Category: cabotegravir
GlaxoSmithKline’ majority-owned HIV unit ViiV has scored a key FDA approval, getting approval for its long-acting drug cabotegravir as the first injectable for pre-exposure prophylaxis (PrEP) –challenging market leader Gilead Sciences. Cabotegravir – given the trade name Apretude – can be dosed just six times a year and showed superior results to daily, oral therapy […]
Shots: The P- IIIb ATLAS-2M study involves assessing long-acting cabotegravir and rilpivirine regimen for the treatment of HIV The ATLAS-2M 96wks. data reinforce the 1EPs @48wks. demonstrated the efficacy of every 2mos. dosing (q8w) was non-inferior to monthly dosing (q4w) dosing with (2.1% & 1.1%) participants having HIV-1 RNA ≥50 c/mL. The 2EPs @96 wks. […]
In a recent interview with PharmaShots, Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare shared information on the positive findings presented at the 2020 Infectious Diseases Society of America (IDWeek) and the impact of COVID-19 on the development of long-acting cabotegravir and rilpivirine. Shots: The company reported the positive findings of […]
Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020) Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing […]
Shots: The company reported the positive findings of a pooled analysis of six ongoing clinical studies which includes P-IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE studies evaluating long-acting cabotegravir and rilpivirine regimen in 1,744 patients with HIV-1 infection across 16 countries The positive findings showed 93% of participants maintained their injection visits amid the […]
The company said Tuesday that a final analysis of its Phase IIb/III study of cabotegravir showed greater efficacy in HIV prevention than Gilead’s Truvada. The study, among men and transgender women who have sex with men, was stopped in May following an interim analysis.