ArticleThe Journal of antimicrobial chemotherapy2022
Safety and efficacy of a biodegradable implant releasing tenofovir alafenamide for vaginal protection in a macaque model.
Article in The Journal of antimicrobial chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 12 citations in OpenAlex.
- An ultra-long-acting dimeric bictegravir prodrug defined by a short pharmacokinetic tail.Nature communications · 2026Article
- Review
- Willingness of adolescent girls and young women to participate in future clinical trials of long-acting PrEP implants for HIV prevention, Kampala Uganda.PLOS global public health · 2025Article
- Zero-Order Kinetics Release of Lamivudine from Layer-by-Layer Coated Macromolecular Prodrug Particles.International journal of molecular sciences · 2024Article
- REverse transcriptase ACTivity (REACT) assay for point-of-care measurement of established and emerging antiretrovirals for HIV treatment and prevention.Analytical and bioanalytical chemistry · 2024Article
- Weekly Oral Tenofovir Alafenamide Protects Macaques from Vaginal and Rectal Simian HIV Infection.Pharmaceutics · 2024Article
- A Bilayer Microarray Patch (MAP) for HIV Pre-Exposure Prophylaxis: The Role of MAP Designs and Formulation Composition in Enhancing Long-Acting Drug Delivery.Pharmaceutics · 2024Article
- Pharmacokinetic Study of Islatravir and Etonogestrel Implants in Macaques.Pharmaceutics · 2023Article
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Authors and funding
18 authors at 3 institutions in 1 country.
Funding
Abstract
objectivesTo advance the initiative of ending the global epidemic, long-lasting HIV protection is needed through sustained release of antiretroviral drugs for months to years. We investigated in macaques the safety and efficacy of biodegradable polycaprolactone implants releasing tenofovir alafenamide for HIV pre-exposure prophylaxis (PrEP).
methodsImplants were administered subcutaneously in the arm using a contraceptive trocar. Efficacy against vaginal simian-HIV (SHIV) infection was investigated in six pigtailed macaques that received two tenofovir alafenamide implants (0.35 mg/day), one in each arm, for a total release rate of tenofovir alafenamide at 0.7 mg/day. Macaques were exposed to SHIV twice weekly for 6 weeks. Statistical analyses were used to compare outcome with eight untreated controls. Histological assessments were performed on skin biopsies collected near implantation sites.
resultsMedian (range) tenofovir diphosphate level in PBMCs was 1519 (1068-1898) fmol/106 cells. All macaques with tenofovir alafenamide implants were protected against vaginal SHIV infection. In contrast, 7/8 controls were infected after a median of 4 SHIV exposures (P = 0.0047). Histological assessment of tissues near tenofovir alafenamide implant sites showed inflammation and necrosis in 5/6 animals, which were not evident by visual inspection.
conclusionsWe demonstrated complete protection against vaginal SHIV infection with two implants releasing a total of 0.7 mg of tenofovir alafenamide per day. We also identified tenofovir diphosphate concentrations in PBMCs associated with complete vaginal protection. Consistent with previous findings, we observed adverse local toxicity and necrosis near the tenofovir alafenamide implant site. Improved tenofovir alafenamide implants that are safe and maintain high efficacy have the potential to provide long-lasting protection against vaginal HIV infection.
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