(034) Secnidazole for Trichomoniasis: Results from a Clinical Trial with Women and a Systematic Literature Review for Men

Abstract Introduction Trichomoniasis is the most prevalent non-viral sexually transmitted infection (STI) in world, affecting ~4.1% of women and ~1.3% men aged 40–59 United States. Women with T. vaginalis are at 2- to 3-fold increased risk for acquiring human immunodeficiency virus (HIV). also associated vaginitis, pelvic inflammatory disease, post-hysterectomy cuff cellulitis other STIs. In addition, it can cause infertility increase a woman’s adverse pregnancy outcomes including preterm birth, premature rupture membranes, delivery low birthweight infants. men, trichomoniasis non-gonococcal urethritis, although frequently asymptomatic may seek treatment only after knowing that their female partners infected. Current CDC guidelines recommend concurrent both prevent transmission reinfection. Objectives To evaluate efficacy tolerability secnidazole trichomoniasis. Because logistical statistical considerations precluded inclusion clinical trial, we conducted systematic literature search (19May2020) identify studies male patients Secnidazole FDA-approved bacterial vaginosis women. Methods randomized trial (RCT), diagnosis received single, oral dose 2g or placebo baseline (Visit 1). At Visit 2 (days 6–12), they were evaluated test cure (TOC) switched opposite treatment. The primary endpoint was microbiological (ie, InPouch™ culture negative vaginalis) TOC visit. Adverse events (AEs) monitored. A trained research associate used ProQuest Dialog™ BIOSIS Previews, EMBASE, MEDLINE using terms related secnidazole, trials, men/males, Results For RCT, 147 enrolled; modified intent-to-treat population included 131 patients. Cure rates 92.2% 1.5% (P<0.001). commonly reported AEs vulvovaginal candidiasis (2.7%) nausea (2.7%). No serious reported. review, 4 identified, which 211 who one study (n=85), rate 5 days 100%. 3 women, 92–97%. reporting AEs, common (4–9%), dyspepsia (0.5–1.1%). Pharmacokinetics data showed no clinically meaningful differences exposure (Cmax, AUC) between women; however, mean (±SD) half-life (hours) longer versus (20.2 hours [±3.1] vs. 14.3 [±1.3]). Conclusions RCT trichomoniasis, significantly higher single-dose placebo, profiles comparable groups. review rates, tolerability, pharmacokinetics those Disclosure Yes - Lupin Pharmaceuticals, Inc. Industry initiated, executed funded – Yes.