Treatment for HIV-1 Infection Approved

March 10, 2016

The FDA has approved Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients.

Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen).

The new drug is indicated in patients 12 years of age and older who have not had an antiretroviral treatment before and have HIV-1 RNA levels ≤100,000 copies per mL. Additionally, it is indicated as a replacement of a stable antiretroviral regimen in patients who are virologically-suppressed for at least 6 months and have no history of treatment failure or known substitutions associated with resistance to the components of the new drug. For patients with creatinine clearance greater than or equal to 30 mL per minute, no dosage adjustment is required.

Odefsey has a Boxed Warning label for the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.

Odefsey should not be used with drugs that induce CYP3A or increase gastric pH as this may lead to loss of efficacy and possible resistance to Odefsey or the NNRTI class.