HIV prevention pill gets US approval

Australian authorities have been called upon to immediately begin trials and licensing of HIV prevention medication Truvada after the drug was approved for use in the United States.

The US Food and Drug Administration (FDA) overnight approved the sale and use of Truvada, made by Gilead Sciences, saying it could reduce the risk of infection by close to 75 per cent for people who have sex with HIV-positive partners.

“Today’s approval marks an important milestone in our fight against HIV,” FDA commissioner Dr Margaret Hamburg said in a statement.

“Every year, about 50,000 US adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease.”

A combination of two antiretroviral drugs used in HIV treatment – emtricitabine and tenofovir – Truvada will cost about US$14,000 a year for those who wish to take it as a preventative measure.

The drug will need to be taken consistently once a day as sporadic usage could enable the HIV virus to mutate into a form that is unaffected by the drug.

Trials of the drug were run in both the US and parts of Africa from 2008 involving 4,700 discordant couples – where one partner had HIV but not the other – with study results showing a 75 per cent protection rate in the couples where the uninfected partner took Truvada.

Robert Mitchell, president of the National Association of People Living with HIV/AIDS (NAPWA) said the FDA approval of Truvada was a “game-changing moment” since the epidemic took hold in the early 1980s.

“For the first time, we have a completely new biomedical prevention tool to use alongside other proven approaches like community based prevention programs and correct and consistent condom use,” he said.

“This gives us the capacity to dramatically drive down the rate of new HIV infections in Australia and around the world.”

The Australian Federation of AIDS Organisations (AFAO) has said the FDA approval should be followed by swift action by the local Therapeutic Goods Administration.

“While safe sex is the best way to prevent the spread of AIDS, drugs such as Truvada have an important role to play in reducing infection,” AFAO Deputy CEO Simon Donohoe said.

“US authorities have recognized this and Australian policy makers should follow suit.

“We would urge immediate local research to identify the most effective use of Truvada in Australia.”

However, the drug’s approval by the FDA has been met with dismay by the AIDS Healthcare Foundation (AHF), the largest AIDS support group in the United States.

AHF president Michael Weinsten said there was evidence to suggest Truvada could possibly cause kidney damage while there were also valid concerns over whether the HIV virus could become resistant to the drug if taken by people who are unaware of their HIV-positive status.

Other general side effects of Truvada include diarrhoea, pain and weight loss.

“From the beginning, we believe there was a rush to judgment by government officials and others in favour of such approval despite decidedly mixed studies offered in support,” Weinstein said.

“The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people.”