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Effect of in vitro exposure of first-line antiretrovirals on healthy human spermatozoa on kinematics and motility.
Int Urol Nephrol
January 2025
Department of Urology, Faculty of Health Sciences, Steve Biko Academic Hospital, University of Pretoria, Pretoria, South Africa.
Purpose: Contemporary antiretroviral (ARV) medications are used by millions of men for HIV treatment worldwide. Limited data exist on their direct effect on sperm motility. This pilot study hypothesizes that in vitro exposure to ARVs will reduce sperm kinematic and motility parameter values.
View Article and Find Full Text PDFGeneralizing the intention-to-treat effect of an active control from historical placebo-controlled trials: A case study of the efficacy of daily oral TDF/FTC in the HPTN 084 study.
J Am Stat Assoc
July 2024
Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center.
In many clinical settings, an active-controlled trial design (e.g., a non-inferiority or superiority design) is often used to compare an experimental medicine to an active control (e.
View Article and Find Full Text PDFEvaluation of long-acting cabotegravir safety and pharmacokinetics in pregnant women in eastern and southern Africa: a secondary analysis of HPTN 084.
J Int AIDS Soc
January 2025
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Introduction: Long-acting injectable cabotegravir (CAB-LA) for pre-exposure prophylaxis significantly reduced HIV acquisition in HPTN 084. We report on the safety and CAB-LA pharmacokinetics in pregnant women during the blinded period of HPTN 084.
Methods: Participants were randomized 1:1 to either active cabotegravir (CAB) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) placebo or active TDF/FTC plus CAB placebo.
Resolution of Neuropsychiatric Adverse Events After Switching to a Doravirine-Based Regimen in the Open-Label Extensions of the DRIVE-AHEAD and DRIVE-FORWARD Trials.
J Acquir Immune Defic Syndr
January 2025
MSD France, Puteaux, France.
Background: Neuropsychiatric adverse events (NPAEs) are associated with several antiretrovirals. Doravirine (DOR), a non-nucleoside reverse transcriptase inhibitor indicated for HIV-1 treatment, does not interact significantly with known neurotransmitter receptors in vitro. First-line therapy with DOR-based regimens resulted in significantly fewer NPAEs than efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) and similar rates to those of ritonavir-boosted darunavir (DRV/r) with 2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) through Week 96 of the phase 3 DRIVE-AHEAD and DRIVE-FORWARD studies, respectively.
View Article and Find Full Text PDFDeterminants of outcomes in patients with hepatitis B virus-decompensated cirrhosis.
Sci Rep
January 2025
Department of Public Health, College of Public Health, China Medical University, No. 100, Sec. 1, Jingmao Rd., Beitun Dist., Taichung, 406040, Taiwan.
The role of pre-treatment HBV DNA levels on the prognosis of hepatitis B virus-related decompensated cirrhosis is unclear. This study investigated the effects of pre-treatment HBV DNA and other determinants on short-term and long-term survival of chronic hepatitis B (CHB) patients with decompensated cirrhosis. A total of 278 cirrhotic decompensated CHB patients treated with entecavir or tenofovir disoproxil fumarate were retrospectively enrolled.
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