Switching to daily oral bictegravir and lenacapavir dual therapy to simplify ART in ARTISTRY-1 study

10 August 2024. Related: Conference reports, Antiretrovirals, World AIDS 25 Munich 2024.

Simon Collins, HIV i-Base

Impressive 48-week data were presented from a switch study in 128 highly treatment-experienced people with long treatment histories, common age and HIV-related comorbidities and who were on multiple complex combinations.

Participants were randomised to a new dual combination of oral bictegravir and lenacapavir compared to continuing on their current ART.

Participants were randomised 2:2:1 to a new dual combination of oral bictegravir and lenacapavir – BIC (75 mg) + LEN (25 mg) or BIC (75 mg) + LEN (50 mg) or continued on current ART. [1]

Results at week 48 were broadly similar to earlier week 24 results presented earlier this year at CROI 2024. [2]

Baseline characteristics included median age 60 (IQR: 56 to 65) and CD4 count 610 (435 to 766) cells/mm³. Overall, 19% were women, 64% white, 31% Black and 16% were Hispanic/Latinx.

Participants had been on ART for a median 27 years (IQR: 19 to 32), used a median of 6 previous combinations (range 3 to 11), and 52%, 64% and 35% had previous resistance to NNRTIs, NRTIs and PIs respectively. Current ART included a median of 3 (range: 2 to 9) daily pills.

Common comorbidities included dyslipidemia 75%, diabetes mellitus 68%, hypertension (60%) and chronic kidney disease (22%).

Viral efficacy, CD4 responses and tolerability were similar and not statistically different between the three arms including between those using 25 mg and 50 mg lenacapavir.

Although viral efficacy <50 copies/mL was 93% vs 90% vs 100% in the 25 mg, 50 mg and control arms respectively, this was due to 4 participants in the 25 mg arm and 5 in the 50 mg arm with no data, largely due to leaving the study early for reasons other than viral failure, when viral load was <50 copies/mL. None of the 7 serious events were related to treatment.

This study rolls over into a larger phase 3 study using fixed-dose BIC/LEN using the 50 mg dose. [3]

References

1. Segal-Maurer S et al. Efficacy and safety of bictegravir plus lenacapavir: 48-week outcomes in virologically suppressed people with HIV-1 on complex antiretroviral regimens at baseline. AIDS 2024, 22–26 July 2024, Munich. Oral abstract OAB2602.
   https://programme.aids2024.org/Abstract/Abstract/?abstractid=1 (abstract)
   https://presentations.gilead.com/item/5717531250 (slides)
2. Mounzer K, Slim J, Ramgopal M, et al. Phase 2 study of switch to daily BIC + LEN in individuals on a complex HIV treatment regimen. CROI 2024, Denver.
   https://www.croiconference.org/abstract/phase-ii-study-of-switch-to-daily-bic-len-in-individuals-on-a-multitablet-hiv-treatment-regimen/ (abstract)
   https://www.croiconference.org/wp-content/uploads/sites/2/posters/2024/642.pdf (poster)
3. clinicaltrials.gov. Study to compare bictegravir/​lenacapavir versus current therapy in people with HIV-1 who are successfully treated with a complicated regimen (ARTISTRY-1).
   https://clinicaltrials.gov/study/NCT05502341