FDA Approves Triple Combo Efavirenz, Lamivudine, Tenofovir Disoproxil Fumarate HIV Treatment

The US Food and Drug Administration (FDA) approved another HIV triple drug combination by Mylan Pharmaceuticals: efavirenz, lamivudine, tenofovir disoproxil fumarate (Symfi Lo) 600 mg/300 mg/300 mg tablets.

The once-daily, single-tablet regimen is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing at least 40 kg.

“Mylan has been on the forefront of bringing innovative delivery and dosage forms of ARVs to millions of patients in the developing world,” Rajiv Malek, president, Mylan, said in a statement. “We’ve already extended our reach to people in the US living with HIV with the introduction of Symfi Lo and Cimduo. Adding Symfi to our portfolio further strengthens our commitment to investing in developing and manufacturing these important products.”

The introduction of Symfi comes after the recent approval of 2 Mylan antiretrovirals (ARVs).

Lamivudine and tenofovir disoproxil fumarate (Cimduo) 300 mg/300 mg tablets, a once-daily combination of 2 nucleo(t)side reverse transcriptase inhibitors to be taken once-daily is indicated to be used in combination with other ARV agents in treatment of adults and pediatric patients with HIV-1 and weigh at least 35 mg.

Efavirenz, lamivudine and tenofovir disoproxil fumarate (Symfi Lo) 400 mg/300 mg/ 300 mg tablets another Mylan combination product, are also approved for patients with HIV-1 in adults and pediatric patients weighing at least 35 kg.

Following the FDA approval, Mylan launched Symfi Lo earlier this March and expects Cimduo and Symfi to launch in the second quarter of 2018.

Symfi and Symfi Lo feature the same triple combination molecules, but Symfi Lo features a reduced dose of efavirenz while Symfi uses a dosing similar to other efavirenz products currently on the market.

To help reduce the high cost of HIV medications, the list price of these ARVs will be discounted significantly from wholesale acquisition cost of similar medicines on the market.

Lactic acidosis and hepatomegaly with steatosis, including fatal cases were reported with the use of nucleoside analogues including lamivudine and tenofovir disoproxil fumarate, and severe acute exacerbations of hepatitis B have been reported in co-infected patients with hepatitis B and HIV who discontinued lamivudine and tenofovir disoproxil fumarate.