RESUMO
The advents of current direct-acting antiviral treatments has revolutionised the therapeutic approach to hepatitis C, increasing cure rates to above 90% and substantially simplifying treatment, which translates into benefits for patients, clinicians and the health system. These new drugs allow cure to be achieved, irrespective of the patient's characteristics, with tolerability similar to that of placebo and few drug reactions with concomitant medication. This in turn improves patients' quality of life and wellbeing. Moreover, these drugs allow multidisciplinary optimisation of the approach to patients with hepatitis C, thus reducing both short- and long-term costs. All these factors facilitate treatment universality, with treatments that are less influenced by specific factors and that allow better results to be obtained in a larger number of patients. Elimination of hepatitis C is now a real possibility. Supplement information: This article is part of a supplement entitled "The value of simplicity in hepatitis C treatment", which is sponsored by Gilead. © 2019 Elsevier España, S.L.U. All rights reserved.
Assuntos
Antivirais/uso terapêutico , Hepatite C/tratamento farmacológico , Antivirais/efeitos adversos , Redução de Custos , Interações Medicamentosas , Instalações de Saúde , Hepatite C/virologia , Hospitais , Humanos , Atenção Primária à Saúde , Prisões , Centros de Tratamento de Abuso de Substâncias , Carga ViralRESUMO
AIM: To demonstrate the non-inferiority (15% non-inferiority limit) of monotherapy with tenofovir disoproxil fumarate (TDF) vs the combination of lamivudine (LAM) plus adefovir dipivoxil (ADV) in the maintenance of virologic response in patients with chronic hepatitis B (CHB) and prior failure with LAM. METHODS: This study was a Phase IV prospective, randomized, open, controlled study with 2 parallel groups (TDF and LAM+ADV) of adult patients with hepatitis B e antigen (HBeAg)-negative CHB, prior failure with LAM, on treatment with LAM+ADV for at least 6 mo, without prior resistance to ADV and with an undetectable viral load at the start of the study, in 14 Spanish hospitals. The follow-up time for each patient was 48 wk after randomization, with quarterly visits in which the viral load, biochemical and serological parameters, adverse effects, adherence to treatment and consumption of hospital resources were analysed. RESULTS: Forty-six patients were evaluated [median age: 55.4 years (30.2-75.2); 84.8% male], including 22 patients with TDF and 24 with LAM+ADV. During study development, hepatitis B virus DNA (HBV-DNA) remained undetectable, all patients remained HBeAg negative, and hepatitis B surface antigen (HBsAg) positive. Alanine aminotransferase (ALT) values at the end of the study were similar in the 2 groups (25.1 ± 7.65, TDF vs 24.22 ± 8.38, LAM+ADV, P = 0.646). No significant changes were observed in creatinine or serum phosphorus values in either group. No significant differences between the 2 groups were noted in the identification of adverse effects (AEs) (53.8%, TDF vs 37.5%, LAM+ADV, P = 0.170), and none of the AEs which occurred were serious. Treatment adherence was 95.5% and 83.3% in the TDF and the LAM+ADV groups, respectively (P = 0.488). The costs associated with hospital resource consumption were significantly lower with the TDF treatment than the LAM+ADV treatment (4943 ± 1059 vs 5811 ± 1538, respectively, P < 0.001). CONCLUSION: TDF monotherapy proved to be safe and not inferior to the LAM+ADV combination therapy in maintaining virologic response in patients with CHB and previous LAM failure. In addition, the use of TDF generated a significant savings in hospital costs.
Assuntos
Adenina/análogos & derivados , Antivirais/uso terapêutico , Hepatite B Crônica/tratamento farmacológico , Lamivudina/uso terapêutico , Organofosfonatos/uso terapêutico , Tenofovir/uso terapêutico , Adenina/economia , Adenina/farmacologia , Adenina/uso terapêutico , Adulto , Idoso , Alanina Transaminase/sangue , Antivirais/economia , Antivirais/farmacologia , DNA Viral/isolamento & purificação , Farmacorresistência Viral , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/economia , Quimioterapia Combinada/métodos , Feminino , Antígenos de Superfície da Hepatite B/imunologia , Antígenos E da Hepatite B/imunologia , Vírus da Hepatite B/efeitos dos fármacos , Vírus da Hepatite B/fisiologia , Hepatite B Crônica/sangue , Hepatite B Crônica/imunologia , Custos Hospitalares/estatística & dados numéricos , Humanos , Lamivudina/economia , Lamivudina/farmacologia , Masculino , Pessoa de Meia-Idade , Organofosfonatos/economia , Organofosfonatos/farmacologia , Estudos Prospectivos , Tenofovir/economia , Tenofovir/farmacologia , Falha de Tratamento , Carga Viral/efeitos dos fármacosRESUMO
La variedad de situaciones a las que el kinesiológo se ve enfrentado y el carácter evolutivo de la enfermedad, han planteado desde siempre difíciles problemas técnicos y éticos relativos al cúando, cómo, con qué intensidad y hasta dónde el profesional kinesiológo debe llegar con su acción terapéutica. Estos problemas se han visto agravados por el aumento del poder de transformación que ha proporcionado la técnica en relación al diagnóstico, la terapéutica, la rehabilitación, la prevención, lo cual va inexorablemente acompañado del aumento en las posibilidades de causar daño y en el aumento de la magnitud de estas mismas. En consecuencia, salta la pregunta ¿por qué criterios se puede uno guiar para saber cuando es legítimo y bueno abstenerse de algunas acciones kinésicas?. Este problema relativo a la regulación y linitación de la acción tiene hoy particular relevancia en relación a la limitación de tratamiento y sobre él nos centraremos