Another Single-Tablet HIV Treatment Awaits FDA Action

Gilead Sciences is seeking FDA approval for its third tenofovir alafenamide-based HIV treatment.

Gilead Sciences is seeking FDA approval for its third tenofovir alafenamide (TAF)-based HIV treatment.

This once-daily, single-tablet regimen combines Gilead's emtricitabine 200 mg and TAF 25 mg with Janssen’s rilpivirine 25 mg (R/F/TAF) to treat HIV-1 infection in adult and pediatric patients aged 12 years or older.

In addition to the R/F/TAF filing, 2 other TAF-based HIV treatments from Gilead are currently under FDA review.

In November 2014, the drug developer filed an NDA for a once-daily, single-tablet HIV regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and TAF 10 mg (E/C/F/TAF).

Then, in April 2015, it filed another NDA for 2 doses of an investigational, fixed-dose combination of emtricitabine and TAF (200/10 mg and 200/25 mg) (F/TAF) for use in combination with other HIV

antiretroviral agents.

The NDA for R/F/TAF was supported by clinical data demonstrating that the regimen achieved the same drug levels of emtricitabine and TAF as E/C/F/TAF, as well as the same drug levels of rilpivirine as a 25-mg dose of rilpivirine (Edurant) alone.

The FDA is expected to act on E/C/F/TAF on November 5, 2015, and then F/TAF on April 7, 2016. The anticipated FDA action date for R/F/TAF is 6 months after the agency accepts the New Drug Application (NDA).

A fourth investigational regimen containing Gilead's TAF, emtricitabine, and cobicistat with Janssen's darunavir is currently under development.

“…We are looking forward to the potential to offer people living with HIV another effective treatment option with a favorable safety profile,” stated Norbert Bischofberger, executive vice president of research and development and chief scientific officer at Gilead.

The FDA has not yet determined that TAF-based treatments are safe or effective.