Secnidazole May Successfully Treat STI Disproportionately Affecting Black Women
Lupin Pharmaceuticals Inc. (Lupin) announced positive results from its phase 3 trial assessing the efficacy and safety of secnidazole (Solosec) in female patients with trichomoniasis. Although trichomoniasis is common in the United States, the risk of being infected with the infection is nearly 10 times higher for African American women compared with non-Hispanic white women.
Lupin Pharmaceuticals Inc. (Lupin)
Trial Results
Although the STI is common in the United States, the risk of being infected with trichomoniasis is nearly 10 times higher for African American women compared with non-Hispanic white women.Trichomoniasis is 4 to 5 times more prevalent in women than men and is associated with adverse reproductive health outcomes such as infertility, preterm birth, and a 2- to 3-fold increased risk of HIV infection. Symptoms can include discomfort with urination and vaginal discharge. However, “most infected persons (70%-85%) have minimal or no symptoms, and untreated infections might last for months to year.”
Current treatments for the STI
“Labelling discussions will take place after FDA review of the clinical data,” Lupin stated when asked about the treatment’s efficacy in males. Additional clinical trials for secnidazole are under evaluation and consideration, according to the company.
However, the current
Secnidazole is currently approved by the FDA for bacterial vaginosis (BV) in adult women. Although full trial results are not yet available, Lupin plans to submit a supplemental
The infection is caused by a protozoan parasite called Trichomonas vaginalis (T. vaginalis). “Up to 53% of women with
Trial participants completed test-of-cure (TOC) visits within 6 to 12 days after trichomoniasis confirmation. The primary endpoint of microbiological cure was defined as a negative T. vaginalis culture.
In the per-protocol population, the cure rate was 94.9% (56/59) for secnidazole compared with 1.7% (1/60) for placebo (P <.001). The most commonly reported adverse events among participants were vulvovaginal candidiasis (2.7%) and nausea (2.7%).
Trichomoniasis Risk Factors
A separate, modified intent-to-treat (mITT) population (all randomized subjects who were culture positive for T. vaginalis and negative for gonorrhea and chlamydia at baseline) exhibited similar positive results: 92.2% (59/64) of secnidazole recipients achieved endpoint versus 1.5% (1/67) for placebo (P<.001). One
Among women, increased poverty level, lower educational attainment, unmarried status, and having been born in the United States were significantly associated with T. vaginalis infection. Additional risk factors include “younger age at sexual debut, greater number of lifetime and/or past 12 months sex partners, and chlamydia infection in the past 12 months.”
In
Although the CDC only recommends routine trichomoniasis screening of asymptomatic women with HIV, researchers
Socioeconomic determinants of health, including reduced access to healthcare, may partially contribute to racial disparities present in rates of trichomoniasis. The asymptomatic nature of the STI could also inhibit individuals from seeking out testing or treatment.
“From a social justice lens, it cannot be underscored that structural racism could be a contributing factor; neighborhood social disorganization has been shown to be significantly associated with T. vaginalis infection,”
High burden of infection in the black population may also be due to differences in sexual network characteristics (e.g., assortative mixing—favoring sexual partners of the same race), differences in individual-level sexual risk behaviors (e.g., higher numbers of sexual partners), and biological differences in susceptibility to infection.
However, researchers found racial disparities in T. vaginalis infection persisted despite adjustment for the number of sexual partners in the past year. This finding, in addition to the STI’s exceedance of perceived disparities present in other infections, points to additional underlying factors besides induvial-level sexual risk behaviors.
Although there is insufficient empirical evidence that increased screening can lead to epidemic control or reductions in racial dipartites, “it would be an injustice to the black population to continue to ignore this STI until such evidence is available,” researchers said. “Increased public health action is needed to eliminate the stark racial disparities in T. vaginalis infection and achieve racial equity in sexual health,” authors conclude.
References:
1. Flagg EW, Meites E, Phillips C, et al. Prevalence of trichomonas vaginalis among civilian, noninstitutionalized male and female population aged 14 to 59 Years: United States, 2013 to 2016. Sex Transm Dis. 2019; 46(10):e93-e96. doi: 10.1097/OLQ.0000000000001013.
2. Muzny CA. Why does trichomonas vaginalis continue to be a ‘neglected’ sexually transmitted infection? Clin Infect Dis. 2018; 67(2):218-220. doi: 10.1093/cid/ciy085.
3.Patel EU, Gaydos CA, Packman ZR, et al. Prevalence and correlates of trichomonas vaginalis infection among men and women in the United States. Clin Infect Dis. 2018; 67(2): 211-217. doi: 10.1093/cid/ciy079.
Newsletter
Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics.
Related Articles
- Barriers to Gender-Affirming Surgery Persist Despite High Satisfaction Rate
September 18th 2025
- Eating Behaviors May Predict GLP-1 Therapy Success in Type 2 Diabetes
September 18th 2025