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The Condition

The Condition

Vulvovaginal candidasis (VVC) is a vaginal yeast infection caused by a type of fungus called Candida, whereas bacterial vaginosis (BV) is caused by a decrease in the normal protective bacteria called lactobacillus and an overgrowth of various pathogenic bacteria. About 15% of the time, these two conditions coexist as a mixed (concomitant) infection¹.

Diagnosing and treating vaginal infections can be challenging. Accurate diagnoses can be expensive, time-consuming and, in many cases, requires expertise in the use of wet mount microscopy. One study showed that within community practice settings, on-site diagnosis of vaginitis resulted in correct treatment in only half of the women².

Another difficulty is that many women believe self-treatment without diagnosis is appropriate. While existing therapies are often effective for uncomplicated VVC or BV, recurrence can occur in up to 30% of women. Mixed (concomitant) infections often go unrecognized³ and undertreated. Successful treatment for mixed infections or recurrent VVC or BV is especially challenging.

The Impact

The Impact

Nearly all women experience a vaginal infection at some point in their life. Sexual activity, hormonal contraception, and use of vaginal douches may increase the risk. Those who have diabetes, suffer from a weakened immune system (eg, HIV/AIDS, cancer), or take antibiotics also have an increased risk of developing vaginal infections.

 

Despite the general perception that VVC and BV can be managed easily, most women report  that vaginal infections have a debilitating impact on their quality of life. More than half do not  adhere to their full course of therapy because of side effects, duration, and limitations while  taking their medication. Women with recurrent infections report feeling losses of confidence  and self-esteem, as well as decreased sexual activity and intimate relationships.

Prescription Market

The Prescription Market

There are 6.3 million total prescriptions (TRx) filled annually in the US for the treatment of BV. The most common therapy prescribed is oral metronidazole, a systemic medication that can cause an unpleasant taste and GI distress. BV is also frequently treated with vaginal drugs, such as metronidazole gel, which reduces systemic exposure to medication.

 

Annually, there are 12.4 million TRx and more than three million OTCs that are used to treat VVC in the US. The most common prescription treatment is oral fluconazole, a systemic medication. VVC is also treated with a prescription vaginal cream known as terconazole. OTC products for VVC are vaginal dosage forms and are often recommended by healthcare providers. Unfortunately, women who self-treat without a healthcare visit also are high users of OTCs.

 Out of the total 18.7 million women who are prescribed treatment for BV and VVC, it is likely that up to three million have mixed (concomitant) BV and VVC. However, mixed infections are not often recognized by healthcare providers. Additionally, most women with mixed infections receive treatment for only one of their infections. The problem is compounded because no drug in the US is indicated for mixed BV and VVC.

BV
5.3 million visits
VVC
10.4 million visits
Mixed BV and VVC
3 million visits

Estimated Number of Patient Visits: 2018

Drugs indicated for BV
6.3 million TRx
Drugs indicated for VVC
12.4 million TRx
Drugs indicated for Mixed BV and VVC
0

Estimated Number of U.S. Prescriptions: 2018

References

  1. Gaydos CA, Beqaj S, Schwebke JR, Lebed J, Smith B, Davis TE, Fife KH, Nyirjesy P, Spurrell T, Furgerson D, Coleman J, Paradis S, Cooper CK. Clinical validation of a test for the diagnosis of vaginitis. Obstet Gynecol. 2017 Jul;130(1):181-189. doi:10.1097/AOG.0000000000002090

  2. Hillier SL, Austin M, Macio I, Meyn L, Badway D, & Beigi R. Clinical practice and accuracy of vaginitis diagnosis in community-based settings. Am J Obstet Gynecol, 219(6),641. doi:10.1016/j.ajog.2018.10.083.

  3. Schwebke JR, Gaydos CA, Nyirjesy P, Paradis S, Kodsi S, Cooper CK. Diagnostic performance of a molecular test versus clinician assessment of vaginitis. J Clin Microbiol. 2018 May 25;56(6). doi: 10.1128/JCM.00252-18.  

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