FDA Approves New TAF-Containing Analogue of Complera; Complera Approved for Pediatrics

The FDA has approved a single-pill combination of rilpivirine + emtricitabine + tenofovir alafenamide (TAF); its brand name is Odefsey.

It is intended for initial treatment of HIV-1-infected persons age 12 years and older whose pretreatment HIV RNA is ≤100,000 copies/mL, or as a substitute (switch) regimen for persons who are on a first ART regimen with sustained HIV suppression and no resistance mutations to the ARV components. Recommended dosage is 1 tablet once daily. As with Complera, it must be taken with a meal and cannot be taken concurrently with proton pump inhibitors.

FDA approval was not based on clinical studies showing efficacy of rilpivirine + emtricitabine + TAF but instead was based on pharmacokinetic (PK) studies showing similar plasma drug concentrations of TAF and emtricitabine as were seen with elvitegravir/cobicistat/emtricitabine/TAF, and bioequivalent levels of rilpivirine as with rilpivirine monotherapy. Efficacy and safety were inferred from other studies of the component ARVs.

Studies of TAF-containing regimens suggest that TAF may cause less risk of renal and bone toxicity than tenofovir disoproxil fumarate (TDF); further study will be needed to determine whether this is clinically relevant. For more information, see New Data on Tenofovir Alafenamide Fumarate. TAF is active against hepatitis B but has not been approved for treatment of hepatitis B.

Complera for Pediatric Patients

Meanwhile, the FDA announced that the coformulation rilpivirine + emtricitabine + TDF has been approved for pediatric patients age 13 to 18 years. Recommended dosage is the same as for adults, 1 tablet once daily with a meal.