2022年2月2日,美国食品和药物管理局(FDA)批准扩大Cabenuva (cabotegravir/rilpivirine)注射剂的标签,每2个月给药一次,用于治疗成人的HIV-1感染,以替代目前的抗逆转录病毒疗法。 这些患者为病毒学抑制的成人(HIV-1 RNA 50拷贝/mL或更少),...
The US FDA approval of long-acting cabotegravir and rilpivirine for use every two months is based on the global ATLAS-2M phase IIIb trial results, which demonstrated that every-two-month dosing was non-inferior to once-monthly dosing.2Non-inferiority was determined by ...
Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required mo...
The approval was supported by the Phase IIIATLAS trial, which showed that 93% of people randomly assigned to switch to Cabenuva maintained viral suppression at 48 weeks, as did 96% of those who stayed on their daily oral regimen. The follow-upATLAS-2M studyshowed that every-other-month dosi...
No, Cabenuva is a long-acting medication given by your healthcare provider as 2 separate injections (cabotegravir and rilpivirine) into your gluteal (buttock) muscles once every month OR once every other month. Cabenuva is used for the treatment of HIV-1 infection in patients 12 years of age...
ATLAS (NCT02951052)is a Phase 3, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity, safety and tolerability of a two-drug regimen of long-acting, injectable rilpivirine and cabotegra...