Trial Shows Non-Inferiority Between HIV Treatment Regimens

Tenofovir alafenamide plus emtricitabine, which belongs in the class of nucleoside reverse transcriptase inhibitors, poses little risk for bone or renal toxicity in virologically suppressed patients with HIV, and this therapy regimen can be safely used as an alternative to abacavir plus lamivudine in these patients, according to findings from a randomized, double-blind, phase 3 trial reported in a recent issue of the Lancet HIV.

“To the best of our knowledge, this randomized, double-blind, multicentre, active-controlled, non-inferiority trial is the first to provide a head-to-head comparison of regimens containing tenofovir alafenamide plus emtricitabine with those containing abacavir plus lamivudine,” stated the study investigators Alan Winston, MD, et al. “Bone and renal safety profiles of tenofovir alafenamide plus emtricitabine and abacavir plus lamivudine were similar, reinforcing the evidence for improved bone and renal safety profile of tenofovir alafenamide compared with tenofovir disoproxil fumarate.”

Investigators screened a total of 501 HIV-1-positive adults at 79 sites across North America and Europe. All participants were virologically suppressed, as identified by HIV-1 RNA <50 copies per mL, and were on a stable 3-drug regimen comprised of abacavir and lamivudine.

The investigators randomized (1:1) participants to switch to fixed-dose tablets of 10 mg or 25 mg tenofovir alafenamide plus 200 mg emtricitabine (n= 253) or to remain on 600 mg abacavir plus 300 mg lamivudine with matching placebo (n= 248). The proportion of patients with virological suppression at 48-week follow-up comprised the primary endpoint.

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