FDA Approves First Generic Version of Gilead's HIV Drug Truvada

Regulatory NewsRegulatory News
| 09 June 2017 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Friday announced it has approved Teva Pharmaceuticals' generic version of Gilead's HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate).

However, Teva has not said how much its version of the drug will cost or when it will be available to patients. A Teva representative declined to comment other than to say the company had received approval.

Truvada and HIV PrEP

Truvada was initially approved by FDA in 2004 to treat HIV in combination with other antiretroviral drugs, and later gained approval as the first drug to prevent sexually transmitted HIV-1 infection in uninfected adults in 2012.

Despite showing strong efficacy in preventing the spread of HIV, Gilead initially declined to promote Truvada for pre-exposure prophylaxis (PrEP) in response to criticism that the drug could lead to unsafe sexual practices.

But, over time its use for PrEP has increased as a result of grassroots awareness campaigns, recommendations from the US Centers for Disease Control and Prevention in 2014 and Gilead's recent marketing efforts. According to Gilead, there are around 125,000 people taking Truvada in the US as of the first quarter of 2017.

The drug is also a significant earner for Gilead. In 2016, Gilead made nearly $2.4 billion on Truvada sales in the US, and $3.5 billion globally. Though in the first quarter of 2017 US sales of Truvada fell to $464 million, compared to $576 million in Q1 2016.

Despite the growing uptake of Truvada for PrEP in the US, only a small percentage of patients at risk for HIV infection are taking the drug. While Gilead offers an assistance program for uninsured patients and a co-pay assistance program for Truvada, many have cited its cost, which is around $1,500 a month in the US, as a barrier to access.

Paul Volberding, director of the AIDS Research Institute at the University of California, San Francisco, told Focus he hopes the introduction of a generic version improves access to the drug.

"There are often ways to cover the cost of Truvada for PrEP … but those can be kind of cumbersome, and I think in many situations if there was just a straight-forward way insurance provides it, I think that would increase access to PrEP," he said.

However, when it comes to uptake Volberding said that increasing awareness about PrEP is still one of the biggest challenges.

Volberding said he believes the cost for generic versions of Truvada will eventually reduce spending on PrEP significantly once there are several competitors on the market.

"You have to get competition within the generic companies," he said, adding that the manufacturing cost for generic HIV drugs is relatively low.

However, it is unclear how soon other generic versions of the drug will be available. Gilead has sued other generic drugmakers, including Lupin and Cipla, and most recently Amneal Pharmaceuticals over their versions of Truvada.



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Tags: Truvada, Teva, Gilead, PrEP

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