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BACKGROUND AND AIMS: Chronic hepatitis D (CHD) is the most severe form of chronic viral hepatitis, with a high risk of developing hepatocellular carcinoma (HCC) and liver-related mortality. Risk stratification is needed to guide HCC surveillance strategies and to prioritize treatment with antiviral agents. METHODS: We conducted a multicenter retrospective cohort of anti-HDV positive individuals managed at sites in the Netherlands and the United Kingdom. We studied the 5-year cumulative incidences of HCC and liver-related events (first of HCC, liver transplantation and liver-related mortality), in the overall cohort and among relevant subgroups. RESULTS: We analyzed 269 anti-HDV positive individuals with a median follow-up of 4.3 years in which 47 first events occurred. The 5-year cumulative incidences of HCC and liver-related events were 3.8% and 15.6% in the overall cohort. The 5-year cumulative incidence of HCC and liver-related events for individuals without cirrhosis was 0% and 0.9% compared to 12% and 41.3% for individuals with cirrhosis (p<0.001). The 5-year cumulative incidence of HCC and liver-related events was 0% and 2.1% among individuals with low PAGE-B scores, compared to 3.2% and 21.1% with intermediate and 25.4% and 45.5% with high risk scores (p<0.001). We found comparable results for the FIB-4 score. Findings were consistent regardless of cirrhosis or detectable HDV RNA (p<0.001). CONCLUSION: Anti-HDV positive individuals are at high risk of adverse liver-related outcomes. The incidences of HCC was negligible among individuals without cirrhosis and among individuals with low baseline PAGE-B and/or FIB-4 scores. Therefore, these score can be used to guide HCC surveillance strategies and potentially also for treatment prioritization.
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Background: Several promising human immunodeficiency virus (HIV) treatment adherence interventions have been identified, but data about their cost-effectiveness are lacking. This study examines the trial-based cost-effectiveness and cost-utility of the proven-effective Adherence Improving Self-Management Strategy (AIMS), from a societal perspective, with a 15-month time horizon. Methods: Treatment-naive and treatment-experienced patients at risk for viral rebound were randomized to treatment as usual (TAU) or AIMS in a multicenter randomized controlled trial in the Netherlands. AIMS is a nurse-led, 1-on-1 self-management intervention incorporating feedback from electronic medication monitors, delivered during routine clinical visits. Main outcomes were costs per reduction in log10 viral load, treatment failure (2 consecutive detectable viral loads), and quality-adjusted life-years (QALYs). Results: Two hundred twenty-three patients were randomized. From a societal perspective, AIMS was slightly more expensive than TAU but also more effective, resulting in an incremental cost-effectiveness ratio (ICER) of 549 per reduction in log10 viral load and 1659 per percentage decrease in treatment failure. In terms of QALYs, AIMS resulted in higher costs but more QALYs compared to TAU, which resulted in an ICER of 27759 per QALY gained. From a healthcare perspective, AIMS dominated TAU. Additional sensitivity analyses addressing key limitations of the base case analyses also suggested that AIMS dominates TAU. Conclusions: Base case analyses suggests that over a period of 15 months, AIMS may be costlier, but also more effective than TAU. All additional analyses suggest that AIMS is cheaper and more effective than TAU. This trial-based economic evaluation confirms and complements a model-based economic evaluation with a lifetime horizon showing that AIMS is cost-effective. Clinical Trials Registration: NCT01429142.
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Análisis Costo-Beneficio , Manejo de la Enfermedad , Infecciones por VIH/tratamiento farmacológico , Cumplimiento de la Medicación , Automanejo , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Sensibilidad y Especificidad , Carga ViralRESUMEN
Health care interventions are increasingly expected to improve subjective well-being (SWB) rather than health-related quality of life (HRQOL) only. However, little is known about how HRQOL and other relevant quality of life (QOL) domains relate to SWB among people living with HIV. People living with HIV treated in Dutch HIV centers (n = 191) completed a cross-sectional survey on SWB, HRQOL, and other QOL domains (social, financial, sexual, and environmental well-being). In bivariate analyses, all QOL domains were significantly related to SWB (r = .17 to .42). In structural equation models, physical health (ß = .14; p < .05), mental health (ß = .27; p < .01), and environmental well-being (ß = .41; p < .01) directly predicted SWB, while financial and social well-being explained SWB indirectly. Thus, environmental well-being and mental health are the main predictors of SWB, and physical health, social well-being, and financial well-being to a lesser extent. Given that most of HIV-care is directed at improving physical health, from the perspective of promoting SWB HIV care should also be directed at other life domains.