US to rule on preventive use of HIV drug

In a significant milestone in the battle against AIDS, Gilead Sciences (GILD) of Foster City on Thursday asked the government to make one of its drugs the world's first approved medication to help prevent the spread of HIV, the virus that can lead to the deadly disease.
Studies of the drug have shown it sharply reduces the risk of HIV infection in those who don't have the AIDS virus but who often engage in risky practices that lead to the disease. The drug, called Truvada, has been used for years as a treatment for people who already have HIV.
"This is really an exciting moment," said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, which closely tracks AIDS-related studies. "The implications are huge." Although health authorities say the best way to avoid becoming infected with HIV is to use condoms and avoid other risky behavior, such as sharing drug needles, he said, "there are many people who can benefit from an additional prevention option."
Because several international trials done by federal agencies and others have shown Truvada to be effective in blocking transmission of the virus, many people are hoping the U.S. Food and Drug Administration reviews Gilead's application swiftly, said Dr. Connie Celum of the University of Washington.


The two most significant clinical trials submitted this week to US regulators showed that Truvada reduced the risk of contracting HIV in men who have sex with men by 44 per cent, and by 73 per cent among heterosexual couples when one of the partners was already infected.
John Martin, Gileads chief executive, said: The data from these large-scale clinical trials suggest that Truvada may have a role to play in meeting the urgent public health need to reduce new HIV infections.
Criticisms which regulators will have to debate including the argument that wider use of Truvada could trigger the development and spread of a form of HIV resistant to the pill, undermining its use as a therapy particularly if it is only taken intermittently. Evidence of resistance in the two trials was very limited.
Others have suggested that those without HIV taking the pill could be disinhibited, taking greater risks and abandoning other practices which sharply cut the likelihood of infection such as the use of condoms.
Mitchell Warren, head of Avac, an advocacy group, welcomed Gileads decision to seek approval, while cautioning the drug would need to be prescribed with broader preventive advice. Prep is not just a pill.
The Aids Healthcare Foundation, a US-based HIV treatment and advocacy group, cautioned this autumn that preventive use should not be pursued at the risk of contributing to, rather than controlling, the epidemic.
For those on low incomes in developing countries and with inadequate health insurance, including in the US, Truvadas preventive use could also create fresh ethical problems, with tensions between patients and those without HIV both seeking access to the medicine.