Next Generation HIV Drug Combination Shows Improved Safety Profile

Experimental combination shows similar rates of HIV virologic suppression to Truvada.

A recent phase 3 trial offered a glimpse into the next generation of HIV suppressing drugs that may offer an improved safety profile.

Gilead announced this week the investigational fixed-dose combination emtricitabine and tenofovir alafenamide (F/TAF) met its primary objective evaluating the efficacy and safety of an F/TAF-based regimens in virologically suppressed adult patients who switched from the HIV treatment regimen with emtricitabine/tenofovir disoproxil fumarate (Truvada).

The phase 3 randomized, double-blind clinical trial followed 663 virologically suppressed adults with HIV on a stable Truvada regimen for 6 consecutive months. Patients were randomized to either maintain a regimen of Truvada, a placebo and a third agent, or switch to a regimen of F/TAF, placebo and a third agent.

After 48 weeks, the F/TAF-based regimens achieved similar virologic suppression rates as Truvada, as 94.3% of patients on the F/TAF-based had HIV RNA levels of less than 50 copies/mL versus 93.% on Truvada.

Patients in the F/TAF group showed statistically significant differences in mean bone mineral density at the hip and spine and in the median change for estimated glomerular filtration rate compared with Truvada. The general safety and discontinuation rates from adverse events were comparable between both treatment arms.

The most common adverse events included upper respiratory tract infection, diarrhea, nasopharyngitis, headache, and bronchitis, as both regimens were generally well tolerated, according to Gilead.

“For more than a decade, Truvada has been a cornerstone of HIV therapy, and the results of this and other recent trials demonstrate the potential of F/TAF to become a next-generation backbone,” said Norbert Bischofberger, PhD, executive vice president of Research and Development and chief scientific officer at Gilead Sciences. “The results from this study reinforce the efficacy, as well as the renal and bone safety advantages of TAF for patients who face a lifetime of treatment.”