FDA Approves First Generic for TRUVADA

FILE – In this Thursday, May 10, 2012 file photo, a doctor holds Truvada pills at her office in San Francisco. A study released Tuesday, Feb. 24, 2015 shows that the drug, used to treat HIV infection, also can help prevent it when taken before and after risky sex by gay men. The study, done in France and Canada, is the first to test “on demand” use of Truvada, a pill combining two AIDS drugs, by people planning to have risky sex. The uninfected men who took it were 86 percent less likely to get HIV compared to men given dummy pills. (AP Photo/Jeff Chiu)

In an article on the Regulatory Affairs Professionals Society website (RAPS for short) in an article posted by Michael Mezher on June 9, 2017, reports that although Teva Pharmaceuticals’ generic version has been approved, representatives of the company have so far refused to say when the drug will be available or how much it will cost, only that the approval was granted.

Without prescription coverage, a monthly supply of TRUVADA. which should be taken daily to maintain maximum protection, currently costs $1,800 or more for 30 pills. Gilead, the current manufacturer, has a program that will pay all or most of the cost of the prescription, but not everyone qualifies.

According to the FDA,

First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.

Note: Approved drugs are not always available on or after the listed approval date. Please contact the listed ANDA applicant for more information about a drug product’s availability.

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 and it is the first and only drug currently on the market which is approved for use as a Pre Exposure Prophylactic, commonly known as PrEP.

Studies have shown that its effectiveness in preventing the transmission of HIV-1 to non-infected individuals to be extremely high. In fact, one study, which was published in 2014, showed that over a 2 year time frame  there were no transmissions within couples from a partner with an undetectable viral load to the partner taking Truvada.

The study researchers acknowledged,

No transmissions is not the same as zero chance of transmission. The researchers calculated the 95% confidence intervals for the results seen. What this means is that they calculated the odds of zero transmissions being the ‘true’ figure and what the maximum possible risk of transmission was, given the results seen.

Nonetheless, the approval first of Truvada was a breakthrough in first the treatment and now the prevention of transmission of HIV. It is now hoped that Teva’s generic version of the drug will bring down costs of treatment making more accessible to a wider spectrum of the community.

In case you were wondering . . .