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