A Comparison of Newer and Traditional Approaches to Diagnosing Vaginal Infections.

Molecular diagnostic testing (eg, polymerase chain reaction [PCR]-based vaginitis testing) is widely used in clinical practice, although vaginitis experts have reservations about its use for vaginitis diagnosis. As with any new technology, cost to the health system is a large concern. Although clinical evaluation of signs and symptoms along with wet mount microscopy is traditionally used for vaginitis diagnosis, it is less accurate compared with molecular diagnostic testing. Here we review the benefits of adopting newer molecular diagnostics into routine gynecologic practice with some guidance from vaginitis experts that favor both traditional and more modern approaches. We argue that instead of trying to resist the oncoming tide of molecular diagnostics, we can embrace them and put them to appropriate use to effect rapid, accurate, and more flexible diagnosis of vaginitis conditions for our patients.

Fluconazole-Resistant Candida albicans Vaginal Infections at a Referral Center and Treated With Boric Acid.

OBJECTIVE: The authors investigate the incidence of clinical and mycological resistance of Candida albicans vulvovaginitis (VVC) at the Jefferson Vulvovaginal Health Center. They also review their experience with boric acid in the treatment of fluconazole-resistant VVC. METHODS: The authors conducted a retrospective chart review of all patients with C. albicans VVC diagnosed at the Jefferson Vulvovaginal Health Center between November 2019 and December 2021. Patients with clinically defined fluconazole resistance were identified. Information about demographics, in vitro susceptibility testing, and treatment outcomes with boric acid was obtained. RESULTS: Of 970 patients with vaginal C. albicans isolates, 71 (7.3%) with clinically defined fluconazole-resistant C. albicans infections were identified. Relevant demographics included 45.1% African American, 43.7% aged younger than 30 years, and 43.7% with body mass index less than 25. Of the 71 patients, 58 (81.7%) received vaginal boric acid treatment. The mycological and clinical cure rates were 85.7% and 73.7%, respectively. After successful boric acid treatment and negative yeast cultures, 14.3% of patients had a mycological recurrence within 3 months. Of 31 isolates with antifungal susceptibility testing, 83.9% (26/31) were found to have minimal inhibitory concentration results consistent with fluconazole resistance. CONCLUSIONS: In a tertiary care vulvovaginal health center, fluconazole-resistant Candida albicans VVC is by no means uncommon and usually responds in the short term to treatment with boric acid. However, in the absence of maintenance boric acid, recurrence of culture-positive VVC is likely.

Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306.

Background: Ibrexafungerp is a novel antifungal treatment for acute vulvovaginal candidiasis (VVC). Using pooled data from two phase three studies (VANISH 303 and 306) in the treatment of acute VVC, this analysis sought to determine the effectiveness of ibrexafungerp in various patient subgroups that may impact outcomes. Materials and Methods: Data from VANISH 303 (NCT03734991) and VANISH 306 (NCT03987620) evaluating ibrexafungerp 300 mg twice daily (BID) for 1 day versus placebo, were pooled and analyzed to determine clinical cure rate, clinical improvement, and mycological cure at the test-of-cure visit (day 11 ± 3) and symptom resolution at the follow-up visit (day 25 ± 4) in the overall population. Patient subgroups analyzed included race, body mass index (BMI), baseline vulvovaginal signs and symptoms (VSS) score, and Candida species. Results: At the test-of-cure visit, patients receiving ibrexafungerp, compared with those who received placebo, had significantly higher rates of clinical cure (56.9% [214/376 patients] vs. 35.7% [65/182 patients]), clinical improvement (68.4% [257/376 patients] vs. 45.1% [82/182 patients]), and mycological cure (54.0% [203/376 patients] vs. 24.2% [44/182 patients]; all p < 0.0001). At the follow-up visit, patients receiving ibrexafungerp had sustained responses with higher symptom resolution rates (66.8% [251/376 patients]) versus placebo (48.4% [88/182 patients]; p < 0.0001). Race, BMI, baseline VSS score (including VSS severity score 13-18), and Candida species infection did not adversely affect clinical cure rates. Safety analysis results were consistent with the individual studies. Conclusions: Ibrexafungerp provides a safe and well-tolerated first-in-class fungicidal, 1-day oral treatment for patients with acute VVC, the first new therapy in >20 years. Clinical Trial Registration Number: NCT03734991.

Vulvovaginal Candidiasis: A Review of the Evidence for the 2021 Centers for Disease Control and Prevention of Sexually Transmitted Infections Treatment Guidelines.

BACKGROUND: Vulvovaginal candidiasis (VVC) is a common cause of vulvovaginal itching and discharge. This article discusses the latest CDC STI Treatment Guidelines for VVC. METHODS: A literature search of relevant topics was performed, and a team of experts was convened to discuss (1) diagnosis/testing modalities; treatment of (2) uncomplicated VVC , (3) complicated VVC, and (4) VVC caused by non-albicans yeast; (5) alternative treatment regimens; (6) susceptibility testing of yeast; Special Populations: (7) pregnancy and (8) HIV and VVC. RESULTS: Yeast culture remains the gold standard for diagnoses. Newer molecular assays have been developed for the diagnosis of VVC and perform well. Azole antifungals remain the treatment of choice for uncomplicated VVC. Two new drugs, TOL-463 and recently FDA-approved ibrexafungerp, appeared promising in clinical trials. For recurrent VVC, oteseconazole, not yet commercially available, may represent a new option. For non-albicans yeast infections in symptomatic patients, boric acid appears useful. No evidence supports the use of alternative treatments, including probiotics. Fluconazole during pregnancy may be associated with spontaneous abortion and craniofacial and heart defects. In women with HIV infection, lower CD4+ T-cell counts are associated with increased rates of VVC, and VVC is associated with increased viral shedding. Treatment measures in women with HIV infection are identical to those women without HIV infection. CONCLUSIONS: There has been significant new knowledge generated about VVC since the 2015 CDC Guidelines which have led to changing recommendations.

Ibrexafungerp Versus Placebo for Vulvovaginal Candidiasis Treatment: A Phase 3, Randomized, Controlled Superiority Trial (VANISH 303).

BACKGROUND: Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC. METHODS: Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4). RESULTS: Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P = .001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity. CONCLUSIONS: Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.

Phase 2 Randomized Study of Oral Ibrexafungerp Versus Fluconazole in Vulvovaginal Candidiasis.

BACKGROUND: Vulvovaginal candidiasis affects approximately 75% of women in their lifetime. Approved treatment options are limited to oral or topical azoles. Ibrexafungerp, a novel, first-in-class oral triterpenoid glucan synthase inhibitor, has demonstrated broad fungicidal Candida activity and a favorable tolerability profile. The primary objective of this dose-finding study was to identify the optimal dose of oral ibrexafungerp in patients with acute vulvovaginal candidiasis. METHODS: Patients with vulvovaginal signs and symptoms score ≥7 were randomized equally to 6 treatments groups: 5 treatment doses of oral ibrexafungerp or oral fluconazole 150 mg. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms) at the test-of-cure visit (day 10). RESULTS: Overall, 186 patients were randomized into the 6 treatment groups. Results, using the modified intent-to-treat population (baseline positive culture), are reported for ibrexafungerp 300 mg twice daily (BID) for 1 day (n = 27), which was the dose selected for phase 3 studies, and fluconazole 150 mg for 1 day (n = 24). At day 10, the clinical cure rates for ibrexafungerp and fluconazole were 51.9% and 58.3%, respectively; at day 25, patients with no signs or symptoms were 70.4% and 50.0%, respectively. During the study ibrexafungerp patients required less antifungal rescue medications compared with fluconazole (3.7% vs 29.2%, respectively). Ibrexafungerp was well tolerated, with the most common treatment-related adverse events being mild gastrointestinal events. CONCLUSIONS: Ibrexafungerp is a well-tolerated novel antifungal with comparable efficacy to fluconazole in the treatment of acute vulvovaginal candidiasis. CLINICAL TRIALS REGISTRATION: NCT03253094.

Oteseconazole: an advance in treatment of recurrent vulvovaginal candidiasis.

Recurrent vulvovaginal candidiasis (RVVC) has significant disease, financial and quality-of-life burdens, affects women from all strata of society worldwide, and lacks an approved therapeutic solution. Fluconazole emerged in 2004 as an antifungal for RVVC; it provides symptom control and has been accepted worldwide as a first-line treatment. Its limitations include the development of resistance and a high rate of vulvovaginal candidiasis recurrence after therapy cessation. There is now an improved treatment option on the horizon: oteseconazole - a novel, oral, selective fungal cytochrome P450 enzyme 51 inhibitor, designed to avoid off-target toxicities. In clinical studies to date, oteseconazole has demonstrated impressive efficacy, a positive tolerability profile and hope for a superior RVVC treatment option.

Lay abstract Many women are affected by vaginal fungal infections, also called yeast infections. These infections can affect normal daily activities and have negative emotional and financial effects as well, especially for women who have yeast infections repeatedly. There is no US FDA-approved treatment for repeated yeast infections although the symptoms are often managed with a prescription antifungal medication, fluconazole. However, using fluconazole can have health risks, especially when it is used repeatedly over months or years. Another problem is that the yeasts that cause the infection can become resistant to the treatment. A new medication has been developed and tested in clinical studies and may soon provide women with an effective treatment option for repeated yeast infections that is also safer.

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.

BACKGROUND: Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis. METHODS: 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. Fifty patients per group (N = 100) provided approximately 95% power to detect a statistically significant difference between treatment groups. RESULTS: Between April 2019 and March 2020, 147 women enrolled at 10 sites in the United States. The modified intention-to-treat (mITT) population included 131 randomized patients (secnidazole, n = 64; placebo, n = 67). Cure rates were significantly higher in the secnidazole vs placebo group for the mITT population (92.2% [95% confidence interval {CI}: 82.7%-97.4%] vs 1.5% [95% CI: .0%-8.0%]) and for the per-protocol population (94.9% [95% CI: 85.9%-98.9%] vs 1.7% [95% CI: .0%-8.9%]). Cure rates were 100% (4/4) in women with human immunodeficiency virus (HIV) and 95.2% (20/21) in women with bacterial vaginosis (BV). Secnidazole was generally well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were vulvovaginal candidiasis and nausea (each 2.7%). No serious TEAEs were observed. CONCLUSIONS: A single oral 2 g dose of secnidazole was associated with significantly higher microbiological cure rates vs placebo, supporting a role for secnidazole in treating women with trichomoniasis, including those with HIV and/or BV. CLINICAL TRIALS REGISTRATION: NCT03935217.

Sequence of Pelvic Examination Does Not Affect Patients With Baseline Vulvovaginal Syndromes: A Randomized Clinical Trial.

OBJECTIVE: The purpose of this study is to determine the optimal sequence in performing a pelvic examination to reduce discomfort in patients with baseline vaginal pain. METHODS: A randomized controlled trial of women presenting for a new appointment at the Drexel Vaginitis Center was conducted. Women were assigned to either group A, a Q-tip touch test, speculum examination, then bimanual examination, or group B, a Q-tip touch test, bimanual examination, then speculum examination. The primary outcome was visual analog scales to assess pain at baseline and after each portion of the examination. Secondary outcomes were responses to questionnaires for self-esteem, quality of life, and sexual function. RESULTS: Two hundred women were enrolled in the trial. For both group A and group B, each portion of the examination was similarly scored regardless of whether the speculum examination was performed before or after bimanual examination. Pain during the speculum examination was higher than pain during the other components of the examination, although not significant (P = 0.65).When looking at reported pain outcomes, outcomes did not differ as a whole or between groups in relation to sexual activity, sexual orientation, and previous hysterectomy. The data were not significantly different between groups for self-esteem scores, sexual dysfunction, or quality of life scores. CONCLUSION: In women with baseline vaginal pain, there was no difference in pain scores between the different components of the pelvic examination, nor is there a significant difference in pain during the examination compared with their baseline pain. Most patients reported minimal pain during each component.

A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis.

BACKGROUND: Acute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT-1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51. In this phase 2 clinical study, we evaluated the efficacy and safety of VT-1161 vs fluconazole in participants with moderate to severe acute VVC. METHODS: Participants presenting with an acute episode of VVC (n = 55) were randomized to receive VT-1161 300 mg once daily (q.d.) for 3 days, 600 mg q.d. for 3 days, or 600 mg twice daily (b.i.d.) for 3 days or to receive a single dose of fluconazole 150 mg (FDA-approved dose to treat acute VVC). Participants were followed for 6 months. The primary outcome was the proportion of participants with therapeutic (clinical and mycological) cure at day 28. RESULTS: A larger proportion of participants in the per-protocol population experienced therapeutic cure in the VT-1161 300 mg q.d. (75.0%), VT-1161 600 mg q.d. (85.7%), and VT-1161 600 mg b.i.d. (78.6%) groups vs the fluconazole group (62.5%); differences were not statistically significant. At 3 and 6 months, no participants in the VT-1161 groups vs 28.5% and 46.1% in the fluconazole group, respectively, had evidence of mycological recurrence. No serious adverse events or treatment-emergent adverse events leading to discontinuation were reported. CONCLUSIONS: The majority of participants across all treatment groups achieved therapeutic cure at day 28. VT-1161 was well tolerated at all dose levels through 6 months of follow-up. CLINICAL TRIALS REGISTRATION: NCT01891331.

Physician Awareness and Adherence to Clinical Practice Guidelines in the Diagnosis of Vaginitis Patients: A Retrospective Chart Review.

Vaginitis is one of the main causes of primary care and gynecological visits in the United States. The most common infectious causes are bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis. A physician survey was conducted to measure awareness of vaginitis clinical guidelines and availability of in-office point-of-care (POC) diagnostic tools. Participants were asked to perform a chart review to evaluate diagnostic practices for their symptomatic vaginitis patients. A total of 333 physicians and 984 patient charts were included. Physicians were most familiar with VVC and BV diagnostic guidelines; fewer than half were aware of current trichomoniasis guidelines. Although access to POC tools used to evaluate and diagnose vaginitis varied by practice, there was limited access to all 3 tools (microscope, pH test strips, potassium hydroxide solution) required to perform a full Amsel workup for BV (47% obstetricians/gynecologists vs. 32% primary care physicians, P < .05). Based on guidelines, 66% of patients evaluated for VVC, 45% of patients evaluated for BV, and 17% evaluated for trichomoniasis received an optimal workup. Among trichomoniasis positive patients, 75% received chlamydia/gonorrhea testing, 42% were tested for HIV, partner therapy was noted in 59% of cases, and 47% returned to be retested within 3 months. Limited awareness of recommended diagnostic practices and lack of access to POC tools contributed to broad guideline nonadherence. This study demonstrates that clinicians commonly fall short of current guidelines and suggests the need for lab-based assessments and appropriate insurance coverage to fill the present diagnostic void.

Fractionated CO2 Laser as Therapy in Recalcitrant Lichen Sclerosus.

OBJECTIVES: The aim of this study was to evaluate the efficacy of the fractionated CO2 laser in treating recalcitrant lichen sclerosus (LS). MATERIALS AND METHODS: The study population was 40 women diagnosed with LS who were symptomatic despite medical treatment. Patients had at least 2 or more laser sessions with a 2-month follow-up visit at the Drexel Vaginitis Center. A fractionated CO2 laser was used on affected areas at mild or standard power settings. Analyses were performed of changes in symptom rating scales, verbal reports, and physical examination findings. RESULTS: In the LS cohort of 40 patients, 22 women (55%) experienced symptoms that had persisted longer than 5 years before treatment. After the appropriate laser sessions, 72.5% of women described their improvement as significant or more than 66% improvement. In addition, there was a statistically significant reduction in vaginal pain, itching, dyspareunia, and dysuria. The presence of white epithelium decreased 20% after treatment. Furthermore, the mean corticosteroid use declined from 4.28 times per week to 2.04 times per week, indicating a resolution of many symptoms. CONCLUSIONS: The fractionated CO2 laser may be a helpful approach for managing LS that is unresponsive to traditional treatment options.

Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study.

Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians' diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians' diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.

Management of Resistant Trichomoniasis.

PURPOSE OF REVIEW: Trichomonas vaginalis is the most prevalent sexually transmitted parasite in the USA; resistant infection is emerging. New drug therapies and dosing regimens of standard therapies are being studied to treat resistant infection. RECENT FINDINGS: Diagnosis of trichomoniasis has become more sensitive, specific, and widely available with the advent of nucleic acid amplification tests (NAATs). Women with resistant trichomoniasis should be treated with high-dose regimens of metronidazole or tinidazole. Alternative treatment options have been described, and there has been some success particularly with high-dose tinidazole/intravaginal paromomycin cream combination, intravaginal boric acid, and intravaginal metronidazole/miconazole. Resistant trichomoniasis is a growing public health concern with implications for long-term health consequences. More data are needed to further evaluate mechanisms by which resistance occurs as well as promising therapies for those affected.

Current patient perspectives of vulvovaginal candidiasis: incidence, symptoms, management and post-treatment outcomes.

BACKGROUND: Vulvovaginal candidiasis (VVC) is a common infection affecting women worldwide. Reports of patterns/risk factors/trends for episodic/recurrent VVC (RVVC) are largely outdated. The purpose of this study was to obtain current patient perspectives of several aspects of VVC/RVVC. METHODS: Business cards containing on-line survey information were distributed to healthy volunteers and patients seeking standard, elective, or referral gynecologic care in university-affiliated Obstetrics/Gynecology clinics. The internet-based questionnaire was completed by 284 non-pregnant women (78% Caucasian, 14% African American, 8% Asian). RESULTS: The majority of the participants (78%) indicated a history of VVC with 34% defined as having RVVC. The most common signs/symptoms experienced were itching, burning and redness with similar ranking of symptoms among VVC and RVVC patients. Among risk factors, antibiotic use ranked highest followed by intercourse, humid weather and use of feminine hygiene products. A high number of respondents noted 'no known cause' (idiopathic episodes) that was surprisingly similar among women with a history of either VVC or RVVC. VVC/RVVC episodes reported were primarily physician-diagnosed (73%) with the remainder mostly reporting self-diagnosis and treating with over-the-counter (OTC) medications. Most physician-diagnosed attacks utilized a combination of pelvic examination and laboratory tests followed by prescribed antifungals. Physician-treated cases achieved a higher level of symptom relief (84%) compared to those who self-medicated (57%). The majority of women with RVVC (71%) required continual or long-term antifungal medication as maintenance therapy to control symptoms. CONCLUSIONS: Current patient perspectives closely reflect historically documented estimates of VVC/RVVC prevalence and trends regarding symptomatology, disease management and post-treatment outcomes.

CD101 Topical Compared With Oral Fluconazole for Acute Vulvovaginal Candidiasis: A Randomized Controlled Trial.

OBJECTIVES: Vulvovaginal candidiasis (VVC) is an infection of the vagina's mucous membranes, caused by Candida albicans in more than 90% of acute VVC. Several topical and oral azole agents are available in a variety of formulations, and all seem to have similar effectiveness. Azoles are fungistatic, meaning that the fungi are inhibited from growth or replication but are not eradicated. Recurrent infection and developing azole resistance demonstrate a significant need for alternative treatments. MATERIALS AND METHODS: One hundred twenty-six women were randomized to 1 of the following 3 treatment cohorts: CD101 3% gel (n = 50) applied intravaginally on days 1 and 2, CD101 6% ointment (n = 50) applied intravaginally on day 1, or oral fluconazole 150 mg (n = 26) on day 1. Primary outcomes of clinical and mycological cure, as demonstrated by changes in the vaginal scores and mycological culture, were assessed on day 7 (±2 days), day 14 (±2 days), and day 28 (±7 days). Safety assessments included treatment-emergent adverse events. RESULTS: Ninety-nine women with positive Candida culture remained in the modified intent-to-treat population with 40 in each CD101 arm and 19 in the fluconazole arm. In the CD101 gel, CD101 ointment, and oral fluconazole groups, 35%, 30%, and 52.6% demonstrated clinical cure and 45%, 40%, and 57.9% had mycological cure at day 28, respectively. CONCLUSIONS: CD101 3% gel and CD101 6% ointment were well tolerated and produced similar rates of clinical and mycological cure in patients with an acute, moderate-to-severe episode of VVC. However, cure rates for these 2 formulations and regimens of CD101 were lower than those in patients treated with fluconazole.

Metronidazole-Resistant Trichomoniasis: Beneficial Pharmacodynamic Relationship With High-Dose Oral Tinidazole and Vaginal Paromomycin Combination Therapy.

Metronidazole-resistant trichomoniasis is an uncommon condition that presents significant therapeutic challenges. Combination therapy with high-dose oral tinidazole and vaginal paromomycin cream has been uniformly successful. We present a case report of a patient who responded to combination therapy with high-dose oral tinidazole and intravaginal paromomycin.

Long-Term Outcomes of Women With Recurrent Vulvovaginal Candidiasis After a Course of Maintenance Antifungal Therapy.

OBJECTIVES: Data about long-term clinical outcome after a course of maintenance fluconazole in those with recurrent vulvovaginal candidiasis (RVVC) is lacking. We aimed to determine the rate of recurrence at a minimum of 6 months after completion of maintenance therapy. METHODS: A retrospective analysis of women with Candida albicans RVVC from January 2008 to January 2017 was performed using chart review to obtain information about recurrence after maintenance therapy. Patients were considered resolved if they had no further episodes of candidiasis, sporadic with less than 3 episodes yearly and ongoing with greater than 3 episodes yearly. RESULTS: Approximately 1,672 patients with C. albicans vaginal isolates were identified. Of these, 201 met the criteria for RVVC. The mean age was 40.4 years; 151 (77.4%) were white, 133 (66.2%) had comorbid vulvar conditions, and 76 (37.8%) had a risk factor for vulvovaginal candidiasis. One hundred twenty complete charts were further analyzed. The mean length of follow-up after discontinuing maintenance therapy was 39.9 months. After the initial course, 23 (19.2%), 21 (17.5%), and 76 (63.3%) were resolved, sporadic and ongoing, respectively. Risk factors, comorbid vulvar conditions, obesity, menopause status, and length of therapy were not associated with relapse. Age 40 or older was associated with relapse (p = .018). Of the 201 total patients with RVVC, 22 (10.9%) of patients self-reported at least 1 adverse event. The most common was gastrointestinal symptoms (8 [4%]). CONCLUSIONS: Although RVVC can be controlled, relapse is common after an initial course of maintenance fluconazole. Ongoing maintenance remains the most effective treatment option.