Abstract
We compared the preclinical safety and efficacy of tenofovir (TFV) 1% gel with that of MZC gel [containing 50 μM MIV-150, 14 mM Zn(O2CCH3)2(H2O)2, and 3% carrageenan] through a series of in vitro, ex vivo, and in vivo assays. The two gels showed good antiviral therapeutic indexes (50% cytotoxic concentration/50% effective concentration ratios; range, >25 to 800). MZC showed greater anti-simian-human immunodeficiency virus reverse transcriptase (SHIV-RT) activity than TFV 1% gel in rhesus macaque vaginal explants. MZC protected mice from vaginal herpes simplex virus 2 (HSV-2) challenge (P < 0.0001), but the TFV 1% gel did not.
Highlights
We compared the preclinical safety and efficacy of tenofovir (TFV) 1% gel with that of MZC gel [containing 50 M MIV-150, 14 mM Zn(O2CCH3)2(H2O)2, and 3% carrageenan] through a series of in vitro, ex vivo, and in vivo assays
CAPRISA 004 and the VOICE trial showed a reduction in herpes simplex virus 2 (HSV-2) acquisition that correlated with the use of TFV vaginal gel
The 50% effective concentrations (EC50s) were calculated based on gel dilution factor in order to compare the efficacies of the two gels, each containing a different active pharmaceutical ingredient (API)
Summary
We compared the preclinical safety and efficacy of tenofovir (TFV) 1% gel with that of MZC gel [containing 50 M MIV-150, 14 mM Zn(O2CCH3)2(H2O)[2], and 3% carrageenan] through a series of in vitro, ex vivo, and in vivo assays. TZM-bl cells (1.5 ϫ 105/ml) or activated PBMCs (2 ϫ 106/ml) were treated for 1 h with dilutions of gels (triplicates) before adding 100 focus forming units (FFU) or one hundred 50% tissue culture infective doses (TCID50) of virus, respectively.
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