ABSTRACT
BACKGROUND: Treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals achieves a sustained virologic response rate higher than 95%. However, virologic failure remains a clinical challenge, and data on retreatment are limited, especially in special populations such as liver transplant (LT) recipients. OBJECTIVES: This study evaluated the sofosbuvir plus glecaprevir-pibrentasvir (GLE/PIB) regimen in LT recipients who had failed to a nonstructural protein 5A (NS5A) inhibitor-based regimen. MATERIAL AND METHODS: Retrospective study of 111 liver transplant recipients between January 2018 and December 2020; 18 patients presented with HCV recurrent infection after LT, out of whom three had a history of at least one NS5A inhibitor-based regimen. Salvage therapy with sofosbuvir plus GLE/PIB was started for 12 weeks; baseline characteristics and outcomes were recorded. RESULTS: All three patients (100%) achieved an undetectable HCV viral load 12 weeks after treatment completion. No serious adverse events were observed. CONCLUSION: In our series, sofosbuvir plus GLE/PIB for 12 weeks is an effective and safe salvage therapy after LT in patients previously treated with NS5A inhibitors.
ANTECEDENTES: El tratamiento del virus de la hepatitis C (VHC) crónica con antivirales de acción directa logra tasas de respuesta virológica sostenida superiores a 95 %. Sin embargo, el manejo del fracaso virológico sigue siendo un desafío clínico y la evidencia sobre el retratamiento es limitada, especialmente en poblaciones como los receptores de trasplante hepático (TH). OBJETIVO: Este estudio evaluó el régimen de sofosbuvir más glecaprevir/pibrentasvir (GLE/PIB) en receptores de TH en quienes falló el régimen basado en inhibidores de la proteína no estructural 5A (NS5A). MATERIAL Y MÉTODOS: Estudio retrospectivo de 111 pacientes trasplantados entre enero de 2018 y diciembre de 2020; 18 pacientes presentaron infección recurrente por VHC posterior al TH, tres de ellos tuvieron antecedentes de al menos un régimen basado en inhibidores de NS5A. Se inició terapia de rescate con sofosbuvir más GLE/PIB durante 12 semanas posterior al TH; se registraron las características basales de los pacientes y sus desenlaces. RESULTADOS: En los tres pacientes se logró obtener una carga viral indetectable de VHC a las 12 semanas de finalizar el tratamiento. No se observaron eventos adversos graves. CONCLUSIÓN: En nuestra serie, sofosbuvir más GLE/PIB durante 12 semanas demostró ser una terapia de rescate efectiva y segura posterior al TH en pacientes previamente tratados con inhibidores de NS5A.
Subject(s)
Hepatitis C, Chronic , Hepatitis C , Liver Transplantation , Humans , Sofosbuvir/therapeutic use , Salvage Therapy , Hepatitis C, Chronic/drug therapy , Antiviral Agents/therapeutic use , Retrospective StudiesABSTRACT
Resumen Antecedentes: El tratamiento de la infección crónica por el virus de la hepatitis C (VHC) con antivirales de acción directa logra tasas de respuesta virológica sostenida superiores a 95 %. Sin embargo, el manejo del fracaso virológico sigue siendo un desafío clínico y la evidencia sobre el retratamiento es limitada, especialmente en poblaciones como los receptores de trasplante hepático (TH). Objetivo: Este estudio evaluó el régimen de sofosbuvir más glecaprevir/pibrentasvir (GLE/PIB) en receptores de TH en quienes falló el régimen basado en inhibidores de la proteína no estructural 5A (NS5A). Material y métodos: Estudio retrospectivo de 111 pacientes trasplantados entre enero de 2018 y diciembre de 2020; 18 pacientes presentaron infección recurrente por VHC posterior al TH, tres de ellos tuvieron antecedentes de al menos un régimen basado en inhibidores de NS5A. Se inició terapia de rescate con sofosbuvir más GLE/PIB durante 12 semanas posterior al TH; se registraron las características basales de los pacientes y sus desenlaces. Resultados: En los tres pacientes se logró obtener una carga viral indetectable de VHC a las 12 semanas de finalizar el tratamiento. No se observaron eventos adversos graves. Conclusión: En nuestra serie, sofosbuvir más GLE/PIB durante 12 semanas demostró ser una terapia de rescate efectiva y segura posterior al TH en pacientes previamente tratados con inhibidores de NS5A.
Abstract Background: Treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals achieves a sustained virologic response rates higher than 95%. However, virologic failure remains a clinical challenge, and data on retreatment are limited, especially in special populations such as liver transplant (LT) recipients. Objective: This study evaluated the sofosbuvir plus glecaprevir-pibrentasvir (GLE/PIB) regimen in LT recipients who had failed to a nonstructural protein 5A (NS5A) inhibitor-based regimen. Material and methods: Retrospective study of 111 liver transplant recipients between January 2018 and December 2020; 18 patients presented with HCV recurrent infection after LT, out of whom three had a history of at least one NS5A inhibitor-based regimen. Salvage therapy with sofosbuvir plus GLE/PIB was started for 12 weeks; baseline characteristics and outcomes were recorded. Results: All three patients (100%) achieved an undetectable HCV viral load 12 weeks after treatment completion. No serious adverse events were observed. Conclusion: In our series, sofosbuvir plus GLE/PIB for 12 weeks is an effective and safe salvage therapy after LT in patients previously treated with NS5A inhibitors.
ABSTRACT
Resumen El sangrado varicoso es una urgencia médica con altas tasas de morbimortalidad. De los pacientes que llegan para recibir manejo hospitalario, hasta un 10% no responden a medidas hemostáticas convencionales, por lo que se ha planteado el uso de prótesis metálicas autoexpandibles para el manejo con resultados prometedores de dichos pacientes. En el presente documento se discute la literatura mundial disponible acerca de la experiencia en el uso de dichos dispositivos; la eficacia en el control agudo; el pronóstico a largo plazo; el tipo de prótesis utilizadas y las alternativas, complicaciones y retos del manejo de pacientes con esta técnica, que puede considerarse emergente en nuestro medio.
Abstract Variceal bleeding is a medical emergency which has high rates of morbidity and mortality. Up to 10% of these patients treated in hospitals do not respond to conventional hemostatic measures. For this reason, the use of self-expanding metal stents (SEMS) has been proposed for management of these patients. It has had promising results. This paper discusses the literature available internationally about experience with the use of SEMS, their efficacy for acute control, long-term patient prognoses, types of stents, alternatives, complications, and challenges for the use of SEMS for patient management that should be considered in our environment.
Subject(s)
Humans , Prostheses and Implants , Stents , Hemorrhage , PrognosisABSTRACT
BACKGROUND: Presence of lymph node metástasis (LNM) at salvage radical prostatectomy (sRP) is associated with poor outcome. Predictors of outcome in this context remain undetermined. ThE objective was to assess the role of number of positive lymph node on outcome of patients with LNM after sRP and for radio-recurrent prostate cancer. MATERIAL AND METHODS: We analyzed data from a consecutive cohort of 215 men treated with sRP at a single institution. We used univariate Cox proportional hazard regression models for biochemical recurrence (BCR) and metastatic outcomes, with prostate-specific antigen, Gleason score, extraprostatic extension, seminal vesicle invasion, time between radiation therapy and sRP, and number of positive nodes as predictors. RESULTS: Of the 47 patients with LNM, 37 developed BCR, 11 developed distant metastasis and 4 died with a median follow-up of 2.3 years for survivors. The risk of metastases increased with higher pre-operative PSA levels (HR 1.19 per 1ng/ml; 95% CI: 1.06-1.34; P=.003). The remaining predictors did not reach conventional levels of significance. However, removal of 3 or more positive lymph nodes demonstrated a positive association, as expected, with metastatic disease (HR 3.44; 95% CI: 0.91-13.05; P=.069) compared to one or 2 positive nodes. Similarly, the presence of extraprostatic extension, seminal vesicle invasion and Gleason grade greater than 7 also demonstrated a positive association with higher risk of metástasis, with hazard ratios of 3.97 (95% CI: 0.50, 31.4; P=.2), 3.72 (95% CI: 0.80-17.26; P=.1), and 1.45 (95% CI: 0.44-4.76; P=.5), respectively. CONCLUSIONS: In patients with LNM after sRP for radio-recurrent prostate cancer, the risk of distant metástasis is likely to be influenced by the number of positive nodes (3 or more), high preoperative PSA, Gleason grade and advanced pathologic stage. These results are consistent with the findings of number of nodes (1 to 2 vs. 3 or more nodes positive) as a prognostic indicator after primary radical prostatectomy and strengthen the plea for a revision of the nodal staging for prostate cancer.
Subject(s)
Lymph Nodes/pathology , Neoplasm Recurrence, Local/pathology , Prostatectomy , Prostatic Neoplasms/pathology , Prostatic Neoplasms/radiotherapy , Aged , Humans , Lymphatic Metastasis , Male , Middle Aged , Prostatectomy/methods , Prostatic Neoplasms/surgery , Salvage Therapy , Treatment OutcomeABSTRACT
OBJECTIVE: To study the influence, in terms of prognosis, of the finding of seminal vesicle involvement in patients with prostate adenocarcinoma treated with radical prostatectomy. MATERIAL AND METHOD: We reviewed a series of patients with seminal vesicle involvement with clinically localized prostate adenocarcinoma who underwent radical prostatectomy between 1989 and 2009, focusing on their clinical-pathological characteristics, biochemical progression-free survival (BPFS) and specific survival (SS). We assessed the variables that influenced BPFS and designed a risk model. RESULTS: A total of 127 out of 1,132 patients who underwent surgery (11%) presented seminal vesicle invasion (i.e., pT3b). In the multivariate study of the entire series (Cox model), pT3b affects the BPFS (HR: 2; 95% CI: 1.4-3.3; P=.001). Other influential factors were the affected borders, initial prostate-specific antigen levels, pathological Gleason score and the presence of palpated tumor. The pT3b tumors have poorer clinical-pathological variables when compared with pT2 and pT3a tumors. Sixty-five percent of the patients evidenced biochemical progression. The BPFS was significantly poorer for pT3b (40 ± 4% and 28 ± 4% at 5 and 10 years, respectively) than for pT2 and pT3a (P<.0001). The SS was also poorer in patients with pT3b tumors (91 ± 2% and 76 ± 4% at 5 and 10 years, respectively) (P<.0001). The predictors within the pT3b patient group were: PSA levels >10 ng/mL (HR: 1.9; 95% CI: 1.04-3.6; P=.04) and pathological Gleason score 8-10 (HR: 2.1; 95% CI: 1.2-3.5; P=.03). We designed a risk model that accounts for the variables involved, which entails 2 groups with different BPFS (P=.004): Group 1 (0-1 variable), with a BPFS of 46 ± 7% and 27 ± 8% at 5 and 10 years, respectively; and Group 2 (2 variables), with a BPFS of 14 ± 7% and 5 ± 5% at 5 and 10 years, respectively. CONCLUSION: Seminal vesicle involvement severely and negatively affects the BPFS and SS. We designed a risk model with the independent influential variables in BPFS (pathological Gleason score 8-10 and PSA levels >10 ng/mL). This model confirms that pT3b tumors are a heterogeneous group, which includes an important group with better prognosis when surgical treatment is performed.
Subject(s)
Adenocarcinoma/pathology , Prostatectomy , Prostatic Neoplasms/pathology , Seminal Vesicles/pathology , Adenocarcinoma/blood , Adenocarcinoma/surgery , Aged , Cell Differentiation , Disease-Free Survival , Follow-Up Studies , Humans , Male , Middle Aged , Models, Biological , Neoplasm Invasiveness , Neoplasm Staging , Prognosis , Proportional Hazards Models , Prostate-Specific Antigen/blood , Prostatectomy/methods , Prostatic Neoplasms/blood , Prostatic Neoplasms/surgery , Retrospective Studies , Risk AssessmentABSTRACT
The effectiveness of antenatal corticosteroid therapy for foetal lung maturation in pre-term infants is well known, but there is uncertainty about the time that the treatment remains effective. A descriptive, longitudinal study was conducted to determine whether the need for surfactant administration was determined by the time-lapse between corticosteroids administration and delivery, and when repeating the doses of maternal corticosteroids should be considered. A total of 91 premature infants ≤32 weeks and/or ≤1,500 g (limit 34+6 weeks) whose mothers had received a complete course of corticosteroids were included. In patients at 27-34+6 weeks, we found that the longer the time elapsed between delivery and administration of corticosteroids, most likely were the babies to require treatment with surfactant (P=.027). The resulting ROC curve determined an 8-days cut-off after which repeating a dose of corticosteroids should be assessed.
