Outcomes of an automated alert system from Microbiology to link diagnosis to treatment in patients with hepatitis C virus.

INTRODUCTION: simplification strategies for the care circuit of patients with hepatitis C virus (HCV) are key to achieve eradication. An electronic identification system was set up for HCV serology to link diagnosis to specialist management, aimed to reduce patient loss. MATERIAL AND METHODS: a retrospective, single-center study was performed in patients with HCV identified from 15/3/2020 to 15/12/2021, using an alert system from Microbiology that notified specialists of positive cases. The patient was contacted and appointed a Fibroscan® and viral load measurement, with antiviral therapy prescribed on the same day. Origin, public health data, patient location rate and antiviral therapy prescription were recorded. RESULTS: of 174 patients identified, 171 had positive viremia, with a mean age of 59.6 ± 15.9 years, 61.5 % were males and 81.2 % were Spanish nationals. Origin in the outpatient setting predominated (57.9 %, 99/171), particularly Primary Care (51/171), penitentiaries (21/171) and addiction units (14/171). Overall, 43.3 % (74/171) were aware of their diagnosis; 19.4 % (20/103) of patients had F3 fibrosis and 25.2 % (26/103) had F4 fibrosis. Also, 78.4 % (134/171) were deemed candidates for treatment. Of these, 74.6 % (100/134) were located and treatment was initiated, and all those who completed their treatment achieved a sustained viral response (96/96). This system managed 58.5 % (100/171) of the patients identified. The only association found between antiviral therapy and patient variables was comorbidities with being untreated (OR, 7.14; p ˂ 0.001). CONCLUSIONS: this alert system allows to minimize patient loss in the care circuit and provides high rates of treated patients.

Telaprevir-based therapy in patients coinfected with chronic hepatitis C virus infection and HIV: INSIGHT study.

OBJECTIVES: INSIGHT (ClinicalTrials.gov NCT01513941) evaluated the efficacy, safety and pharmacokinetics of telaprevir-based therapy and specific antiretroviral agents in hepatitis C virus genotype 1 (HCV-1)/HIV-1-coinfected patients. PATIENTS AND METHODS: Open-label, Phase IIIb, multicentre study of telaprevir with pegylated-IFN (Peg-IFN) α2a and ribavirin in treatment-naive or -experienced HCV-1/HIV-1-coinfected patients on stable HIV HAART comprising efavirenz, atazanavir/ritonavir, darunavir/ritonavir, raltegravir, etravirine or rilpivirine with two nucleos(t)ide analogues. Patients received 750 mg telaprevir (1125 mg, if on efavirenz) every 8 h plus 180 µg/week Peg-IFNα2a and 800 mg/day ribavirin for 12 weeks, followed by Peg-IFNα2a and ribavirin alone for 12 weeks (HCV treatment naive and relapsers without cirrhosis, with extended rapid virological response) or 36 weeks (all others). RESULTS: Overall, 162 patients (median age of 46 years, 78% male, 92% Caucasian and mean CD4 count of 687 cells/mm(3)) were treated; 13% had cirrhosis. One-hundred-and-thirty-two patients (81%) completed telaprevir; 14 (9%) discontinued due to an adverse event (AE). Sustained virological response (SVR) 12 rates (<25 IU/mL HCV RNA 12 weeks after the last planned treatment dose) in treatment-naive patients, relapsers and non-responders were 64% (41 of 64), 62% (18 of 29) and 49% (34 of 69), respectively. SVR12 rates ranged from 51% (33 of 65) (patients receiving efavirenz) to 77% (13 of 17) (patients receiving raltegravir). Most frequently reported AEs during telaprevir treatment were pruritus (43%) and rash (34%) special search categories. Anaemia special search category occurred in 15% of patients; 6% of patients reported a serious AE. CONCLUSIONS: In treatment-naive/-experienced HCV-1/HIV-1 patients there were significantly higher SVR rates with telaprevir-based therapy compared with pre-specified historical controls, and safety comparable to that in HCV-monoinfected patients.

Opportunistic population screening as a hepatitis elimination strategy: the CRIVALVIR-FOCUS program.

OBJECTIVES: Hepatitis B (HBV) and hepatitis C (HCV) viruses are significant causes of primary liver cancer, responsible for over a million deaths annually. We aimed to develop a screening strategy for viral hepatitis elimination in Spain, aligned with WHO's 2030 objectives. DESIGN: The CRIVALVIR-FOCUS program, conducted at the Consortium General University Hospital of Valencia, aimed to identify individuals with active blood-borne viral infections through opportunistic population screening. The hospital's Health Department serves more than 280,000 adults. RESULTS: Of the 31,995 adults screened (52% women; 15% immigrants), HBV prevalence was 0.44%, with higher rates in men (0.57%) than women (0.32%), and notably higher in migrants (1.27%) compared to Spanish nationals (0.30%). The 45-64 age group had the highest HBV prevalence (0.65%). HCV prevalence was 0.35%, again higher in men than women (0.51% vs 0.20%) and in migrants compared to Spanish nationals (0.58% vs 0.31%), with the 45-64 age group showing the highest HCV prevalence (0.76%). From the positive tests, 78.0% (110/141) of HBV cases and 71.4% (80/112) of HCV cases were patients previously unaware of their infections. CONCLUSION: Opportunistic screening effectively identifies early cases, potentially enhancing prevention of new infections. Our study highlights the need for targeted interventions for individuals aged 45-64 and migrants. Designing specific screening programs, in collaboration with social workers and cultural mediators, is critical to improve access to care. Training and involving primary care professionals are vital actions for the program's success.

HIV screening and linkage to care in a health department in Valencia, Spain: Lessons learned from a healthcare quality improvement project.

Spain's rate of new human immunodeficiency virus (HIV) diagnoses exceeds that of the European Economic Area average (8.6 vs 5.6:100,000 in 2018). The country has failed to meet the first of United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 targets for HIV control by 2020, with 87.0% of people living with HIV knowing their status, and late presentation rates of 47.6% and 51.5% country-wide and in the Valencian autonomous community, respectively. Advancing screening and linkage to care (SLTC) practices is necessary to effectively control the epidemic. The Valencia Viral Screening (CRIVALVIR) project adopted the TEST model for opportunistic and systematic HIV SLTC in individuals aged 18 to 80 who required blood work for any purpose, as of February 2019. SLTC was integrated into routine clinical workflow across primary care centers serving a population of 360,000 people in Valencia, Spain. Our project successfully upscaled total HIV testing by 194% to over 32,000 patients tested in 14 months. We found an overall prevalence of 0.13% (0.08-0.21) among those screened per protocol (n = 13,061), with foreign-born citizens presenting a 12.5 times significantly higher likelihood of acquiring HIV (95% confidence interval 4.63-33.96, P < .0001). We improved late presentation by 18.2 percentage points and prevented an estimated 58 to 70 new secondary infections. HIV screening of the general population in primary care is an effective strategy for achieving timely diagnosis and preventing new infections. Opportunistic, systematic, opt-out approaches are essential to control the HIV epidemic.

The F4/AS01B HIV-1 Vaccine Candidate Is Safe and Immunogenic, But Does Not Show Viral Efficacy in Antiretroviral Therapy-Naive, HIV-1-Infected Adults: A Randomized Controlled Trial.

The impact of the investigational human immunodeficiency virus type 1 (HIV-1) F4/AS01B vaccine on HIV-1 viral load (VL) was evaluated in antiretroviral therapy (ART)-naive HIV-1 infected adults.This phase IIb, observer-blind study (NCT01218113), included ART-naive HIV-1 infected adults aged 18 to 55 years. Participants were randomized to receive 2 (F4/AS01B_2 group, N = 64) or 3 (F4/AS01B_3 group, N = 62) doses of F4/AS01B or placebo (control group, N = 64) at weeks 0, 4, and 28. Efficacy (HIV-1 VL, CD4 T-cell count, ART initiation, and HIV-related clinical events), safety, and immunogenicity (antibody and T-cell responses) were evaluated during 48 weeks.At week 48, based on a mixed model, no statistically significant difference in HIV-1 VL change from baseline was demonstrated between F4/AS01B_2 and control group (0.073 log10 copies/mL [97.5% confidence interval (CI): -0.088; 0.235]), or F4/AS01B_3 and control group (-0.096 log10 copies/mL [97.5% CI: -0.257; 0.065]). No differences between groups were observed in HIV-1 VL change, CD4 T-cell count, ART initiation, or HIV-related clinical events at intermediate timepoints. Among F4/AS01B recipients, the most frequent solicited symptoms were pain at injection site (252/300 doses), fatigue (137/300 doses), myalgia (105/300 doses), and headache (90/300 doses). Twelve serious adverse events were reported in 6 participants; 1 was considered vaccine-related (F4/AS01B_2 group: angioedema). F4/AS01B induced polyfunctional F4-specific CD4 T-cells, but had no significant impact on F4-specific CD8 T-cell and anti-F4 antibody levels.F4/AS01B had a clinically acceptable safety profile, induced F4-specific CD4 T-cell responses, but did not reduce HIV-1 VL, impact CD4 T-cells count, delay ART initiation, or prevent HIV-1 related clinical events.

Prevalence and factors associated with liver steatosis as measured by transient elastography with controlled attenuation parameter in HIV-infected patients.

OBJECTIVE: To assess the prevalence and factors associated with significant hepatic steatosis (SHS, steatosis involving ≥10% hepatocytes) in HIV-infected patients. DESIGN: A prospective, cross-sectional study. METHODS: Five hundred and five HIV-infected patients were included in this study. All patients underwent a transient elastography examination with the controlled attenuation parameter (CAP). SHS was defined using the previously identified CAP cut-off of 238 dB/m. We analysed the associations between SHS and demographics, metabolic data, coinfections and drug therapy. RESULTS: SHS was detected in 201 (40%) patients. Individuals with and without plasma HIV RNA of 50 copies/ml or less presented SHS in 168 (42%) and 33 (31%) cases, respectively (P = 0.030). Patients with SHS compared with those without SHS presented higher median (IQR) BMI [BMI, 25.6 (22.5-28) vs. 22.3 (20.3-24.2) kg/m; P < 10], DBP [79 (72-85) vs. 74 (68-81) mmHg; P = 0.0001], fasting plasma glucose [95 (87-106) vs. 91 (84-97) mg/dl; P = 0.002] and triglycerides [128 (92-189) vs. 109 (80-167) mg/dl; P = 0.002], and lower HDL cholesterol [44 (37-54) vs. 48 (40-59), mg/dl; P = 0.004]. In multivariate analysis, the only factor associated with SHS was BMI [per unit increase, adjusted odds ratio (95% confidence interval) 1.34 (1.22-1-47); P < 10]. CONCLUSION: SHS measured by CAP is highly prevalent among HIV-infected patients. High BMI is the main predictor of SHS in this setting.

Resultados de un sistema de alertas automático desde Microbiología para ligar diagnóstico y tratamiento en pacientes con virus de la hepatitis C / Outcomes of an automated alert system from Microbiology to link diagnosis to treatment in patients with hepatitis C virus

Introducción: las estrategias de simplificación del circuitoasistencial para pacientes con virus de la hepatitis C (VHC)son fundamentales para lograr su erradicación. Para ello,introdujimos un sistema electrónico de detección de serología VHC con el objetivo de ligar diagnóstico y asistenciaespecializada para disminuir la pérdida de pacientes.Material y métodos: estudio retrospectivo unicéntrico depacientes VHC detectados del 15/3/2020 al 15/12/2021 mediante un sistema de alertas desde Microbiología que notificaba los casos positivos a facultativos especialistas. Se contactaba con el paciente concertando una cita donderealizaban Fibroscan® y determinación de carga viral y sepautaba tratamiento antiviral el mismo día. Registramosprocedencia, datos sociosanitarios, tasa de localización delpaciente y prescripción de tratamiento antiviral.Resultados: de 174 pacientes detectados, 171 presentaronviremia positiva, con edad media de 59,6 ± 15,9 años, un61,5 % varones y el 81,2 % españoles. Predominó la procedencia del ámbito extrahospitalario (57,9 %, 99/171), destacando Atención Primaria (51/171), centro penitenciario(21/171) y unidades de adicción (14/171). El 43,3 % (74/171)conocía el diagnóstico. Registramos un 19,4 % (20/103) depacientes con fibrosis F3 y un 25,2 % (26/103) con F4. Consideramos candidatos a tratamiento al 78,4 % (134/171). Deestos, fueron localizados e iniciaron tratamiento el 74,6 %(100/134) y lograron respuesta viral sostenida todos los quelo completaron (96/96). Con este sistema hemos tratado al58,5 % (100/171) de los pacientes detectados. La única asociación detectada entre tratamiento antiviral y variablesdel paciente fue que presentar comorbilidades se asociócon no ser tratado (OR 7,14, p < 0,001).Conclusiones: este sistema de alerta permite minimizar lapérdida de pacientes en el circuito asistencial y presentatasas elevadas de pacientes tratados. (AU)

Tratamiento libre de interferón de la infección por virus de la hepatitis C por manifestaciones extrahepáticas: vasculitis leucocitoclástica / Interferon-free treatment regimen for hepatitis C virus infection for extrahepatic manifestations: leukocytoclastic vasculitis

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Hepatitis C / Hepatitis C

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