FDA Approves Single Tablet HIV Treatment

Gilead’s Genvoya is the first TAF-based regimen approved by the FDA.

The FDA today granted approval to a significant new therapy for HIV-1.

Gilead Sciences’s elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF (Genvoya) is the first TAF-based regimen granted approval by the FDA.

The therapy was approved as a complete regimen for HIV-1 infection in adults and pediatric patients aged 12 years and older who did not receive prior antiretroviral treatment; to replace a current antiretroviral regimen in virologically-suppressed patients with HIV-1 RNA levels under 50 copies per mL on a stable antiretroviral regimen for at least 6 months with no prior treatment failures and no known substitutions from resistance to individual Genvoya components.

"As the HIV patient population ages there is an increased risk for development of age- and treatment-related comorbidities, including low bone mineral density and renal impairment. This is due to the combination of HIV infection, antiretroviral treatments and the natural aging process," said lead author of the Genvoya efficacy study David Wohl, MD. "Given its demonstrated efficacy and safety profile, Genvoya represents an important new treatment option for a range of patients who are either new to therapy or who choose to switch treatments."

There is no dosage adjustment of the treatment required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute, according to Gilead.

Genvoya carries a boxed warning for the risk of lactic acidosis/severe hepatomegaly with steatosis, along with post treatment acute exacerbation of hepatitis B.

Genvoya was approved following a pair of 48-week phase 3 double-blind studies evaluating 1733 treatment-naïve patients that met the primary objective of non-inferiority compared with elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF (Stribild).

The results of the trials showed 92.4% of patients administered Genvoya had HIV-1 RNA levels less than 50 copies/mL at week 48 compared with 90.4% of patients administered Stribild.

Furthermore, testing for specific renal and bone laboratory parameters supported Genvoya over Stribild, according to Gilead.

"While exceptional progress has been made in the field of HIV, there is still a need for new treatment options that may help improve the health of people as they grow older with the disease," said John C. Martin, PhD, chairman and chief executive officer of Gilead. "For more than 25 years, Gilead has been committed to changing the trajectory of HIV management and we are now pleased to introduce Genvoya, the first in a portfolio of TAF-based products that have the potential to advance the long-term treatment of HIV."