The Wall Street Journal - Tuesday, February 2, 1999
Michael Waldholz, Staff Reporter of the Wall Street Journal

In a presentation at a major HIV/AIDS science meeting here Monday, researchers reported that a preliminary analysis of a large study in Africa found that administering the two Glaxo Wellcome PLC AIDS drugs, AZT and 3TC, to pregnant women at the time of birth and to both the mother and infant for a week afterward reduced transmission of the virus, HIV, by 37%, compared with women who received a placebo.

The study of more than 1,357 women over the past few years provides persuasive evidence that a potentially simple and inexpensive strategy may be effective in decreasing AIDS among children in countries where the medicines, because of their cost and the difficulty of daily dosing requirements, aren't being widely used. Over the past few years, transmission of HIV to children has been sharply reduced in the U.S. and other wealthier nations by use of a 20-week regimen of AZT.

But that length of treatment is impractical in much of sub-Saharan Africa and other poor nations, where 90% of the world's 34 million HIV-infected people live.

As a result, researchers at UNAIDS, the United Nations-run agency that oversees efforts to fight HIV in the developing world, embarked on the study to determine whether a much simpler, cheaper method that could realistically be used in the poorer nations might also be effective. In an early look at data pulled together in recent days, the research shows that in women and their newborns given the drugs for one week beginning at labor, the virus was transmitted 10.8% of the time. The transmission rate for women given a placebo, or dummy pills, was 17.2%, meaning the drugs' use lowered risk of transmission by 37%.

In a separate, more expensive and arduous arm of the study, an even lower 8.6% of women given the drug four weeks prior to delivery and one week afterward passed on the virus, a reduction of 50% compared with a placebo. "The data, though preliminary, mean we can save a lot of children using several strategies, whichever makes sense for the women, their doctors or the community in which they live," said Joseph Saba, the UNAIDS official managing the study.

Speaking here at the Sixth Conference on Retroviruses and Opportunistic Infections, Dr. Saba said the study was preliminary because the data for an additional 400 women hadn't yet been completed. Moreover, the current study involves children followed for only six weeks after birth. Dr. Saba said the full power of the intervention therapy won't be known until the children are followed for 18 months. That is especially important, because many women in the study breastfeed, and doctors worry that the virus can still be transmitted through breast milk.

UNAIDS has been seeking a simple way to prevent transmission because each year an estimated 600,000 babies world-wide are infected with HIV via their infected mothers. Last year, scientists reported a 50% reduction in transmission rates in a study in Thailand in which non-breastfeeding women received the drugs for four weeks prior to delivery and one week afterward. Also, a new study in the U.S. reported last week found that Caesarean-section surgeries along with use of AZT can decrease the risk even more.

But getting intervention therapy into poor communities will require an investment from developing-world nations and funding agencies in wealthier countries. "The new data should prove to them that the treatment is cost-effective," Dr. Saba said in an interview at the conference. Last year, Glaxo Wellcome said it would reduce the price of AZT by 60% to 75% for use in the developing countries. Dr. Saba said that only a few clinics and hospitals are currently using the drugs but that he hoped the new study would promote wider acceptance by doctors and health agencies in the developing countries.

Peter Young, director of HIV therapeutics at Glaxo Wellcome, said his company will negotiate sharply discounted prices "with any country that's seriously committed to building a program around these intervention strategies." Mr. Young said Glaxo will price the one-week therapy of the two drugs at "less than $50," noting that the prices will vary depending on negotiations the company conducts within each country.

The study is expected to generate some controversy because, in giving some mothers a placebo, researchers denied them access to the drugs. Some critics say this is unethical, but the researchers argued that use of the placebo produced a powerful statistical difference that was more persuasive and quicker to develop than if a placebo hadn't been used.

Pius Okong, a physician at St. Francis Hospital in Kampala, Uganda, one of the sites of the study, defended the use of the placebo, noting that the study found that the transmission rate for untreated women was lower than the 25%-to-35% transmission rate researchers had believed was taking place. In addition, he said, since 99% of women in sub-Saharan Africa don't have access to any medicines, "it was appropriate to compare drug use to placebo, which is the standard of care for most women right now."

UNAIDS had hoped that adding 3TC to AZT might increase the drugs' protective powers, but the new research so far suggests that AZT alone may be just as good, Dr. Saba said.

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