BV Challenge

What percentage of women with BV are asymptomatic?

84% of women are asymptomatic for the infection.2

Below are some factors of differential diagnosis:


Based on a vaginal pH greater than 4.5, which diagnosis do you suspect:

BV provides a high pH environment allowing T. vaginalis to grow.4


Vaginal pH


In the Longitudinal Study of Vaginal Flora, women who presented for routine health visits and were diagnosed with BV were 1.5 – 2x more likely to develop trichomonal, gonococcal, and/or chlamydial infections.4

What percentage of women with trichomoniasis are also co-infected with BV?

Research demonstrated that approximately 70% of women with trichomoniasis were PCR positive for BV.5

CDC recommends diagnostic testing for T. vaginalis be performed in women seeking care for vaginal discharge.2

SOLOSEC is the only antibiotic therapy that delivers a complete course of treatment for BV and trichomoniasis in just one oral dose
1


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current treatments for bacterial vaginosis comparison chart
current treatments for bacterial vaginosis comparison chart
* Combination oral contraceptive ethinyl estradiol plus norethindrone
The comparative efficacy of SOLOSEC with the listed treatments has not been adequately studied. This is not a complete list of attributes for each product that may be important to a clinical decision. For the most updated information, consult the PI for each product.

Research has shown that what percentage of patients with BV do not adhere to a full course of metronidazole treatment (500mg BID x 7d)?

To get the full benefit of a drug's studied efficacy, it is important for patients to fully adhere to treatment as prescribed.12

SOLOSEC 2 g ONCE


1 dose
Metronidazole 500 mg
BID x 7 days*


14 doses
*CDC recommended oral regimen for both BV and trichomoniasis
SOLOSEC provides a complete course of therapy with one oral dose.1

For many women, BV is a recurrent problem. What percentage of women experience a recurrence of BV within 1 year?

Recurrent vaginal discharge could be a symptom of unidentified or inadequately treated bacterial vaginosis (BV).2



  • Non-compliance to a multiple-day metronidazole regimen is a contributing factor to persistent BV.13
  • As many as 50% of patients do NOT complete a full 7-day course of metronidazole.11

Select the health risk below that is NOT associated with bacterial vaginosis.

BV is associated with increased risk of other infections and complications.2
2.5x
risk for pelvic inflammatory disease (PID)16
3.0x
risk for postprocedural gynecological infections17
3.2x
risk for post-hysterectomy cuff cellulitis if co-infected with trichomoniasis18
2.4x
higher risk to be co-infected with trichomoniasis19


Increased risk of acquisition of gonorrhea, chlamydia, HPV, and HSV20
Increased risk of acquisition and transmission of HIV21
Increased risk of acquisition of gonorrhea, chlamydia, HPV, and HSV20
Increased risk of acquisition and transmission of HIV21

Select the neonatal complications that have been associated with bacterial vaginosis:

Maternal BV was associated with increased risk among preterm infants::
24%
increased risk for admission to NICU22
Maternal BV was associated with increased risk among full-term infants::
28%
increased risk of assisted ventilation at birth22
42%
increased risk for admission to NICU22
60%
increased risk for neonatal sepsis22
SOLOSEC has no pregnancy restrictions.1*

* Available data on pregnancy are limited to animal studies.
Metronidazole and tinidazole are contraindicated in the first trimester of pregnancy.6,7

What's the half-life of SOLOSEC?

The long half-life of secnidazole supports a 1-day, single-dose regimen of SOLOSEC.23

Comparative Half-Lives of 5-Nitroimidazole Compounds7,8
SOLOSEC offers an effective solution to assure adherence in patients without the need for multiple days of pills or creams/gels that may leak.1,24,25



References:
1. SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2021. 2. Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, Markowitz LE. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive healthexternal icon. Sex Transm Dis. 2007 Nov;34(11):864-9. 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. Brotman RM. Vaginal microbiome and sexually transmitted infections: an epidemiologic perspective. J Clin Invest. 2011;121(12):4610-4617. 5. 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. 6. Flagyl [prescribing information]. New York, NY: Pfizer; 2021. 7. Tinidazole Tablets [prescribing information]. Buffalo Grove, IL: G.D. PACK Pharmaceuticals, LLC; 2018. 8. Clindesse [prescribing information]. Allegan, MI: Pharmacia & Upjohn Company, LLC; 2014. 9. Metrogel [prescribing information]. Sellersville, PA. Teva Pharmaceuticals, USA; 2005. 10. Nuvessa [prescribing information. Irvine, CA: Allergan Pharmaceuticals International, Ltd.; 2018. 11. Bartley JB, Ferris DG, Allmond LM, Dickman ED, Dias JK, Lambert J. Personal digital assistants used to document compliance of bacterial vaginosis treatment. Sex Transm Dis 2004;31(8):488-491.23. 12. Kardas P, Bishai WR. Compliance in anti-infective medicine. Adv Stud in Med. 2006:6(July);652-658. 13. Marrazzo JM, Thomas KK, Fledler TL, Ringwood K, Fredricks DN. Relationship of Specific Vaginal Bacteria and Bacterial Vaginosis Treatment Failure in Women Who Have Sex with Women. Ann Intern Med 2008;149:20-28. 14. Hillier SL, Austin M, Macio I, et al. Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings. Clin Infect Dis 2020:1-6. 15. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis 2006; 193:1478–89. 16. Ness RB, Kip KE, Hillier SL et al. A Cluster Analysis of Bacterial Vaginosis-Associated Microflora and Pelvic Inflammatory Disease. Am J Epidemiol 2005;162(6):585-590. 17. Soper DE, Bump RC, Hurt WG. Bacterial vaginosis and trichomoniasis vaginitis are risk factors for cuff cellulitis after abdominal hysterectomy. Am J Obstet Gynecol 1990;163(3):1016-1021. 18. Persson E, Bergstrom M, Larsson PG et al. Infections after hysterectomy. A prospective nation-wide Swedish study. Acta Obstet Gynecol Scand 1996;75(8):757-761. 19. Balkus JE, Richardson BA, Rabe LK, et al. Bacterial vaginosis and the risk of Trichomonas vaginalis acquisition among HIV-1 negative women. Sex Trans Dis 2014;41(2):123-128. 20. Chavoustie SE, Maribona AS, Hanna M. Bacterial Vaginosis and the Risk for Sexually Transmitted Infections. Contemp Ob Gyn 2020. Educational Supplement. 21. Thurman AR, Kimble t, Herold B et al. Bacterial Vaginosis and Subclinical Markers of Genital Tract Inflammation and Mucosal Immunity. Aids Res Hum Retrovir 2015;31(11):1139-1152. 22. Dingens, AS, Fairfortune, TS, Reed, S et al. Bacterial vaginosis and adverse outcomes among full-term infants: a cohort study. BMC Pregnancy Childbirth 2016;278(16):1-8. 23. Nyirjesy P, Schwebke JR. Secnidazole: Next-generation antimicrobial agent for bacterial vaginosis treatment. Future Microbiol 2018;13:507-524. 8. Gillis JC, Wiseman LR. Secnidazole. A Review of its antimicrobial activity, pharmacokinetic properties and therapeutic use in the management of protozoal infections and bacterial vaginosis. Drugs 1996;51(4):621-638. 24. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetricians-Gynecologists, Number 215. Obstet Gynecol 2020:135(1):e1-e17. 25. U of Illinois-Chicago Drug Information Group. How to Use Vaginal Suppositories. Healthline.com. Updated 22 May 2017.