FDA Approves First HIV Preventive Drug, Gilead Sciences Inc.’s Truvada
On the heels of FDA approval of first take home kit for HIV testing comes another historical FDA decision on HIV/AIDS. FDA approved the first preventive drug for HIV infection, Truvada, on 16 July 2012, as reported in New York Times. The human immunodeficiency virus (HIV) is the causative agent of AIDS, and Truvada developed by Gilead Sciences, can now be used as a preventive measure among high-risk population (people whose partners are infected). According to the Centers for Disease Control and Prevention, there are 1.1 million HIV infected people in the US and every year 50,000 Americans are newly infected.
Truvada is a drug that has already been approved by FDA for treating people infected with HIV. Truvada is a combination of tenofovir and emtricitabine. Two clinical trials claim to have caused a turning point in AIDS/HIV drug research by finding data in support of Truvada preventing HIV infections. Two studies from Africa have found that Truvada reduced rate of HIV infection by 62% to 75% among heterosexual patients. In the two clinical studies mentioned above, the participants were randomly assigned to take either Truvada or placebo. The studies open up a preventive mechanism for slowing down spread of the dreaded HIV virus. The new strategy employed for administering the drug is known as PREP/pre exposure prophylaxis.
The FDA approval of Truvada comes with its down sides too, the most significant being that of providing false security. The pills might provide people with a sense of security that might lead them to stop using condoms, which prevents spread of all kinds of STDs and unintended pregnancies.
Another very important fact that struck me was what happens if an infected person starts taking the drug. Would he develop a resistant form of the HIV virus and unconsciously spread the same under the security blanket of Truvada…