FDA Approves Combination Treatment Symfi for HIV-1 Infection

Symfi contains efavirenz 600mg, lamivudine 300mg, and tenofovir disoproxil fumarate 300mg
Symfi contains efavirenz 600mg, lamivudine 300mg, and tenofovir disoproxil fumarate 300mg

Mylan announced that the Food and Drug Administration (FDA) has approved Symfi (efavirenz, lamivudine, tenofovir disoproxil fumarate) 600mg/300mg/300mg tablets as a complete regimen for the treatment of HIV-1 infection in adults and children weighing ≥40kg.

Symfi contains the same triple combination ingredients found in the recently approved and launched Symfi Lo but with a 600mg dose of efavirenz vs 400mg seen in Symfi Lo. In addition, the FDA recently approved Mylan's Cimduo (lamivudine, tenofovir disoproxil fumarate) 300mg/300mg tablets intended for use with other antiretroviral agents for the treatment of HIV-1 infection in adults and children weighing ≥35kg.

Symfi, a once-daily, single-tablet regimen, consists of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), and lamivudine and tenofovir disoproxil fumarate, both nucleo(t)side reverse transcriptase inhibitors. 

Related Articles

Safety findings from the ENCORE 1 study showed the 600mg combination dose of efavirenz was found to have a slightly higher rate for most adverse events than the 400mg dose including abnormal dreams (11.3% vs 8.7%), insomnia (6.5% vs 6.2%), somnolence (3.9% vs 3.1%), depression (1.6% vs 3.1%), and dizziness (35% vs 27%). 

Both Symfi and Cimduo are anticipated to launch in the second quarter of 2018. Symfi Lo is already available as 400mg/300mg/300mg strength tablets in 30-count bottles. 

For more information call (877) 446-3679 or visit Mylan.com.