A daily pill to protect people at risk of HIV from infection has been approved by the US Food and Drug Administration (FDA). The drug, named Truvada, has the potential to be a powerful weapon against the development of HIV/AIDS.
Truvada will be available in the U.S. only for those at extreme risk of HIV, because their partners are infected, according to The Guardian. The costs are crazy expensive though, it comes out to $14,000 a year. Although that price is a lot cheaper than a lifetime of treatment after infection, those without health insurance are unlikely to get their hands on it.
However, thankfully in the long term, advocates hope it can be offered in Africa and other parts of the developing world. However, manufacturer Gilead Sciences discounts the drug in the developing world, lowering the price to as low as $100 a year.
But the approval was immediately criticized within the U.S. by the largest AIDS support organization. They call the move reckless.
The Aids Healthcare Foundation (AHF) said evidence published recently showed the drug could possibly cause kidney damage.
It also argued Truvada should not be given without an HIV test to ensure the person taking the pills is not already infected. Otherwise the HIV virus could become resistant to the drug, making the pill useless and dangerous.
Michael Weinstein, AHF president, called the FDA decision:
"Completely reckless and a move that will ultimately set back years of HIV prevention efforts. 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. 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."
Trials of the drug were run both in the U.S. and in Africa. The University of Washington's international clinical research center recruited more than 4,700 discordant couples where one partner had HIV, but the other did not. In Kenya and Uganda starting in 2008, the Partners PrEP (pre-exposure prophylaxis) study was one of the largest-ever HIV prevention trials.
The New England Journal of Medicine's recently published study found a 75 percent protection rate in the couples where the uninfected partner took Truvada.
The results were higher than the 42 percent protection rate found over three years in the U.S. studies, which recruited gay and bisexual men at risk of HIV because of their partners.
In the U.S. and in Africa, those part of the study were given counseling and were told to still use condoms to protect themselves, whether they were given Truvada or not.
The U.S. has 1.2 million people who are HIV-positive and infections are increasing.
Dr. Margaret Hamburg, FDA commissioner said in a statement:
"Today's approval marks an important milestone in our fight against HIV, 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."
General side effects of Truvada include diarrhea, pain and weight loss, but the FDA considered that they were outweighed by the benefit to people who were at high risk of HIV infection.
The FDA wants further data, however, on the effects on women who become pregnant and, crucially, on the development of resistance.
It will be important for the drug to be taken every day, once a day, around the same time, otherwise the virus could mutate into a form that is unaffected by the drug.
This is a great achievement in the medical world. We hope that the necessary research is being done in order to make sure that this drug can be used safely, and responsibly.