GSK's Long-Acting HIV-1 Therapy Cabenuva Demonstrates Non-Inferiority to Gilead's Biktarvy in Phase III SOLAR Trial

On February 23, GSK announced that its long-acting injectable Cabenuva (cabotegravir + rilpivirine) met the non-inferiority primary endpoint in the Phase III SOLAR study for the treatment of HIV-1 infection.

Cabenuva (Cabotegravir + Rilpivirine) is a long-acting injectable developed by GSK, where Cabotegravir is an HIV-1 integrase inhibitor developed by GSK, and Rilpivirine is an HIV-1 reverse transcriptase inhibitor developed by Johnson & Johnson. In February 2021, Cabenuva was approved by the FDA for the treatment of HIV-1 infection; however, patients were required to take oral doses of Cabotegravir and Rilpivirine tablets for one month (oral lead-in period) before receiving Cabenuva treatment. In March 2022, the FDA updated the prescribing information for Cabenuva, allowing patients to receive Cabenuva treatment without the need for an oral lead-in period.

SOLAR is a randomized, open-label, multicenter, non-inferiority study that enrolled 670 patients, aiming to evaluate the efficacy and safety of switching HIV-1 adult patients from taking Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide, once daily) to injecting Cabenuva (once every 2 months). The primary endpoints included: ① the proportion of patients in the Cabenuva group with oral lead-in who had plasma HIV-1 RNA ≥50 copies/mL at month 12; ② the proportion of patients in the direct injection Cabenuva group with plasma HIV-1 RNA ≥50 copies/mL at month 11; ③ the proportion of patients in the Biktarvy group with plasma HIV-1 RNA ≥50 copies/mL at month 12. The main endpoint was the comparison between ② and ③.

The study results showed that, in the modified intention-to-treat exposed (mITT-E) population, Cabenuva was non-inferior to Biktarvy. For the primary endpoint, the proportion of patients with plasma HIV-1 RNA ≥50 copies/mL in the Cabenuva group and the Biktarvy group met the criteria for non-inferiority (1% vs <1%). Regarding secondary endpoints, the viral suppression rates were similar between the two groups (90% vs 93%). Additionally, among the 425 patients who switched from Biktarvy to Cabenuva and completed the questionnaire, 90% preferred Cabenuva.

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