This article is in today's (2/2/99) issue of the Washington Post.  I think
it might be of interest to Lactnetter's, especially the last two sentences.

Kathy

http://www.washingtonpost.com/wp-srv/WPlate/1999-02/02/152l-020299-idx.html

Short Treatment Reduces Possibility Of Mother-Child HIV Transmission
By David Brown
Washington Post Staff Writer
Tuesday, February 2, 1999; Page A06

CHICAGO, Feb. 1—A controversial medical experiment in Africa has found that
two antiviral drugs reduce mother-to-child transmission of the AIDS virus by
more than one-third when they are given for only a week, which is just a
fraction of the duration customarily prescribed in wealthy countries.

The study raises the possibility that for even the poorest nations, a
practical method of cutting "perinatal" transmission of the virus is within
reach. According to some estimates, as many as 600,000 babies are infected
each year worldwide, either during delivery or from breast feeding
afterward. Most of those infections occur in Africa.

With a five-week course of the drugs, AZT and 3TC, the reduction was even
more dramatic, about 50 percent. Which prevention strategy will be used
where depends on cost-effectiveness calculations and the size of drug
discounts various governments will be able to negotiate, said Joseph Saba,
an official of the international organization UNAIDS, which ran the study.

"Whatever the local context is will determine what is the right treatment,"
he said.

The results of the PETRA (for perinatal transmission) trial were reported at
the Sixth Conference on Retroviruses and Opportunistic Infections, being
held here through Thursday.

The experiment, run at two sites in Uganda, two in South Africa, and one in
Tanzania, was strongly criticized two years ago because it included a
"placebo arm," in which some women were randomly assigned to take inactive
pills. A study done in the United States and reported in 1994 showed
conclusively that AZT given for the last trimester of pregnancy, and to the
baby for six weeks after birth, cut the transmission rate by about
two-thirds.

Critics faulted the African research, which began recruiting patients in
July 1996, on two grounds.

The first was that it would be unethical to give some women only placebos
because such a study would not be permitted in the United States and other
industrialized nations in light of the 1994 findings.

The second was that close analysis of the 1994 study showed that most of the
protective effect occurred at the time of delivery, and consequently the
question of whether the 20-week course of AZT could be shortened already had
been answered. At most, these critics said, the researchers doing the
African study should test strategies that all "covered" infected women
during delivery.

The study's defenders said that because no preventive treatment was the
"standard of care" in the African nations, it was ethical to compare an
alternative to it. As practical matter, they further argued, only a
placebo-controlled study would convince the agencies that would be asked to
donate either drugs or money to implement a continent-wide treatment
campaign, should one be found to work.

In the African experiment, women were divided into four groups. One took AZT
and 3TC (which is also called lamivudine) starting four weeks before
expected labor, and continuing through a week after delivery. That group had
a transmission rate of 8.6 percent. The second group took the drugs only
during labor and delivery and for a week thereafter. Its transmission rate
was 10.8 percent. The third group took the drugs only during labor and
delivery, and had a transmission rate of 17.7 percent. The fourth group took
placebos during all three treatment phases, and had a transmission rate of
17.2 percent.

Saba defended the use of an all-placebo arm, saying that without it "we
would have been completely misled as to the size of the efficacy [of
different treatments]." He said that he had a "peaceful mind that we made
the right choice."

His fiercest critic, Sidney M. Wolfe of the Public Citizen Health Research
Group, which does research and lobbying, said the PETRA results support his
view the research was unethical.

"Both of these two arms [that is, the ones with the 8.6 and 10.8
transmission rates] were so radically different from previous untreated
arms, that nobody would have possibly concluded they weren't effective," he
said.

Transmission in the women taking placebos in the 1994 American study was
25.5 percent, and the rate among African women was assumed to be even
higher.

There were two surprising results from the PETRA study.

The first was the unexpectedly low rate of transmission in the African
women.

The second was that antiviral treatment after delivery appeared to confer a
major benefit. In fact, the women who got the drugs only during labor and
delivery, but not afterward, got no benefit at all.

Breast feeding increases a baby's risk of acquiring HIV from an infected
mother by up to three-fold, depending on when the child is weaned.

A major moment of risk may occur in the first few days, when the child can
take in more than 25,000 HIV-containing cells in the thick fluid known as
colostrum.


© Copyright 1999 The Washington Post Company


~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Kathy Koch,
BSEd, IBCLC
Great Mills, MD
mailto:[log in to unmask]
"Parents are often so busy with the physical rearing of children that they
miss the glory of parenthood, just as the grandeur of the trees is lost when
raking leaves. ~Marcelene Cox ~