Sofosbuvir/Velpatasvir Pharmacokinetics, Safety, and Efficacy in Pregnant People with Hepatitis C Virus.

Background: Treatment of hepatitis C virus (HCV) during pregnancy can cure maternal HCV and prevent perinatal HCV transmission. The primary objective was to compare the pharmacokinetics (PK) of sofosbuvir/velpatasvir (SOF/VEL) in pregnant versus nonpregnant people.

Methods: Pregnant people with chronic HCV infection were enrolled between 23-25 weeks' gestation and were provided SOF/VEL daily for 12 weeks.

Respiratory Viral Infections and Infection Prevention Practices Among Women With Acute Respiratory Illness During Delivery Hospitalizations During the 2019-2020 Influenza Season.

Background: We conducted a cross-sectional study of pregnant women with acute respiratory illness during delivery hospitalizations during influenza season to describe clinical testing for respiratory viruses and infection prevention practices.

Methods: Women had nasal swabs tested for influenza and other respiratory viruses. Among 91 enrolled women, 22 (24%) had clinical testing for influenza.

Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study.

Background: Hepatitis C virus (HCV) infection is increasing among pregnant women because of the opioid epidemic, yet there are no interventions to reduce perinatal HCV transmission or to treat HCV during pregnancy. Physiological changes in pregnancy alter the pharmacokinetics of some medications; thus, our aim was to compare the pharmacokinetic parameters of ledipasvir 90 mg plus sofosbuvir 400 mg during pregnancy with non-pregnant women.

Methods: This was an open-label, phase 1 study of pregnant women with genotype 1 HCV infection and their infants.

Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings.

Background: Although vaginal symptoms are common, diagnosis of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV) is not standardized. Diagnostic approaches and appropriateness of treatment were evaluated for women with symptoms of vaginitis who were seeking care at community practice sites.

Methods: Three hundred three symptomatic women, across 8 University of Pittsburgh Medical Center-affiliated clinics, were evaluated per standard office-based practice.

A Randomized Controlled Trial of Ceftriaxone and Doxycycline, With or Without Metronidazole, for the Treatment of Acute Pelvic Inflammatory Disease.

Background: Anaerobic organisms are important pathogens in acute pelvic inflammatory disease (PID). The currently recommended PID regimen of a single dose of ceftriaxone and doxycycline for 14 days has limited anaerobic activity. The need for broader anaerobic coverage is unknown and concerns have been raised about metronidazole tolerability.

Heterogeneity of HIV-1 Replication in Ectocervical and Vaginal Tissue Ex Vivo.

In clinical trials evaluating HIV-1 prevention products, ex vivo exposure of mucosal tissue to HIV-1 is performed to inform drug levels needed to suppress viral infection. Understanding assay and participant variables that influence HIV-1 replication will help with assay implementation. Demographic and behavioral data were obtained from 61 healthy women aged 21-45.

Use of Nucleic Acid Amplification Testing for Diagnosis of Extragenital Sexually Transmitted Infections.

Nucleic acid amplification testing (NAAT) is the preferred method to detect and , but no commercial tests are cleared by the U.S. Food and Drug Administration for use with extragenital swab samples.

HIV-1 infection of female genital tract tissue for use in prevention studies.

Objective: Ex vivo HIV-1 challenge has been proposed as a bioindicator of microbicide product effectiveness. The objective of this study was to establish optimal parameters for use of female genital tract tissue in this model.

Design: Ex vivo challenge involves in vivo product use, followed by tissue biopsy, and exposure of the tissue to HIV-1 in the laboratory.

The safety, persistence, and acceptability of an antiretroviral microbicide candidate UC781.

Objective: : To evaluate the persistence and acceptability of a minimally absorbed vaginal gel antiretroviral designed to block the acquisition of HIV.

Methods: : Sixty healthy women aged 18-45 participated in a phase-1 randomized placebo-controlled trial of a vaginal gel containing the nonnucleoside reverse transcriptase inhibitor UC781. Women underwent a single timed exposure ranging from 0 to 8 hours and were followed for 35 days.

Use of nucleic acid amplification testing for diagnosis of anorectal sexually transmitted infections.

Nucleic acid amplification testing (NAAT) has become the preferred method to detect Chlamydia trachomatis and Neisseria gonorrhoeae, but no commercial tests are cleared by the U.S. Food and Drug Administration for use with rectal swab samples.

Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy.

Unlabelled: Tenofovir (TFV) 1% vaginal gel has been found to decrease sexual transmission of human immunodeficiency virus. To initiate investigations during pregnancy, 16 healthy pregnant women scheduled for cesarean delivery received a single application of TFV gel preoperatively. Maternal serum drug concentrations were determined and fetal cord blood, amniotic fluid, placental tissue, and endometrial tissue specimens were collected.

The infrequent use of office-based diagnostic tests for vaginitis.

Objective: This study was undertaken to determine physician use of simple office-based tests in the evaluation of women with vulvovaginal symptoms.

Study Design: A medical record review of 52 women seeking care at a referral-based vaginitis clinic was performed. The evaluation performed and the care management were recorded for 150 previous physician-provided office visits.

The vaginal introitus: a novel site for Chlamydia trachomatis testing in women.

Objective: We evaluated the vaginal introitus as a noninvasive sampling site for testing for Chlamydia trachomatis.

Study Design: Swabs from the vaginal introitus were obtained from 300 women attending a sexually transmitted diseases clinic and tested for the presence of Chlamydia trachomatis by polymerase chain reaction. Additionally, 200 of these women self-collected an additional introitus swab and submitted a urine sample for polymerase chain reaction testing.

Ductal carcinoma in situ of the breast: results of treatment by conservative surgery and definitive irradiation.

Purpose: To determine local control, survivorship, and cosmesis in women with ductal carcinoma in situ treated by conservative surgery and radiation therapy.

Methods And Materials: We retrospectively analyzed the results of treatment in 56 women with in situ carcinoma of the breast, treated between 1976 and 1990 by conservative surgery and irradiation. Two women had bilateral tumors, for a total of 58 breasts at risk.