It has been reported that Gilead Sciences Inc., the South San Francisco-based Biopharmaceutical firm has asked the Food and Drug Administration (FDA) to announce their decision regarding the approval of its HIV drug Truvada.
It has been informed that Truvada is a HIV drug which contains the elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. On December 15, the Company announced that it has asked FDA to speed up with the decision making.
It is expected that decision over the approval of drug would be announced by June 2012. It is believed that even after getting approval from FDA, the prescription of Truvada would be having some restrictions and limitations.
The clinical trials of Truvada have showed that regular use of condom together with Truvada can reduce the chances of a person coming in contact with HIV. HIV is a deadly disease which affects millions of lives all over the world on a yearly basis.
It is believed that if the drug is made available for use, then many HIV negative patients could be benefited. Project Inform Executive Director Dana Van Gorder said, “We believe in the right of HIV-negative people to choose the evidence-based prevention methods that best support their efforts to remain negative, and we urge quick FDA approval of Truvada for prevention”.
The trails of the drug were conducted in six different countries over 2,500 gay and bisexual men as well as transgender people. During the trail, it was found that the chances of transmitting HIV reduces significantly by 44% after using condom and the drug.
However, a trail conducted over the drug in Rome has showed that the transmission of HIV or AIDS reduces by 90%. Although the drug promises of protection against HIV, some experts have raised question over the long term side effect of its usage. The authorities concerned are yet to answer any of their queries.
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