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Drug Donation Reduces Mother-Child HIV Transmission - 2003-08-13

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Every year, nearly 1 million children are born HIV positive. Most will die of an AIDS-related illness long before they reach adolescence. But hope is growing that a new approach to preventing mother-to-child transmission of HIV could give more than 40 percent of these babies a healthy start in life. A unique drug donation program is making that new approach possible.

At the Parenting Place in Boulder, Colorado, mothers bring toddlers and babies to a playground that's just right for them. The carefree moment makes it easy to imagine a happy tomorrow for these children.

But among children who are born HIV positive, few get the chance to be a grownup. Without medical intervention, 30 percent of HIV positive women pass the virus to their children. This year, more than 800,000 babies will be infected by their mothers. In developing nations, most of these children will die before their sixth birthday.

The continent hardest hit is Africa, as some moms at the Parenting Place know. "Africa has always been sort of the neglected child from the whole world, and I just don't think it's right that people die of HIV, and there are drugs available but just not affordable or available for most of the people," says one mother.

In more prosperous nations, when a pregnant woman is HIV positive, modern medicines and high-tech equipment are used throughout the pregnancy to protect her unborn child. According to Lynne Mofenson, Chief of the Pediatric, Adolescent and Maternal AIDS Branch at the National Institutes of Health, these efforts reduce transmission by 70 percent.

But she says that regimen is unaffordable in developing nations, including those in Africa. "It was very long. It was very expensive, and it was given in a way during labor that was really not feasible to do in many places in Africa, due to the fact that it required an intravenous transfusion," she says.

Dr. Mofenson says the push to develop a more affordable regimen began in the 1990s, after scientists realized that the placenta protects most unborn children from HIV. Infection only becomes likely if the placenta is damaged, or after it breaks naturally, during labor.

So researchers focused on the more cost-effective method of preventing HIV transmission right before birth, rather than throughout a pregnancy. This led them to the drug Nevirapine. Given in a single dose during labor, it significantly reduces the risk of a baby becoming HIV positive.

To help in this effort, the German drug company Boehringer-Ingelheim is providing its trade-named version of the drug, Viramune, at no cost to mother-to-child HIV prevention programs in developing nations.

A spokesperson for the company says that it may be the first, and only full donation of an anti-retroviral drug for HIV-AIDS prevention.

"If you're a manufacturer of these drugs, there is a certain responsibility that's brought along with these drugs," says Larry Phillips, who directs Boehringer-Ingelheim's HIV drug franchise programs. He says his company began the Viramune donations three years ago, and also provides support services, such as program outreach and quality control. "We have 44 countries that are now participating, and there are 84 programs that are actively distributing the drugs."

This year, he says the company is donating enough doses of its medication to treat 166,000 mother-child pairs, and Boehringer-Ingelheim is expanding the outreach further with each passing month. Through the program, an HIV positive mother is given a single dose of Viramune during labor and her baby gets one dose within 48 hours of birth.

Lynne Mofenson of the National Institutes of Health says even in remote locations, this procedure is affordable and effective. "It is a very potent antiretroviral drug. It decreases viral load much more rapidly and greater than [the drug] Zidovadene, and it has a very long half life, particularly in pregnancy. That means the drug hangs around in circulation in the mother and the baby, so that the baby has active levels in its bloodstream for at least the first week of life," she says.

As the Viramune Donation Program becomes better known, Dr. Mofenson predicts that it will reduce annual deaths caused by mother-child HIV transmission from 800,000 to 300,000.

The drug's long half-life even protects many babies during the early period of breastfeeding. This is important because experts estimate that when HIV-positive mothers breastfeed babies who are HIV-negative, 10 to 20 percent of those infants become infected.

Infant formula is a solution for some, but in areas without clean drinking water, Dr. Mofenson says there may still be reasons to breastfeed. "The highest cause of infant mortality is diarrheal and respiratory tract infections that are reduced in breast fed infants. Additionally, if there's not enough food or if you can't afford the formula or if people are diluting down the formula, what you get is a baby that dies of malnutrition," she says. "I don't think there is right now a right or wrong answer in Africa."

She says that researchers are looking at the benefits of giving babies a drug such as Viramune once a day for the first six months while they're breastfeeding, then having an early weaning.

Back at Boulder's Parenting Center, mothers say that they'd like more help for HIV positive mothers and children across the globe. "Because look at them. How cute they are. And I think, no matter where a child grows up, they should have a good life, and they need the chance for a good life," says one of the moms. "And I mean, if you're born HIV positive, your chances are just very slim."

To improve those chances, Larry Phillips of Boehringer-Ingelheim says more pharmaceutical companies must work in partnership with relief agencies confronting the HIV/AIDS pandemic, and local governments must pledge their unwavering commitment to support these programs.

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