An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity.

Background: Immunocompromised individuals have a limited humoral immune response to SARS-CoV-2 vaccination and are at higher risk of severe COVID-19. Sotrovimab is a monoclonal antibody (mAb) targeting a conserved SARS-CoV-2 spike protein epitope.

Methods: This phase II open-label study evaluated the safety and tolerability of sotrovimab pre-exposure prophylaxis in immunocompromised adults with impaired vaccine response.

Monitoring the emergence of resistance with sotrovimab in immunocompromised patients with COVID-19: LUNAR study.

Objectives: To assess outcomes in sotrovimab-treated immunocompromised patients in the United Kingdom.

Methods: Multicenter, prospective, observational, descriptive study in immunocompromised, non-hospitalized adults infected with SARS-CoV-2 who received intravenous sotrovimab 500 mg as standard-of-care (July 1, 2022-June 30, 2023; Omicron predominance). Virology analyses included determination of SARS-CoV-2 viral load, spike sequencing, and determination of amino-acid substitutions in the spike protein and sotrovimab epitope.

Pharmacokinetics and Safety of Single-Dose Sotrovimab in High-Risk Children and Adolescents With Mild-to-Moderate COVID-19.

Sotrovimab was well tolerated by children/adolescents (6 to <18 years) with mild-to-moderate COVID-19 at high risk of progression to severe disease. Pharmacokinetic parameters in adolescents (12 to <18 years) were generally similar to those reported in adult studies of sotrovimab.

Safety and tolerability of intramuscular sotrovimab administered at different injection sites: results from the Phase 1 COSMIC study.

ClinicalTrials.gov identifier, NCT05280717.

Pharmacokinetics of the Monoclonal Antibody, Sotrovimab, in Healthy Participants Following IM Administration at Different Injection Sites.

Sotrovimab is a recombinant human monoclonal antibody for the early treatment of mild-to-moderate COVID- 19. A phase I, open-label, randomized, parallel-group study was conducted to investigate the pharmacokinetics, relative bioavailability, safety, and tolerability of two concentrations of sotrovimab administered intramuscularly at different injection sites in healthy volunteers. The study consisted of three parts (A, B, and C) and the pharmacokinetic results from Part A are reported herein.

Pharmacokinetic and pharmacokinetic/pharmacodynamic characterization of the dolutegravir/rilpivirine two-drug regimen in SWORD-1/-2 phase 3 studies.

Aim: SWORD-1 and SWORD-2 phase 3 studies concluded that switching virologically suppressed participants with HIV-1 from their current three- or four-drug antiretroviral regimen (CAR) to the two-drug regimen of once-daily dolutegravir (DTG, 50 mg) and rilpivirine (RPV, 25 mg) was safe, well tolerated and noninferior for maintaining HIV-1 suppression at week 48 and highly efficacious to week 148. A secondary objective was to characterize drug exposure and exposure-efficacy/safety relationships.

Methods: Adults with plasma HIV-1 RNA <50 copies/mL were randomized to switch to once-daily DTG + RPV on day 1 or to continue CAR for 52 weeks before switching.

Brief Report: Evaluation of Inflammation and Atherogenesis Biomarkers Through 148 Weeks Postswitch to Dolutegravir and Rilpivirine in SWORD-1/SWORD-2.

Background: Switching to the 2-drug regimen dolutegravir + rilpivirine demonstrated noninferiority vs continuing a 3-drug or 4-drug current antiretroviral regimen (CAR) at week 48 and maintained high levels of virologic suppression to week 148 in the SWORD studies. We report inflammation and atherogenesis biomarkers postswitch to dolutegravir + rilpivirine.

Setting: SWORD-1: 65 centers, 13 countries; SWORD-2: 60 centers, 11 countries.

Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study.

Background: Dolutegravir is a once-daily integrase strand transfer inhibitor with no need for pharmacokinetic boosting that is approved for the treatment of HIV-1 infection. Because women are often under-represented in HIV clinical trials, we addressed the safety and efficacy of dolutegravir in women with HIV-1.

Methods: The ARIA study is a randomised, open-label, multicentre, active-controlled, parallel-group, non-inferiority phase 3b study done in 86 hospital and university infectious disease clinics, local health clinics, and private infectious disease clinics in 12 countries and one US territory, in North America, South America, Europe, Africa, and Asia.