The Food and Drug Administration (FDA) has approved Symfi Lo (efavirenz, lamivudine, tenofovir disoproxil fumarate; Mylan) as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥35kg.
Symfi Lo combines efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors.
The efficacy of Symfi Lo was evaluated in a double-blind, active-controlled multicenter trial (Trial 903) comparing EFV 600mg + 3TC 300mg + TDF 300mg vs. EFV 600mg + 3TC 300mg + stavudine (d4T) 40mg in 600 antiretroviral-naive patients. At Week 48, 79% of patients in the EFV/3TC/TDF group were responders (defined as HIV-1 RNA levels <400 copies/mL) vs 82% in the EFV/3TC/d4T group. At Week 144, responder rates were 68% and 62% for the two treatment groups, respectively.
ENCORE1 was a randomized, multinational study (N=630) that compared efavirenz 400mg in a triple drug regimen vs efavirenz 600mg in a triple drug regimen in antiretroviral-naive adults. Patients were randomized to receive EFV 400mg in combination with TDF 300mg + emtricitabine (FTC) 200mg given once daily or EFV 600mg in combination with TDF 300mg + FTC 200mg given once daily. At Week 48, 86% of patients in the efavirenz 400mg group and 84% of patients in the efavirenz 600mg group were confirmed responders (defined as HIV-1 RNA levels <50 copies/mL).
Symfi Lo will be available as 400mg/300mg/300mg fixed-dose tablets in 30-count bottles.
For more information call (877) 446-3679 or visit Mylan.com.