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Why did it take so long for Descovy® to be available as PrEP?

Truvada® and Descovy® are fixed-dose combination tablets that include emtricitabine 200mg. The difference is that Truvada® also contains tenofovir disoproxil 300mg and Descovy® contains a different version of tenofovir called tenofovir alafenamide 25mg. Tenofovir alafenamide is a newer medication and although similar to tenofovir disoproxil, its effectiveness at preventing HIV infection has only recently been studied in clinical trials.

Truvada® was first FDA-approved for use as HIV treatment (ART) on August 2, 2004. The newer drug, Descovy®, was FDA-approved for use as HIV treatment nearly 12 years later, on April 4, 2016. 

Truvada® was first FDA-approved for use as HIV prevention (PrEP) on July 16, 2012. The newer drug, Descovy®, was FDA-approved for use as PrEP nearly 7 years later, on October 3, 2019. 

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human drugs, biological products, medical devices, etc, which can be a time-intensive process. Rushing this process could be detrimental to public health. 

Why is there a lawsuit?

There is currently an ongoing lawsuit against Gilead Sciences, the maker of Truvada®, alleging that Gilead deliberately withheld Descovy® from the public, which has not been shown to cause the effects on bone density levels that occur in a small percentage of patients who take Truvada®, in an attempt to maximize the profits of Truvada®. This lawsuit does not mean that Truvada® is not effective at protecting against HIV, or that it is not safe to use.