RESUMEN
OBJECTIVES: Studies evaluating the efficacy and safety of the fixed-dose combination ledipasvir (LDV)/sofosbuvir (SOF) in patients coinfected with HIV-1 and hepatitis C virus (HCV) have mainly included treatment-naïve patients without cirrhosis. We aimed to evaluate the efficacy and safety of this combination in treatment-experienced patients with and without cirrhosis. METHODS: We conducted a multicentre, open-label, double-arm, nonrandomized study in patients coinfected with HIV-1 and HCV genotype 1 with and without cirrhosis, who had good viral suppression on their antiretroviral regimens. All patients were pretreated with a first-generation NS3/4A protease inhibitor (PI) plus pegylated interferon/ribavirin. Patients received a fixed-dose combination of LDV/SOF for 12 weeks, or for 24 weeks if cirrhosis was present. The primary endpoint was a sustained virological response (SVR) 12 weeks after the end of therapy. Secondary endpoints included safety, pharmacokinetics and patient-reported outcomes. RESULTS: Of the 68 patients enrolled, 39.7% had cirrhosis. Sixty-five patients [95.6%; 95% confidence interval (CI): 87.6-99.1%; P < 0.0001] achieved an SVR, with similar rates of SVR in those with and without cirrhosis. Tolerance was satisfactory, with mainly grade 1 or 2 adverse events. Among patient-reported outcomes, only fatigue significantly decreased at the end of treatment compared with baseline [odds ratio (OR): 0.36; 95% CI: 0.14-0.96; P = 0.04]. Mean tenofovir area under the plasma concentration-time curve (AUC) at week 4 was high, with mean ± SD AUC variation between baseline and week 4 higher in cirrhotic than in noncirrhotic patients (3261.57 ± 1920.47 ng/mL vs. 1576.15 ± 911.97 ng/mL, respectively; P = 0.03). Mild proteinuria (54.4%), hypophosphataemia (50.0%), blood bicarbonate decrease (29.4%) and hypokalaemia (13.2%) were reported. The serum creatinine level was not modified. CONCLUSIONS: LDV/SOF provided a high SVR rate in PI-experienced subjects coinfected with HCV genotype 1 and HIV-1, including patients with cirrhosis.
Asunto(s)
Bencimidazoles/administración & dosificación , Coinfección/tratamiento farmacológico , Fluorenos/administración & dosificación , Infecciones por VIH/tratamiento farmacológico , Hepatitis C Crónica/tratamiento farmacológico , Medición de Resultados Informados por el Paciente , Sofosbuvir/administración & dosificación , Anciano , Bencimidazoles/efectos adversos , Esquema de Medicación , Femenino , Fibrosis , Fluorenos/efectos adversos , Genotipo , Inhibidores de la Proteasa del VIH/uso terapéutico , VIH-1/genética , Hepacivirus/genética , Hepatitis C Crónica/patología , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Sofosbuvir/efectos adversos , Respuesta Virológica Sostenida , Resultado del TratamientoAsunto(s)
Neoplasias Encefálicas/complicaciones , Neoplasias Encefálicas/diagnóstico , Confusión/etiología , Linfoma de Células B/complicaciones , Linfoma de Células B/diagnóstico , Alcoholismo/complicaciones , Neoplasias Encefálicas/tratamiento farmacológico , Glucocorticoides/uso terapéutico , Humanos , Linfoma de Células B/tratamiento farmacológico , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Factores de Riesgo , Fumar/efectos adversos , Resultado del TratamientoRESUMEN
Q fever is a worldwide-occurring zoonosis caused by Coxiella burnetii. There are various clinical manifestations of acute Q fever, of which acute cholecystitis is a very rare clinical presentation. This study reports seven cases of acute cholecystitis associated with Coxiella burnetii and reviews two other cases from the literature. All patients were admitted to hospital for fever and abdominal pain in the right upper quadrant. Abdominal echography showed a distended gallbladder with biliary sludge without concrements in eight cases and with a single stone in one case. Diagnosis was made by specific serological investigation (microimmunofluorescence assay) for Coxiella burnetii. All nine patients were cured, six after laparoscopic cholecystectomy and three with antibiotics only. Histological examination of the gallbladders showed inflammation in five cases, although Coxiella burnetii was not detected by immunohistochemistry. The results show that laboratory investigations in patients admitted to hospital for symptoms consistent with acute acalculous cholecystitis should include a systematic search for Coxiella burnetii.
Asunto(s)
Colecistitis/diagnóstico , Fiebre Q/complicaciones , Enfermedad Aguda , Adulto , Anciano , Antibacterianos/uso terapéutico , Colecistitis/tratamiento farmacológico , Colecistitis/microbiología , Colecistitis/cirugía , Coxiella burnetii/aislamiento & purificación , Femenino , Humanos , Masculino , Persona de Mediana EdadAsunto(s)
Antiinflamatorios/uso terapéutico , Difosfonatos/uso terapéutico , Interferón-alfa/uso terapéutico , Mastocitosis/tratamiento farmacológico , Osteoporosis/tratamiento farmacológico , Antiinflamatorios/farmacología , Densidad Ósea/efectos de los fármacos , Difosfonatos/farmacología , Humanos , Interferón-alfa/farmacología , Masculino , PamidronatoAsunto(s)
Síndrome de Inmunodeficiencia Adquirida/complicaciones , Factor 2 de Crecimiento de Fibroblastos/sangre , Interleucina-6/sangre , Sarcoma de Kaposi/sangre , Sarcoma de Kaposi/etiología , Síndrome de Inmunodeficiencia Adquirida/sangre , Ensayo de Inmunoadsorción Enzimática , Seropositividad para VIH/sangre , Seropositividad para VIH/complicaciones , Humanos , MasculinoRESUMEN
We report the case of a 71-year old male patient with a chronic lymphoid leukaemia of 10 years' duration who abruptly suffered deterioration of this general condition and haematological disturbances suggesting worsening of this blood disease (Richter's syndrome). Blood cultures demonstrated a Campylobacter coli septicaemia. Treatment with antibiotics resulted in a return to the previous clinical and biological situation. The various visceral manifestation of the infection are discussed.