Effectiveness of hepatitis C antiviral treatment and feasibility of hepatitis C elimination goal.

OBJECTIVES: Second-generation direct-acting antivirals (DAAs) have shown high efficacy in the treatment of chronic hepatitis C virus (HCV) infections in clinical trials. This study aimed to estimate the effectiveness in real-life conditions and their capacity to eliminate HCV infection in the general population. METHODS: In this observational cohort study, patients with active HCV infection who commenced DAA treatment between 2015 and 2020 in Navarre, Spain, were studied. Sustained virological response (SVR), defined as an undetectable viral load 12 weeks after the end of treatment, was evaluated until the end of 2021. RESULTS: Of a total 1366 HCV-infected patients that commenced treatment, 19.3% (n = 263) were HIV-coinfected. After the first DAA treatment, SVR was achieved in 96.6% (n = 1320/1366) of patients and in 97.7% (95% confidence interval [CI] 96.6%-98.3%) of those who completed treatment (per-protocol analysis; n = 1320/1351). SVR was achieved in 97.9% (n = 1066/1089) and 96.9% (n = 254/262) of mono-infected and HIV-coinfected patients, respectively. Thirty-one patients had virological failure due to non-response (n = 19), poor compliance (n = 9), and with adverse events (n = 3). Of 27 patients that received a second treatment, 24 attained SVR (one after a third treatment), two died, and one that did not achieve SVR declined a third treatment. Three patients were re-infected, re-treated, and achieved SVR. At the end of the study, 1344 patients (98.4%, 95% CI 97.6%-98.9%) had achieved SVR, and only 1.8% needed more than one course of treatment. All patients who completed the treatment and were followed-up achieved SVR. CONCLUSION: With DAAs, SVR was achieved in all patients with active HCV infection who completed follow-up, and a second course of treatment was only necessary in a small proportion of patients. Adherence to treatment is essential for HCV infection elimination.

Clinical course of patients with severe COVID-19 pneumonia treated with remdesivir: A real-life study.

BACKGROUND: There is currently much uncertainty regarding the most optimal treatment for COVID-19. This study analyze the change in the clinical condition of patients hospitalized for severe COVID-19 pneumonia and treated with remdesivir in a real-life setting, based on the WHO Ordinal Scale. Clinical complications, treatment safety, and impact of other associated drugs were also analyzed. METHODS: We conducted an observational, retrospective study including patients treated with remdesivir. The need for admission to the ICU, the length of ICU and hospital stay, and the need for ventilatory support were analyzed. The laboratory parameters, drugs administered concomitantly, and difference in the length of hospital stay according to the concomitant treatment received were also evaluated. A univariate and multivariate Cox regression analysis was performed to analyze associated factors. RESULTS: A total of 92 patients were included. The mean length of hospital stay was 15 days, and 90% of the patients had been discharged from the hospital 28 days after starting treatment with remdesivir. The likelihood of hospital discharge among patients not presenting with hypertension as a comorbidity was significantly higher than that of those with this condition (HR = 3.19, P = 0.008). Nineteen patients had to be admitted to the ICU (mean of 18 days). Approximately 11% required invasive mechanical ventilation (mean of 22 days). Almost 37% of the patients received high-flow oxygen therapy and 14% non-invasive mechanical ventilation. Four deaths were recorded within the first week. Main adverse events were increases in transaminase and creatinine levels. Nosocomial infections were more frequent when remdesivir was combined with immunosuppressive drugs. CONCLUSIONS: Patients with severe COVID-19 pneumonia and treated with remdesivir require relatively prolonged hospital stays, many with a need for ventilatory support and, in a considerable proportion of cases, admission to the ICU. However, the observed survival rate is high, and the drug is well tolerated.

Methylprednisolone Pulses in Hospitalized COVID-19 Patients Without Respiratory Failure: A Randomized Controlled Trial.

Background: Corticosteroids are the cornerstone of the treatment of patients with COVID-19 admitted to hospital. However, whether corticosteroids can prevent respiratory worsening in hospitalized COVID-19 patients without oxygen requirements is currently unknown. Aims: To assess the efficacy of methylprednisolone pulses (MPP) in hospitalized COVID-19 patients with increased levels of inflammatory markers not requiring oxygen at baseline. Methods: Multicenter, parallel, randomized, double-blind, placebo-controlled trial conducted in Spain. Patients admitted for confirmed SARS-CoV-2 pneumonia with raised inflammatory markers (C-reactive protein >60 mg/L, interleukin-6 >40 pg/ml, or ferritin >1,000 µg/L) but without respiratory failure after the first week of symptom onset were randomized to receive a 3-day course of intravenous MPP (120 mg/day) or placebo. The primary outcome was treatment failure at 14 days, a composite variable including mortality, the need for ICU admission or mechanical ventilation, and clinical worsening, this last parameter defined as a PaO2/FiO2 ratio below 300; or a 15% decrease in the PaO2 from baseline, together with an increase in inflammatory markers or radiological progression. If clinical worsening occurred, patients received tocilizumab and unmasked corticosteroids. The secondary outcomes were 28-day mortality, adverse events, need for ICU admission or high-flow oxygen, length of hospital stay, SARS-CoV-2 clearance, and changes in laboratory parameters. Results: A total of 72 patients were randomized and 71 patients were analyzed (34 in the MPP group and 37 in the placebo group). Twenty patients presented with treatment failure (29.4 in the MPP group vs. 27.0% in the placebo group, p = 0.82), with no differences regarding the time to treatment failure between groups. There were no cases of death or mechanical ventilation requirements at 14 days post-randomization. The secondary outcomes were similar in MPP and placebo groups. Conclusions: A 3-day course of MPP after the first week of disease onset did not prevent respiratory deterioration in hospitalized COVID-19 patients with an inflammatory phenotype who did not require oxygen.

Calidad de vida relacionada con la salud en pacientes con artritis reumatoide, artritis psoriásica y espondilitis anquilosante tratados con certolizumab pegol / Health-related quality of life in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis treated with certolizumab pegol

Objetivo: Las enfermedades articulares inflamatorias causan dolor y discapacidad. El objetivo fue medir la calidad de vida de los pacientes conart ritis reumatoide, artritis psoriásica, espondilitis anquilosante en tratamientocon certolizumab pegol y compararla con la de la población general.Método:Con un diseño transversal se recogieron variables sociodemográficasy clínicas, adherencia al tratamiento y calidad de vidamediante el cuestionario Euroqol-5d-5L (EQ-5D). La calidad de vida dela población general se obtuvo de la Encuesta Nacional de Salud. ElEQ-5D se analizó en ambos grupos mediante modelos de dos partesque miden la probabilidad de tener una salud perfecta y la disutilidadcausada por la enfermedad.Resultados: La muestra incluyó 59 pacientes con una adherencia alta(92,3%). La utilidad media fue de 0,78 y el dolor resultó la dimensión másafectada. La reducción de utilidad (índice EQ-5D) de los pacientes conenfermedades articulares inflamatorias respecto a la población generalfue de 0,127.Conclusiones: Los pacientes muestran una calidad de vida significativamentemenor que la población general a pesar del buen control de laenfermedad. Los modelos de dos partes facilitan la interpretación de losestudios de calidad de vida mediante EQ-5D.

Objective: Inflammatory joint diseases cause pain and disability. Theobjective of this study was to measure the quality of life of patients withrheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis treatedwith certolizumab pegol and compare the results with those of the generalpopulation.Method: Using a cross-sectional design and sociodemographic andclinical variables, adherence to treatment and quality of life data werecollected using the Euroqol-5d-5L (EQ-5D) questionnaire. The quality oflife of the general population was obtained from the Spanish NationalHealth Survey. Answers to the EQ-5D questionnaire were analyzed inboth groups using two-part models, which measure the probability ofhaving perfect health as well as the disutility caused by the disease.Results: The sample included 59 patients with high adherence (92.3%).The mean utility value was 0.78 and pain was the most affected dimension. The reduction in utility (EQ-5D index) of patients with inflammatoryjoint disease as compared to the general population was 0.127.Conclusions: The subjects of the study showed a significantly lowerquality of life than the general population despite effective control of thedisease. Two-part models facilitate the interpretation of quality-of-life studiesusing the EQ-5D.

Health-related quality of life in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis treated with certolizumab pegol.

OBJECTIVE: Inflammatory joint diseases cause pain and disability. The objective of this study was to measure the quality of life of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis treated with certolizumab pegol and compare the results with those of the  general population. METHOD: Using a cross-sectional design and sociodemographic and clinical  variables, adherence to treatment and quality of life data were collected using  the Euroqol-5d-5L (EQ-5D) questionnaire. The quality of life of the general  population was obtained from the Spanish National Health Survey. Answers to  the EQ-5D questionnaire were analyzed in both groups using two-part models,  which measure the probability of having perfect health as well as the disutility  caused by the disease. RESULTS: The sample included 59 patients with high adherence (92.3%). The  mean utility value was 0.78 and pain was the most affected dimen sion. The  reduction in utility (EQ-5D index) of patients with inflammatory joint disease as  compared to the general population was 0.127. CONCLUSIONS: The subjects of the study showed a significantly lower quality of  life than the general population despite effective control of the disease. Two- part models facilitate the interpretation of quality-of-life studies using the EQ- 5D.

OBJETIVO: Las enfermedades articulares inflamatorias causan dolor y  discapacidad. El objetivo fue medir la calidad de vida de los pacientes con artritis reumatoide, artritis psoriásica, espondilitis anquilosante en  tratamiento con certolizumab pegol y compararla con la de la población  general.Método: Con un diseño transversal se recogieron variables sociodemográficas y clínicas, adherencia al tratamiento y calidad de vida mediante el cuestionario Euroqol-5d-5L (EQ-5D). La calidad de vida de la  población general se obtuvo de la Encuesta Nacional de Salud. El EQ-5D se  analizó en ambos grupos mediante modelos de dos partes que miden la  probabilidad de tener una salud perfecta y la disutilidad causada por la  enfermedad. RESULTADOS: La muestra incluyó 59 pacientes con una adherencia alta (92,3%). La utilidad media fue de 0,78 y el dolor resultó la dimensión más afectada. La reducción de utilidad (índice EQ-5D) de los pacientes con enfermedades articulares inflamatorias respecto a la población general fue de  0,127. CONCLUSIONES: Los pacientes muestran una calidad de vida significativamente menor que la población general a pesar del buen control de  la enfermedad. Los modelos de dos partes facilitan la interpretación de los  estudios de calidad de vida mediante EQ-5D.

Health-related quality of life in hepatitis C patients who achieve sustained virological response to direct-acting antivirals: a comparison with the general population.

PURPOSE: To compare health-related quality of life (HRQoL) between hepatitis C patients who achieve sustained virological response (SVR) to direct-acting antivirals and a sex- and age-paired sample of the general population. METHODS: HRQoL was evaluated in patients recruited in Navarre, Spain, from May 2016 to April 2017 at baseline and after SVR, using the EQ-5D-5L questionnaire. Both results were compared to those of general population of the same sex and age obtained from the 2011/12 National Health Survey in Spain. Observed/expected (O/E) ratios for health dimensions and differences between O-E in EQ-5D utility and visual analogical scale (VAS) scores were calculated. RESULTS: 206 patients were studied. Before treatment, patients had more problems than the general population in every domain of EQ-5D-5L, except in self-care dimension (O/E = 1.1). After SVR, patients continued having more limitation, especially for usual activities (O/E = 3.1), anxiety/depression (O/E = 2.8) and EQ-5D utility (- 0.086, p < 0.001); however, differences in VAS score between patients and general population disappeared (74.8 vs 76.5, p = 0.210). F0-F1 patients with SVR had minor differences with the general population in EQ-5D-5L dimensions, utility and VAS score. Although cirrhotic patients also reduced that difference, they still had worse HRQoL, especially in usual activities, self-care, EQ-5D utility (- 0.152, p < 0.001) and VAS score (- 8.5, p = 0.005). CONCLUSIONS: HRQoL of chronic hepatitis C patients remains lower than that of the general population despite viral clearance, with primary problems in usual activities and anxiety/depression. Knowledge of these on-going problems despite cure serves to guide healthcare interventions and patient's follow-up.