Gilead's anti-HIV drug shows promise in study

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Aug. 15, 2006

Researchers offered hopeful news Tuesday from the first of several studies measuring whether drugs made by Gilead Sciences of Foster City can prevent people from getting the AIDS virus.

It remains unclear whether the drugs can block the virus. But Viread, one of the Gilead drugs used in the studies, caused no troubling side effects among 859 sexually active African women tested from June 2004 to March 2006, according to Family Health International officials, who unveiled the data at a Toronto AIDS conference.

Just two of the women who took Viread contracted HIV, the study found. But of the women who did not take the drug, only six became infected over the period -- too few to determine whether Viread made the difference.

``It's not at all a statistical difference,'' said Leigh Peterson, who oversaw the study conducted in Ghana, Cameroon and Nigeria. ``It could have happened by chance.''

Peterson said researchers had expected that up to 30 of the women might become infected, since they were chosen for the study because of their risky sexual behavior. But she noted that Family Health International counseled them on condom use and other safe-sex practices during the study, which may have lessened their likelihood of getting HIV even without taking the drug.

Even though the study was inconclusive about Viread's preventive attributes, Howard Jaffe, Gilead's senior medical adviser, called the data ``a tantalizing bit of information.''

The studies involving Viread are part of an unprecedented international effort to examine whether drugs marketed to treat HIV also can shield people from infection.

If such drugs do successfully block the virus, they still would not be the vaccine many have labored for years to create. A vaccine would trigger the immune system to attack the virus after perhaps a single inoculation. Viread is a daily pill that prevents the virus from duplicating by blocking an enzyme called reverse transcriptase.

Nonetheless, if Viread can shield people from the disease, it might offer a tremendous health benefit. Worldwide, about 11,000 people become infected with HIV each day.

Health officials hope some of the other studies under way or planned in countries hard hit by AIDS will provide more definitive data on the ability of Gilead's drugs to prevent infection.

The U.S. Centers for Disease Control and Prevention is testing Viread among needle drug users in Thailand, and sexually active gay men in San Francisco and Atlanta. The agency also is testing another Gilead drug, Truvada, with men and women in Botswana. And the National Institutes of Health plans to begin a Truvada test among Peruvian gay men this year.

Researchers are intrigued with Truvada -- which combines Viread with Emtriva, also made by Gilead -- because a recent CDC study showed it prevented six macaque monkeys from getting the AIDS virus.

Dr. Lynn Paxton, who oversees the CDC's preventive AIDS-virus studies, said the 1,600 subjects to be evaluated in Thailand should generate useful information about Viread's effectiveness by late next year or 2008.

In the meantime, she added, it's nice to know from the Family Health International study that Viread, which was already approved for use by HIV-infected people, doesn't sicken people who don't have the virus.

``We were absolutely encouraged that they gave it to so many people and determined it was safe,'' Paxton said.



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