HIV

Gilead Collaborates with Merck to Jointly Develop and Commercialize Lenacapavir + Islatravir for HIV

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Shots: The companies will co-develop & co-commercialize the combination of Gilead’s Lenacapavir and Merck’s Islatravir in long-acting oral & injectable formulations for HIV. Gilead & Merck will share global development & commercialization costs (60%/40%) respectively For oral products, Gilead will lead commercialization in the US… Read More »Gilead Collaborates with Merck to Jointly Develop and Commercialize Lenacapavir + Islatravir for HIV

Gilead Present Results of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV at CROI

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Shots: The P-II/III CAPELLA trial involves assessing lenacapavir (SC, every 6mos.) vs PBO in 36 participants in a ratio (2:1) with multi-drug resistant HIV-1 infection The study demonstrated virologic suppression @26wks., viral load reduction from baseline of ≥ 0.5 log10 copies/mL for 14days functional monothx.… Read More »Gilead Present Results of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV at CROI

ViiV Healthcare Presents Results of GSK3640254 (GSK’254) in P-IIa study for the Treatment of HIV at CROI

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Shots: The P-IIa POC study involves assessing GSK3640254 (GSK’254, qd) in 34 treatment-naïve adults with HIV. The study is divided into 2 parts- in part 1, patients received GSK’254 (10/200mg) vs PBO for 10days and in part 2, patients got GSK’254 (40/80140 mg) vs PBO… Read More »ViiV Healthcare Presents Results of GSK3640254 (GSK’254) in P-IIa study for the Treatment of HIV at CROI

ViiV Healthcare Present Results of Long- Acting Cabotegravir and Rilpivirine in P-IIIb ATLAS-2M Study for HIV at CROI 2021

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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%)… Read More »ViiV Healthcare Present Results of Long- Acting Cabotegravir and Rilpivirine in P-IIIb ATLAS-2M Study for HIV at CROI 2021

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

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Shots: The approval is based on P1093 & ODYSSEY (Penta20) studies assessing safety, tolerability & dose-finding of Tivicay (5mg) in pediatric patients aged 4wks.-18yrs. while the second study assessed the 1L & 2L treatment in patients of the same age The approval includes updated dosing… Read More »ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

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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… Read More »ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention