FDA Approves TAF-Based Single Tablet HIV Regimen for Certain Patients

Odefsey is the smallest single tablet regimen to treat patients 12-years-old and above infected with HIV.

The FDA has approved Gilead’s second TAF-based single tablet regimen for the treatment of HIV-1.

Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) is now the smallest pill for a single tablet regimen to treat patients 12 years and older who had no prior antiretroviral treatment and HIV-1 RNA levels less than or equal to 100,000 copies per mL.

Odefsey can also be used as a replacement for antiretroviral therapy in patients that are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for a minimum of 6 months, with no history of treatment failure and no known resistance.

“As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients,” said Chairman and Chief Executive Officer of Gilead Sciences, John C. Martin, PhD. “Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.”

TAF is a novel targeted prodrug of tenofovir, which has shown high antiviral efficacy similar to, and at a dose less under one-tenth that of Viread (tenofovir disoproxil fumarate, TDF). TAF has been found to penetrate HIV-infected cells more efficiently than TDF, requires a significantly lower dose, and carries 90% less tenofovir in the bloodstream.

This approval followed a successful study that showed Odefsey achieves similar drug levels of emtricitabine and TAF in the blood as Genvoya, as well as similar levels of rilpivirine as Edurant.

The efficacy, tolerability, and safety of Odefsey was shown in a clinical trial using rilpivirine-based therapy in patients suffering from HIV. This included treatment naïve adolescents and adults, virologically suppressed adults that had switched from PI-, NNRTI- and INSTI-based regimens, and adults with mild-to-moderate renal impairment who are virologically suppressed.

The most common adverse reactions for rilpivirine were depressive disorders, insomnia, and headache. While the most common reaction was nausea for emtricitabine and tenofovir alafenamide.