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Bhat M.,McGill University | Romagnuolo J.,Medical University of South Carolina | Da Silveira E.,San Jose Gastroenterology | Reinhold C.,McGill University | And 4 more authors.
Alimentary Pharmacology and Therapeutics

Background The preferred initial investigation with either magnetic resonance (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) in patients with suspected biliary obstruction remains controversial in many clinical settings. Aim To assess the effectiveness of an initial MRCP vs. ERCP in the work-up of patients at moderate likelihood of a suspected biliary obstruction. Methods Patients with an unconfirmed benign biliary obstruction, based on laboratory and ultrasound findings, were randomised to an ERCP-first or MRCP-first strategy, stratified by level of obstruction. The primary outcome was the occurrence of a disease or procedure-related bilio-pancreatic adverse events within the next 12 months. Secondary outcomes were the number of subsequent bilio-pancreatic procedures, duration of hospitalisation, days away from activities of daily living (ADL), quality of life (SF-36) and mortality. Results We randomised 126 patients to ERCP-first and 131 to MRCP-first (age 54 ± 18 years, 62% female, 39% post-cholecystectomy). In follow-up, 18/126 (14.3%) ERCP-first and 25/131 (19.1%) MRCP-first patients experienced a procedure- or disease-related complication (P = 0.30) (disease-related in 13 and 18 patients, and procedure-related in 5 and 7 patients respectively). A cause of biliary obstruction was found in 39.7% vs. 49.6% of patients (P = 0.11). Sixty-six (50%) patients in the MRCP-first group ended up avoiding an ERCP in follow-up. ERCP-first and MRCP-first patients were away from usual activities for 3.4 ± 7.7 days and 2.0 ± 4.8 days respectively (P < 0.001). Conclusion A strategy of MRCP-first decreased the need for subsequent MRCPs, but not complications. Further study is required to define factors influencing the eventual use of MRCP vs. ERCP in appropriately selected patients (ClinicalTrial.gov: NCT01424657). © 2013 John Wiley & Sons Ltd. Source

Gao L.,Stanford University | Trinh H.N.,San Jose Gastroenterology | Li J.,View Medical | Nguyen M.H.,Stanford University
Alimentary Pharmacology and Therapeutics

Background Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are the two first-line anti-viral therapies for chronic hepatitis B (CHB); however, there are limited studies directly comparing their effectiveness. Aim To compare the effectiveness of ETV and TDF in nucleos(t)ide-naïve CHB patients with high hepatitis B virus (HBV) DNA levels, defined as serum HBV DNA greater than 6 log10 IU/mL. Methods We performed a retrospective multicentre cohort study of adult CHB patients who were seen between 2009 and 2012 at four Northern California community gastroenterology and hepatology clinics. Results We identified 59 consecutive patients treated with TDF and 216 patients treated with ETV. Pre-treatment characteristics were similar between the two groups. Among HBeAg-negative patients, there was no significant difference in viral suppression rates between ETV and TDF (P = 0.72). In contrast, among HBeAg-positive patients, those treated with TDF achieved viral suppression significantly more rapidly than those treated with ETV (P < 0.0001); the Kaplan-Meier estimated probability of complete suppression was 18% vs. 11% at 6 months, 51% vs. 28% at 12 months and 72% vs. 39% at 18 months respectively. Multivariate Cox proportional hazards analysis indicated that treatment with TDF compared to ETV was a significant predictor of viral suppression, but only for HBeAg-positive patients (HR = 2.59; 95% CI 1.58-4.22; P < 0.001). Conclusion Tenofovir is significantly more effective than entecavir for achieving complete viral suppression in HBeAg-positive, nucleos(t)ide-naïve chronic hepatitis B patients with HBV DNA greater than 6 log10 IU/mL. © 2014 John Wiley & Sons Ltd. Source

Zhang S.,University of California at Los Angeles | Nguyen H.A.,San Jose Gastroenterology | Nguyen M.H.,Stanford University
Digestive Diseases and Sciences

Background and Objectives Previous studies have found that a major proportion of patients with chronic hepatitis B (CHB) do not receive antiviral therapy. The objective of this study was to characterize treatment eligibility on the basis of current guidelines, determine whether eligible patients actually receive treatment, and examine associated predictors. Methods We conducted a retrospective study of patients who were evaluated for CHB at two community gastroenterology clinics between April 2007 and February 2009. Using criteria published by the American Association for the Study of Liver Diseases (AASLD) in 2007-2009 and by a panel of US hepatologists (US Panel) in 2006-2008, treatment eligibility was determined for the patients. Results Of 612 consecutive CHB patients included, mean age was 44 ± 13 years, 54 % were male, and 99 % were Asian. Half (51 %) were eligible for treatment on the basis of the US Panel algorithm and 47 % of these patients also met AASLD treatment criteria. Overall, antiviral therapy was initiated for 50 % of eligible patients: 72 % of AASLD-eligible patients and 29 %of patients who were US Panel-eligible only. Independent predictors for actual treatment initiation were higher ALT for AASLD-eligible patients and higher ALT and older age for patients who were US Panel-eligible only. The leading reasons for nontreatment were further observation recommended by the physician, followed by loss of follow-up and patient refusal. Conclusions Approximately half of the CHB patients evaluated at community referral clinics met treatment criteria of at least one guideline; however, only about half received antiviral therapy within 12 months of presentation. Further studies are needed to optimize treatment of eligible CHB patients. © 2012 Springer Science+Business Media, LLC. Source

Pan C.Q.,New York University | Trinh H.,San Jose Gastroenterology | Yao A.,AE and LY Medical Associates | Bae H.,Asian Pacific Liver Center | And 3 more authors.

Background and aims: Chronic hepatitis B (CHB) disproportionately affects the Asian-American population in the USA. Tenofovir disoproxil fumarate (TDF) has demonstrated potent antiviral activity in clinical trials, but data in Asian-Americans from community studies are lacking. Methods: Adult Asian-American patients with CHB from private medical and community-based practices were prospectively enrolled and treated with open-label TDF 300 mg once daily in a single-arm study for 48 weeks. After Week 48, patients had the option to transition to commercially available CHB therapy. The primary efficacy endpoint was hepatitis B virus (HBV) DNA <400 copies/mL at Week 48. Secondary endpoints were safety and tolerability, serologic and biochemical responses, liver fibrosis by FibroTest, and the development of drug-resistant mutations. Results: Of the 90 patients enrolled, 53 (58%) were hepatitis B e antigen (HBeAg)-positive at baseline. At Week 48, 74 patients (82% overall; 70% HBeAg-positive and 100% HBeAg-negative) had HBV DNA <400 copies/mL. Six (12%) HBeAg-positive patients achieved HBeAg loss/seroconversion. The percentage of patients with alanine aminotransferase in the normal range increased from 26% at baseline to 66% at Week 48. The percentage of patients with F0 (no or minimal) fibrosis by FibroTest increased from 48% to 51%, and those with F4 (severe) fibrosis decreased from 4% to 1%. No resistance to TDF developed. Treatment was well tolerated. Most adverse events were mild in severity and considered unrelated to study drug. Conclusions: TDF is effective and well tolerated in Asian-American CHB patients in community clinic-based settings, consistent with larger registration trials. Improvement in liver fibrosis was seen in a proportion of patients. No resistance to TDF developed through 48 weeks of treatment. Trial Registraton: Clinicaltrial.gov identifier NCT00736190 © 2014 Pan et al. Source

Ha N.B.,University of California at Davis | Ha N.B.,Stanford University | Ha N.B.,University of California at San Francisco | Nguyen H.A.,San Jose Gastroenterology | And 2 more authors.
Digestive Diseases and Sciences

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. © 2013 Springer Science+Business Media New York. Source

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