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Drugs in R&D Mar 2022On 2 June, 2021, the US Food and Drug Administration approved ibrexafungerp (formerly MK-3118 and SCY-078) for the treatment of vulvovaginal candidiasis, also known as... (Review)
Review
On 2 June, 2021, the US Food and Drug Administration approved ibrexafungerp (formerly MK-3118 and SCY-078) for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection. Ibrexafungerp is the first drug approved in a novel antifungal class in more than two decades, and the Food and Drug Administration's decision was based on positive results from two pivotal phase III studies in which oral ibrexafungerp proved both safe and effective in patients with vulvovaginal candidiasis. The decision was also based on substantial preclinical and clinical work in both the pharmacokinetics and pharmacodynamics of ibrexafungerp. This paper reviews that research and looks ahead to explore how this novel antifungal agent may be used in the future to address the expanding problem of drug-resistant mycotic infections.
Topics: Antifungal Agents; Candidiasis, Vulvovaginal; Female; Glycosides; Humans; Triterpenes; United States
PubMed: 34961907
DOI: 10.1007/s40268-021-00376-x -
Probiotics and Antimicrobial Proteins Oct 2023Vaginitis is a common problem in women. Candida albicans is responsible for more than 85% of vaginal fungal infections. The aim of this study was to compare the effects... (Randomized Controlled Trial)
Randomized Controlled Trial
Vaginitis is a common problem in women. Candida albicans is responsible for more than 85% of vaginal fungal infections. The aim of this study was to compare the effects of probiotic and fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). This triple-blinded randomized controlled trial was conducted on 80 married women, aged 18-49 years, with VVC, as confirmed by clinical and laboratory diagnosis. The participants were allocated into two groups using blocked randomization method. The fluconazole-treated group received a single dose of fluconazole (150 mg) supplemented with 30 placebo capsules of probiotic, and the probiotic-treated group got 30 probiotic capsules containing 1 × 10 CFU/g LA-5 with 1 fluconazole placebo capsule. The samples were taken from patients to evaluate the vaginal pH and microbiological tests before, 30-35 days, and 60-65 days after starting the treatment. The signs and symptoms were assessed before the intervention and the first and second follow-ups. Chi-square, Fisher's exact, independent t, and ANCOVA tests were then used for data analysis. There was no statistically significant difference between the two groups (p = 0.127) in the frequency of negative culture 30-35 days after starting the treatment, but the frequency of negative culture 60-65 days after starting treatment in the fluconazole group was significantly higher than that of the probiotic group (p = 0.016). The abnormal discharge and vulvovaginal erythema in the first and second follow-ups and also pruritus in the second follow-up in the fluconazole group were significantly lower than those in the probiotic group (p < 0.05). There was, however, no statistically significant difference in burning, frequent urination, dysuria, and dyspareunia between the groups (p > 0.05). Lactobacillus acidophilus supplementation had an effect similar to that of fluconazole in treating most symptoms of VVC, but it was less effective than the latter in preventing recurrence. Trial Registration: Iranian Registry of Clinical Trials (IRCT): IRCT20110826007418N5. Date of registration: 3 March 2021; URL: https://en.irct.ir/trial/50819 ; Date of first registration: 10 March 2021.
Topics: Humans; Female; Fluconazole; Candidiasis, Vulvovaginal; Antifungal Agents; Capsules; Iran; Probiotics
PubMed: 36198994
DOI: 10.1007/s12602-022-09997-3 -
Beneficial Microbes Apr 2023Health of reproductive tract is tightly associated with balance of microbial communities in this area. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC)... (Randomized Controlled Trial)
Randomized Controlled Trial
Health of reproductive tract is tightly associated with balance of microbial communities in this area. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) represent common disturbances of vaginal communities. Vaginal discharge due to BV or VVC is a very frequent reason for visiting gynaecologist. We aimed to evaluate the impact of the novel evidence-based probiotics on BV and VVC patients. The study group included 89 BV and 93 VVC patients (aged 18-50 years) who were recruited into randomised double-blind placebo-controlled two-arm parallel trial. The patients of each diagnosis group received oral or vaginal probiotic capsules, or placebo capsules during 3 months. A probiotic capsule contained two (DSM32717 and DSM32720, in case of BV) or three (DSM32720, DSM32718 and DSM32716, in case of VVC) strains. Vaginal, intestinal and general health was monitored weekly by questionnaire. Blood analyses were done in the beginning and at the end of trial. Vaginal samples were collected monthly, microscopic and molecular analyses were performed. The study revealed that both oral and vaginal capsules reduced the signs and symptoms in BV patients. Remarkable improvement was noted in Nugent score, amount and smell of discharge, but also in itching/irritation. Consumption of vaginal probiotics significantly increased the lactobacilli counts in their vagina while mean proportion of some BV-related bacteria decreased. In VVC patients, both oral and vaginal capsules lowered the combined score of two most important symptoms, amount of discharge and itching/irritation. In conclusion, the novel formulations of evidence-based well-focused probiotic strains are effective against BV and VVC being suitable for both vaginal and oral administration. Clinical trial registration: ISRCTN34840624, BioMed Central.
Topics: Female; Humans; Lactobacillus crispatus; Probiotics; Vagina; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Double-Blind Method
PubMed: 36856121
DOI: 10.3920/BM2022.0091 -
Current Problems in Pediatric and... Jul 2020Vulvovaginitis, referring to inflammation of the vulva and vagina, is a commonly reported concern among adolescents and young women presenting for gynecologic care.... (Review)
Review
Vulvovaginitis, referring to inflammation of the vulva and vagina, is a commonly reported concern among adolescents and young women presenting for gynecologic care. Symptoms of vulvovaginitis may include vaginal discharge, odor, itching, pain, dysuria, skin irritation, burning, and dyspareunia. Vulvovaginitis may result from infectious or non-infectious causes. Bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis represent the three most common infectious causes of vulvovaginitis in adolescents and young adults. Additionally, non-infectious causes such as the presence of a foreign body in the vagina, chemical irritants, douching, and poor hygiene may also lead to symptoms of vulvovaginitis. A thorough history in combination with the appropriate physical examination and laboratory evaluation is necessary to identify the cause of a patient's symptoms. Importantly, adolescent patients should be given the opportunity to speak privately with the provider without a parent or guardian present in the room, particularly when gathering the sexual history. Appropriate anticipatory guidance and counseling should be provided once a diagnosis has been made, and prevention of future episodes of vulvovaginitis should be discussed.
Topics: Anti-Infective Agents; Candidiasis, Vulvovaginal; Female; Humans; Sexual Behavior; Sexually Transmitted Diseases; Vagina; Vulvovaginitis
PubMed: 32778468
DOI: 10.1016/j.cppeds.2020.100836 -
Drugs Jun 2022Oteseconazole (VIVJOA™) is an orally administered azole antifungal agent developed by Mycovia Pharmaceuticals for the treatment of fungal infections. It inhibits... (Review)
Review
Oteseconazole (VIVJOA™) is an orally administered azole antifungal agent developed by Mycovia Pharmaceuticals for the treatment of fungal infections. It inhibits cytochrome P450 (CYP) 51, thereby affecting the formation and integrity of the fungal cell membrane, but has a low affinity for human CYP enzymes due to its tetrazole metal-binding group. Oteseconazole is the first agent to be approved (in April 2022) for recurrent vulvovaginal candidiasis (RVVC) in the USA, where it is indicated to reduce the incidence of RVVC in females with a history of RVVC who are NOT of reproductive potential. Clinical development for the treatment of onychomycosis, and invasive and opportunistic infections is ongoing. This article summarizes the milestones in the development of oteseconazole leading to this first approval for reducing the incidence of RVVC in females with a history of RVVC who are NOT of reproductive potential.
Topics: Antifungal Agents; Azoles; Candidiasis, Vulvovaginal; Female; Humans; Incidence; Recurrence
PubMed: 35713845
DOI: 10.1007/s40265-022-01734-y -
Sexually Transmitted Diseases Dec 2019A retrospective chart review characterized clinicians' use of maintenance intravaginal boric acid for women with recurrent vulvovaginal candidiasis or bacterial...
A retrospective chart review characterized clinicians' use of maintenance intravaginal boric acid for women with recurrent vulvovaginal candidiasis or bacterial vaginosis. Average length of use was 13 months with high patient satisfaction and few adverse events. Prospective studies are needed to evaluate the efficacy of maintenance boric acid for these conditions.
Topics: Administration, Intravaginal; Adult; Anti-Infective Agents, Local; Boric Acids; Candidiasis, Vulvovaginal; Drug Administration Schedule; Female; Humans; Middle Aged; Patient Satisfaction; Recurrence; Retrospective Studies; Treatment Outcome; Vaginosis, Bacterial
PubMed: 31663976
DOI: 10.1097/OLQ.0000000000001063 -
Journal of Midwifery & Women's Health 2024
Topics: Humans; Female; Candidiasis, Vulvovaginal; Antifungal Agents; Pregnancy
PubMed: 38738848
DOI: 10.1111/jmwh.13650 -
Frontiers in Public Health 2020The microbiome of the female genital tract may undergo changes in pregnancy due to metabolic, endocrinological, and immunological alterations. These dysbiotic states may... (Review)
Review
The microbiome of the female genital tract may undergo changes in pregnancy due to metabolic, endocrinological, and immunological alterations. These dysbiotic states may cause infections which may ascend upwards to the feto-placental unit or may be seeded hematogenously. These low grade and often low virulent infectious states lead to chronic inflammatory states and maybe associated with adverse maternal and neonatal outcome. Organisms have been isolated from amniotic fluid and placentae from women delivering pre-term; however the possibility of contamination cannot be conclusively ruled out. Common vaginal dysbiotic states often cause symptoms that are overlooked and often untreated. Vulvovaginal Candidiasis (VVC), Bacterial Vaginosis (BV), and Trichomonas Vaginitis (TV) are the commonly occurring dysbiotic states leading to vaginal infective states in pregnancy. With the advent of novel technologies like Next Generation sequencing (NGS), it will soon be possible to comprehensively map the vaginal microbiome and assess the interplay of each microbial state with their effects in pregnancy. This may open new avenues for antibiotic recommendations, probiotics and potential alternate therapies for dysbiotic states leading to pregnancy complications.
Topics: Candidiasis, Vulvovaginal; Dysbiosis; Female; Humans; Pregnancy; Pregnancy Complications, Infectious; Prevalence; Trichomonas Vaginitis; Vaginosis, Bacterial
PubMed: 32612969
DOI: 10.3389/fpubh.2020.00225 -
Drugs Aug 2021Ibrexafungerp (BREXAFEMME) is an orally active triterpenoid antifungal drug being developed by SCYNEXIS, Inc. for the treatment of fungal infections. The inhibition of... (Review)
Review
Ibrexafungerp (BREXAFEMME) is an orally active triterpenoid antifungal drug being developed by SCYNEXIS, Inc. for the treatment of fungal infections. The inhibition of β-1,3-D glucan synthetase by ibrexafungerp compromises the integrity of fungal cell walls. Ibrexafungerp has been recently approved for the treatment of vulvovaginal candidiasis (VVC), and it is the first novel antifungal drug class to be approved in more than 20 years. Development for the treatment of recurrent VVC and invasive fungal infections is ongoing. This article summarizes the milestones in the development of ibrexafungerp leading to this first approval for the treatment of VVC in adult and postmenarchal paediatric females.
Topics: Antifungal Agents; Candidiasis, Invasive; Candidiasis, Vulvovaginal; Female; Glycosides; Humans; Invasive Fungal Infections; Male; Pulmonary Aspergillosis; Triterpenes
PubMed: 34313977
DOI: 10.1007/s40265-021-01571-5 -
BJOG : An International Journal of... Jan 2020Vaginal probiotics claiming to cure and/or prevent bacterial and/or fungal vaginal dysbiosis are available on the market but, until recently, did not have to be approved...
BACKGROUND
Vaginal probiotics claiming to cure and/or prevent bacterial and/or fungal vaginal dysbiosis are available on the market but, until recently, did not have to be approved as drugs for human use.
OBJECTIVES
We evaluated the impact of vaginal probiotics on bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) cure and/or recurrence, as well as vaginal microbiota (VMB) composition and vaginal detection of probiotic strains.
SEARCH STRATEGY
We performed a systematic literature search in MEDLINE and Embase up to 15 January 2019.
SELECTION CRITERIA
There were no restrictions in probiotic strains/formulations, study populations, and designs. BV had to be diagnosed by Nugent or Ison-Hay Gram stain scoring, VVC by culture, wet mount or PCR, and VMB composition/detection by molecular techniques.
DATA COLLECTION AND ANALYSIS
The authors independently extracted data.
MAIN RESULTS
All 22 vaginal probiotics evaluated in the 34 eligible studies contained Lactobacillus strains, and some contained additional active ingredients. The probiotics hold promise for BV cure and prevention, but much less so for VVC cure and prevention. No major safety concerns were reported in any of the studies. Vaginal detection of probiotic strains never lasted long beyond the dosing period, suggesting that they did not colonise the vagina. However, findings are not definitive because heterogeneity was high and the quality of most studies suboptimal.
CONCLUSIONS
Availability of vaginal probiotics for vaginal health indications will likely decline in 2020 because of regulatory changes. We urge the field to invest in clinical evidence-based product development and to conduct future trials more rigorously.
TWEETABLE ABSTRACT
Lactobacilli-containing vaginal probiotics hold promise for bacterial vaginosis cure and prevention, but not for vulvovaginal candidiasis.
Topics: Candidiasis, Vulvovaginal; Dysbiosis; Female; Humans; Lactobacillus; Microbiota; Probiotics; Treatment Outcome; Vagina; Vaginosis, Bacterial
PubMed: 31299136
DOI: 10.1111/1471-0528.15870