SOLOSEC is a newly approved, effective treatment for trichomoniasis in patients and partners1
Single 2 g dose of SOLOSEC delivers 92.2% efficacy in women.2*
* 131 women were included in the modified intent-to-treat (mITT) population. The mITT population included all randomized patients who were culture positive for T. vaginalis and negative for STIs. The mITT population was the primary efficacy population. Microbiologic cure defined as InPouch™ test negative for T. vaginalis at V2. Subjects with no test results were assumed to be positive.
95% CI: 82.7, 97.4
95% CI: 0.04, 8.0
Same single dose 2 g SOLOSEC approved to treat male partners1
CDC recommends simultaneous treatment of partners to prevent reinfection.3
Reported cure rates in males ranged from
91.7%
(165/180) to
100%
(30/30)1
SOLOSEC demonstrated high clinical efficacy in patients co-infected with trichomoniasis and BV.
95.2% cure rate was demonstrated in trichomoniasis patients with BV at baseline.2*
* Post-hoc analysis was performed on a subgroup of patients with BV at baseline (N = 21). Patients met all four of the Amsel criteria (abnormal discharge, clue cells > 20% of total epithelial cells, positive potassium hydroxide (KOH) whiff test, and vaginal pH > 4.7.
95% CI: 76.18, 99.88
95% CI: 0.00, 19.51
Co-existence of trichomoniasis and bacterial vaginosis (BV) is common.4
Research demonstrated that approximately
70%
of women with trichomoniasis were PCR positive for BV.4
SOLOSEC demonstrated efficacy against trichomoniasis in the female HIV+ immunocompromised population.2
For patients with HIV+ infection, the cure rate in the SOLOSEC 2 g group was
100%
(4/4 patients)
compared to 0% in the placebo group (0/5).2
SOLOSEC: the 2 g single-dose choice approved for treating trichomoniasis in both patients and partners1
2021 CDC STI guidelines no longer recommend single dose metronidazole for the treatment of trichomoniasis in women.3
2021 CDC STI guidelines no longer recommend single dose metronidazole for the treatment of trichomoniasis in women.3
SOLOSEC Trichomoniasis Pivotal Study Design2
  • Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2 g 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.
  • Study enrolled 147 nonpregnant female patients ≥ 12 years of age.
  • Patients were excluded from the modified intent to treat (mITT) due to negative trichomoniasis culture at baseline (n = 7 in the secnidazole group; n = 5 in the placebo group) and testing positive for other STIs (n=4 in the secnidazole group; n = 1 in the placebo group). Patients could have multiple reasons for exclusion.

The primary efficacy endpoint was microbiological cure at visit 2 (test-of-cure [TOC]). In the modified intent to treat (mITT) population, the microbiologic cure rate was significantly higher (p < 0.001) in the secnidazole group vs. the placebo group (92.2% [95% confidence interval {CI}: 82.7% - 97.4%] vs. 1.5% [95% CI: .0% - 8.0%]).


Post-hoc efficacy analyses were performed on subgroups that included women with BV at baseline and women with HIV.


Microbiological Cure in Women with Bacterial Vaginosis or Human Immunodeficiency Virus at Baseline – Post-Hoc Analysis
** P value vs placebo from a Cochran-Mantel-Haenszel test adjusted for clinical symptoms (present/absent) of trichomoniasis at baseline.
† p < 0.001, 95% CI: 76.2-99.9
‡ P value and 95% CI not calculated due to small sample size.

The single oral 2 g secnidazole dose was also assessed in four open-label trials in males (one comparative study with metronidazole and ornidazole in males only and three single-arm studies in males and females).1,5-8

Parasitological evaluation was performed both pre- and post-treatment and reported cure rates ranged from 91.7% (165/180) to 100% (30/30) at time points ranging from 2 to 20 days (n=437, 211 males and 226 females).1,5-8

In addition, the natural history of trichomoniasis in men was evaluated in one study. The spontaneous resolution during a mean follow-up of 16 ± 12 days was noted in 36% (5/14) (95% CI: 12.8%, 64.9%) of untreated men.1,9

References:
1. SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2021. 2. Muzny CA, Schwebke JR, Nyirjesy P, et al. Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study. Clin Infect Dis 2021. 3. Workowski KA, Bachmann LH, Chan PA, et al. CDC Sexually Transmitted Diseases Treatment Guidelines, 2021. MMWR Recomm Rep 2021;70(RR-04):1-192. 4. Sobel JD, Subramanian C, Foxman B, Fairfax M, Gygax S. Mixed Vaginitis—More than Coinfection and with Therapeutic Implications. Curr Infect Dis Rep 2013;15:104-108. 5. Özbilgin A, Özbel Y, Alkan MZ et al. Trichomoniasis in non-gonococcic urethritis among male patients. J Egypt Soc Parasitol. 1994; 24(3):621-625. 6. Dyudyun AD, Polyon NM, Gorbuntsov VV. Secnidazole in complex treatment of patients with urogenital trichomoniasis. Dermatovenerology Cosmetology Sexopathology. 2016;1(4): 287-292. 7. Siboulet A, Catalan F, Videau D, Niel G. Urogenital trichomoniasis. Trials with a long half- life imidazole: secnidazole. Med Mal Infect. 1977;7(9):400-409. 8. Videau D, Niel G, Siboulet A, Catalan F. Secnidazole: A 5-nitroimidazole derivative with a long half-life. Br J Vener Dis. 1978;54(2):77-80. 9. Krieger JN, Verdon M, Siegel N, Holmes KK. Natural history of urogenital trichomoniasis in men. J Urol. 1993 Jun;149(6):1455-8.