Rod Shaped Bacteria

BV is the most prevalent gynecologic infection in the U.S. among women ages 14-49, with more than 21 Million affected and four million women treated annually [1,2,3]. BV is an infection of the vagina by gram (-) and gram (+) anaerobic bacteria, with loss of the healthy and protective lactobacilli spp.microbiome.

The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including the following:

  • Increasing the risk of contracting other sexually transmitted diseases, such as chlamydia and gonorrhea, trichomoniasis, and herpes, which, if untreated, may lead to pelvic inflammatory disease and infertility;
  • Increasing the risk of HIV transmission; and,
  • In pregnant women, increasing the risk of pre-term birth [4].

BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women’s health outcomes [5].

BV has a significant impact on the work productivity and quality-of-life of affected women, with 60% of recurrent sufferers reporting a negative impact on work attendance, job performance and productivity, and 95% reporting a severe restriction in intimate partner relations [6,7].

The current recommended BV treatment regimen of a first-generation oral nitroimidazole (metronidazole)requires twice-a-day dosing for seven days for a total administration of seven grams of drug [8]. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent [9]. Poor adherence to anti-infective therapy is a problem that increases with the length and complexity of the drug regimen, and can lead to treatment failures, recurrent disease and the more rapid development of resistant microorganisms [10]. These, in turn, may lead to higher health care costs, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity [11].

More than 50 percent of women treated for BV will experience a recurrence within 12 months [12].

  1. Allsworth J.E., Peipert, J.F. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstetrics and gynecology 2007;109:114-20.
  3. IMS Health, 2014
  5. Fiscella, K. (1996). “Racial disparities in preterm births. The role of urogenital infections.” Public Health Rep 111(2): 104-113.
  6. Payne et al. (2010). “Evidence of African-American women’s frustrations with chronic, recurrent bacterial vaginosis.” Jn AANP 22(2010) 101-108.
  7. Bilardi et al. (2013). “The Burden of Bacterial Vaginosis: Women’s Experience of the Physical, Emotional, Sexual and Social Impact of Living with Recurrent Bacterial
  9. Bartley, J.B., et al. (2004). “Personal digital assistants used to document compliance of bacterial vaginosis treatment.” Sex Transm Dis 31(8): 488-491.
  10. Kardas, P. (2002). “Once-Daily Dosage Secures Better Compliance With Antibiotic Therapy of Respiratory Tract Infections Than Twice-Daily Dosage.” WONCA Europe 2002 Conference, London.
  11. Kardas, P., Bishai, W., (2006). “Compliance in anti-infective medicine.” Adv Stud Med 2006; 6(7C):S652:S658.
  12. Bradshaw CS, et al. (2006). “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 Jun 1;193(11):1478-86.
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