Single Oral Dosing of Secnidazole for Trichomoniasis in Wome
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Trichomoniasis is the most prevalent non-viral sexually transmitted infection (STI) worldwide, affecting 3.7 million people in the US. Women with Trichomonal Vaginalis have a two- to three-fold increased risk for acquiring HIV and other STIs. Trichomoniasis is also associated with infertility and adverse birth outcomes. National guidelines recommend annual screening of women with HIV for trichomoniasis.

Researchers evaluated the efficacy and safety of secnidazole vs. placebo in women with trichomoniasis. The study was published in Clinical Infectious Diseases.

Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2g or placebo. The primary endpoint was a microbiological test of cure (TOC) by culture 6–12 days after dosing. At the TOC visit, participants were given the opposite treatment. They were followed for resolution of infection afterward and offered treatment at subsequent visits if needed. Fifty patients per group provided ~95% power to detect a statistically significant difference between treatment groups.

147 women enrolled at 10 US sites. The modified intent-to-treat (mITT) population included 131 randomized patients.

--Cure rates were significantly higher in the secnidazole vs. placebo group for the mITT population and for the per-protocol population.

--Cure rates were 100% in women with HIV and 95.2% in women with bacterial vaginosis (BV).

--Secnidazole was generally well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were vulvovaginal candidiasis and nausea. No serious TEAEs were observed.

In particular, a single oral 2g dose of secnidazole was associated with significantly higher microbiological cure rates vs. placebo, supporting a role for secnidazole in treating women with trichomoniasis, including those with HIV and/or BV.