Background: Efforts to end the human immunodeficiency virus (HIV) epidemic may be threatened if limited preexposure prophylaxis (PrEP) resources are funneled from tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) to tenofovir alafenamide with emtricitabine (TAF/FTC) without proportional clinical benefits.
Methods: The study population was patients at a Boston community health center who were assigned male sex at birth, aged ≥18 years, and prescribed TDF/FTC for PrEP in the 12 months before TAF/FTC approval (October 2019). We determined the frequency of switching to TAF/FTC in the 12 months after approval, including clinically indicated switching (ie, creatinine clearance <60 mL/minute or reduced bone density), potentially unnecessary switching (ie, no indications for switching and no cardiovascular risk factors), and potentially harmful switching (ie, no indications for switching and either obesity or dyslipidemia).
Results: Of 2892 TDF/FTC users, mean age was 38 years, 96.0% were cisgender men, and 78.9% were white. A total of 343 (11.9%) switched to TAF/FTC. Based on documented renal, bone, and cardiovascular risk factors, we identified 24 (7.0%) with clinically indicated switching, 271 (79.0%) with potentially unnecessary switching, and 48 (14.0%) with potentially harmful switching. When indications for switching additionally included hypertension, diabetes, and creatinine clearance 60-70 mL/minute, 27.1% of switching was clinically indicated.
Conclusions: Few who switched to TAF/FTC had documented indications for switching, although some appear to have been switched in anticipation of indications developing. As generic TDF/FTC is further discounted, provider education and patient decision aids are needed to facilitate selection of PrEP medications that is both clinically sound and cost-effective.
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http://dx.doi.org/10.1093/ofid/ofab372 | DOI Listing |
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 PDFJ 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 PDFJ 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.
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 PDFSci 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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