FDA OKs 2 Fixed Dose HIV Treatments

FEBRUARY 08, 2018
Laurie Toich, Associate Editor
Officials with the FDA have approved 2 different fixed dose drugs indicated to treat HIV-1: Symfi Lo tablets and Biktarvy.

Symfi Lo tablets are a combination of efavirenz (EFV) 400-mg, lamivudine (3TC) 300-mg, tenofovir disoproxil fumarate (TDF) 300-mg. Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir alafenamide.

Symfi Lo

Symfi Lo is indicated to treat adults and children weighing at least 35 kg who are HIV positive, according to the FDA.
Prior to initiating therapy, the FDA advises health care providers to test patients for hepatitis B virus and obtain estimated creatinine clearance (CrCL), urine glucose, and urine protein.
The recommended dose of Symfi Lo tablets is 1 oral tablet once per day on an empty stomach, preferably before bed, according to an FDA release. The FDA noted that taking the treatment at bedtime may make nervous system symptoms more tolerable.


Biktarvy is indicated as a complete regimen for patients with HIV-1 who are treatment-naïve or who are virologically suppressed on a stable antiretroviral treatment for at least 3 months, according to the FDA.
The agency noted that this treatment requires the same testing as Symfi Lo prior to administration. Biktarvy is also not recommended for patients with estimated CRCL lower than 30-mL/minute or for those with severe hepatic impairment.

To read more about these approvals, visit .