Vertical Transmission of Hepatitis C Virus Among Women with a History of Injection Opioid Use.

We evaluated vertical transmission and linkage to care in women with HCV and history of injection drug use employing co-localized testing and treatment. Transmission occurred in 1 of 23 infants, with mother-infant genetic distance of 1.26%. Rates for infant testing, maternal linkage and cure were 77%, 52%, and 100%, respectively.

Optimal hepatitis C treatment adherence patterns and sustained virologic response among people who inject drugs: The HERO study.

BACKGROUND & AIMS: Direct-acting antivirals (DAAs) are highly effective for treating HCV infection even among people who inject drugs (PWID). Yet, little is known about patients' adherence patterns and their association with sustained virologic response (SVR) rates. We aimed to summarize various adherence patterns and determine their associations with SVR. METHODS: Electronic blister packs were used to measure daily adherence to once-a-day sofosbuvir/velpatasvir during the 12-week treatment period among active PWIDs. Blister pack data were available for 496 participants who initiated DAAs for whom SVR status was known. Adherence was summarized in multiple patterns, such as total adherent days, consecutive missed days, and early discontinuations. Thresholds for adherence patterns associated with >90% SVR rates were also determined. RESULTS: The overall SVR rate was 92.7%, with a median adherence rate of 75%. All adherence patterns indicating greater adherence were significantly associated with achieving SVR. Participant groups with ≥50% (>42/84) adherent days or <26 consecutive missed days achieved an SVR rate of >90%. Greater total adherent days during 9-12 weeks and no early discontinuation were significantly associated with higher SVR rates only in those with <50% adherence. Participants with first month discontinuation and ≥2 weeks of treatment interruption had low SVR rates, 25% and 85%, respectively. However, greater adherent days were significantly associated with SVR (adjusted odds ratio 1.10; 95% CI 1.04-1.16; p <0.001) even among participants with ≥14 consecutive missed days. CONCLUSIONS: High SVR rates can be achieved in the PWID population despite suboptimal adherence. Encouraging patients to take as much medication as possible, with <2 weeks consecutive missed days and without early discontinuation, was found to be important for achieving SVR. IMPACT AND IMPLICATIONS: People who inject drugs can be cured of HCV in >90% of cases, even with relatively low adherence to direct-acting antivirals, but early discontinuations and long treatment interruptions can significantly reduce the likelihood of achieving cure. Clinicians should encourage people who inject drugs who are living with HCV to adhere daily to direct-acting antivirals as consistently as possible, but if any days are interrupted, to continue and complete treatment. These results from the HERO study are important for patients living with HCV, clinicians, experts writing clinical guidelines, and payers. CLINICAL TRIAL NUMBER: NCT02824640.

Correlates of Recent HIV Testing Among People Who Inject Drugs in Rural Areas: A Multi-site Cross-Sectional Study, 2018-2020.

The Rural Opioid Initiative surveyed 2693 people who inject drugs (PWID) in eight rural U.S. areas in 2018-2020 about self-reported HIV testing in the past 6 months. Correlates of interest included receipt of any drug-related services, incarceration history, and structural barriers to care (e.g., lack of insurance, proximity to syringe service programs [SSP]). Overall, 20% of participants reported receiving an HIV test within the past 6 months. Multivariable generalized estimating equations showed that attending substance use disorder (SUD) treatment (OR 2.11, 95%CI [1.58, 2.82]), having health insurance (OR 1.42, 95%CI [1.01, 2.00]) and recent incarceration (OR 1.49, 95%CI [1.08, 2.04]) were positively associated with HIV testing, while experiencing a resource barrier to healthcare (inability to pay, lack of transportation, inconvenient hours, or lack of child care) had inverse (OR 0.73, 95%CI [0.56, 0.94]) association with HIV testing. We found that the prevalence of HIV testing among rural PWID is low, indicating an unmet need for testing. While SUD treatment or incarceration may increase chances for HIV testing for rural PWID, other avenues for expanding HIV testing, such as SSP, need to be explored.

Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

What Hepatitis C (HCV) diagnostic tools are needed to advance diagnosis of current HCV infection in outreach settings and in a non-clinical setting?

Given the growing HCV epidemic in the U.S., it is imperative to implement a coordinated, equitable public health approach to HCV testing that will facilitate immediate access to treatment, especially for individuals with limited healthcare access and those who inject drugs. Point-of-care (POC) RNA diagnostic tests have the greatest potential to address this need. Future regulatory approval has been facilitated by a recent change in the FDA's approach to evaluating POC diagnostic tests that have been developed and validated.

Principles for Ending Human Immunodeficiency Virus as an Epidemic in the United States: A Policy Paper of the Infectious Diseases Society of America and the HIV Medical Association.

While we have the tools to achieve this goal, the persistent barriers to healthcare services experienced by too many individuals will need to be addressed to make significant progress and improve the health and quality of life of all people with human immunodeficiency virus (HIV). The necessary structural changes require actions by federal, state, and local policymakers and range from ensuring universal access to healthcare services to optimizing care delivery to ensuring a robust and diverse infectious diseases and HIV workforce. In this article, we outlines 10 key principles for policy reforms that, if advanced, would make ending the HIV epidemic in the United States possible and could have much more far-reaching effects in improving the health of our nation.

Contraception and Healthcare Utilization by Reproductive-Age Women Who Use Drugs in Rural Communities: a Cross-Sectional Survey.

BACKGROUND: Women who use drugs (WWUD) have low rates of contraceptive use and high rates of unintended pregnancy. Drug use is common among women in rural U.S. communities, with limited data on how they utilize reproductive, substance use disorder (SUD), and healthcare services. OBJECTIVE: We determined contraceptive use prevalence among WWUD in rural communities then compared estimates to women from similar rural areas. We investigated characteristics of those using contraceptives, and associations between contraceptive use and SUD treatment, healthcare utilization, and substance use. DESIGN: Rural Opioids Initiative (ROI) - cross-sectional survey using respondent-driven sampling (RDS) involving eight rural U.S. regions (January 2018-March 2020); National Survey on Family Growth (NSFG) - nationally-representative U.S. household reproductive health survey (2017-2019). PARTICIPANTS: Women aged 18-49 with prior 30-day non-prescribed opioid and/or non-opioid injection drug use; fecundity determined by self-reported survey responses. MAIN MEASURES: Unweighted and RDS-weighted prevalence estimates of medical/procedural contraceptive use; chi-squared tests and multi-level linear regressions to test associations. KEY RESULTS: Of 855 women in the ROI, 36.8% (95% CI 33.7-40.1, unweighted) and 38.6% (95% CI 30.7-47.2, weighted) reported contraceptive use, compared to 66% of rural women in the NSFG sample. Among the ROI women, 27% had received prior 30-day SUD treatment via outpatient counseling or inpatient program and these women had increased odds of contraceptive use (aOR 1.50 [95% CI 1.08-2.06]). There was a positive association between contraception use and recent medications for opioid use disorder (aOR 1.34 [95% CI 0.95-1.88]) and prior 6-month primary care utilization (aOR 1.32 [95% CI 0.96-1.82]) that did not meet the threshold for statistical significance. CONCLUSION: WWUD in rural areas reported low contraceptive use; those who recently received SUD treatment had greater odds of contraceptive use. Improvements are needed in expanding reproductive and preventive health within SUD treatment and primary care services in rural communities.

Escalating costs of self-injury mortality in the 21st century United States: an interstate observational study.

BACKGROUND: Estimating the economic costs of self-injury mortality (SIM) can inform health planning and clinical and public health interventions, serve as a basis for their evaluation, and provide the foundation for broadly disseminating evidence-based policies and practices. SIM is operationalized as a composite of all registered suicides at any age, and 80% of drug overdose (intoxication) deaths medicolegally classified as 'accidents,' and 90% of corresponding undetermined (intent) deaths in the age group 15 years and older. It is the long-term practice of the United States (US) Centers for Disease Control and Prevention (CDC) to subsume poisoning (drug and nondrug) deaths under the injury rubric. This study aimed to estimate magnitude and change in SIM and suicide costs in 2019 dollars for the United States (US), including the 50 states and the District of Columbia. METHODS: Cost estimates were generated from underlying cause-of-death data for 1999/2000 and 2018/2019 from the US Centers for Disease Control and Prevention's (CDC's) Wide-ranging ONline Data for Epidemiologic Research (WONDER). Estimation utilized the updated version of Medical and Work Loss Cost Estimation Methods for CDC's Web-based Injury Statistics Query and Reporting System (WISQARS). Exposures were medical expenditures, lost work productivity, and future quality of life loss. Main outcome measures were disaggregated, annual-averaged total and per capita costs of SIM and suicide for the nation and states in 1999/2000 and 2018/2019. RESULTS: 40,834 annual-averaged self-injury deaths in 1999/2000 and 101,325 in 2018/2019 were identified. Estimated national costs of SIM rose by 143% from $0.46 trillion to $1.12 trillion. Ratios of quality of life and work losses to medical spending in 2019 US dollars in 2018/2019 were 1,476 and 526, respectively, versus 1,419 and 526 in 1999/2000. Total national suicide costs increased 58%-from $318.6 billion to $502.7 billion. National per capita costs of SIM doubled from $1,638 to $3,413 over the observation period; costs of the suicide component rose from $1,137 to $1,534. States in the top quintile for per capita SIM, those whose cost increases exceeded 152%, concentrated in the Great Lakes, Southeast, Mideast and New England. States in the bottom quintile, those with per capita cost increases below 70%, were located in the Far West, Southwest, Plains, and Rocky Mountain regions. West Virginia exhibited the largest increase at 263% and Nevada the smallest at 22%. Percentage per capita cost increases for suicide were smaller than for SIM. Only the Far West, Southwest and Mideast were not represented in the top quintile, which comprised states with increases of 50% or greater. The bottom quintile comprised states with per capita suicide cost increases below 24%. Regions represented were the Far West, Southeast, Mideast and New England. North Dakota and Nevada occupied the extremes on the cost change continuum at 75% and - 1%, respectively. CONCLUSION: The scale and surge in the economic costs of SIM to society are large. Federal and state prevention and intervention programs should be financed with a clear understanding of the total costs-fiscal, social, and personal-incurred by deaths due to self-injurious behaviors.

Prevention and Initial Management of HIV Infection.

Since July 2017, when In the Clinic last addressed management of HIV infection, there have been meaningful improvements in our ability to prevent HIV and to manage patients living with HIV. New approaches to preexposure prophylaxis and more effective treatments have made the elimination of HIV infection a feasible goal. The federal "Ending the HIV Epidemic" initiative aims at a 90% reduction in new HIV diagnoses by 2030. This article provides updated information on how clinicians should use these improvements to manage their patients who are at risk for HIV infection or are newly diagnosed with HIV.

A Video-Observed Treatment Strategy to Improve Adherence to Treatment Among Persons Who Inject Drugs Infected With Hepatitis C Virus: Qualitative Study of Stakeholder Perceptions and Experiences.

BACKGROUND: Direct-acting antiviral medications have the potential to eliminate the hepatitis C virus (HCV) epidemic among people who inject drugs; yet, suboptimal adherence remains a barrier. Directly observed treatment (DOT), an effective strategy for optimizing adherence, has been frequently implemented in opioid treatment programs but less commonly in community health settings due to the heavy burden of daily visits. An alternative is video-observed therapy (VOT), which uses mobile health technology to monitor adherence. VOT has not been widely studied among people who inject drugs with HCV. OBJECTIVE: This qualitative study, part of a larger implementation evaluation, investigates stakeholder perceptions and experiences with VOT in Project HERO (Hepatitis C Real Outcomes), a multisite pragmatic trial testing treatment delivery models for people who inject drugs with HCV. Our goal was to understand the potential barriers and facilitators to the implementation of the VOT technology. METHODS: Qualitative interviews were conducted with 27 Project HERO study staff and 7 patients. Interviews focused on perceptions and experiences with the VOT app and barriers and facilitators to implementation. Team meeting minutes over the first 2 years of the project were transcribed. A coding system was developed and applied to the data. We summarized thematic data and compared participant perceptions to generate a close understanding of the data. RESULTS: Frequent barriers to VOT included mechanical failure, stolen or lost phones, and a steep learning curve for participants and study staff. In sites with older and less technically skilled participants, staff found it difficult to implement the VOT app. Research staff found that the routine monitoring of app use led to closer engagement with participants. This was both a benefit and a potential threat to the validity of this pragmatic trial. Patient participants reported mixed experiences. CONCLUSIONS: VOT may be a useful alternative to DOT for some patients, but it may not be feasible for all. Significant staff involvement may be required.

Houselessness and syringe service program utilization among people who inject drugs in eight rural areas across the USA: a cross-sectional analysis.

BACKGROUND: Research conducted in urban areas has highlighted the impact of housing instability on people who inject drugs (PWID), revealing that it exacerbates vulnerability to drug-related harms and impedes syringe service program (SSP) use. However, few studies have explored the effects of houselessness on SSP use among rural PWID. This study examines the relationship between houselessness and SSP utilization among PWID in eight rural areas across 10 states. METHODS: PWID were recruited using respondent-driven sampling for a cross-sectional survey that queried self-reported drug use and SSP utilization in the prior 30 days, houselessness in the prior 6 months and sociodemographic characteristics. Using binomial logistic regression, we examined the relationship between experiencing houselessness and any SSP use. To assess the relationship between houselessness and the frequency of SSP use, we conducted multinomial logistic regression analyses among participants reporting any past 30-day SSP use. RESULTS: Among 2394 rural PWID, 56.5% had experienced houselessness in the prior 6 months, and 43.5% reported past 30-day SSP use. PWID who had experienced houselessness were more likely to report using an SSP compared to their housed counterparts (adjusted odds ratio [aOR] = 1.24 [95% confidence intervals [CI] 1.01, 1.52]). Among those who had used an SSP at least once (n = 972), those who experienced houselessness were just as likely to report SSP use two (aOR = 0.90 [95% CI 0.60, 1.36]) and three times (aOR = 1.18 [95% CI 0.77, 1.98]) compared to once. However, they were less likely to visit an SSP four or more times compared to once in the prior 30 days (aOR = 0.59 [95% CI 0.40, 0.85]). CONCLUSION: This study provides evidence that rural PWID who experience houselessness utilize SSPs at similar or higher rates as their housed counterparts. However, housing instability may pose barriers to more frequent SSP use. These findings are significant as people who experience houselessness are at increased risk for drug-related harms and encounter additional challenges when attempting to access SSPs.

Factors Associated with Non-Evidence-Based Overdose Responses among People Who Use Prescription Opioids Non-Medically in Rural Appalachia.

Background: Opioid-related overdose deaths recently accelerated. In response, overdose education and naloxone distribution (OEND) has been implemented widely, though access remains sparse in rural Appalachia. Despite increasing OEND, risk factors for non-evidence-based overdose responses among the training-naïve remain unknown. Methods: We enrolled 169 adults who use prescription opioids non-medically and reside in rural West Virginia (August 2014-March 2015). Participants were interviewed about witnessing overdose (lifetime and prior-year), characteristics of the most recent overdose, responses to the overdose, and OEND acceptability. Logistic regression was used to assess factors associated with non-evidence-based responses to overdose. Results: Among the 73 participants who witnessed an opioid-related overdose, the majority (n = 53, 73%) reported any non-evidence-based responses. Participants were significantly more likely to report a non-evidence-based response when victims were unresponsive (OR = 3.36; 95% CI = 1.07, 10.58). Common evidence-based responses included staying with the victim until help arrived (n = 66, 90%) and calling 911 (n = 63, 86%), while the most common non-evidence-based responses were hitting or slapping the victim (n = 37, 51%) and rubbing the victim with ice or placing them in a cold shower or bath (n = 14, 19%). While most (n = 60, 82%) had never heard of OEND, the majority (n = 69, 95%) were willing to train, particularly those reporting non-evidence-based responses (n = 52, 98%). Conclusions: These findings underscore the need to expand access to OEND in rural communities and indicate OEND is acceptable to training-naïve individuals who use opioids in rural Appalachia. Given the "harm reduction deserts" in the region, approaches to expand OEND should be pursued.

The opioid crisis and HIV in the USA: deadly synergies.

The opioid epidemic is one of the greatest public health problems that the USA faces. Opioid overdose death rates have increased steadily for more than a decade and doubled in 2013-17, as the highly potent synthetic opioid fentanyl entered the drug supply. Demographics of new HIV diagnoses among people who inject drugs are also changing, with more new HIV diagnoses occurring among White people, young people (aged 13-34 years), and people who reside outside large central metropolitan areas. Racial differences also exist in syringe sharing, which decreased among Black people and Hispanic people but remained unchanged among White people in 2005-15. Recent HIV outbreaks have occurred in rural areas of the USA, as well as among marginalised people in urban areas with robust HIV prevention and treatment services (eg, Seattle, WA). Multiple evidence-based interventions can effectively treat opioid use disorder and prevent HIV acquisition. However, considerable barriers exist precluding delivery of these solutions to many people who inject drugs. If the USA is serious about HIV prevention among this group, stigma must be eliminated, discriminatory policies must change, and comprehensive health care must be accessible to all. Finally, root causes of the opioid epidemic such as hopelessness need to be identified and addressed.

Using the electronic medical record to increase testing for HIV and hepatitis C virus in an Appalachian emergency department.

BACKGROUND: The ongoing Appalachian opioid epidemic has led to increasing hepatitis C virus (HCV) infections among people who inject drugs (PWID), and Human Immunodeficiency Virus (HIV) outbreaks have been observed. The primary aim of this study was to assess the potential increase in screening for HIV and HCV in an academic central Appalachian emergency department (ED) through the use of Best Practice Alerts (BPAs) in the electronic medical record (EMR). A secondary aim was to assess for an increase in linkage to care using patient navigators. METHODS: EMR algorithms based on current Centers for Disease Control and Prevention HIV and HCV testing recommendations were created that triggered Best Practice Alerts (BPAs), giving providers a one-click acceptance option to order HIV and/or HCV testing. Placards were placed in care areas, informing patients of the availability of routine screening. Patient navigators facilitated linkage to care for seropositive patients. RESULTS: The BPA appeared 58,936 times on 21,098 patients eligible for HIV screening and 24,319 times on 11,989 patients eligible for HCV screening over a one-year period. Of those, 7106 (33.7%) patients were screened for HIV and 3496 (29.2%) patients were screened for HCV, for an overall testing increase of 2269% and 1065% for HIV and HCV, respectively. Linkage to care increased by 15% for HIV to 100, and 14% for HCV to 64%. CONCLUSION: HIV and HCV screening and linkage to care were increased in an academic ED setting in central Appalachia using EMR alerts. This approach could be utilized in multiple ambulatory settings. Increased testing and earlier linkage to care may help combat the current injection drug use-related HCV epidemic and avoid additional HIV outbreaks.

Trends in Hepatitis B Infection and Immunity Among Women of Childbearing Age in the United States.

BACKGROUND: The current opioid injection drug use epidemic has been associated with an increase in hepatitis C virus infections among women of childbearing age in the United States, but changes in hepatitis B virus (HBV) infections have not been studied. METHODS: A retrospective analysis of HBV statuses among women of childbearing age nationally and by state was conducted, utilizing the Quest Diagnostics database. Rates of HBV in women born before and after the implementation of universal HBV vaccination recommendations were determined. RESULTS: We identified 8 871 965 women tested for HBV from 2011-2017. Nationally, the annual rate of acute HBV infections was stable, but rates increased in Kentucky, Alabama, and Indiana (P < .03). The national prevalence of new, chronic HBV diagnoses decreased significantly, from 0.83% in 2011 to 0.19% in 2017 (P < .0001), but increased in Mississippi, Kentucky, and West Virginia (P ≤ .05). A declining prevalence of HBV seroprotection was evident over time, especially within the birth-dose cohort (which dropped from 48.5% to 38.5%; P < .0001). CONCLUSIONS: National rates of newly diagnosed acute and chronic HBV infections declined or were stable overall, but increased significantly in specific Appalachian states. The HBV vaccine is effective in decreasing infections, but seroprotection wanes over time. These trends in new infections may be related to increased injection drug use and highlight potential gaps in HBV vaccine protection.

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV?

PURPOSE OF REVIEW: To describe models of integrated and co-located care for opioid use disorder (OUD), hepatitis C (HCV), and HIV. RECENT FINDINGS: The design and scale-up of multidisciplinary care models that engage, retain, and treat individuals with HIV, HCV, and OUD are critical to preventing continued spread of HIV and HCV. We identified 17 models within primary care (N = 3), HIV specialty care (N = 5), opioid treatment programs (N = 6), transitional clinics (N = 2), and community-based harm reduction programs (N = 1), as well as two emerging models. Key components of such models are the provision of (1) medication-assisted treatment for OUD, (2) HIV and HCV treatment, (3) HIV pre-exposure prophylaxis, and (4) behavioral health services. Research is needed to understand differences in effectiveness between co-located and fully integrated care, combat the deleterious racial and ethnic legacies of the "War on Drugs," and inform the delivery of psychiatric care. Increased access to harm reduction services is crucial.

Management of Newly Diagnosed HIV Infection.

No field in medicine has moved as swiftly as HIV/AIDS over the past 35 years. Because of the rapid turnover of key information, this In the Clinic focuses on essential principles of care for newly diagnosed adults with HIV-1 infection and how to prevent infection in persons at risk. To ensure continued usefulness, future directions in therapy and how to access updated information on a continuous basis are emphasized.