FDA Evaluating HIV Single-Tablet Regimen

Gilead Sciences is seeking FDA approval for its third tenofovir alafenamide (TAF)-based HIV treatment. The 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 a new drug application (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). 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 the E/C/F/TAF regimen, 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 its NDA.

A fourth investigational regimen containing Gilead’s TAF, emtricitabine, and cobicistat with Janssen’s darunavir is currently under development. The FDA has not yet determined that TAF-based treatments are safe or effective.