Groups working on a gel to protect women from the AIDS virus say they are moving ahead to develop the product that was hailed as "groundbreaking" after a study on its effectiveness was released in July.
The developers, who met last week with the U.S. Food and Drug Administration, said the FDA informed them it would only require a limited amount of new information about the gel's safety and efficacy before considering licensing it.
The gel, containing Gilead Sciences AIDS drug tenofovir, reduced HIV infections in women by 39 percent over 21/2 years in a trial in South Africa that was called "groundbreaking" by the World Health Organization.
The FDA requires more information on whether the gel works and is safe, but will help speed up the process, said Dr. Henry Gabelnick, executive director of Conrad, one of the groups developing the gel.
"They gave it what is called fast-track designation," Gabelnick said. "That means you can report data on a rolling submission — you don't have to wait and put everything together. Then they have six months to review the data."
The need for such a gel is compelling — most infections with the AIDS virus are in Africa, and most new cases are among women infected during sex with men. The human immunodeficiency virus that causes AIDS infects 33 million people globally and has killed 25 million.
There is no vaccine and no cure.
Condoms can protect women and men, but many African men refuse to use them, and often a married woman is trying to conceive a child but risks being infected by her husband.
A gel, cream or drug-releasing ring called a microbicide could help protect against HIV while allowing a woman to get pregnant, and, if necessary, she could use the product without her partner knowing.
A second trial
Conrad, a division of the Eastern Virginia Medical School in Norfolk, Va., was a partner with the Centre for Programme Research for AIDS in South Africa and U.S.-based Family Health International on the study.
Gilead has licensed tenofovir for use in the gel, and researchers were stunned by the findings of the study, presented to an AIDS conference in Vienna in July.
"We still have to get a final report from the (first) study," Gabelnick said. But in the meantime, a second study is under way to determine the safety and efficacy of the gel. "We are trying to do things simultaneously to the extent that it could be done."
The FDA will want to see results from a second study, called VOICE, due in 2013 or 2014, before considering approval of the gel. And it is possible, Gabelnick said, that South African authorities will want their own approval. The FDA has also asked for data on how the gel works in adolescents and women past menopause. Separately, the University of Pittsburgh School of Medicine is testing the tenofovir gel in men who have sex with other men, who may be infected rectally.
By the numbers
people were living with HIV worldwide in 2008.
people were living with HIV in low- and middle-
income countries in 2008.
of all people living with HIV are in sub-Saharan Africa.
children were living with HIV worldwide at the end of 2008. Of those children, 1.8 million live in sub-Saharan Africa.
Source: World Health OrganizationCopyright © 2015, Los Angeles Times