NEW YORK (Reuters Health) – In HIV patients, combination therapy with tenofovir alafenamide and emtricitabine is non-inferior to that of abacavir plus lamivudine, according to a manufacturer-sponsored trial.
Until recently, fixed-dose combinations for HIV treatment consisted of tenofovir disoproxil fumarate plus emtricitabine or abacavir plus lamivudine, note Dr. Martin S. Rhee of Gilead Sciences, in Foster City, California, and colleagues in The Lancet HIV, online February 20.
There has been concern about the toxicity of nucleoside reverse transcriptase inhibitors (NRTIs), the team adds, and tenofovir alafenamide appears to offer improved bone and renal safety.
To investigate, the researchers studied 501 virologically suppressed patients with HIV who were on a stable three-drug regimen containing abacavir plus lamivudine and another agent (a boosted protease inhibitor or unboosted drug). All had creatinine clearance of 50 mL/min or more.
They were randomized to switch to fixed-dose tablets of tenofovir alafenamide (10 mg or 25 mg) plus emtricitabine (200 mg) or remain on abacavir (600 mg) plus lamivudine (300 mg), with matching placebo, while continuing to take the third drug.
At 48 weeks, HIV suppression in the tenofovir group was not inferior to that with the abacavir-based regimen (90% vs. 93%). Corresponding proportions who discontinued treatment because of adverse events were also similar (4% vs. 3%).
Changes from baseline in hip and lumbar spine bone mineral density were “minimal” and did not differ significantly between groups. This was also true of changes in creatinine clearance and of relevant lipid parameters.
“These data suggest that, in virologically suppressed patients, the effects of tenofovir alafenamide on renal function and bone are no different from those of abacavir,” the researchers say.
Dr. Santiago Moreno of the University of Alcalá, in Madrid, who coauthored an accompanying editorial, told Reuters Health by email, “With tenofovir alafenamide on board, the nucleosides are not inevitably toxic drugs.”
“With the current nucleosides, three-drug regimens can be built without significant concerns about long-term toxicity,” said Dr. Moreno, who reported financial ties to Gilead.
Dr. David Burger, a professor of clinical pharmacy at Radboud University Nijmegen, the Netherlands, told Reuters Health by email that “Abacavir (ABC) and tenofovir alafenamide (TAF) are alternatives for tenofovir disoproxil fumarate in patients with renal or bone toxicity.”
Dr. Burger, who also has ties to the company but was not involved in the new study, added, “So far it has not been possible to define a preference for either ABC or TAF. This switch study in patients on stable ABC regimen showed non-inferiority of TAF but it must be noted that TAF is more expensive than generic ABC.”
Dr. Rhee did not respond to requests for comments.
SOURCE: http://bit.ly/2FwvStS and http://bit.ly/2FOoqcC
Lancet HIV 2018.
Tidak ada komentar:
Posting Komentar