Transgender Women’s Barriers, Facilitators, and Preferences on Tailored Injection Delivery Strategies to Administer Long-Acting Injectable Cabotegravir (CAB-LA) for HIV Pre-exposure Prophylaxis (PrEP) Abstract
Methods: The ECLAIR study (ClinicalTrials.gov identifier, NCT02076178) was a randomized, placebo-controlled study in healthy men not at high risk of acquiring HIV-1. Participants were randomized (5:1) to once-daily oral cabotegravir 30mg or placebo tablets for 4 weeks, followed by gluteal ...
Ultra-long-acting delivery platforms for HIV pre-exposure prophylaxis (PrEP) may increase adherence and maximize public health benefit. We report on an injectable, biodegradable, and removable in-situ forming implant (ISFI) that is administered subcutane
A long-acting injectable formulation of the HIV integrase inhibitor cabotegravir (CAB-LA) is currently in clinical development for PrEP. Although the long plasma half-life of CAB-LA is an important attribute for PrEP, it also raises concerns about drug resistance emergence if someone becomes infe...
"A long-acting injectable for PrEP that does not require adherence to an oral daily pill is a great addition to the HIV prevention toolbox," said HPTN 083 protocol co-chair Beatriz Grinsztejn, MD, Ph.D., director of the Instituto de Pesquisa Clinica Evandro Chagas HIV/AIDS Clinical Researc...
US FDA approval is based on the results from two international phase IIb/III multicenter, randomised, double-blind, active-controlled trials, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men who have sex with men, transgen...
Zusammen können diese Probleme zu niedrigen PrEP-Anwendungsraten und damit zur Ausdehnung der HIV-Epidemie beitragen. Unsere Gemeinschaft braucht seit geraumer Zeit dringend weitere HIV-Präventionsoptionen, die ihren sich wandelnden Anforderungen gerecht werden können. Lang wirkendes Cabo...
Cabotegravir(S/GSK1265744, brand name Vocabria) was approved in 2021 by the FDA for the treatment of human AIDS in adults in combination withrilpivirineand for PrEP in persons who are at risk. It is available in tablet form and as anintramuscular injection, as well as in an injectable com...
Clinical Trials Experience In Adolescents In adolescents receiving APRETUDE for HIV-1 PrEP, the safety data were comparable to the safety data reported in adults receiving APRETUDE for HIV-1 PrEP [seeUse In Specific Populations]. Postmarketing Experience ...
ViiV Healthcare has begun a rolling submission of a new drug application (NDA) with the US Food and Drug Administration (FDA) for its long-acting cabotegravir to prevent human immunodeficiency virus (HIV) or pre-exposure prophylaxis (PrEP)....