Groups developing 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 the product.
The gel, containing Gilead Sciences AIDS drug tenofovir, reduced HIV infections in women by 39 percent over two and a half years in a trial in South Africa that was called “groundbreaking by the World Health Organisation.
The FDA would require 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 in a telephone interview. “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 letting her partner know.
CONRAD, a division of the Eastern Virginia Medical School in Norfolk, was a partner with the Centre for Programme Research for AIDS in South Africa (CAPRISA) 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 CAPRISA study,” Gabelnick said. But in the meantime, a second study, called VOICE, is under way.
“We are trying to do things simultaneously to the extent that it could be done,” Gabelnick said.
“We are working with partners in South Africa to establish an eventual manufacturing site and distribution network.”
VOICE, which stands for Vaginal and Oral Interventions to Control the Epidemic, is being run by the Microbicide Trials Network with U.S. government funding and aims to confirm the safety and efficacy of the gel.
The FDA will want to see results from VOICE, due in 2013 or 2014, before considering approval of the gel.
It is possible, Gabelnick said, that South African authorities will want their own approval but Gabelnick said CONRAD was working with a South African company - he would not say which one - to lay the groundwork for making the gel as part of a public-private partnership.
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 Maggie Fox