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FDA Approval of HIV Prevention Pill Truvada Moved Until ‘Further Notice’

Posted Jun 18 2012 3:15pm

More than a million Americans are infected with Human Immunodeficiency Virus or HIV.  

That's why when the Gilead Sciences Company unveiled a HIV prevention pill they named "Truvada", last May, a lot of people rejoiced.

The drug is pending approval from the Food and Drug Administration, but the motion was delayed, with regulators wanting more time to review Gilead's risk mitigation action.  

The FDA lauds Truvada as a preventive measure for people at risk for contracting HIV.

In a study conducted, 90% of the subjects who took Truvada every day did not contract HIV. On the other hand, only 44% of those who used the pill sporadically did not catch the virus.  



Although the pill has shown promise in clinical tests, those against the approval of Truvada say that it's only partially effective in averting the possibility of contracting the virus. After all, there's the 10% of the subjects who acquired HIV even after Truvada use.  

Some antagonists, on the other hand, believe that taking a pill every day is a forgettable task for most takers, especially the healthy ones.

Some health advocates are afraid that those who plan on using Truvada will forego condom use. Although the pill has helped prevent HIV in most cases, using a condom is still important for those with multiple sexual partners.  

The cost is staggering as well. A person who decides to stick through with the daily Truvada course is estimated to spend $14,000 yearly.  

Another concern of the FDA is training and educating the physicians who will prescribe this drug.

If Truvada is approved, the FDA will also ask the doctors to subject their patients to HIV screening to determine if they have contracted the disease throughout the course of the treatment.  


Drug-resistant HIV?

Perhaps the biggest concern of the FDA regarding Truvada is the development of drug-resistant HIV strains. Because of the potency of the drug, those taking it might be at risk of developing a stronger strain.  

Truvada can only prevent HIV and not cure one stricken with the virus. It also can't cure a person who acquires HIV while on treatment.

The fear is that a drug-resistant virus might develop while somebody takes Truvada during the course of his infection. This event is feared by most physicians and scientists.

After all, drug-resistant conditions such as Methicillin-resistant Staphylococcus aureus have proliferated in the last few years.  

Like other drugs, Truvada has side effects too. The pill can cause stomach problems. Those taking Truvada should also be monitored for their kidney functions and bone masses (the pill can cause bone thinning.)

The review date of Truvada has been moved to September 14. Until then, one could only speculate whether it's going to be the first preventive pill for HIV in the United States.

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