The Food and Drug Administration announced that it has approved Symfi Lo tablets, a fixed-dose combination product containing efavirenz (400 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg, equivalent to 245 mg of tenofovir disoproxil). The tablets are indicated as a complete regimen for treating HIV-1 in adults and in pediatric patients weighing at least 35 kg.
The recommended dose is one tablet taken daily by mouth on an empty stomach, preferably at bedtime, as that may improve the tolerability of nervous system symptoms, according to an email release by the FDA Office of Health and Constituent Affairs.
The most common adverse reactions (in more than 5% of patients taking Symfi Lo) were rash and dizziness. The warnings and precautions contained in the label are: lactic acidosis/severe hepatomegaly with steatosis; new-onset or worsening renal impairment; and serious psychiatric symptoms, such as severe depression and suicidal ideation.
The FDA approval was primarily based upon the results of two randomized trials: Study 903 and Encore-1.
SOURCE: FDA email release and full label with prescribing information.