SOLAR: It starts with proven efficacy
CABENUVA phase 3b head-to-head clinical trial efficacy:
Every-2-month CABENUVA was proven as effective as continuing daily oral therapy with BIKTARVY1,2
SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA HIV treatment with daily oral BIKTARVY1
SOLAR primary endpoint
The SOLAR clinical trial primary endpoint was met (mITT-E, HIV-1 RNA ≥50 copies/mL)1:
Every-2-month CABENUVA was noninferior to BIKTARVY at the Month 12 analysis (mITT-E: 1% [5/447] vs <1% [1/223], respectively, adjusted difference = 0.7% [95% CI -0.7% to 2.0%]). Noninferiority shown if upper bound of the 95% CI for the treatment difference was <4%.
SOLAR confirmed virologic failure
CVF Breakdown1
SOLAR: Confirmed virologic failures were seen in 2 patients receiving CABENUVA (in mITT-E)1
- Patients who met the CVF criteria were tested for emergent INSTI (cabotegravir) or NNRTI (rilpivirine) substitutions conferring resistance
- Patient 1: Emergent RPV RAM (M230L) and an INSTI RAM (Q148R) at Month 6
- Patient 2: Emergent RPV RAM (K101E) and an INSTI RAM (G118R) at Month 11
- An additional patient on CABENUVA in the ITT-E population met CVF at Month 3 with treatment-emergent RPV RAMs E138E/K and Y181Y/C
Patients who met CVF re-suppressed on highly suppressive antiretroviral therapies2
Key differences in ATLAS-2M: all patients had previously received an NNRTI-, PI-, or INSTI-based regimen.4
Through Week 152, there were 12 (2%) CVFs* in the every-2-month arm and 2 (<1%) in the once-monthly arm.5
- CVF was defined as 2 consecutive RNA levels ≥200 copies/mL.2
Other every-2-month dosing trials
Review detailed pivotal study data for ATLAS- 2M.
CABENUVA access and affordability
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BMI=body mass index; CVF=confirmed virologic failure; HBV=hepatitis B virus; INSTI=integrase strand transfer inhibitor; INSTI RAM=integrase strand transfer inhibitor resistance-associated mutations; IM=intramuscular; IQR=interquartile range; ITT-E=intent-to-treat exposed; M=Month; mITT-E=modified intent-to-treat exposed; NNRTI=non-nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; RVP RAM=rilpivirine resistance-associated mutations; SWI=starting with injections.
References:
- Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023;10(9):E566-E577. doi.org/10.1016/S2352-3018(23)00136-4
- Data on file. ViiV Healthcare group of companies. Durham, NC.
- ClinicalTrials.gov. SOLAR Study. Available at: https://clinicaltrials.gov/ct2/show/NCT04542070. Accessed February 16, 2023.
- Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2020;396(10267):1994-2005. doi:10.1016/S0140-6736(20)32666-0
- Overton E, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with human immunodeficiency virus 1 type 1 infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b, noninferiority study. Clin Infect Dis. 2023;76:1646-1654. doi: 10.1093/cid/ciad020
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