Tuesday, August 3, 2010

New York Times Examines Questions Left Unanswered By Microbicide Trial

Via Kaiser Daily Global Health Policy Report

The New York Times examines a set of questions raised by news out of the International AIDS Conference-AIDS 2010 last week that a microbicide gel containing the antiretroviral (ARV) tenofovir used by women before and after sex helped reduce their risk of HIV infection by 39 percent.

"After more than a dozen microbicide failures, [the news of the trial] was a huge relief …," the newspaper writes, before noting researchers' questions regarding the amount of testing needed before the drug could win approval from regulators, the cost of the drug for poor countries and the potential for tenofovir-resistance from using the microbicide gel.

According to the newspaper, "The price of a dose could fall below that of a condom because the applicators are just molded plastic and, without patents restrictions, 'the Chinese could make them for half a penny,' [Principal investigator Salim Abdool Karim, professor of epidemiology at the University of KwaZulu-Natal in South Africa and Columbia University] said." Other questions, such as how to improve drug efficacy, would be dependent on what researchers find in future clinical trials. "A complex multination trial of several methods, including microbicide, is due to end in 2013, but a rapid new one may be designed as quickly as possible. … Globally, more than a million women a year die of AIDS, so speed is important," the newspaper writes.

The article explores still more questions raised by the trial – such as the viability of the microbicide gel offering protection against HIV transmission for gay men – and includes comments by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases; Kevin Fenton, director of the AIDS division of the CDC; Catherine Hankins, chief scientific adviser for UNAIDS; as well as a microbicide researcher and HIV/AIDS advocate (McNeil, 7/26).

For more click here.

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