Human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) strategies with proven in vivo efficacy rely on antiretroviral drugs, creating the potential for drug resistance and complicated treatment options in individuals who become infected. Moreover, on-demand products are currently missing from the PrEP development portfolio. Griffithsin (GRFT) is a non-antiretroviral HIV entry inhibitor derived from red algae with an excellent safety profile and potent activity in vitro. When combined with carrageenan (CG), GRFT has strong activity against herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV) in vitro and in vivo. Here, we report that GRFT/CG in a freeze-dried fast dissolving insert (FDI) formulation for on-demand use protects rhesus macaques from a high dose vaginal SHIV SF162P3 challenge 4 h after FDI insertion. Furthermore, the GRFT/CG FDI also protects mice vaginally against HSV-2 and HPV pseudovirus. As a safe, potent, broad-spectrum, on-demand non-antiretroviral product, the GRFT/CG FDI warrants clinical development.

中文翻译：

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Griffithsin 角叉菜胶快速溶解插入物可防止体内 SHIV HSV-2 和 HPV 感染。

已证明体内功效的人类免疫缺陷病毒 (HIV) 暴露前预防 (PrEP) 策略依赖于抗逆转录病毒药物，这为被感染的个体产生耐药性和复杂的治疗选择创造了可能性。此外，PrEP 开发组合中目前缺少按需产品。Griffithsin (GRFT) 是一种源自红藻的非抗逆转录病毒 HIV 侵入抑制剂，具有出色的安全性和有效的体外活性。当与角叉菜胶 (CG) 结合使用时，GRFT 在体外和体内对单纯疱疹病毒 2 (HSV-2) 和人乳头瘤病毒 (HPV) 具有很强的活性。在这里，我们报告说，用于按需使用的冻干快速溶解插入物 (FDI) 配方中的 GRFT/CG 可以在 FDI 插入后 4 小时保护恒河猴免受高剂量阴道 SHIV SF162P3 攻击。此外，GRFT/CG FDI 还可以保护小鼠阴道免受 HSV-2 和 HPV 假病毒的侵害。作为一种安全、有效、广谱、按需的非抗逆转录病毒产品，GRFT/CG FDI 值得临床开发。