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 […]Read More
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 […]Read More
Shots: The MAA is based on P-III ATLAS and FLAIR studies results assessing cabotegravir + rilpivirine (monthly injectable) in 1,100+ patients with HIV-1 infection with suppressed viral load who are not resistant to cabotegravir or rilpivirine demonstrated similar efficacy to 3-drug oral regimen The EMA’s MAA follows NDA submission of dual regimen to the US […]Read More
Shots: The P-III ATLAS (n= 616) & FLAIR (n= 566) studies involve assessing of Rilpivirine + Cabotegravirin vs oral HIV therapies in virally suppressed HIV patients The ATLAS (NCT02951052) & FLAIR (NCT02938520) studies resulted in meeting its 1EPs i.e, plasma HIV-1 RNA ≥50 copies per milliliter (c/mL) & patients with virologic failure, non-inferior to Triumeq […]Read More
Copyright ©2020 PharmaShots | Powered by Octavus Consulting
