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Pharmacokinetics and safety of bictegravir in pregnant and postpartum persons with HIV and their infants.
J Acquir Immune Defic Syndr
November 2024
Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.
Background: Limited data exist on bictegravir pharmacokinetics in pregnancy among persons with HIV (PWH) and infant washout.
Setting: Nonrandomized, open-label, multi-center phase-IV prospective study of bictegravir pharmacokinetics and safety in pregnant PWH and their infants.
Methods: Steady-state 24-hour pharmacokinetic sampling of oral bictegravir 50 mg once daily (a component of fixed-dose combination bictegravir/emtricitabine/tenofovir alafenamide) during the 2nd and 3rd trimesters and postpartum was performed.
Week 96 Results of Bictegravir/Emtricitabine/Tenofovir Alafenamide for HIV Treatment in People With Substance Use Disorders.
Open Forum Infect Dis
January 2025
College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Background: The BASE study (NCT03998176), a phase 4, 48-week (W), single-arm, prospective trial, revealed that the use of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with HIV and substance use disorders (PWH/SUD) was safe and effective without emergent antiretroviral resistance despite incomplete adherence. Here, we present the W96 results.
Methods: A retrospective analysis of all participants enrolled in the BASE study was completed from W48 to W96.
Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve and treatment-experienced people with HIV: 12-month virologic effectiveness and safety outcomes in the BICSTaR Japan cohort.
PLoS One
January 2025
AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
BICSTaR (BICtegravir Single Tablet Regimen) is an ongoing, observational cohort study assessing the virologic effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-experienced (TE) and treatment-naïve (TN) people with HIV across 14 countries over 24 months. We present 12-month outcomes from participants in the BICSTaR Japan cohort. Retrospective and prospective data were pooled from people with HIV aged ≥20 years receiving B/F/TAF within routine clinical care in Japan.
View Article and Find Full Text PDFSafety and efficacy of lamivudine/dolutegravir vs. bictegravir/emtricitabine/tenofovir alafenamide in antiretroviral-naive adults with HIV-1 infection in Shanghai, China: a single-centre retrospective study.
J Med Microbiol
January 2025
Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, PR China.
Lamivudine plus dolutegravir (3TC/DTG) and bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) regimens are commonly used as first-line treatments for people living with human immunodeficiency virus (HIV) (PLWH) worldwide. There are limited comparative data on the antiviral activity and safety between these regimens in ART-naive PLWH, particularly in China, where the 3TC/DTG regimen was integrated into first-line therapy in 2021 and gained broader adoption after its inclusion in the National Health Insurance in 2022. This study aims to provide real-world evidence comparing the 3TC/DTG regimen to the B/F/TAF regimen in ART-naive PLWH in China.
View Article and Find Full Text PDFEffectiveness, safety, and patient-reported outcomes of bictegravir/emtricitabine/tenofovir alafenamide in routine clinical care in Italy: 12-Month results from the BICSTaR cohort.
Int J STD AIDS
January 2025
Department of Medical Sciences, Infectious Diseases, University of Turin, Turin, Italy.
Background: BICSTaR is a multi-national, observational cohort evaluating the effectiveness, safety, and patient-reported outcomes (PROs) in treatment-naïve (TN) and -experienced (TE) people with HIV-1 receiving bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine clinical care. We present the 12-month (M12) outcomes of the Italian BICSTaR cohort.
Methods: Participants initiating B/F/TAF in routine care were prospectively followed.
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