections.”

The goal of the study conducted by researchers at the Univdersity of Washington in Seattle, was to use retroviral drugs to prevent AIDS. The results: 50% to 58% of women assigned to treatment arms did not take the medications. Of the 5,029 women in the study, 312 (5.7%) became infected.

Read more about the African study here

 

Vera Sharav

 

THE WALL STREET JOURNAL

Baby Cured of HIV for the First Time, Researchers Say Success With Aggressive Drug Regimen Could Spur Wider Use of Such Treatment  By Ron Winslow

A Mississippi baby born with the AIDS virus appears to have been cured after being treated with an aggressive regimen of drugs just after her birth 2½ years ago, an unusual case that could trigger changes in care for hundreds of thousands of babies born globally each year with HIV.

The findings, reported Sunday by researchers, mark only the second documented case of a patient being cured of infection with the human immune-deficiency virus. The first, an adult man known as the Berlin patient, was cured as a result of a 2007 bone-marrow transplant.

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Deborah Persaud of Johns Hopkins Children’s Center called it ‘really unheard of’ that after the treatment ended, there was no detectable virus.

The new case was discovered after the baby girl’s mother stopped treatment on her, and doctors realized that the virus was undetectable even without drugs, which HIV patients normally must take for the rest of their lives.

Researchers cautioned that the report on the baby girl involves just one patient, and the findings appear to have little immediate relevance to people who contract HIV as adults or adolescents and are almost always diagnosed and treated long after their initial infection. But if further study confirms that very early treatment can cure HIV-infected newborns, it could spur widespread use of such an aggressive regimen in babies born with HIV, nearly all of them in low- and middle-income countries.

World Health Organization guidelines now call for treating infants born to an HIV-infected mother with a modest daily dose of antiretroviral treatment for four to six weeks—or until testing determines the baby’s own HIV status. If the baby tests positive, a more aggressive treatment is begun.

But WHO doesn’t address use of a more intense medication approach right after birth, in part because few studies have examined the issue. In addition, it is difficult to determine with certainty that early whether a baby is HIV-positive, and overtreatment would risk wasting scarce medications that offer a better chance of helping other patients.

 In this case, researchers believe that a doctor’s decision to start an aggressive antiretroviral treatment within 31 hours of the infant’s birth led to the cure. They theorize that the drugs prevented the formation of so-called viral reservoirs that harbor the virus. These reservoirs have been the key stumbling block to a cure because even though AIDS drugs stop HIV from replicating, the virus lurks in the reservoirs, ready to come surging back when treatment is stopped.

In this case, “the child got therapy and then went off therapy, and now there’s no detectable virus,” said Deborah Persaud, a pediatrician and AIDS researcher at Johns Hopkins Children’s Center in Baltimore and lead author of a study reporting the cure. “That’s really unheard of. If people go off therapy, most of them rebound…within a few She described the findings at a news conference Sunday in advance of their presentation Monday at the annual Conference on Retroviruses and Opportunistic Infections in Atlanta.

“This is a very important proof of concept” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, an arm of the National Institutes of Health. Further research is required “to see if you can generalize this to children who are born into situations where their risk of infection is very high.”

The chance an infected pregnant woman will transmit the virus to her baby during gestation, birth or breast-feeding ranges from 15% to 45%, according to WHO. But treatment with antiretroviral therapy during pregnancy and especially around the time of birth cuts the risk of mother-to-child transmission to below 2%. Still, estimates are that between 300,000 and 400,000 infants are born globally each year with the infection, about 90% of them in resource-poor countries in sub-Saharan Africa.

In the U.S., high compliance with prenatal care and routine HIV testing during pregnancy has all but eliminated HIV-positive newborns. From a peak of 1,650 cases in 1991, the U.S. Centers for Disease Control and Prevention says the number is now down to fewer than 200 a year.

In 2010, the number was 174. One of them, born in a rural Mississippi hospital that fall, is now the first case of a child considered cured of the disease.

The baby was born to a mother who hadn’t had prenatal care and didn’t know her HIV status. A rapid HIV test after the birth revealed that she was infected, prompting doctors to transfer the baby to University of Mississippi Medical Center more than 100 miles away.

There, Hannah Gay, a pediatrician and infectious-disease expert, ordered an HIV test for the infant. She didn’t wait for the result. Figuring this was an especially high-risk case, Dr. Gay started the baby on three standard antiretroviral drugs at higher, treatment-level doses. A few days later, the test came back positive, she said, and she kept the infant on the treatment-level doses.

Over the next few weeks, the baby’s viral levels gradually declined, and by day 29, HIV couldn’t be detected with standard testing. That remained the case for more than a year.

“I saw her once a month; her viral load was undetectable, and her immune system was healthy—what we expect with a baby taking the medicines regularly,” Dr. Gay said.

But at about 18 months, for reasons that aren’t clear, the mother stopped bringing the baby in for the checks. Dr. Gay summoned health-department and child-protection workers, who found her last August, and she returned to the clinic. The baby had been off therapy for at least five months, Dr. Gay said.

Before resuming treatment, Dr. Gay ordered a test to make sure the baby’s virus hadn’t developed resistance to any of the drugs. To her astonishment, technicians couldn’t find any virus to test.

At first, Dr. Gay worried that she had been treating an uninfected baby for more than a year. But a quick check of her records verified that five different tests had detected the virus in the days and weeks following her birth.

When she was convinced last August, she called a longtime friend and colleague, Katherine Luzuriaga, a researcher at University of Massachusetts Medical School. Dr. Luzuriaga had been working with Dr. Persaud on a study of a group of teenagers who had been born with the virus and treated since infancy and who now had no evidence of virus that could replicate. The pair had set up a network of labs to study whether they could consider taking the teenagers off the drugs.

With that lab network, established with a grant from the Foundation for AIDS Research, a New York-based philanthropy, samples from the baby have been subjected to a variety of the most advanced tests to detect and monitor the AIDS virus.

While the tests have detected an occasional “signal” of the virus, the various analyses from several labs using different techniques “confirms to us that this is a case of ‘functional cure,’ meaning that the virus hasn’t rebounded and that…we can’t detect virus activity in this child,” Dr. Persaud said. The work also was supported by the NIH.

Write to Ron Winslow at ron.winslow@wsj.com