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LATTE-2: Two-drug injectable ART regimen as effective as three-drug oral regimen
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A two-drug injectable ART regimen received monthly or bimonthly is as effective in maintaining HIV suppression as a three-drug oral regimen through 96 weeks, according to findings from the LATTE-2 trial.
Researchers presented the findings of their phase 2b trial of the long-acting combination of cabotegravir (ViiV Healthcare) and Edurant (rilpivirine, Janssen) at the International AIDS Society conference in Paris. Results were also published in The Lancet.
“I think they are exceptionally good results,” researcher Peter Williams, PhD, compound development team leader of HIV projects for Janssen Global Public Health, told Infectious Disease News. “They are a demonstration that we can use an all-injectable regimen of two antiretrovirals and maintain suppressed viral load over almost 2 years of therapy.”
Janssen is developing the investigational combination, which is administered in two separate injections by a health care provider and could become the first all-injectable ART regimen. Researchers previously tested oral cabotegravir with oral rilpivirine in the LATTE-1 trial.
In LATTE-2, the researchers enrolled treatment-naive adults with HIV who received oral cabotegravir plus Epzicom (abacavir/lamivudine, ViiV Healthcare) once daily for a 20-week induction period.
Among the cohort, 286 patients who achieved viral suppression (HIV-1 RNA < 50 copies/mL) entered what the researchers called the maintenance period. They were randomly assigned to continue the oral regimen, to receive the injections of cabotegravir and rilpivirine once every 4 weeks (Q4W) or receive the injections once every 8 weeks (Q8W).
In all, 56 patients continued the oral regimen. The Q4W and Q8W groups each included 115 patients.
At 32 weeks after the start of the maintenance period, 51 (91%) patients in the oral regimen group maintained viral suppression, compared with 108 (94%) in the Q4W group and 109 (95%) in the Q8W group.
At 96 weeks, 47 (84%) patients who received the oral regimen maintained viral suppression, compared with 100 (87%) in the Q4W group and 108 (94%) in the Q8W group.
In all, three patients had virological failure, the researchers said — two in the Q8W group and one in the oral treatment group. As for adverse events, mild injection-site reactions occurred in 3,648 (84%) injections, and moderate reactions in occurred in 673 (15%) injections. Two of the 230 patients who received either Q4W or Q8W discontinued treatment.
Serious adverse events in the trial’s maintenance period were reported in 22 (10%) patients receiving Q4W or Q8W and in seven (13%) of those receiving the oral regimen, but none were drug related, the researchers said.
According to Williams, injectable ART could be a desirable alternative for patients who want to keep their therapy more private, among other reasons.
“This effort comes out of recognition that some people are not particularly good at adhering to their therapy, or they want a way of being treated discreetly so that they don’t have to reveal that they’re on medication,” he said. “With an occasional visit to a clinic, it should be possible to discreetly treat them, and they can leave that clinic and effectively forget about the fact that they are infected for the next period of weeks before they come back for their next injection.” – by Joe Green
Disclosure: Williams reports that he is an employee of Janssen and a stockholder of AstraZeneca, GlaxoSmithKline and Johnson & Johnson. Please see the study for a list of all other authors’ relevant financial disclosures.
References:
Margolis DA, et al. Lancet. 2017;doi:10.1016/S0140-6736(17)31917-7.