Single-Dose Oral Secnidazole for Treatment of Trichomoniasis in Women With BV Co-infection [A119]

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INTRODUCTION: Bacterial vaginosis (BV) and trichomoniasis are the most common causes of vaginitis. Both infections are associated with increased risk for HIV/STIs and adverse reproductive health outcomes. Coexistence of BV pathogens and Trichomoniasis vaginalis is common, with co-infection rates of 60–80%. In this secondary analysis of clinical trial data of single-dose oral secnidazole (SEC) for the treatment of women with trichomoniasis, we review a subset of women with both trichomoniasis and BV. METHODS: In an institutional review board‒approved study, women with clinically diagnosed trichomoniasis were randomized to SEC 2 g oral granules or placebo at baseline (Visit 1). At Visit 2 (days 6–12), patients were evaluated for test-of-cure by T. vaginalis culture and were provided the opposite treatment. The primary endpoint was microbiological cure (negative culture for T. vaginalis) at the TOC visit. BV was clinically diagnosed at both visits using Amsel’s criteria. RESULTS: Overall, 147 women were enrolled; the modified intent-to-treat (mITT) population included 131 randomized patients. Cure rates were 92.2% and 1.5% for SEC and placebo (P<.001). The per-protocol population included 119 patients. Cure rates were 94.9% and 1.7% for SEC and placebo, respectively. In the mITT subgroup of women with BV based on at least three Amsel criteria (n=79), cure rates for trichomoniasis were 97.67% (42/43) for SEC and 0/36 for placebo. CONCLUSION: Single-dose oral SEC was highly effective in treating trichomoniasis in women with BV co-infection. Co-infection is common and appropriate treatment for both infections is critical. SEC is the only FDA-approved single-dose treatment for BV in women and trichomoniasis in women and men.

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