High Rates of High-risk HPV Anal Infection and Abnormal Cytology in a Cohort of Transgender People Assigned Male at Birth.

Background: Transgender people assigned male at birth (TG-AMAB) have higher rates of anal human papillomavirus (HPV) infection and anal cancer compared with cisgender populations. In a cohort of TG-AMAB in Washington DC, we determined the prevalence and epidemiological factors associated with anal high-risk HPV (HR-HPV) infection and cytological abnormalities.

Methods: In an urban academic-community clinic, we recruited adults identifying as a gender different than their sex assigned at birth.

Dose-specific clinical outcomes in patients with opioid use disorder treated with 24-32 mg/day of buprenorphine.

Background/aims: In people with opioid use disorder (OUD), buprenorphine is a vital treatment to decrease opioid use and overdose. The US Food and Drug Administration's prescribing information for buprenorphine advises dosing up to 24 mg/day; however, doses of buprenorphine up to 32 mg have been shown to be safe and effective. We compared outcomes associated increased dosing from 24 to 32 mg/day.

Hospitalization is a missed opportunity for HIV screening, pre-exposure prophylaxis, and treatment.

Background: Hospitalization is a "reachable moment" for people who inject drugs (PWID), but preventive care including HIV testing, prevention and treatment is rarely offered within inpatient settings.

Methods: We conducted a multisite, retrospective cohort study of patients with opioid use disorder with infectious complications of injection drug use hospitalized between 1/1/2018-12/31/2018. We evaluated HIV care continuum outcomes using descriptive statistics and hypothesis tests for intergroup differences.

Undertreatment of opioid use disorder in patients hospitalized with injection drug use-associated infections.

Objective: To evaluate the association between medication for opioid use disorder (MOUD) initiation and addiction consultation and outcomes for patients hospitalized with infectious complications of injecting opioids.

Method: This was a retrospective cohort study performed at four academic medical centers in the United States. The participants were patients who had been hospitalized with infectious complications of injecting opioids in 2018.

Use of nonstigmatizing language is associated with improved outcomes in hospitalized people who inject drugs.

Background: Stigma surrounding opioid use disorder (OUD) is a barrier to treatment. The use of stigmatizing language may be evidence of negative views toward patients.

Objective: We aimed to identify associations between language and clinical outcomes in patients admitted for infectious complications of OUD.

Manufacture and Characterization of Good Manufacturing Practice-Compliant SARS-COV-2 Cytotoxic T Lymphocytes.

Background: Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 virus-specific cytotoxic T-cell lymphocytes (vCTLs) could provide a promising modality in COVID-19 treatment. We aimed to screen, manufacture, and characterize SARS-CoV-2-vCTLs generated from convalescent COVID-19 donors using the CliniMACS Cytokine Capture System (CCS).

Hepatitis C cure and medications for opioid use disorder improve health-related quality of life in patients with opioid use disorder actively engaged in substance use.

Background: This study aims to determine whether Hepatitis C (HCV) treatment improves health-related quality of life (HRQL) in patients with opioid use disorder (OUD) actively engaged in substance use, and which variables are associated with improving HRQL in patients with OUD during HCV treatment.

Methods: Data are from a prospective, open-label, observational study of 198 patients with OUD or opioid misuse within 1 year of study enrollment who received HCV treatment with the primary endpoint of Sustained Virologic Response (SVR). HRQL was assessed using the Hepatitis C Virus Patient Reported Outcomes (HCV-PRO) survey, with higher scores denoting better HRQL.

PrEP Indications and PrEP Knowledge, Access, and Interest Among Individuals With HCV.

Background: Individuals with hepatitis C (HCV) represent a population that may benefit from pre-exposure prophylaxis (PrEP), given the overlapping risk factors and transmission networks of HCV and HIV. This analysis assesses the prevalence of PrEP indications among individuals with HCV monoinfection and PrEP awareness, interest, and access in this population.

Methods: GRAVITY was an observational study for the collection of epidemiologic data from individuals with HCV and/or HIV in Washington DC and Baltimore, with the present analysis limited to HCV-monoinfected patients.

"I got so much on my plate": Understanding care discontinuity for HIV and HCV among formerly incarcerated persons.

Objective: To explore barriers to care continuity among formerly incarcerated persons with HIV and/or hepatitis C.

Data Sources And Study Setting: We draw on data from semi-structured interviews conducted in 2018-2019 with 30 formerly incarcerated persons and 10 care providers. Data were collected across two clinics in Baltimore, Maryland, and Washington, D.

Suboptimal Uptake, Retention, and Adherence of Daily Oral Prexposure Prophylaxis Among People With Opioid Use Disorder Receiving Hepatitis C Virus Treatment.

Background: Daily oral preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) prevents human immunodeficiency (HIV) among people who inject drugs (PWID). Despite rising HIV incidence and injection drug use (IDU), PrEP use remains low and there is limited research about uptake, adherence, and retention among PWID.

Methods: The ANCHOR investigation evaluated a community-based care model collocating hepatitis C virus (HCV) treatment, medication for opioid use disorder (OUD), and PrEP in individuals in Washington, DC, and Baltimore, Maryland.

Expanding the Evidence on Integrated Opioid Use Disorder and Infectious Disease Care.

Low-barrier to access programs has emerged as a way to overcome the significant hurdles associated with buprenorphine initiation. However, there has been limited research evaluating services set in low-barrier programs outside of buprenorphine. In this issue of the Journal of Addiction Medicine, Harvey and colleagues evaluate a sexually transmitted and blood-borne infection screening protocol implemented in a low-barrier access program in Boston, Massachusetts.

Initiation of Low-threshold Buprenorphine in Nontreatment Seeking Patients With Opioid Use Disorder Engaged in Hepatitis C Treatment.

Objective: The ANCHOR program offered buprenorphine treatment to people who inject drugs engaged in hepatitis C (HCV) treatment at a Washington, DC harm reduction organization. This analysis describes the program model and outcomes of the opioid care continuum at 1 year.

Methods: Primary outcomes were initiation of buprenorphine and retention in care, defined by an active buprenorphine prescription at given time points.

The Effect of GS-548351 on the Pharmacokinetics of Midazolam Following Multiple Doses of ANS-6637 in Healthy Adults.

ANS-6637, a pro-drug of GS-548351, is a selective, reversible inhibitor of aldehyde dehydrogenase isoform 2 under development as an anticraving agent for the treatment of substance use disorders. In vitro testing indicates that GS-548351 is an inhibitor and inducer of cytochrome P450 family 3, subfamily A (CYP3A). In this phase 1 single-center, open-label, fixed-sequence drug-drug interaction study we assessed the impact of steady-state GS-548351 on single-dose pharmacokinetics of midazolam, an index substrate for CYP3A.

Concurrent Initiation of Hepatitis C and Opioid Use Disorder Treatment in People Who Inject Drugs.

Background: People who inject drugs have a high prevalence of hepatitis C virus (HCV) and significant disease associated with drug use; however, HCV treatment often occurs in absence of interventions to address opioid use disorder and drug use-related harms. The impact of concurrent initiation of opioid agonist therapy (OAT) on HCV treatment and drug use outcomes is unknown.

Methods: In this prospective, open-label, observational trial at a harm reduction organization's drop-in center in Washington, DC, 100 patients with chronic HCV infection, opioid use disorder, and ongoing injection drug use were treated with sofosbuvir-velpatasvir for 12-weeks and offered buprenorphine initiation.

Long-term changes in hepatic fibrosis following hepatitis C viral clearance in patients with and without HIV.

Background: While acute changes in hepatic fibrosis are recognized shortly after achieving sustained virological response (SVR) using direct-acting antiviral therapies, long-term outcomes for the growing population of successfully treated patients with HCV remain uncertain. The aim of this study is to characterize long-term changes in fibrosis following SVR in patients with and without HIV and to identify potential factors associated with progression or regression of fibrosis.

Methods: We completed a prospective longitudinal study of 162 subjects with HCV (34% HIV-coinfected) with pre-treatment fibrosis stage determined by liver biopsy and post-SVR transient elastography.

A pilot study of safety and efficacy of HCV retreatment with sofosbuvir/velpatasvir/voxilaprevir in patients with or without HIV (RESOLVE STUDY).

Background & Aims: Cure rates in response to retreatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) are high, but this regimen has not been studied in patients with a history of poor adherence or treatment interruption, nor in patients with HIV/HCV coinfection. Herein, we aimed to assess the safety and efficacy of this combination in patients with genotype 1 HCV infection who had relapsed following combination direct-acting antiviral (DAA) therapy, regardless of HIV infection or previous treatment course.

Methods: The RESOLVE study was a multicenter, open-label, phase IIb study investigating the safety, tolerability and efficacy of SOF/VEL/VOX in 77 patients with virologic rebound following combination DAA therapy.

High Morbidity and Mortality Among Patients With Sentinel Admission for Injection Drug Use-Related Infective Endocarditis.

Background: Hospitalizations for individuals with injection drug use-related infective endocarditis (IDU-IE) represent an increasing portion of all patients with endocarditis. This study describes the evolving trends in demographics, clinical characteristics, rates of surgical intervention, and mortality among patients hospitalized with IE, comparing those with and without injection drug use.

Methods: This is a retrospective cohort study of patients admitted between January 1, 2007 to June 30, 2015 at a tertiary care center in Boston, Massachusetts.

Opioids and Infectious Diseases: A Converging Public Health Crisis.

A converging public health crisis is emerging because the opioid epidemic is fueling a surge in infectious diseases, such as human immunodeficiency virus infection with or without AIDS, the viral hepatitides, infective endocarditis, and skin and soft-tissue infections. An integrated strategy is needed to tailor preventive and therapeutic approaches toward infectious diseases in people who misuse and/or are addicted to opioids and to concurrently address the underlying predisposing factor for the infections-opioid use disorder. This commentary highlights the unique and complementary roles that the infectious diseases and substance use disorder communities can play in addressing this crisis of dual public health concerns.

Testosterone in Men With Chronic Hepatitis C Infection and After Hepatitis C Viral Clearance.

Background: Hepatitis C virus (HCV) and hepatic dysfunction are associated with low total and free testosterone (TT and FT) and high sex hormone-binding globulin (SHBG). However, little is known about changes in testosterone following successful HCV treatment.

Methods: We evaluated testosterone levels and the prevalence of low testosterone in a cohort of 327 men with chronic HCV infection (human immunodeficiency virus [HIV] coinfection = 150) and in a subset of 85 men with testosterone levels obtained pre-HCV treatment and after sustained virologic response (SVR).

Multitarget Direct-Acting Antiviral Therapy Is Associated With Superior Immunologic Recovery in Patients Coinfected With Human Immunodeficiency Virus and Hepatitis C Virus.

Patients coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) have higher levels of immune activation, impaired antigen-specific responses, and accelerated fibrogenesis compared to patients monoinfected with HCV. Whether different direct-acting antiviral (DAA) combinations have differential effects on immunophenotypes and functions following successful HCV therapy remain unknown. Therefore, we aimed to assess the peripheral T-cell immunophenotypes and functions in patients coinfected with HIV/HCV who were successfully treated with combination DAA treatment regimens.

No Improvement in Hemoglobin A1c Following Hepatitis C Viral Clearance in Patients With and Without HIV.

Hepatitis C clearance with directly acting antivirals (DAAs) may be associated with acute decreases in hemoglobin A1c (HbA1c). We prospectively evaluated 251 chronic hepatitis C virus (HCV)-infected subjects (31% human immunodeficiency virus [HIV] positive) pre- and post-DAA therapy (median follow-up 28 months). Changes in HbA1c and glucose were minimal and did not differ by sustained virologic response (SVR), HIV, diabetes, or fibrosis.

Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial.

Background: Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection has resulted in high rates of disease cure; however, not enough specialists currently are available to provide care.

Objective: To determine the efficacy of HCV treatment independently provided by nurse practitioners (NPs), primary care physicians (PCPs), or specialist physicians using DAA therapy.

Design: Nonrandomized, open-label clinical trial initiated in 2015.