BOSTON — Switching to Biktarvy is noninferior to continuing on Triumeq for HIV treatment, according to results from a phase 3 study comparing the two single-tablet regimens in adult patients with HIV who are virologically suppressed.
Jean-Michel Molina, MD, of the University of Paris Diderot and the department of infectious diseases at Saint-Louis Hospital in Paris, presented the results of a 48-week randomized, double-blind trial today at CROI.
Molina and colleagues assessed whether it was safe and efficacious to switch patients from Triumeq (dolutegravir/abacavir/lamivudine; DTG/ABC/3TC, ViiV Healthcare), an older but effective regimen, to Biktarvy (bictegravir/emtricitabine/tenofovir; B/F/TAF, Gilead Sciences), which was recently approved for HIV treatment in the United States, or whether it was preferable for patients to remain on the old regimen.
“The idea was to see whether this regimen was as good in terms of viral suppression to the other one, and of course that was shown,” Molina said in a press conference here. “In addition, when you switch regimens, [it is important] to make sure that the new regimen is well-tolerated because when you switch one regimen for another, people usually have a number of adverse events that might be related to the new drugs. What was remarkable in this study was that the tolerability was very good and overall similar with both regimens.”
For the study, Molina and colleagues randomly assigned adults with HIV who were virologically suppressed on DTG/ABC/3TC to switch to B/F/TAF (n = 282) or remain on their current regimen (n = 281). The primary endpoint was the proportion of patients with HIV-1 RNA of 50 c/mL or higher.
Molina called the results “quite straightforward.” The efficacy of both regimens was very high, with just 1.1% of patients who switched to the study drug and 0.4% of patient who remained on DTG/ABC/3TC having HIV-1 RNA of 50 c/mL or higher. Moreover, none of the participants developed resistance to either drug, and the safety profile — a main driver in choosing regimens — was similar in both.
Molina said clinicians can use the data from the trial to provide more information to patients about the options they have for treatment.
“In the clinic right now, we are optimizing therapy for our patients,” said Diane Havlir, MD, professor of medicine at the University of California, San Francisco, who was not connected with the study. “We are switching many patients, and we really rely on evidence to let us know which switches are safe and which might be optimal for our patients. This study answers those questions.”– by Gerard Gallagher
Molina JM, et al. Abstract 22. Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston.
Disclosures: Havlir reports no relevant financial disclosures. Molina reports relationships with Gilead, Merck and ViiV Healthcare.