Gilead’s pill shows promise in HIV prevention
pharmafile | November 25, 2010 | News story | Research and Development, Sales and Marketing | AIDS, Bill and Melinda Gates Foundation, Gilead, HIV, UN, UNAIDS, emtricitabine, tenofovir
Gilead’s HIV drug Truvada can help prevent men from contracting the disease through sexual intercourse, a new study shows.
The clinical trial is the first ever to show a pill could actually prevent the transmission of the disease, opening up the possibility of prophylactic use of HIV drugs.
It showed an average 44% reduction in HIV risk for participants receiving treatment compared to placebo.
Antiretroviral combination drug Truvada (tenofovir/emtricitabine) was approved by the FDA in 2004 for the treatment of HIV infected patients, and Gilead now hopes it can win approval for a pre-exposure indication.
When taken daily as a prophylaxis Truvada reduces the risk of HIV infection for men who have sex with men, according to the study. Men in both arms of the study were provided with condoms and safe sex advice, which is recognised as the best way of preventing infection. However new infections are still taking place in the real world, as some men and women ignore the risks, and the study reflected this reality.
The iPrEx pre-exposure prophylaxis – or PrEP – trial evaluating the drug has been hailed as a breakthrough by non-profit organisation AVAC, who also see the results as a call for action.
“There is a global imperative to act on the results with ambitious, carefully prioritised research and implementation agendas, including strategic demonstration projects,” says AVAC executive director Mitchell Warren.
He added: “Gay men and others at risk of HIV need to give crucial input and have influence on what the next steps for this new intervention might be.”
It’s those next steps that will be closely watched by California-based Gilead and a follow up trial is due to begin in early 2011.
Gilead said it was encouraged by this new evidence that Truvada could reduce the risk of acquiring HIV, and that it will work with the appropriate regulatory agencies moving forward.
Truvada costs $5,000 to $14,000 a year in the US and it’s not yet clear if government funding would be available for any new indication. The costs of post-infection treatment will be something for the FDA to consider in light of pre-exposure prescription.
The Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organisation (WHO) also welcomed the research.
Dr Margaret Chan, WHO director general, said: “We look forward to further examining these data to consider how we can best use this tool to enhance HIV prevention when used in combination with other prevention such as condom promotion in this population at higher risk.”
The research included 2,499 men from six countries. Its findings compliment those from a study released earlier this year that found a vaginal microbicide gel containing tenofovir used before and after sex to be 39% effective in preventing new HIV infections in women.
Brett Wells
Gates Foundation could rival pharma, analysts warn
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