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.

Sexual and Reproductive Health Knowledge, Attitudes, and Self-Efficacy Among Young Adult Filipino American Women.

INTRODUCTION: Little is known about Filipino American women's (FAW) sexual and reproductive health (SRH). The purpose of this study was to examine the SRH knowledge, attitudes, and self-efficacy among young adult FAW. METHOD: This was a qualitative, descriptive interpretive design. Four focus group interviews and one individual interview were conducted. Purposive sampling was used for this study. Inclusion criteria were female, Filipino American, between the ages 18 and 24 years old, and be able to understand and speak English. RESULTS: Twelve participants (n = 12) were recruited. Three themes emerged from this study: (a) sources of SRH information; (b) influence of cultural values, religion, and intergenerational factors; and (c) facilitators of and barriers to women's health services. DISCUSSION: Themes emerged from the content analysis identifying SRH disparities within the Filipino American community, which may inform future interventions and research on this topic.

Ospemifene versus local estrogen: adherence and costs in postmenopausal dyspareunia.

Aim: Objective was to compare adherence and persistence, as well as direct healthcare costs and utilization, of ospemifene to available local estrogen therapies (LETs). Patients & methods: This retrospective database study used integrated medical and pharmacy claims data from the IQVIA Real-World Data Adjudicated Claims - US Database. Results: Ospemifene patients had significantly greater adherence and persistence compared with the other nonring LETs. Ospemifene had the lowest mean outpatient costs of any of the LET cohorts, including the estradiol vaginal ring. Total all-cause healthcare costs were also significantly less for ospemifene patients compared with all other LETs.

Characterization and Treatment of Recurrent Bacterial Vaginosis.

Bacterial vaginosis (BV) is a common but treatable condition, with a number of effective available treatments, including oral and intravaginal metronidazole and clindamycin and oral tinidazole. However, as many as 50% of women with BV experience recurrence within 1 year of treatment for incident disease. Some reasons for recurrence include the persistence of residual infection, resistance, and possibly reinfection from either male or female partners. Persistence may occur due to the formation of a biofilm that protects BV-causing bacteria from antimicrobial therapy. Poor adherence to treatment among patients with genitourinary infections may lead to resistance. However, the underlying mechanisms of recurrent etiology of BV are not known. Recommended treatment for recurrent BV consists of an extended course of metronidazole treatment (500 mg twice daily for 10-14 days); if ineffective, metronidazole vaginal gel 0.75% for 10 days, followed by two times per week for 3-6 months, is an alternate treatment regimen. Past studies of clindamycin and tinidazole in the treatment of recurrent BV have focused on patients with evidence of metronidazole resistance. Secnidazole may be an attractive new option due to one-time dosing. Initial studies on biofilm disruption, use of probiotics and prebiotics, and botanical treatments have shown some promise, but must be studied further before use in the clinic. Despite limitations, antimicrobial therapy will remain the mainstay of treatment for recurrent BV for the foreseeable future.

Female Sexual Health: Barriers to Optimal Outcomes and a Roadmap for Improved Patient-Clinician Communications.

BACKGROUND: Although sexual health can be considered a vital sign for overall health, several barriers prevent women from receiving proper medical counseling, support, and/or care for their sexual health needs and concerns. METHODS: Experts in sexual health compiled research and experience on the impediments to women receiving adequate assessment and treatment for their sexual health. Specific solutions and a roadmap for overcoming such barriers and improving patient-clinician communication are presented. RESULTS: Social stigma around female sexuality remains in Western culture and as a result, women often avoid and/or are embarrassed to discuss their sexual health with their health care professionals (HCPs). Moreover, midlife women are typically unaware or have misconceptions about conditions that may adversely impact their sexual life, such as genitourinary syndrome of menopause and hypoactive sexual desire disorder. Without understanding there may be underlying medical conditions, there is also a lack of awareness that safe and effective treatments are available. Lack of training, tools, time, and limited treatment options impede HCPs from providing women with necessary sexual health support. Educating women, training HCPs, and providing communication tools to HCPs can facilitate effective dialog between patients and HCPs. More specifically, HCPs can be trained to initiate and maintain a sexual health conversation in a manner that is comfortable for women to convey sexual health needs and concerns, and for HCPs to correctly identify, diagnose, and treat the sexual problems of their female patients. CONCLUSIONS: Solutions exist to address the barriers currently impeding patient-clinician interactions around sexual health.

The International Society for the Study of Women's Sexual Health Process of Care for Management of Hypoactive Sexual Desire Disorder in Women.

The International Society for the Study of Women's Sexual Health process of care (POC) for management of hypoactive sexual desire disorder (HSDD) algorithm was developed to provide evidence-based guidelines for diagnosis and treatment of HSDD in women by health care professionals. Affecting 10% of adult females, HSDD is associated with negative emotional and psychological states and medical conditions including depression. The algorithm was developed using a modified Delphi method to reach consensus among the 17 international panelists representing multiple disciplines. The POC starts with the health care professional asking about sexual concerns, focusing on issues related to low sexual desire/interest. Diagnosis includes distinguishing between generalized acquired HSDD and other forms of low sexual interest. Biopsychosocial assessment of potentially modifiable factors facilitates initiation of treatment with education, modification of potentially modifiable factors, and, if needed, additional therapeutic intervention: sex therapy, central nervous system agents, and hormonal therapy, guided in part by menopausal status. Sex therapy includes behavior therapy, cognitive behavior therapy, and mindfulness. The only central nervous system agent currently approved by the US Food and Drug Administration (FDA) for HSDD is flibanserin in premenopausal women; use of flibanserin in postmenopausal women with HSDD is supported by data but is not FDA approved. Hormonal therapy includes off-label use of testosterone in postmenopausal women with HSDD, which is supported by data but not FDA approved. The POC incorporates monitoring the progress of therapy. In conclusion, the International Society for the Study of Women's Sexual Health POC for the management of women with HSDD provides a rational, evidence-based guideline for health care professionals to manage patients with appropriate assessments and individualized treatments.