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BACKGROUND: It is unknown whether diltiazem, a moderate cytochrome P450 enzyme (CYP3A4) and P-glycoprotein (P-gp) inhibitor, increases the incidence of bleeding events in combination with rivaroxaban, a CYP3A4 and P-gp substrate. OBJECTIVE: To assess major and clinically relevant nonmajor (CRNM) bleeding outcomes in patients with nonvalvular atrial fibrillation (NVAF) on rivaroxaban with concomitant diltiazem in a real-world setting. METHODS: This retrospective case-cohort study included adult patients with NVAF prescribed both rivaroxaban and diltiazem for at least 30 days. Patients were matched 1:1 by age and baseline creatinine clearance (CrCl) to control patients taking rivaroxaban alone. The primary outcome was the composite of major and CRNM bleeding. Additional outcomes included bleeding events resulting in discontinuation of rivaroxaban, time to first bleeding event, and type of first bleed. RESULTS: A total of 143 cases and 143 controls were included. The mean age was 69 years and median baseline CrCl was 87 mL/min. Median follow-up time was 12.4 months for cases and 16.5 months for controls. There was no significant difference in proportion of patients experiencing a major and/or CRNM bleeding event between cases and controls: 23.1% versus 28.0%, respectively; 9 cases and 8 controls permanently discontinued rivaroxaban because of bleeding. Gastrointestinal/rectal bleeding and hematuria were the most frequently reported bleeding events in both groups. Conclusion and Relevance: This is the first study to assess major and CRNM bleeding outcomes in patients with NVAF on rivaroxaban and diltiazem. Diltiazem use was not associated with an increased rate of bleeding events.
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Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Bloqueadores de los Canales de Calcio/uso terapéutico , Diltiazem/uso terapéutico , Inhibidores del Factor Xa/uso terapéutico , Rivaroxabán/uso terapéutico , Anciano , Anticoagulantes/farmacología , Bloqueadores de los Canales de Calcio/farmacología , Diltiazem/farmacología , Inhibidores del Factor Xa/farmacología , Femenino , Humanos , Masculino , Estudios Retrospectivos , Rivaroxabán/farmacología , Resultado del TratamientoRESUMEN
OBJECTIVE: To review current literature for anticoagulation in patients with cirrhosis and provide a summary of the effects of cirrhosis on the coagulation cascade, therapeutic monitoring through interpretation of antifactor Xa (anti-Xa), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) as well as current prophylaxis and treatment recommendations in cirrhotic patients. METHODS: A systematic electronic literature search was conducted in PubMed using the key termsanticoagulation, warfarin, low-molecular-weight heparin(LMWH),unfractionated heparin(UFH),target-specific oral anticoagulants, deep-vein thrombosis(DVT),pulmonary embolism(PE),portal vein thrombosis(PVT),venous thromboembolism, anti-Xa, activated partial thromboplastin time, anticoagulation therapeutic monitoring, coagulopathy, coagulation cascade, chronic liver disease, cirrhosis, anddecompensated liver disease STUDY SELECTION: Studies written in the English language from January 2000 to December 2015 were considered for this review article. All search results were reviewed, and the relevance of each article was determined by authors independently. CONCLUSIONS: Patients with cirrhosis are at higher risk for both bleeding and thrombosis-related complications. Cirrhosis affects production of both procoagulant and anticoagulant factors, thus resulting in increased INR and aPTT levels and decreased anti-Xa levels. LMWH is the treatment of choice for the prevention and treatment of DVT/PE/PVT in patients with cirrhosis, and monitoring with anti-Xa levels for dose adjustment is not recommended. UFH is an alternative in cirrhotic patients for shorter-term use and in cases of severe renal dysfunction and/or hemodynamic instability. Cirrhotic patients on anticoagulation therapy should be monitored closely for signs and symptoms of bleeding and thrombosis.
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Anticoagulantes/uso terapéutico , Cirrosis Hepática/sangre , Hemorragia/inducido químicamente , Heparina/uso terapéutico , Humanos , Relación Normalizada Internacional , Tiempo de Tromboplastina Parcial , Embolia Pulmonar/prevención & control , Tromboembolia Venosa/prevención & control , Trombosis de la Vena/prevención & control , Warfarina/uso terapéuticoRESUMEN
BACKGROUND: Drug-drug interactions (DDIs) with warfarin and antimicrobial agents are a common cause of international normalized ratio (INR) instability, which can affect the risk for bleeding and thrombotic events. OBJECTIVE: The purpose of this study was to assess the impact of a comprehensive guideline for the management of warfarin-antimicrobial DDIs across transitions of care. The guideline emphasizes improving identification of significant antimicrobial-warfarin DDIs during hospitalization, empirical warfarin dose modification based on DDI and baseline INR, patient education, documentation of the DDI, communication with outpatient providers regarding the DDI and anticipated antimicrobial stop date, and warfarin dose adjustment on discontinuation of antimicrobial. METHODS: This retrospective, single-center, quasiexperimental, pre-post study compared end points 3 months before and after guideline implementation. The primary outcome was time within therapeutic range (TTR). RESULTS: The study included 78 preguideline and 31 postguideline patients; baseline characteristics were similar between groups. Implementation of the guideline resulted in greater in-hospital TTR (72% vs 50%, P = 0.04) and improved TTR across transition of care (70% vs 46%, P = 0.01). Documentation of DDI in the pharmacy anticoagulation discharge summary significantly improved in the postguideline group (40% vs 14%, P = 0.02) and numerically improved within the daily pharmacy progress notes (94% vs 82%, P = 0.13). The implementation of the guideline was associated with a nonsignificant, numerical reduction in bleeding events compared with the preguideline group (0 vs 4 events, P = 0.11). CONCLUSION: This single-center approach to optimize the comprehensive management of significant antimicrobial-warfarin DDIs resulted in improved communication with outpatient providers and improved INR TTR.
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Antiinfecciosos/efectos adversos , Anticoagulantes/efectos adversos , Relación Normalizada Internacional/métodos , Guías de Práctica Clínica como Asunto/normas , Cuidado de Transición/normas , Warfarina/efectos adversos , Anciano , Antiinfecciosos/administración & dosificación , Antiinfecciosos/uso terapéutico , Anticoagulantes/administración & dosificación , Anticoagulantes/uso terapéutico , Coagulación Sanguínea/efectos de los fármacos , Interacciones Farmacológicas , Femenino , Hemorragia/inducido químicamente , Hemorragia/tratamiento farmacológico , Hospitalización , Humanos , Pacientes Internos , Relación Normalizada Internacional/normas , Masculino , Persona de Mediana Edad , Transferencia de Pacientes , Servicios Farmacéuticos/normas , Estudios Retrospectivos , Cuidado de Transición/organización & administración , Warfarina/administración & dosificación , Warfarina/uso terapéuticoRESUMEN
BACKGROUND AND AIMS: Tenofovir (TDF)-associated renal dysfunction has been described in various studies of human immunodeficiency virus-infected patients. Our goal is to examine the incidence and magnitude of decrease in renal function in chronic hepatitis B patients treated with TDF. METHODS: We performed a case-cohort study of 103 patients on TDF 300 mg and 103 patients unexposed to TDF (Entecavir) at 4 centers, who were matched for age±10 years, sex, and baseline estimated glomerular filtration rate (eGFR) group. Calculation and evaluation of eGFR were performed with both the Cockcroft-Gault formula and the Modification of Diet in Renal Disease formula. RESULTS: The exposed and unexposed populations were well matched with a similar mean age (44±10 y), proportion of male patients (63.1%), and baseline eGFR groups (86.4% unimpaired). There was no significant difference in the proportion of patients reclassified to a more severe renal classification (RMSRC) or in the proportion of patients with decrease in eGFR of ≥20% in those exposed to TDF versus control. The incidence density for RMSRC was 7.4 cases per 100 patient-years in the exposed group compared with 11.5 cases per 100 patient-years in the unexposed group (95% CI, 0.31-1.34). The relative risk of exposed to unexposed was 0.64 (95% CI, 0.31-1.34). On Cox proportional hazard analysis following adjustment for sex, age, baseline diagnosis hypertension, diabetes, impaired baseline renal function, and cirrhosis, TDF was not a predictor for RMSRC or decrease in eGFR≥20%. CONCLUSIONS: TDF treatment was not an independent predictor for significant deterioration of renal function. Renal function of chronic hepatitis B patients on antiviral therapy should be monitored, especially in those who are older and/or with mildly impaired renal function.
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Lesión Renal Aguda/inducido químicamente , Antivirales/efectos adversos , Guanina/análogos & derivados , Hepatitis B Crónica/tratamiento farmacológico , Tenofovir/efectos adversos , Lesión Renal Aguda/epidemiología , Adulto , Estudios de Casos y Controles , Femenino , Tasa de Filtración Glomerular , Guanina/efectos adversos , Humanos , Incidencia , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Factores de RiesgoRESUMEN
BACKGROUND AND AIMS: The dose recommendation for entecavir (ETV) is 0.5 mg daily for treatment-naïve chronic hepatitis B (CHB) patients and 1.0 mg daily for lamivudine-refractory patients; however, few data are available for the efficacy of a 1.0-mg daily dose in treatment-naïve CHB patients. Our goal is to examine the treatment outcome of treatment-naïve patients placed on ETV 0.5 mg or ETV 1.0 mg daily through week 48. METHODS: Cases were 40 consecutive hepatitis B e antigen (HBeAg)-positive CHB patients treated with ETV 1.0 mg daily between January 2005 and September 2010, and controls were 40 consecutive CHB patients treated with ETV 0.5 mg daily between January 2005 and September 2010 at three US gastroenterology/liver clinics. Controls were matched for age (±5 years), sex, HBeAg, and baseline hepatitis B virus (HBV) DNA (±0.5 log10 IU/ml). Complete viral suppression was defined as undetectable HBV DNA by polymerase chain reaction (<100 IU/ml). RESULTS: Both groups had similar distributions of age (38 ± 11 years), male patients (55 %), and mean HBV DNA (7.7 ± 1.1 log10 IU/ml). The complete viral suppression rate was similar in both cases and controls through week 24 (15 vs. 15 %, p = 1.00) and week 48 (22 vs. 36 %, p = 0.17). Non-adherence was reported in three patients in the ETV 1.0 mg daily cohort at week 48. CONCLUSIONS: There were no significant differences in the proportion of patients with complete viral suppression in patients treated with ETV 0.5 mg daily or the higher daily dose of 1.0 mg.
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Antivirales/administración & dosificación , Guanina/análogos & derivados , Hepatitis B Crónica/tratamiento farmacológico , Adulto , Femenino , Guanina/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Venous thromboembolism (VTE) is a prevalent medical condition with high morbidity, mortality, and associated costs. Anticoagulation remains the main treatment for VTE, though the decision on when, how, and for how long to administer anticoagulants is increasingly complex. This review highlights the different phases of VTE management, with special circumstances for consideration such as antiphospholipid syndrome, coronary artery disease, cancer-associated thrombus, COVID-19, and future anticoagulation options. Anticoagulation management will continue to be a complex decision, applying evidence-based medicine to individual patients with the hope of maximizing effectiveness while minimizing risks.
RESUMEN
BACKGROUND: Despite its high potency against hepatitis B virus (HBV), entecavir (ETV) 0.5 mg daily may not be sufficient to induce complete viral suppression in some patients with very high pretreatment viremia. It is not clear whether ETV 1.0 mg daily would have additive effect in such patients. GOALS: Our goal was to examine virologic outcome of ETV 1.0 mg daily in patients with partial response to ETV 0.5 mg daily. METHODS: We retrospectively studied 31 consecutive treatment-naive patients who were switched to ETV 1.0 mg daily after partial response [reduction of HBV DNA ≥2 log10 IU/mL but with detectable HBV DNA levels (>100 IU/mL) after 24 weeks of therapy or longer] with ETV 0.5 mg daily from January 2005 to January 2010 at 2 clinics. RESULTS: All patients were Asians and 90% had positive hepatitis B e antigen. Mean HBV DNA was 8.04±0.65 log10 IU/mL before therapy and 3.64±0.91 log10 IU/mL at the time of switch. Overall rate of complete viral suppression were 29% (n=9/31) after 24 weeks of ETV 1.0 mg daily and 22% (n=5/23) after 48 weeks. Complete viral suppression after 24 weeks with ETV 1.0 mg daily was significantly higher in patients with lower HBV DNA (<3 log10 IU/mL) at time of switch: 75% versus 5%, P<0.0001. CONCLUSIONS: The majority of patients with partial response to ETV 0.5 mg daily did not achieve complete viral suppression with the higher dose of ETV 1.0 mg daily except those with minimal residual viremia (HBV DNA <3 log10 IU/mL).
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Antivirales/administración & dosificación , Guanina/análogos & derivados , Virus de la Hepatitis B/efectos de los fármacos , Hepatitis B Crónica/tratamiento farmacológico , Carga Viral/efectos de los fármacos , Viremia/tratamiento farmacológico , Adulto , ADN Viral/sangre , Relación Dosis-Respuesta a Droga , Femenino , Guanina/administración & dosificación , Antígenos e de la Hepatitis B/sangre , Virus de la Hepatitis B/genética , Hepatitis B Crónica/virología , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Viremia/virología , Adulto JovenRESUMEN
BACKGROUND AND AIMS: Prior studies have underlined the need for increased screening and awareness of chronic hepatitis B (CHB), especially in certain high-risk populations. However, few studies have examined the patterns of evaluation and management of CHB between primary care physicians (PCP) and specialists according to commonly-used professional guidelines. Our goal was to examine whether necessary laboratory parameters used to determine disease status and eligibility for antiviral therapy were performed by PCPs and specialists. METHODS: We conducted a retrospective study of 253 treatment-naïve CHB patients who were evaluated by PCP only (n=63) or by specialists (n=190) for CHB at a community multispecialty medical center between March 2007 and June 2009. Criteria for CHB management and treatment eligibility were based on the American Association for the Study of Liver Diseases 2007 guideline and the US Panel 2006 algorithm. Required parameters for optimal evaluation for CHB included hepatitis B e antigen (HBeAg), HBV DNA, and alanine aminotransferase (ALT). Preferred antiviral agents for CHB included pegylated interferon, adefovir, and entecavir. RESULTS: The majority of patients were Asians (90%) and (54%) with a mean age of 43±11.6 years. Compared to PCPs, specialists were more likely to order laboratory testing for ALT (94 vs. 86%, P=0.05), HBeAg (67 vs. 41%, P<0.0001) and HBV DNA (83 vs. 52%, P<0.0001). The proportion of patients having all three laboratory parameters was significantly higher among those evaluated by specialists compared to PCP (62 vs. 33%, P<0.0001). A total of 55 patients were initiated on antiviral treatment (n=47 by specialists and n=6 by PCPs). Lamivudine was prescribed more often by PCPs than specialists (33 vs. 2%, P=0.05). Preferred agents were used 96% of the time by specialists compared to 67% of those treated by PCPs (P=0.05). CONCLUSION: Patients evaluated by specialists for CHB are more likely to undergo more complete laboratory evaluation and, if eligible, are also more likely to be treated with preferred longer-term agents for CHB compared to those evaluated by PCPs only. A collaborative model of care involving both PCP and specialists may further optimize management of patients with CHB.
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Antivirales/uso terapéutico , Centros Comunitarios de Salud , Hepatitis B Crónica/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Atención Primaria de Salud , Adulto , Centros Comunitarios de Salud/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atención Primaria de Salud/estadística & datos numéricos , Estudios RetrospectivosRESUMEN
Our goal is to examine the prevalence, risk factors, and disease knowledge of chronic hepatitis B (CHB) among Vietnamese Americans in California. We also examined treatment eligibility and linkage to care among patients who tested positive for CHB. We enrolled 717 subjects from ten different hepatitis B virus (HBV) screening events in five locations from January 2009 to June 2010 in California. HBV status was determined by hepatitis B surface antigen (HBsAg) and antibody. Data were collected by a 36-question survey. A total of 99 patients (13.8 %) had positive HBsAg, especially those aged 31-40 years (23.6 %), and 177 (24.7 %) were still susceptible to HBV infection. A significant proportion of those who were HBsAg positive or still susceptible reported a history of HBV vaccination (10 and 20 %, respectively). Following adjustments for age and sex, significant predictors for HBsAg positivity were lack of healthcare coverage (OR=2.4, p=0.004), having a family history of CHB (OR=2.1, p=0.009), and prior occupational exposure (OR=3.0, p=0.007). Of those who tested positive, 13.3 % met criteria for antiviral therapy, but none had been initiated on treatment. HBV prevalence in Vietnamese Americans in California was high (13.8 %), especially in those between 31 and 40 years of age. Patient disease and treatment knowledge was poor, as were follow-up and management of those found to have CHB and/or have indication for antiviral therapy.
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Asiático , Conocimientos, Actitudes y Práctica en Salud/etnología , Hepatitis B Crónica/etnología , Adolescente , Adulto , Anciano , Antivirales/administración & dosificación , California , Estudios Transversales , Femenino , Alfabetización en Salud , Encuestas Epidemiológicas , Vacunas contra Hepatitis B/administración & dosificación , Hepatitis B Crónica/epidemiología , Hepatitis B Crónica/prevención & control , Hepatitis B Crónica/transmisión , Humanos , Cobertura del Seguro , Masculino , Tamizaje Masivo , Pacientes no Asegurados/etnología , Persona de Mediana Edad , Factores de Riesgo , Vietnam/etnología , Adulto JovenRESUMEN
The majority of data on risk factors (RFs) for hepatocellular carcinoma (HCC) comes from studies involving populations without underlying liver disease. It is important to evaluate RFs for HCC in patients with chronic liver disease since HCC rarely occurs in those without underlying liver disease. We conducted a hospital-based case-control study of 259 incident HCC cases and 781 controls by convenience sampling between 02/2001 and 12/2009 from the liver clinic at Stanford University Medical Center. The study population was 41% White, 14% Hispanic, 3% African American, 40% Asian American, and 2% other race/ethnicity. RFs were examined through medical records and an in-person questionnaire. Alcohol and tobacco use was calculated by cumulative grams of alcohol or cumulative pack(s) of cigarette consumed over one's lifetime. Diabetes mellitus (DM) was defined by random glucose level of ≥200 mg/dL. RFs were evaluated using multivariate logistic regression. Independent predictors of HCC risk, after mutual adjustment and additional control for alcohol use, etiology of liver diseases, and DM, included age >40 (OR = 8.5 [2.6-28.3]), male gender (OR = 3.5 [2.2-5.8]), presence of cirrhosis (OR = 2.8 [1.6-4.9]), Asian ethnicity (OR = 2.8 [1.8-4.6]), AFP > 50 (OR = 4.2 [2.6-6.8]), and cumulative lifetime tobacco use of >11,000 packs (OR = 1.7 [1.0-2.9]). Heavy prolonged cigarette smoking, but not alcohol use, was a significant independent predictor for HCC in patients with underlying liver disease. Besides older age, male gender, presence of cirrhosis, and elevated AFP, Asian ethnicity and heavy cumulative tobacco use are strong independent predictors of HCC.
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Carcinoma Hepatocelular/epidemiología , Neoplasias Hepáticas/epidemiología , Adulto , Consumo de Bebidas Alcohólicas/efectos adversos , Carcinoma Hepatocelular/etnología , Estudios de Casos y Controles , Distribución de Chi-Cuadrado , Enfermedad Crónica , Etnicidad , Femenino , Humanos , Estilo de Vida , Cirrosis Hepática/complicaciones , Neoplasias Hepáticas/etnología , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Estudios Prospectivos , Factores de Riesgo , Fumar , Estadística como Asunto , Factores de Tiempo , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND AND AIMS: Antiviral treatment responses for patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are well-defined by data from registration trials but may differ from patients seen in community settings where medical adherence is usually not as strictly monitored. The goal of this study was to examine the long-term outcomes of HBeAg-negative patients in a community clinical setting. METHODS: We performed a cohort study of 189 consecutive treatment-naïve patients with CHB who were treated with either entecavir (ETV) 0.5 mg daily (n=107) or adefovir dipivoxil (ADV) 10 mg daily (n=82) from 2002 to 2009 at two community clinics. RESULTS: All patients were Asians. Both ETV and ADV cohorts had similar median baseline ALT and HBV DNA levels. By year 4, a similar proportion of ETV and ADV patients who remained on monotherapy achieved complete viral suppression (91-96%); however, more patients in the ADV cohort required alternative therapy (27 vs. 5%). No patients in the ETV cohort developed resistance while 18% of the ADV cohort did. Cumulative nonadherence rates were 10 and 12% in ADV and ETV cohorts, respectively. CONCLUSIONS: Failure to monotherapy in a community clinical setting is due to both antiviral resistance and patient nonadherence. Medication nonadherence is likely to be a more important contributor to treatment failure than antiviral resistance, especially with new anti-HBV agents such as ETV and tenofovir.
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Antivirales/uso terapéutico , Guanina/análogos & derivados , Hepatitis B Crónica/tratamiento farmacológico , Cumplimiento de la Medicación/estadística & datos numéricos , Adenina/análogos & derivados , Adenina/uso terapéutico , Adulto , Pueblo Asiatico/estadística & datos numéricos , Estudios de Cohortes , Servicios de Salud Comunitaria/estadística & datos numéricos , Farmacorresistencia Viral , Femenino , Guanina/uso terapéutico , Antígenos e de la Hepatitis B/sangre , Antígenos e de la Hepatitis B/efectos de los fármacos , Hepatitis B Crónica/sangre , Humanos , Masculino , Persona de Mediana Edad , Organofosfonatos/uso terapéutico , Resultado del Tratamiento , Carga Viral/efectos de los fármacosRESUMEN
PURPOSE: Limited guidance is available to assist practitioners in managing complex human immunodeficiency virus (HIV) related pharmacotherapy. Management recommendations of oral anticoagulation (warfarin and direct oral anticoagulants [DOACs]) and highly active antiretroviral therapy (HAART) based on drug-drug interactions (DDI) studies and pharmacokinetic (PK) data are provided. METHODS: Search of PubMed, EMBASE, and Google Scholar (01/1985 to 12/2018) using the terms "HIV," "DDI," and names of HAART. PK information and DDI screening were obtained from medication package inserts and drug information resources: Micromedex, Lexicomp, HIV-DDI Checker- University of Liverpool. All English literature on DDI or PK interactions was considered for inclusion. In the absence of data, PK principles were used to predict the likelihood of interactions. RESULTS: No clinically significant DDI are expected to occur between DOACs and nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs), maraviroc, enfuvirtide, or integrase strand inhibitors (INSTIs) that do not include a pharmacologic booster. Potent cytochrome P (CYP) 450 enzyme inhibition by protease inhibitors (PIs) or pharmacologic boosters may lead to higher concentrations of the DOAC and potentially increase the risk of bleeding. CYP450 enzyme induction by non-nucleoside reverse transcriptase inhibitors (NNRTIs) may lower concentrations of DOACs, which may lead to treatment failure. Warfarin DDIs are variable, therefore close monitoring of the INR is recommended. CONCLUSIONS: The potential for DDIs between HAART and oral anticoagulation exists based on PK profiles. Management of these interactions should involve careful selection based on patient characteristics and HAART and anticoagulants with a low potential for DDI should be selected.
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Terapia Antirretroviral Altamente Activa , Infecciones por VIH , Antirretrovirales/uso terapéutico , Anticoagulantes/uso terapéutico , Interacciones Farmacológicas , VIH , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , HumanosRESUMEN
UNLABELLED: Renal dysfunction has been reported in patients treated with adefovir dipivoxil (ADV); however, its incidence and clinical importance may be underappreciated given the lack of long-term follow-up and data outside of a clinical trial setting. Our goal was to examine the severity and incidence of renal dysfunction in a real-life setting for patients treated with ADV and whose baseline estimated glomerular filtration rate (eGFR) was >50 mL/minute. We performed a cohort study of 290 chronic hepatitis B patients: 145 patients treated with 10 mg ADV and 145 patients unexposed to ADV at two community clinics, who were matched for age (+/-10 years), sex, and baseline eGFR. The exposed and unexposed populations were well-matched with a similar mean age (46-47 years), proportion of male patients (76.5%), baseline serum creatinine (0.97-0.99 mg/dL), and baseline creatinine clearance (85.0-85.4 mL/minute). The incidence density for renal dysfunction defined by treatment termination and/or development of eGFR < or =50 mL/minute was five cases per 100 patient-years in the exposed group compared with 1.36 cases per 100 patient-years in the unexposed group (P = 0.02). The relative risk of exposed to unexposed was 3.68 (95% confidence interval 1.1-19.3). On Cox proportional hazard analysis also inclusive of sex, ADV was a significant predictor of significant renal dysfunction (hazard ratio [HR] 3.94, P = 0.03). There were also significant trends for age >50 years (HR 3.49, P = 0.087), mild renal impairment at baseline (HR 4.49, P = 0.073), and hypertension and/or diabetes mellitus (HR 2.36, P = 0.074). CONCLUSION: ADV is an independent predictor for significant deterioration of renal function. Patients on ADV should be monitored, especially patients who are older, have baseline renal insufficiency, or have hypertension and/or diabetes mellitus.
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Adenina/análogos & derivados , Hepatitis B Crónica/tratamiento farmacológico , Fallo Renal Crónico/inducido químicamente , Organofosfonatos/efectos adversos , Adenina/efectos adversos , Adenina/uso terapéutico , Adulto , Anciano , Antivirales/efectos adversos , Antivirales/uso terapéutico , Estudios de Cohortes , Creatinina/sangre , Femenino , Tasa de Filtración Glomerular , Humanos , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , Organofosfonatos/uso terapéutico , Estudios RetrospectivosRESUMEN
BACKGROUND: Screening for hepatocellular carcinoma (HCC) has been shown to improve survival via earlier cancer detection. Although HCC screening is considered standard of care in the USA, little is known of the adherence to this practice, especially in a community setting. AIMS: Our primary goal was to evaluate adherence to HCC screening and to find predictors of screening adherence in a community setting. Our secondary objective was to determine the impact of screening on survival. METHODS: We studied a cohort of 557 consecutive patients at high risk for HCC: patients with cirrhosis and older chronic hepatitis B (CHB) patients without cirrhosis (≥45 years old). Patients initiated screening 1/2001-1/2005 and were monitored ≥12 months to 12/2008 in two community gastroenterology clinics in Northern California. HCC screening was categorized into four groups based on combined frequency of serum alpha-fetoprotein and imaging: optimal, suboptimal, poor, and no screening. RESULTS: About 40.6% of our cohort received poor or no screening. Noncirrhotic CHB patients had worse screening than cirrhotic patients. Multivariate analysis revealed that patients with a greater number of clinical visits per year were 3.4 times more likely to have regular screening than patients with fewer clinical visits per year (P<0.001). There was a trend for association between HCC screening and greater access to curative treatment. CONCLUSION: Since more frequent clinic visits is a strong independent predictor of improved screening adherence, regular routine clinic visits may help improve adherence to HCC screening, which may also lead to improved clinical outcomes.
Asunto(s)
Carcinoma Hepatocelular/diagnóstico , Servicios de Salud Comunitaria , Adhesión a Directriz , Hepatitis B Crónica/complicaciones , Cirrosis Hepática/virología , Neoplasias Hepáticas/diagnóstico , Tamizaje Masivo , Pautas de la Práctica en Medicina , Adulto , Anciano , California , Carcinoma Hepatocelular/etiología , Carcinoma Hepatocelular/mortalidad , Carcinoma Hepatocelular/terapia , Carcinoma Hepatocelular/virología , Distribución de Chi-Cuadrado , Servicios de Salud Comunitaria/estadística & datos numéricos , Detección Precoz del Cáncer , Femenino , Adhesión a Directriz/estadística & datos numéricos , Hepatitis B Crónica/mortalidad , Hepatitis B Crónica/terapia , Humanos , Estimación de Kaplan-Meier , Cirrosis Hepática/mortalidad , Cirrosis Hepática/terapia , Neoplasias Hepáticas/etiología , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/terapia , Neoplasias Hepáticas/virología , Modelos Logísticos , Masculino , Tamizaje Masivo/métodos , Tamizaje Masivo/estadística & datos numéricos , Persona de Mediana Edad , Visita a Consultorio Médico , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina/estadística & datos numéricos , Valor Predictivo de las Pruebas , Indicadores de Calidad de la Atención de Salud , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Tasa de Supervivencia , Factores de Tiempo , Resultado del Tratamiento , alfa-Fetoproteínas/metabolismoRESUMEN
PURPOSE: Hepatitis B virus (HBV) genotypes can affect treatment response to interferon-based therapy and disease outcomes in patients with chronic hepatitis B (CHB). Little data exist to characterize HBV genotypes in Vietnamese, one of the largest minority groups in the United States and also one with one of the highest CHB and liver cancer disease burdens. The goal of this study was to compare the distribution of HBV genotypes in Vietnamese and Chinese patients. METHODS: We performed a cross-sectional study of 567 consecutive patients of Vietnamese (n = 478) or Chinese (n = 89) descent, with HBV genotype mutation analysis performed between 7/2,005 and 6/2,008 at a community gastroenterology clinic and a university-affiliated liver clinic in the United States. RESULTS: There were no significant differences between the Vietnamese and Chinese groups in mean age (45 and 44 years), gender (58% and 61% male), HBeAg status (64% and 65% negative), median alanine aminotransferase (33 and 41 U/L), and log(10) HBV DNA (4.9 and 5.0 log(10) IU/ml), or the prevalence of precore/basic core promoter mutations (72% and 71%), respectively. Vietnamese patients had a much higher prevalence of HBV genotype B and a lower prevalence of genotype C than Chinese patients: 74% and 25% vs. 55% and 43% (P = 0.001). CONCLUSIONS: Chinese patients with CHB often carry either B or C genotype. Vietnamese patients with CHB mostly have HBV genotype B. Additional studies are needed to further characterize the clinical significance of HBV genotype in the natural history and treatment outcomes of CHB in Vietnamese patients.