Switching to a weekly oral investigational regimen of islatravir and lenacapavir (Sunlenca) was just as effective as daily oral standard-of-care regimens in patients with virologically suppressed HIV, according to two phase III trials.
ISLEND-1 Trial Results
In the double-blind ISLEND-1 trial, 93.4% of patients who switched from once-daily, single-tablet bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy) to once-weekly, single-tablet islatravir and lenacapavir had HIV-1 RNA levels less than 50 copies/mL by week 48 versus 92.4% of those who continued to take the daily regimen.
No patients in the weekly group had HIV-1 RNA levels of 50 copies/mL or greater versus one patient in the daily group, reported Jürgen Rockstroh, MD, of University Hospital Bonn in Germany.
The ISLEND-1 results were published simultaneously in the New England Journal of Medicine.
ISLEND-2 Findings
In the open-label ISLEND-2 trial, 95.2% of patients who switched from daily standard-of-care drugs to weekly islatravir and lenacapavir had HIV-1 RNA levels below 50 copies/mL by week 48 compared with 95.5% of those who remained on daily standard of care. The percentage of people with HIV-1 RNA levels of 50 copies/mL or greater was 0.3% and 1.3%, respectively.
“Once-weekly oral antiretrovirals have the potential to address pill fatigue and adherence challenges related to daily oral treatment for HIV-1, as we are waiting for the HIV cure,” Rockstroh said. “In the face of lifelong therapy, this is clearly an issue.”
People with HIV on daily oral therapy “have expressed a strong interest in longer-acting oral options,” noted Amy Colson, MD, MPH, of the Cambridge Health Alliance in Massachusetts. “Islatravir and lenacapavir have the potential to be the first weekly oral complete regimen for the treatment of HIV-1.”
Adherence Rates
Adherence rates with the weekly regimen were high in both trials. Through week 48 in ISLEND-1, mean adherence rates were 98.9% with the weekly regimen and 95.8% with the daily regimen. Among ISLEND-2 patients, the mean adherence rate to the weekly regimen was 99.3%; 63.7% of patients said daily drugs were more of a burden, while just 0.6% said the same of weekly islatravir and lenacapavir.
Population Characteristics
The ISLEND-1 trial included 607 virologically suppressed adults whose HIV-1 RNA levels were below 50 copies/mL during at least 6 months of daily treatment. Median age was 49, with diverse racial and ethnic backgrounds.
The ISLEND-2 trial enrolled a similar population of 626 patients treated with a variety of daily standard-of-care drugs. Median age was 52, also representing diverse backgrounds.
Safety and Adverse Events
In ISLEND-1, the percentage of patients with a treatment-related adverse event (AE) was the same in both groups, at 13%, while in ISLEND-2, there were treatment-related AEs in 18% of the weekly group versus less than 1% in the daily group.
There were no clinically meaningful weight changes from baseline to week 48 in either trial.
Note de Descargo de Responsabilidad
Los tratamientos mencionados son de uso investigacional y deben ser discutidos con un médico especialista antes de cualquier decisión relacionada con tratamiento.
Fuente: https://www.medpagetoday.com/meetingcoverage/iac/122416
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