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Was An Infant Cured Of HIV?
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"The last time doctors achieved such a 'cure' was three years ago in a person called the 'Berlin patient' who had both an acute form of Leukemia and HIV. Doctors at a Berlin hospital used a radical bone marrow transplantation to cure him of both the cancer and HIV......The 'Berlin patient' reportedly continued to be HIV-free, and two more patients in Boston, who underwent similar bone-marrow therapy, appeared to have been cured of the virus, according to presentations at the 19th International AIDS Congress in Washington DC last year......What the scientists wouldn't however claim was the absolute certainty of a cure. Whether it is the Berlin patient or the Boston patients, all that they would say was that they had been 'functionally cured' and the virus is invisible."
"Now, an apparent elimination of the virus from a two-and-a-half year old child from Mississippi in the US, born to a mother who is HIV-positive, has raised hopes yet again.....The instinctive paediatrician, who was in charge of the baby, therefore, felt that the infant was at higher risk of infection and hence started on a high dose of conventional anti-retroviral (ARV) medicines within 30 hours of birth......child was at higher risk of infection because the mother never took AIDS-drugs......The Johns Hopkins doctor's clinical gamble seems to have worked. The child has been followed up and subjected to tests that look for the presence of the virus, not just in the blood, but elsewhere in the body where it could hide. Even after two and a half years, the child seemed be free from the virus......was justifiably guarded on the Mississippi child too. "You could call this about as close to a cure, if not a cure, that we've seen," he said."
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Was An Infant Cured Of HIV?
CROI, March 3 2013 Forbes
There's amazing news coming out of the annual Conference on Retroviruses and Opportunistic Infections in Atlanta.
Writes Ron Winslow in the Wall Street Journal:
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 2 1/2 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.
via Baby With AIDS Virus Cured After Early Treatment - WSJ.com.
There's already lots of evidence that treating infants born to HIV-infected mothers with anti-retroviral drugs, a practice known as pre-exposure prophylaxis, or PrEP, can prevent the children from becoming infected with the virus. Gilead's Truvada, a combination of two HIV drugs, was approved for this purpose in July 2012.
But this is something different. According to press accounts, this baby had five positive tests for HIV in its first month of life. But then, in an unusual move, a doctor used not just Truvada but a triple drug regimen (probably the Bristol-Gilead pill Atripla, though its not clear from what's been written) aimed at treating infection.
According to Andrew Pollack and Donald McNeil in the New York Times:
Dr. Hannah B. Gay, an associate professor of pediatrics, ordered two blood draws an hour apart to test for the presence of H.I.V. RNA and DNA.
The tests found a level of virus at about 20,000 copies per milliliter, fairly low for a baby. But since tests so early in life were positive, it suggests the infection occurred in the womb rather than during delivery, Dr. Gay said.
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 own experience, she almost immediately used a three-drug regimen aimed at treatment, not prophylaxis, not even waiting for the test results confirming infection.
via For First Time, Baby Is Cured of H.I.V., Doctors Say - NYTimes.com.
As Pollack and McNeil note, one big question is whether infection actually happened. The researchers who presented this case study say there is clear proof the infant was infected and that the infection is functionally gone.
Another big question - if the claims that this will affect hundreds of thousands of babies - is what doctors will do with this information. Treating earlier with more effective therapy in the hopes of curing some patients certainly seems likely. But one case of cure doesn't tell us how often a child treated this way will be cured. It could be this is common if the right treatment is given, and we just didn't know. It could be that only some babies will clear the virus. How will doctors think about stopping HIV drugs in this children?
Still, the fact that a cure can happen is a big change in how doctors think about AIDS. The disease, once a death sentence, now something that can be controlled, might someday be something that can be cured in at least some patients. And that is truly an astounding thing to think.
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Baby Cured of HIV for the First Time, Researchers Say
Success With Aggressive Drug Regimen Could Spur Wider Use of Such Treatment
March 3 Wall St Jnl 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 2 1/2 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.
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 weeks."
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.
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AIDS-cure: How Johns Hopkins' clinical gamble seems to have worked
firstpost.com by G Pramod Kumar Mar 4, 2013
The last time doctors achieved such a 'cure' was three years ago in a person called the 'Berlin patient' who had both an acute form of Leukemia and HIV. Doctors at a Berlin hospital used a radical bone marrow transplantation to cure him of both the cancer and HIV.
In the case of the Mississippi child, the treatment at Johns Hopkins' Children's Centre in Baltimore, was not that radical. The child's mother was HIV-positive, but hadn't been diagnosed until she went in for labour. Since she was undiagnosed, she also had never taken any AIDS-medication. The instinctive paediatrician, who was in charge of the baby, therefore, felt that the infant was at higher risk of infection and hence started on a high dose of conventional anti-retroviral (ARV) medicines within 30 hours of birth.
By doing so, she had departed from the standard protocol of treatment for the reduction of mother-to-child transmission of the AIDS-causing virus. The standard protocol stipulates that the child born to an HIV-positive mother to be put on one of the two prescribed drugs from childbirth up to six weeks. Instead, the doctor put the child on a regular three-drug cocktail that HIV-positive people take to stay alive.
It was just her scientific instinct that seemed to have worked, because she realised that the child was at higher risk of infection because the mother never took AIDS-drugs. Had the mother been on appropriate AIDS-medication, the quantity of the AIDS-causing virus in her blood could have been negligible, which in turn would have reduced the probability of the child getting infected.
The logic behind the intervention to reduce mother-to-child HIV-transmission is to bring down the mother's viral load to undetectable levels during pregnancy, reduce the possibility of exposure of the child to the virus during delivery, and early treatment of the child to knock out the virus, if present, from its body.
The Johns Hopkins doctor's clinical gamble seems to have worked. The child has been followed up and subjected to tests that look for the presence of the virus, not just in the blood, but elsewhere in the body where it could hide. Even after two and a half years, the child seemed be free from the virus.
Now comes the reality check.
Is it just a blip or the real magic bullet?
The 'Berlin patient' reportedly continued to be HIV-free, and two more patients in Boston, who underwent similar bone-marrow therapy, appeared to have been cured of the virus, according to presentations at the 19th International AIDS Congress in Washington DC last year.
While the "Berlin patient's" success was attributed to the new bone-marrow, which contained a factor that was resistant to the virus, the marrows that the Boston patients received were normal. These cases have led to extensive scientific analysis that opened up the possibilities of normal bone-marrow transplant combined with careful ARV treatment working as a cure.
What the scientists wouldn't however claim was the absolute certainty of a cure. Whether it is the Berlin patient or the Boston patients, all that they would say was that they had been 'functionally cured' and the virus is invisible.
Will the treacherous virus bounce back from some hidden trenches? They wouldn't completely rule it out. Even in cutting-edge modern medicine, nothing is absolute and all that one can claim is the highest level of probability.
This is not the first time that the possibility of an AIDS-cure raised unprecedented hopes. When a combination of anti-retroviral drugs (HAART - highly active ARV therapy) had sensationally led to the virus disappearing to undetectable levels in infected people's blood-streams in the 1990s, the medical world was gripped by the same excitement. However, the virus was hiding in the body's reservoirs and bounced back.
Dr Antony Fauci of the National Institutes of Health (NIH), one of the greatest contemporary medical scientists and the man who has done pioneering work on these reservoirs and how they posed challenges to a cure when HAART seemed to have been a miracle, was justifiably guarded on the Mississippi child too. "You could call this about as close to a cure, if not a cure, that we've seen," he said.
However, he sounded more optimistic than ever before. In a 2012 interview, he was certainly more guarded. "A cure is still in the very, very formative stages of discovery because we're not even sure if it's possible and, if so, how we might go about doing that because of the very special characteristics of this virus."
The doctors at Johns Hopkins use the same term for the treatment of the child, that was used for the Berlin and Boston patients - that the infant has been 'functionally cured'. If HIV-reservoirs continue to be undetectable or absent in the baby, it will certainly be a cure or close to a cure, as Dr Fauci termed it.
Even if it doesn't turn out to be an absolute cure in the long run, it certainly offers possibilities for pursuing newer methods of AIDS-treatment, both in infants and adults. That the radical application of the drugs seemed to have worked on the immune system of the child, before it was overridden by the virus, shows promise on further reducing mother-to-child transmission. In the case of adults, it opens up new avenues for tinkering with immune responses.
Compared to the first decade of the epidemic, when it meant a miserable and stigmatised death, AIDS today is a chronic, manageable medical condition. People affected with the virus do not like to be called patients, just as they way people with chronic conditions such as diabetes and hypertension detest the term. They also live long, normal and productive lives.
From a handful of drugs with severe side-effects a few times a day to stave off death in the early years, HIV-positive people today need to take just one pill, once a day. A large number of long term survivors of HIV now die of old age and other illnesses than HIV-related complications. The Mississippi child might bring in better news for them.
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