For patients infected with HIV-1, tenofovir alafenamide plus emtricitabine has a renal and bone safety profile similar to that of abacavir plus lamivudine, according to results published online in Lancet HIV.
A tenofovir alafenamide plus emtricitabine regimen could be an alternative for patients with virologic suppression who are concerned about the new onset of renal or bone toxicities or hyperlipidemia.
The randomized, double-blind, active-controlled, noninferiority phase 3 trial included adults who were HIV-1 positive from 79 sites in 11 countries across North America and Europe (ClinicalTrials.gov Identifier: NCT02469246).
Participants had virologic suppression (<50 RNA copies/mL) and were on a stable 3-drug regimen containing abacavir plus lamivudine. Participants were randomly assigned to switch to fixed-dose tablets of tenofovir alafenamide (10 mg or 25 mg) plus 200 mg emtricitabine (n=253) or to remain on 600 mg abacavir plus 300 mg lamivudine (n=248). The primary outcome was the proportion of participants with virologic suppression (<50 RNA copies/mL) at week 48 with a predefined 10% noninferiority margin.
At week 48, 90% (227) of the participants in the tenofovir alafenamide group maintained virologic suppression compared with 93% (230) of participants in the abacavir group.
Several participants discontinued treatment because of adverse events: 4% of participants in the tenofovir alafenamide group and 3% of participants in the abacavir group.
Among both groups, 3 participants had serious treatment-related adverse events. In the tenofovir alafenamide group, 1 participant had renal colic and 1 had neutropenia. In the abacavir group, 1 participant had myocardial infarction. There were no treatment-related deaths.
“The results of our study suggest that, in the population we studied, tenofovir alafenamide was no different to abacavir from a renal and bone safety standpoint, and tenofovir alafenamide does not seem to be associated with bone or renal toxicity,” concluded the study authors.
Disclosure: This study was sponsored by Gilead Sciences Inc. Please refer to original study for full list of disclosures.
Winston A, Post FA, DeJesus E, et al. Tenofovir alafenamide plus emtricitabine versus abacavir plus lamivudine for treatment of virologically suppressed HIV-1-infected adults: a randomised, double-blind, active-controlled, non-inferiority phase 3 trial [published online February 20, 2018]. Lancet HIV. doi:10.1016/S2352-3018(18)30010-9