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.

Best practices for hepatitis C linkage to care in pregnant and postpartum women: perspectives from the Treatment In Pregnancy for Hepatitis C Community of Practice.

There is an increasing burden of hepatitis C virus among persons of reproductive age, including pregnant and breastfeeding women, in many regions worldwide. Routine health services during pregnancy present a critical window of opportunity to diagnose and link women with hepatitis C virus infection for care and treatment to decrease hepatitis C virus-related morbidity and early mortality. Effective treatment of hepatitis C virus infection in women diagnosed during pregnancy also prevents hepatitis C virus-related adverse events in pregnancy and hepatitis C virus vertical transmission in future pregnancies.

Pediatric Hepatitis C Screening by Maternal Hepatitis C Infection Status During Pregnancy.

Background: Screening for perinatal hepatitis C virus (HCV) infections remains low despite increases in the number of at-risk infants. It is unknown if pediatric screening varies by maternal HCV infection status during pregnancy.

Methods: Using a retrospective cohort of mother-infant pairs born from 2015 to 2019, we identified women with HCV and classified their infection status during pregnancy as active, probable, or previous based on HCV RNA testing obtained during pregnancy.

A randomized trial of double vs single-dose etonogestrel implant to overcome the interaction with efavirenz-based antiretroviral therapy.

Background: Concomitant use of efavirenz-based antiretroviral therapy and a standard-dose etonogestrel contraceptive implant led to 82% lower etonogestrel exposure when compared with women who do not receive antiretroviral therapy. The clinical impact of this reduced exposure is supported by retrospective cohort evaluations that demonstrated higher rates of unintended pregnancies when contraceptive implants were combined with efavirenz. We hypothesized that placement of 2 etonogestrel implants in those taking efavirenz-based antiretroviral therapy could increase etonogestrel exposure and improve measures of contraceptive efficacy.

Postpartum Treatment for Chronic Hepatitis C Virus Among People With Opioid Use Disorder: A Prospective Pilot Clinical Trial.

Objective: The objective of this study was to evaluate the feasibility and acceptability of postpartum hepatitis C virus (HCV) treatment integrated within a substance use treatment program for pregnant and postpartum people with opioid use disorder (OUD).

Methods: We conducted a prospective pilot clinical trial of sofosbuvir/velpatasvir (SOF/VEL) treatment among postpartum people with OUD and HCV. Feasibility outcomes included rates of HCV treatment utilization and completion, medication adherence, and sustained virologic response 12 weeks after treatment completion (SVR12).

DELIVER: A Safety Study of a Dapivirine Vaginal Ring and Oral PrEP for the Prevention of HIV During Pregnancy.

Background: Pregnancy represents a period of high HIV acquisition risk. Safety data for the monthly dapivirine vaginal ring (DVR) during pregnancy are limited. Here, we report data from the first 2 cohorts of pregnant participants in MTN-042/DELIVER, a phase 3b, randomized, open-label safety trial of DVR and oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).

Hepatitis C Virus in Pregnancy: An Opportunity to Test and Treat.

With the advent of safe and well-tolerated direct-acting antiviral (DAA) medications for hepatitis C virus (HCV), disease eradication is on the horizon. However, as the rate of HCV infection among women of childbearing potential continues to rise due to the ongoing opioid epidemic in the United States, perinatal transmission of HCV presents an increasingly difficult barrier. Without the ability to treat HCV during pregnancy, complete eradication is unlikely.

Evidence for Implementation: HIV/HCV Coinfection and Pregnancy.

Purpose Of Review: In the context of the opioid epidemic, hepatitis C virus (HCV) infection prevalence is increasing among women of reproductive age. Pregnant people with HIV/HCV coinfection may be at increased risk of adverse pregnancy and neonatal outcomes, although research in this key population is lacking.

Recent Findings: Treatment with directly acting antivirals (DAAs) has transformed the clinical care for most patients with HCV.

Dextromethorphan as a novel nonopioid adjunctive agent for pain control with medication abortion: A randomized controlled trial.

Objectives: To evaluate efficacy and satisfaction of dextromethorphan as a non-narcotic adjuvant to current analgesic regimens for medication abortion.

Study Design: We conducted a randomized, double-blinded, placebo-controlled trial. We randomized eligible participants (N = 156) 1:1 to adjunctively take dextromethorphan (loading dose 60 mg and two subsequent 30 mg doses at 2 and 5 hours after misoprostol administration) or placebo combined with usual-care nonsteroidal anti-inflammatory medications ± opioids for pain.

Pharmacokinetics of levonorgestrel and etonogestrel contraceptive implants over 48 weeks with rilpivirine- or darunavir-based antiretroviral therapy.

Background: Pharmacokinetic data are lacking for progestin-releasing subdermal contraceptive implants when used with either rilpivirine- or darunavir/ritonavir-based ART.

Objectives: To characterize the pharmacokinetics of etonogestrel or levonorgestrel implants when administered with these ART regimens over 48 weeks.

Patients And Methods: Two separate, parallel, three-group, non-randomized, pharmacokinetic studies evaluated either etonogestrel or levonorgestrel in women receiving rilpivirine- or darunavir-based ART compared with women without HIV (control group).

Postpartum Follow-up Care for Pregnant Persons With Opioid Use Disorder and Hepatitis C Virus Infection.

Among Medicaid-enrolled pregnant persons with opioid use disorder, one third are diagnosed with hepatitis C virus, but only 6% receive postpartum follow-up or medication treatment.

Experiences and Perspectives From Women Taking Investigational Therapy for Hepatitis C Virus During Pregnancy.

Objective: Describe the experiences and perspectives among pregnant people with chronic HCV infection receiving ledipasvir/sofosbuvir (LDV/SOF) therapy during pregnancy.

Methods: We conducted semi-structured, in-depth interviews within an open-label, phase 1 study of LDV/SOF therapy among pregnant people with chronic HCV infection. Participants took 12 weeks of LDV/SOF and were interviewed at enrollment and again at the end of treatment.

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.

Testing for Hepatitis C in Pregnancy: the Time has Come for Routine Rather than Risk-based.

Purpose Of Review: The purpose of this review is to discuss the reasons for HCV testing during pregnancy and to review what is known about antiviral treatment during pregnancy.

Recent Findings: Hepatitis C virus affects over 3 million persons in the United States and is one of the leading infectious causes of death. While HCV is most commonly transmitted via parenteral exposures, thus affecting people who inject drugs, it is also transmitted from mother-to-child.

Feasibility and Safety of IUD Insertion by Mid-Level Providers in Sub-Saharan Africa.

Context: The copper IUD is safe and effective, but underutilized in Sub-Saharan Africa, in part because of a lack of trained providers. The World Health Organization recommends training mid-level providers-including nurses and midwives-to insert IUDs; however, the safety of such task shifting has not been evaluated in Sub-Saharan Africa.

Methods: Data were drawn from baseline surveys and study charts of 535 sexually active women aged 18-45 who used a copper IUD while participating in an HIV-prevention clinical trial conducted from August 2012 through June 2015 in Malawi, South Africa, Uganda and Zimbabwe.

Effect of patient genetics on etonogestrel pharmacokinetics when combined with efavirenz or nevirapine ART.

Background: We previously demonstrated that etonogestrel concentrations were 82% lower in women using etonogestrel contraceptive implants plus efavirenz-based ART compared with women not receiving ART.

Objectives: To investigate the genetic contribution to this previously observed drug-drug interaction through studying SNPs in genes known to be involved in efavirenz, nevirapine or etonogestrel metabolism in the same group of women.

Patients And Methods: Here, we present a secondary analysis evaluating SNPs involved in efavirenz, nevirapine and etonogestrel metabolism and associated etonogestrel pharmacokinetics among 57 women, 19 not receiving ART (control group), 19 receiving efavirenz- (600 mg daily) based ART and 19 receiving nevirapine- (200 mg twice daily) based ART.

Contraceptive method switching among women living in sub-Saharan Africa participating in an HIV-1 prevention trial: a prospective cohort study.

Objective: Long-acting reversible contraceptive (LARC) method uptake has been low within the context of HIV prevention trials. Within a multinational study (MTN-020/ASPIRE), the Contraceptive Action Team improved LARC accessibility and uptake. In this secondary analysis, we determined the rate of contraceptive method continuation among the women enrolled.

Hepatitis C Virus Screening Among Children Exposed During Pregnancy.

Objectives: Because of the opioid epidemic, hepatitis C virus (HCV) infection is increasing among pregnant women, resulting in an increased risk of perinatal transmission and HCV infection among children. Our primary objectives in this study were to determine the prevalence of HCV among pregnant women and the frequency of pediatric HCV screening.

Methods: A population-based, retrospective cohort of pregnant women who delivered between 2006 and 2014 was identified and classified as HCV infected or HCV uninfected by billing codes.

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.