Trichomoniasis is the most prevalent non-viral sexually transmitted infection (STI) worldwide, affecting 3.7 million people in the United States. Women with Trichomonas vaginalis have a two- to three-fold increased risk for acquiring human immunodeficiency virus (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.
In a recent development,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. The results of the study have been published in Clinical Infectious Diseases.
In the current study, researchers evaluated the efficacy and safety of secnidazole vs. placebo in women with trichomoniasis.
The study design consisted of Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2g or placebo. The primary endpoint was 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 (N=100) provided ~95% power to detect a statistically significant difference between treatment groups.
Data analysis revealed some interesting facts.
Between April 2019 and March 2020, 147 women enrolled at 10 US sites. The modified intent-to-treat (mITT) population included 131 randomized patients (64/67, in secnidazole/placebo).
Cure rates were significantly higher in the secnidazole vs. placebo group (92.2% [95% CI: 82.7–97.4] vs. 1.5% [95% CI: 0.0–8.0]) for the mITT population and for the per-protocol population (94.9% [95% CI: 85.9–98.9]) vs. 1.7% [95% CI: 0.0–8.9]).
Cure rates were 100% (4/4) in women with HIV and 95.2% (20/21) 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 (each 2.7%). No serious TEAEs were observed.
"In conclusion, this study demonstrated that a single dose of SEC 2 g was efficacious and well tolerated in women with trichomoniasis and in those with trichomoniasis and comorbid HIV and/or BV. If approved by the FDA for the treatment of trichomoniasis, SEC will be the only single oral-dose medication available for the treatment of BV and T. vaginalis. Future studies should be considered in pregnant women and those with persistent T. vaginalis infection, including the use of SEC multi-dose regimens."The team concluded.
FOR FULL ARTICLE FOLLOW THE LINK: https://doi.org/10.1093/cid/ciab242
PRIMARY SOURCE: Clinical Infectious Diseases