Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial.

Importance: Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. Objective: To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Design, Setting, and Participants: Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Intervention: Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). Main Outcomes and Measures: The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Results: Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Conclusions and Relevance: Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. Trial Registration: ClinicalTrials.gov Identifier: NCT02933970.

Application of Artificial Intelligence for Diagnosis and Risk Stratification in NAFLD and NASH: The State of the Art.

The diagnosis of nonalcoholic fatty liver disease and associated fibrosis is challenging given the lack of signs, symptoms and nonexistent diagnostic test. Furthermore, follow up and treatment decisions become complicated with a lack of a simple reproducible method to follow these patients longitudinally. Liver biopsy is the current standard to detect, risk stratify and monitor individuals with nonalcoholic fatty liver disease. However, this method is an unrealistic option in a population that affects about one in three to four individuals worldwide. There is an urgency to develop innovative methods to facilitate management at key points in an individual's journey with nonalcoholic fatty liver disease fibrosis. Artificial intelligence is an exciting field that has the potential to achieve this. In this review, we highlight applications of artificial intelligence by leveraging our current knowledge of nonalcoholic fatty liver disease to diagnose and risk stratify NASH phenotypes.

A Real-World Experience Utilizing the FAST Score to Identify Patients With Nonalcoholic Steatohepatitis Fibrosis.

Background and Aims: We aimed to test the performance of the Fibroscan-aspartate aminotransferase (FAST) score, a noninvasive test, to identify nonalcoholic steatohepatitis (NASH) and significant fibrosis (NASH + ≥F2) in a cohort of patients with a histological diagnosis of NASH, using a cutoff of ≥0.35 as a rule in factor. We also compared performance to liver stiffness measurement (LSM) ≥8 kPa and the fibrosis-4 index (FIB-4) ≥1.3 and attempted to identify risk factors to develop a model for improving diagnostic accuracy. Methods: Patients with histologically confirmed NASH were identified from 2020-2021. Demographic information, laboratory data, and LSM were collected. The FAST score and FIB-4 were calculated. Univariate and backward entry multivariate logistic regression analyses were performed to identify risk factors in addition to the FAST score ≥0.35 that are associated with an accurate histological diagnosis of NASH + ≥F2. Discrimination and overall accuracy were assessed using area under receiver operating characteristic curves. Results: Using a rule in cutoff of ≥0.35, the FAST score performed with a sensitivity, specificity, negative predictive value, and positive predictive value of 96.4%, 36.8%, 77.7%, and 81.8%, respectively. Age (P = .05) and FAST ≥0.35 (P = .001) correctly identified histologically confirmed NASH + ≥F2. The FAST + age model outperformed FAST ≥0.35 (0.70, confidence interval [CI]: 0.55-0.84), LSM ≥8 kPa (0.72, CI: 0.59-0.85), and FIB-4 ≥1.3 (0.73, CI: 0.59-0.87) with a c-statistic of 0.78 (CI: 0.64-0.92). Conclusion: A FAST score with a rule cutoff of ≥0.35 performed well (c-statistic: 0.70) and was superior to LSM and FIB-4 when age was incorporated into the model (0.78) in detecting NASH + ≥F2 fibrosis in the real world.

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study.

Objective: The Diabetes Prevention Program (DPP) is the gold standard lifestyle modification program that reduces incident type 2 diabetes mellitus. Patients with prediabetes and patients with non-alcoholic fatty liver disease (NAFLD) often share metabolic features; we hypothesized that the DPP could be adapted and used to improve outcomes in patients with NAFLD. Methods: NAFLD patients were recruited into a 1 year modified DPP. Demographics, medical comorbidities, and clinical laboratory values were collected at baseline, 6 and 12 months. The primary endpoint was change in weight at 12 months. Secondary endpoints were changes in hepatic steatosis, metabolic comorbidities, and liver enzymes (per-protocol basis) and retention at 6 and 12 months. Results: Fourteen NAFLD patients enrolled; three dropped out before 6 months. From baseline to 12 months, hepatic steatosis (p = 0.03), alanine aminotransferase (p = 0.02), aspartate aminotransferase (p = 0.02), high-density lipoprotein (p = 0.01) and NAFLD fibrosis score (p < 0.001) improved, but low-density lipoprotein worsened (p = 0.04). Conclusion: Seventy-nine percent of patients completed the modified DPP. Patients lost weight and had improvements in five out of six indicators of liver injury and lipid metabolism. Clinical Trial Registry Number: NCT04988204.

Patients with autoimmune hepatitis who have antimitochondrial antibodies need long-term follow-up to detect late development of primary biliary cirrhosis.

Patients with autoimmune hepatitis (AIH) who have antibodies against mitochondrial proteins (AMA positive) are believed to have an autoimmune syndrome that should be managed as AIH. Of patients with AMA-positive AIH, we report on 3 individuals to demonstrate how autoimmune liver disease can progress over time. Specific features of primary biliary cirrhosis (PBC) overlapped in time in these patients. Our observations indicate the importance of careful follow up of patients with AMA-positive AIH; health care professionals that treat such patients should therefore be aware of longitudinal clinical changes that might indicate development of PBC in this setting.

Endoscopic management and outcomes of pregnant women hospitalized for nonvariceal upper GI bleeding: a nationwide analysis.

BACKGROUND: Upper GI endoscopy has an important diagnostic and therapeutic role in the management of nonvariceal upper GI bleeding (NVUGB). OBJECTIVE: To characterize nationwide patterns of utilization of upper GI endoscopy in pregnant women with NVUGB and to assess health outcomes. DESIGN: Retrospective cohort study. SETTING: Participating hospitals from the Nationwide Inpatient Sample, 1998-2007. PATIENTS: Pregnant and age-matched nonpregnant women admitted for NVUGB. INTERVENTION: The study population was classified as pregnant women with NVUGB (n = 1210) and nonpregnant women with NVUGB (n = 6050). MAIN OUTCOME MEASUREMENTS: Rate of upper GI endoscopy, maternal mortality, fetal death/complications, and premature delivery. RESULTS: Pregnant women were less likely than nonpregnant women to undergo upper GI endoscopy (26% vs 69%; P < .0001) even after adjustment for comorbidities, transfusion requirement, and the presence of hypovolemic shock (adjusted odds ratio, 0.19; 95% confidence interval, 0.16-0.22). Among those who underwent endoscopy, pregnant women were less likely to undergo the procedure within 24 hours of admission (50% vs 57%; P = .02). Mortality was lower among pregnant women compared with nonpregnant women (0% vs 0.6%; P = .006). In comparing outcomes between those who did and did not undergo endoscopy, there was no difference in fetal loss (0.2% vs 0.6%), fetal distress/complications (2.7% vs 2.6%), or premature delivery (7.3% vs 6.4%). LIMITATIONS: The study was based on administrative data. CONCLUSION: A conservative nonendoscopic approach is common in the management of pregnant women with NVUGB and is not associated with worse maternal or fetal outcomes. Upper GI endoscopy is, however, safe when judiciously implemented in the actively bleeding patient.

Endoscopic Devices for Obesity.

The obesity epidemic, recognized by the World Health Organization in 1997, refers to the rising incidence of obesity worldwide. Lifestyle modification and pharmacotherapy are often ineffective long-term solutions; bariatric surgery remains the gold standard for long-term obesity weight loss. Despite the reported benefits, it has been estimated that only 1% of obese patients will undergo surgery. Endoscopic treatment for obesity represents a potential cost-effective, accessible, minimally invasive procedure that can function as a bridge or alternative intervention to bariatric surgery. We review the current endoscopic bariatric devices including space occupying devices, endoscopic gastroplasty, aspiration technology, post-bariatric surgery endoscopic revision, and obesity-related NOTES procedures. Given the diverse devices already FDA approved and in development, we discuss the future directions of endoscopic therapies for obesity.