Real patients with real challenges taking daily oral therapy
SOLAR – the first head-to-head switch study of CABENUVA vs continuing daily oral BIKTARVY1
Patients entering SOLAR on BIKTARVY revealed challenges with taking daily oral therapy at baseline
On Day 1 (exploratory endpoint), all patients in SOLAR (n=670; mITT-E) responded to three baseline questions about their previous experience on a daily oral therapy.2
Challenges experienced
always or often
47% of patients in SOLAR reported experiencing at least one of the following challenges always or often2*
- Worried about people unintentionally discovering their HIV status
- Worried about forgetting to take their HIV medication
- Felt that taking their HIV medication was an uncomfortable reminder of their HIV status
These results are descriptive in nature and should not be used to infer clinical significance.
- Patients were asked each of the following questions: “How often are you worried people may unintentionally discover your HIV status because of your current HIV treatment?”; “How often are you worried about forgetting to take your HIV medication?”; and “How often is taking your HIV medication an uncomfortable reminder of your HIV status?” Patients who responded “always” or “often” to any of these questions were counted one time for the endpoints above.2
Challenges experienced
always, often, or sometimes
80% of patients in SOLAR reported experiencing at least one of the following challenges always, often, or sometimes2*
- Worried about people unintentionally discovering their HIV status
- Worried about forgetting to take their HIV medication
- Felt that taking their HIV medication was an uncomfortable reminder of their HIV status
These results are descriptive in nature and should not be used to infer clinical significance.
- Patients were asked each of the following questions: “How often are you worried people may unintentionally discover your HIV status because of your current HIV treatment?”; “How often are you worried about forgetting to take your HIV medication?”; and “How often is taking your HIV medication an uncomfortable reminder of your HIV status?” Patients who responded "always," "often," or "sometimes" to any of these questions were counted one time for the endpoints above.2
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SOLAR Study Design
SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY1
A large, phase 3b, open-label, noninferiority study of virologically suppressed* adults (≥18 years) with HIV-11
- Efficacy analyses, baseline questionnaire, and preference calculation were based on the mITT-E (n=670) population. After consultation with a blinded external expert, 11 participants at a single study site were excluded from the ITT-E population due to critical findings related to significant and persistent noncompliance to protocol requirements2
- Safety analyses were based on ITT-E (N=681) population1,2
- Suppression defined as plasma HIV-1 RNA <50 copies/mL. A single prior INSTI-based regimen was allowed for reasons other than treatment failure (HIV-1 RNA ≥400 copies/mL).1
- Patients randomized to CABENUVA were given the option of 1-month oral lead-in (OLI) or to start long-acting IM CABENUVA directly (SWI). OLI regimen consisted of 30-mg cabotegravir and 25-mg rilpivirine once daily given for 1 month; on last day of the OLI period, patients received 2 sets of initiation CABENUVA injections 1 month apart followed by every-2-month injections thereafter.1-3
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HBV=hepatitis B virus; IM=intramuscular; INSTI=integrase strand transfer inhibitor; IQR=interquartile range; ITT-E=intent-to-treat exposed; M=month; mITT-E=modified intent-to-treat exposed; 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.
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