ViiV Healthcare (/viːv/ VEEV) is a pharmaceutical company specializing in the development of therapies for HIV infection that was created as a joint venture by Pfizer and GlaxoSmithKline in November 2009 with both companies transferring their HIV assets to the new company. In 2012 Shionogi joined the company. 76.5% of the company is now owned by GlaxoSmithKline, 13.5% by Pfizer and 10% by Shionogi. This ownership structure may change depending upon the achievement of certain milestones.ViiV Healthcare's products have a market share of approximately 19% of the global HIV market, making it the second-largest healthcare company, after Gilead Sciences, which is working on the treatment of HIV.ViiV Healthcare's headquarters are in Brentford in the United Kingdom and it has sites in a number of other countries including; the United States, Australia, Belgium, Canada, France, Germany, Italy, Japan, Mexico, the Netherlands, Portugal, Puerto Rico, Russia, Spain and Switzerland.
Long-acting injectable PrEP (LAI-PrEP) provides opportunities to expand HIV prevention coverage in the Netherlands. Understanding which Dutch gay, bisexual and other men who have sex with men (GBMSM) are interested in using LAI-PrEP when available can support HIV prevention efforts. Survey data was collected online via the PROTECT survey from 1,447 GBMSM in the Netherlands between October 2023 and March 2024. Multivariable logistic analysis was conducted to determine variables associated with GBMSM who intend to use LAI-PrEP when available. Interest and intention to use LAI-PrEP among Dutch GBMSM is high (76.1
BACKGROUND:Randomized trials of long-acting injectable antiretroviral therapy (ART) in persons with human immunodeficiency virus (HIV) who face challenges with adherence to oral medication are lacking. METHODS:We conducted an open-label, randomized trial involving persons with HIV who had inadequate adherence to ART (a persistent HIV-1 RNA level of >200 copies per milliliter or loss to follow-up). Participants received up to 24 weeks of adherence support, conditional economic incentives, and standard care with oral ART (step 1). Participants who had an HIV-1 RNA level of 200 copies per milliliter or lower in step 1 were randomly assigned in a 1:1 ratio to either continue standard care or switch to monthly injections of long-acting cabotegravir plus rilpivirine with or without oral lead-in therapy (step 2). The primary outcome was regimen failure, defined as confirmed virologic failure (two consecutive HIV-1 RNA measurements of >200 copies per milliliter) or treatment discontinuation during step 2. RESULTS:In step 1 of the trial, we enrolled 453 participants; the median age was 40 years, 63% were Black, and 29% had been assigned female sex at birth. In step 2, a total of 306 participants underwent randomization; 152 were assigned to receive cabotegravir-rilpivirine and 154 to receive standard care. Step 2 randomization was stopped early on the basis of the superiority of cabotegravir-rilpivirine to standard care in secondary outcomes at a prespecified analysis performed after a median follow-up of 48 weeks. The cumulative incidence of regimen failure by week 48 was 22.8% in the cabotegravir-rilpivirine group and 41.2% in the standard-care group (difference, -18.4 percentage points; 98.4% confidence interval [CI], -32.4 to -4.3; P = 0.002). The cumulative incidence of an adverse event was 43.5% in the cabotegravir-rilpivirine group and 42.4% in the standard-care group (difference, 1.1 percentage points; 95% CI, -12.7 to 15.0). Resistance-associated mutations developed in 2 participants with confirmed virologic failure in each group. CONCLUSIONS:Monthly injections of long-acting cabotegravir-rilpivirine were superior to standard oral ART in reducing the risk of regimen failure among persons with HIV who had adherence challenges. (Funded by the National Institute of Allergy and Infectious Diseases; LATITUDE ClinicalTrials.gov number, NCT03635788.).
HIV-1 resistance to therapeutics can emerge through diverse mutational routes, yet the determinants guiding pathway selection in vivo remain unclear. Through comprehensive screening, we identify 18 mutations in the HIV-1 Env protein that enhance resistance to the FDA-approved small-molecule therapeutic temsavir. We then examine their occurrence in HIV-infected individuals who developed resistance on therapy. Interestingly, only a subset of the resistance-enhancing mutations emerged in vivo. On-treatment mutation frequencies correlate with their emergence rates in temsavir-untreated individuals and are governed by two parameters: (1) probability of mutation appearance, determined by the number and type of nucleotide changes required, and (2) probability of mutation persistence, determined by Env functional and immune fitness. Notably, non-neutralizing antibodies commonly elicited in HIV-infected individuals restrict emergence of multiple resistant forms, driving convergence to a narrow set of escape routes. These findings establish a quantitative framework for predicting therapeutic resistance and reveal how host immunity constrains viral evolution during treatment.
Introduction Les traitements DTG/3TC (dolutégravir/lamivudine) et CAB+RPV LA (cabotégravir + rilpivirine longue durée d'action) présentent une efficacité et une tolérance établies, avec peu d'interactions médicamenteuses. VOLITION (NCT05917509) est la première étude à évaluer le passage de DTG/3TC vers CAB+RPV LA immédiatement après l'obtention d'une suppression virologique, chez des adultes vivant avec le VIH-1 naïfs de traitement antirétroviral (ARV). Nous présentons les résultats intermédiaires de VOLITION. Matériels et méthodes VOLITION est une étude de phase 3b, multicentrique, non randomisée, en groupes parallèles et en ouvert, évaluant la suppression virale initiale avec DTG/3TC jusqu'à 16 semaines, suivie d'un switch optionnel vers CAB+RPV LA tous les 2 mois ou d'une poursuite du DTG/3TC jusqu'au mois 11/12. Le critère d'évaluation principal lors de la phase de suppression était le délai d'obtention de la suppression virologique (ARN VIH-1 <50 copies/mL). Résultats 171 patients ont été inclus et ont initié le DTG/3TC, avec 26 % (45/171) de femmes, 30 % (51/171) de Noirs ou Afro-Américains et 18% (30/171) d'Hispaniques/latino-américains. Le délai médian (IC à 95 %) pour atteindre la suppression virologique avec DTG/3TC était de 4,1 (4,1–4,3) semaines et 98 % (167/171) ont atteint la suppression virologique au cours des 16 semaines. Un patient a présenté un échec virologique confirmé définie par le protocole (2 valeurs consécutives d'ARN VIH-1 ≥200 c/mL après suppression préalable) sans détection de mutations associées à la résistance. Au total, 10 % (17/171) ont présenté un événement indésirable lié au traitement (tous de grade 1 ou 2), avec peu d'effets indésirables ayant conduit à l'arrêt (<1 %, 1/171). Les patients ont rapporté des niveaux élevés de satisfaction vis-à-vis du traitement avec DTG/3TC (score moyen : 58/66) pendant la phase de suppression. La plupart des patients éligibles au switch ont choisi CAB+RPV LA le jour du choix (89 %, 129/145) et ont exprimé un avis positif sur ce changement. Conclusion DTG/3TC en prise unique quotidienne a permis d'obtenir une suppression virologique rapide dans une population diversifiée d'adultes vivant avec un VIH-1 naïfs de traitement, confirmant sa puissance et permettant aux patients de choisir une transition précoce vers une thérapie injectable LA.
