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  • Efficacy, stability, and biosafety of sifuvirtide gel as a microbicide candidate against HIV-1.

Efficacy, stability, and biosafety of sifuvirtide gel as a microbicide candidate against HIV-1.

PloS one (2012-05-23)
Liangzhu Li, Yinyin Ben, Songhua Yuan, Shibo Jiang, Jianqing Xu, Xiaoyan Zhang
ABSTRACT

Sifuvirtide is a proven effective HIV-1 entry inhibitor and its safety profile has been established for systemic administration. The present study evaluated the potential of sifuvirtide formulated in a universal gel for topical use as a microbicide candidate for preventing sexual transmission of HIV. Our data showed that sifuvirtide formulated in HEC gel is effective against HIV-1 B, C subtypes, CRF07_BC and CRF01_AE, the latter two recombinants represents the most prevalent strains in China. In addition, we demonstrated that sifuvirtide in gel is stable for at least 8 weeks even at 40°C, and did not cause the disruption of integrity of mucosal epithelial surface, or the up-regulation of inflammatory cytokines both in vitro or in vivo. These results suggest that sifuvirtide gel is an effective, safe and stable product, and should be further tested as a vaginal or rectal microbicide in pre-clinical model or clinical trial for preventing HIV sexual transmission.

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