US approves first HIV-prevention pill
US health regulators have for the first time approved an HIV-prevention drug called Truvada that can be used to reduce the risk of infection.
The Food and Drug Administration (FDA) on Monday announced their decision to approve the drug, which would be made available to people at high risk of acquiring HIV and who engage in sexual activity with HIV-infected partners.
Truvada, manufactured by Gilead Sciences in California, has been on the market since 2004 and is already in use for AIDS treatment but at a high cost despite the company reducing the price to as low as $100 a year.
The decision follows their approval of the first over-the-counter HIV test that Americans can use in the privacy of their own homes.
The two developments are seen as a massive step towards reducing the spread of HIV in the US, which has an estimated 1.2 million sufferers, which develops into AIDS if left untreated.
Dr. Demetre Daskalakis, one of the FDA panel that recommended approving the pill, said: “I think the combination of self-testing and a medicine that you can take at home to prevent the infection could mean a new approach to HIV prevention that is a bit more realistic.”
The largest AIDS support organisation, The AIDS Healthcare Foundation (AHF), however, accused the FDA of being reckless as the evidence published recently showed the drugs could possibly cause kidney damage.
It also argued that Truvada should only be given after the HIV test to ensure the patient is not already infected – otherwise the virus could become resistant to the drug.
Michael Weinstein, AHF president, said: “From the beginning, we believe there was a rush to judgement by government officials and others in favour of such approval despite decidedly mixed studies offered in support.
“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.”
Scientists have been studying the drug since 2010, and the studies revealed the drug prevented people from contracting HIV when used as a precautionary measure. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42% when accompanied by other preventive measures. However, Truvada reduced the risk of infection by 75% in a heterosexual couple in which only one of them was infected with HIV.