The Body Covers: The 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention
An Interview With Annette Sohn, M.D.
July 25, 2007
Only 15% of pediatric HIV treatment need around the world is being met. This is about half of overall global treatment coverage. The greatest disparity is in sub-Saharan Africa, where children represent 14% of those who need ART [antiretroviral therapy], but are only 6% of those who receive it. From multi-center studies in Africa, we know that children under treatment there are older, sicker and more likely to die than their adult counterparts. This is largely because we are not identifying more HIV-positive women during pregnancy and we lack the ability to diagnose their infants. So we don't know that they're infected until they're already very sick. By that time, it often is too late to prevent opportunistic infections and maximize the treatment benefits of antiretroviral therapy.
Research presented at this and other recent conferences have increasingly proven that we are waiting too long to treat HIV-positive children in resource limited settings. When we have the capacity to treat children, we are still splitting adult-size tablets into child-size pieces. Although this has been effective, it is not optimal. Children need a wider variety of potent and well tolerated first- and second-line antiretroviral formulations. They must be affordable for national programs to procure. We have limited data on antiretroviral resistance among children in resource limited settings, but what we are seeing is concerning. If we want children to have the chance at a lifetime of treatment, pediatric providers need better access to laboratory monitoring tests, including viral load, in order to effectively manage children. Parallel to these clinical efforts, we should recognize the impact that poverty, death, orphanhood, stigma and violence have on a family's ability to care for their children. Providing social support for a child's family is as much a priority as the clinical interventions we offer.
Finally, I would like to emphasis the importance of pediatric HIV research. Our prevention of mother-to-child transmission programs and pediatric antiretroviral therapy strategies have all been based on the results of studies and clinical trials. Research funding to develop the capacity of local investigators and build research infrastructures is urgently needed to help us provide the best possible care and treatment to children with HIV.
How do the HIV epidemics differ between the developing world and the developed world?
I think the first thing to remember and to respect is that the scale of HIV is very different between a developing country context and the country where I was trained, in the United States. We're dealing with millions and millions of people in sub-Saharan Africa, in Asia and around the world, where maybe even 20% or more of [a country's] entire population might have HIV. That's a very, very different public health emergency than it is in the United States, for example.
What is the biggest challenge for HIV-positive children in the developing world?
I think for children, the biggest challenge is preventing mother-to-child transmission, which was not the focus of my presentation today, but really is the cornerstone for reducing the number of children with HIV in the world. So we need to identify the moms who have HIV and then be able to offer them interventions to prevent transmission of HIV to their children.
Often to move someone on an issue, we talk about the impact it has on children. It's amazing: Here in the world of HIV, so many years have passed and no one has done anything about the children. Why do you think that is?
I think that people have been trying to do things about the children for many years. People who have been working in pediatric HIV their whole lives might take issue with that statement. There are many people who have been trying to advocate for children, but like with so many advances, they usually occur first in the adults, and then in children secondarily.
In the United States we have this rule through the U.S. Food and Drug Administration [FDA] -- it was called the pediatric rule -- where pharmaceutical companies that were developing drugs for adults needed to show that that there was due diligence to conduct research related to children. I don't think we have quite that same focus for antiretrovirals. As a global community, we want so much to be able to see new antiretrovirals, and I certainly would agree with that. I think that we don't need to have the very fancy new antiretrovirals today. What we need are the basic, simple, first-line antiretrovirals, just dosed more appropriately for children, and packaged more appropriately for children. That is what has been taking so long.
Whose fault is this?
I don't know if it's any one person's fault or not. I think that, if you just look at the numbers and the market forces: How many millions of adults need antiretroviral treatment and how many millions of children need it? Actually, according to WHO [World Health Organization], about 780,000 children need treatment around the world. That number, although incredibly large and staggering to us, is still just part of what the overall treatment need is around the world. So the focus has been on adults. Again, I'm not saying that's wrong, I'm just saying there need to be parallel efforts to provide better support for children's issues.
How many pediatric formulations are there in the developing world?
As far as fixed-dose combinations of three drugs, for example, there are none that have been pre-qualified by the World Health Organization or tentatively approved by the U.S. FDA. There are currently four under review at the WHO. The FDA is not able to share that information; it's considered confidential until the time of the approval. So I don't know how many are under review there. But there are other pediatric fixed-dose combinations that are being used today. [The William J.] Clinton Foundation procures a drug for their programs in India, and that drug has not been pre-qualified yet. I don't know if that's under review, because again, WHO can't release that information. There are a few different combinations around the world, but until they're pre-qualified, until they're tentatively approved by the U.S. FDA, donors may be limited in their ability to procure them for their programs.
Which developing world country do you think is doing the best in terms of helping children? Is there anyone that stands out?
It's really hard, for me certainly, [to answer that question]. I don't think I could give you a particular country. I do recognize that there are efforts to support children in every country. You had said earlier that people want to provide support for children, and that is true. The people in these countries where children are dying, they love their children. They want to protect their children. Children may be a motivating factor for an adult to adhere to therapy. They're doing it not for themselves, but for their families. I think the way to ask the question is: Do we all care about the children? The answer to that is yes. Whether or not we're all capable within our individual countries to have the infrastructure to deliver care to them depends on so many different factors.
Thank you very much.
Also included in this podcast is a question that Craig McClure, the International AIDS Society executive director, asked Dr. Sohn at a press conference.
Craig McClure: Dr. Sohn, you outlined so eloquently -- and it's been a buzz at this conference and in the last couple of years, at [the XVI International AIDS Conference in] Toronto as well -- the catastrophe, the shocking failure of us as a global community in delivering treatment and care to children. You mentioned that while there are many fixed-dose, simple combinations of drugs -- both brand name and generic -- available now for adults, that there are shockingly few for children. Can you comment a little bit more on that, and what do you think is currently being done to address that problem and what needs to be done?
Actually, [a representative] of the WHO came up to me after the presentation and said that they are about to release a report, sometime in the next month, I believe, that is based on the abstract that was presented at this conference talking about different formulations -- fixed-dose combinations of two drugs, for example, and lower dosages of certain antiretrovirals. By presenting this report, saying that these are the optimal doses, they've actually been in contact with pharmaceutical manufactures in order to encourage them to develop drugs of that concentration or that fixed dose. So he's quite hopeful that by releasing this report, more manufacturers will follow suit.
Some of you may know that Abbott Laboratories announced just a few days ago that they're submitting for marketing approval a lower dose of their drug Kaletra, the lopinavir/ritonavir combination. Because Kaletra cannot be crushed -- it needs to be swallowed whole -- small children cannot swallow the adult size of Kaletra. So by producing a half-size dose, small children will find that easier to swallow. It's also heat stable, so it doesn't need to be refrigerated. That's the kind of drug that we need generic manufacturers to develop because, although as you have also heard at this conference, there are pricing issues with how Abbott markets their product globally. So we need more of the generic versions of the appropriate dose drugs. Hopefully we will start to see that in the coming years.
Click here to view the slides from Dr. Sohn's presentation.
Click here to watch a Webcast of the press conference.
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