Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316).

BACKGROUND: Few women have been included in darunavir/cobicistat clinical development studies, and hardly any of them were antiretroviral experienced or treated with anything other than triple-based therapies. OBJECTIVES: Our aim was to increase our knowledge about women living with HIV undergoing darunavir/cobicistat-based regimens. METHODS: A multicentre (21 hospitals), retrospective study including a centrally selected random sample of HIV-1 patients starting a darunavir/cobicistat-based regimen from June 2014 to March 2017 was planned. Baseline characteristics, 24 and 48 week viral load response (<50 copies/mL), CD4+ lymphocyte count increase, time to change darunavir/cobicistat and adverse event occurrence were all compared by sex. The study was approved by each of the 21 ethics committees, and patients signed informed consent. RESULTS: Out of 761 participants, 193 were women. Similar characteristics were found for both sexes, except that the women had a longer duration of HIV infection (P = 0.001), and were less frequently pre-treated with darunavir/cobicistat in their previous regimen (P = 0.02). The main reason for using a darunavir/cobicistat-based regimen was simplification, without differences by sex, while monotherapy seems to be more frequently prescribed in women than in men (P = 0.067). The main outcomes, HIV viral load response, CD4+ lymphocyte count increase at 24 or 48 weeks, occurrence of adverse events, main reasons for changing and time to the modify darunavir/cobicistat regimen, did not show differences between the sexes. CONCLUSIONS: No sex disparities were found in the main study outcomes. These results support the use of a darunavir/cobicistat-based regimen in long-term pre-treated women. Clinical Trial.gov No. NCT03042390.

Espondilitis infecciosa en Baleares: análisis de 51 casos / Infectious spondylitis in the Balearic Islands: An analysis of 51 cases

Introducción: La espondilitis infecciosa (EI) es una entidad poco frecuente cuya incidencia ha aumentado en los últimos años. El objetivo de este estudio ha sido describir los casos con EI y realizar una comparación con el resto de series publicadas. Material y métodos: Estudio retrospectivo donde se describen datos epidemiológicos, microbiológicos y clínicos de los pacientes diagnosticados de EI durante un periodo de 10 años (2004-2014) en 2 hospitales de Mallorca. Resultados: Se incluyó un total de 51 pacientes, con una edad mediana de 66 años (rango 22-85). El 72,5% (37/51) fueron varones. El tiempo medio transcurrido desde el inicio de la clínica hasta el diagnóstico fue de 80,1 ± 125,1 días. En 36 ocasiones (70,6%) el origen fue hematógeno. El factor predisponente más frecuente fue presentar bacteriemia previa (10 [43,5%] de origen urinario). Presentaron fiebre 35 pacientes (68,8%), dolor 32 (62,7%), radiculalgia 14 (27,5%) y parálisis/paresia 10 (19,6%). La prueba diagnóstica más utilizada fue la resonancia magnética (46 [90,2%]), resultando patológica en todos los casos. El microorganismo etiológico más frecuente fue Staphylococcus aureus (23 [52,3%]). Los hemocultivos resultaron positivos en 27/41 ocasiones (65,8%) y la punción percutánea en 11/22 (50%). Veintitrés pacientes (45,1%) desarrollaron abscesos paravertebrales, epidurales o del psoas, 7 (13,7%) déficits neurológicos residuales y 6 (11,8%) dolor crónico. Un paciente (1,9%) falleció por motivos relacionados con la infección. Conclusiones: La EI es poco frecuente. Su origen usualmente es hematógeno. La bacteriemia previa es el factor predisponente más importante. El diagnóstico es habitualmente tardío, siendo Staphylococcus aureus el germen implicado con mayor frecuencia. La realización de punciones percutáneas acompañando a los hemocultivos aumenta la rentabilidad diagnóstica (AU)

Introduction: Vertebral osteomyelitis (VO) is a rare entity, although its incidence has increased in recent years. The objective is to describe the patients with this infection in our environment and a comparison with other published series. Methods: A retrospective review was conducted of epidemiological, clinical, microbiological, treatment, complications and evolution data of patients with VO during 10 years (2004-2014) in two hospitals of Mallorca. Results: 51 cases, median age 66 (range 22-85) years, 37 (72.5%) men with a mean onset of symptoms of 80.1 ± 125.1 days. In thirty-six (70.6%) cases the origin of infection was considered hematogenous, although previous bacteremia was documented in 23 (45%) cases, being of urinary in 10 (43.5%) cases. Clinically at the moment of diagnosis 35 (68.8%) had fever, 32 (62.7%) pain, 14 (27.5%) irradiated nerve pain and 10 (19.6%) paralysis/paresia. MRI was the most performed radiological test 46 (90.2%), being pathological in all cases. S. aureus 23 (52.3%) was the most common microbiological isolates. At the moment of the diagnosis, blood cultures were positive in 27 (65.8%) of 41 cases and 11 (50%) of 22 percutaneous puncture was positive. Paraspinal, epidural or psoas abscesses were observed in 23 (45.1%), neurological deficit in 7 (13.7%) and chronic pain in 6 (11.8%). One patient (1.9%) died in relation with infection. Conclusions: Diagnosis was delayed in most cases. Previous bacteremia being main predisposing factor and hematogenous origin the main source of infection. S. aureus was the most isolated. Percutaneous puncture together with blood cultures increase etiologic diagnosis. A high percentage of patients had complications or sequelae (AU)

Infectious spondylitis in the Balearic Islands: An analysis of 51 cases. / Espondilitis infecciosa en Baleares: análisis de 51 casos.

INTRODUCTION: Vertebral osteomyelitis (VO) is a rare entity, although its incidence has increased in recent years. The objective is to describe the patients with this infection in our environment and a comparison with other published series. METHODS: A retrospective review was conducted of epidemiological, clinical, microbiological, treatment, complications and evolution data of patients with VO during 10 years (2004-2014) in two hospitals of Mallorca. RESULTS: 51 cases, median age 66 (range 22-85) years, 37 (72.5%) men with a mean onset of symptoms of 80.1 ± 125.1 days. In thirty-six (70.6%) cases the origin of infection was considered hematogenous, although previous bacteremia was documented in 23 (45%) cases, being of urinary in 10 (43.5%) cases. Clinically at the moment of diagnosis 35 (68.8%) had fever, 32 (62.7%) pain, 14 (27.5%) irradiated nerve pain and 10 (19.6%) paralysis/paresia. MRI was the most performed radiological test 46 (90.2%), being pathological in all cases. S. aureus 23 (52.3%) was the most common microbiological isolates. At the moment of the diagnosis, blood cultures were positive in 27 (65.8%) of 41 cases and 11 (50%) of 22 percutaneous puncture was positive. Paraspinal, epidural or psoas abscesses were observed in 23 (45.1%), neurological deficit in 7 (13.7%) and chronic pain in 6 (11.8%). One patient (1.9%) died in relation with infection. CONCLUSIONS: Diagnosis was delayed in most cases. Previous bacteremia being main predisposing factor and hematogenous origin the main source of infection. S. aureus was the most isolated. Percutaneous puncture together with blood cultures increase etiologic diagnosis. A high percentage of patients had complications or sequelae.