Real-world Prospective Cohort Research Articles

Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study.

BackgroundDe novo combination of lamivudine (Lam) and adefovir (Adv) was not rarely used in clinical practice. However, head-to-head comparisons of entecavir (Etv) monotherapy with this combination in hepatitis B virus (HBV)-related compensated cirrhosis patients are unavailable. This study aimed to compare the efficacy and safety of Etv monotherapy with combination therapy in patients with HBV-related compensated liver cirrhosis.MethodsTreatment-naïve patients with HBV-related compensated liver cirrhosis were recruited to receive either Etv monotherapy or a de novo combination of Lam and Adv. Data were collected at baseline and every 6 months thereafter.ResultsA total of 578 patients (485 in Etv group, 93 in combination group) were included. Baseline characteristics were comparable between the two groups. At the end of 1, 2, and 3 years, HBV DNA was undetectable in 82.7%, 96.2%, and 94.3% of patients in the Etv group and 88.9%, 81.7%, and 84.6% in the combination group, respectively (all P>0.05). The cumulative virological breakthrough rate at 1, 2, and 3 years was 2.7%, 6.7%, and 9.8% in the Etv group and 2.9%, 13.3%, and 32.2% in the combination group, respectively (P=0.003). After propensity-score adjustment for age, sex, and baseline HBeAg, ALT, and total bilirubin, virological breakthrough was higher in the de novo combination of Lam and Adv (HR 2.83, 95% CI 1.37–5.86; P<0.01). The cumulative rate of liver-related events, including decompensation and hepatocellular carcinoma, at 1, 2, and 3 years was 2.9%, 4.2%, and 6.1% in the Etv group and 2.2%, 2.2%, and 6.7% in combination group, respectively (P=0.83). Biochemical response and serological response were similar between the groups.ConclusionEtv treatment had less virological breakthrough and potentially higher HBV-DNA suppression than de novo combination of Lam and Adv during 3 years in treatment-naïve HBV-related compensated liver cirrhosis.

Does everyone who quit smoking gain weight? A real-world prospective cohort study.

ABSTRACTObjective:To evaluate weight changes after 12 months of biochemically confirmed smoking abstinence, comparing patients who lost weight or maintained their baseline weight with those who gained weight. Methods:This was a real-world prospective cohort study conducted at the Outpatient Smoking Cessation Clinic of São Lucas Hospital, in the city of Porto Alegre, Brazil, between 2010 and 2016. The patients evaluated received intensive smoking cessation counseling, focused especially on weight issues, together with pharmacotherapy, and were followed for 12 months. The baseline and final weights were measured. Continuous abstinence was confirmed by determining the concentration of exhaled carbon monoxide (eCO). Results:Of a total of 348 patients evaluated, 161 (46.2%) achieved continuous abstinence (eCO < 10 ppm) over the 12-month follow-up period. Of those 161 patients, 104 (64.6%) maintained their initial weight or had a weight change of no more than 5% in relation to their baseline weight, whereas the remaining 57 (35.4%) had a weight gain of more than 5%, 18 of those patients showing a > 10% increase over their baseline weight. The number needed to harm (i.e., the number of patients required in order to detect one patient with a weight increase) was calculated to be 3.6 (95% CI: 2.8-5.4). Conclusions:Weight gain is not necessarily associated with smoking cessation, and smokers who are motivated to quit should be informed of that fact. This information could also be useful for addressing smokers who are still undecided because of possibility of weight gain.

Low Serum Levels of (Dihydro-)Ceramides Reflect Liver Graft Dysfunction in a Real-World Cohort of Patients Post Liver Transplantation.

Patients after orthopic liver transplantation (OLT) are at risk of developing graft dysfunction. Sphingolipids (SL’s) have been identified to play a pivotal role in the regulation of hepatocellular apoptosis, inflammation and immunity. We aimed to investigate the serum SL profile in a prospective real-world cohort of post-OLT patients. From October 2015 until July 2016, 149 well-characterized post-OLT patients were analyzed. SL’s were assessed in serum probes via Liquid Chromatography/Tandem Mass Spectrometry. Twenty-nine (20%) patients had a biopsy proven graft rejection with decreased C20-ceramide (Cer) (p = 0.042), C18-dihydroceramide (DHC) (p = 0.022) and C24DHC (p = 0.060) levels. Furthermore, C18DHC (p = 0.044) and C24DHC (p = 0.011) were significantly down-regulated in patients with ischemic type biliary lesions (ITBL; n = 15; 10%). One-hundred and thirty-three patients (89%) have so far received tacrolimus as the main immunosuppressive agent with observed elevations of C14Cer (p = 0.052), C18Cer (p = 0.049) and C18:1Cer (p = 0.024). Hepatocellular carcinoma (HCC) pre-OLT was associated with increases in C24:1Cer (p = 0.024) and C24:1DHC (p = 0.024). In this large prospective cross-sectional study of patients, post-OLT serum levels of (very-)long chain (dihydro-)ceramides associate with graft rejection, ITBL, tacrolimus intake and HCC pre-OLT. Hence, serum SL’s may be indicative of graft complications. Further research is necessary to identify their diverse mechanistic role in regulating immunity and inflammation in patients post-OLT.

Clinical course and perinatal transmission of chronic hepatitis B during pregnancy: A real-world prospective cohort study

To determine the clinical course and perinatal transmission of chronic hepatitis B during pregnancy in a real life setting. A total of 221 singleton pregnant women with detectable HBV-DNA levels (≥103 copies/mL) were enrolled during January 2011 to June 2015. Forty-three high viraemic patients (≥106 copies/mL) received telbivudine in the 2nd or 3rd trimester according to their intention, while 89 high viraemic and 79 low viraemic (≥103 and <106 copies/mL) patients were the control cohorts. Primary endpoint was the pregnancy outcomes and secondary endpoint the perinatal transmission including intrauterine infection, immunoprophylaxis failure and occult infection. In all, 209 patients completed pregnancy with 209 infants, while 2 in telbivudine-treated cohort had unexplained late stillbirths. Twenty-nine (70.7%) of telbivudine-treated patients and 3 (3.4%) of untreated high viraemic controls achieved undetectable HBV-DNA levels prior delivery. At 7 months postpartum, immunoprophylaxis failure was significantly lower (2.4%) in telbivudine-treated cohort, compared with 16.9% and 10.1% in untreated high and low viraemic cohorts, respectively. Low viraemic patients may also need antiviral therapy since they bear moderate risk for perinatal transmission of HBV. However, more multicenter, large-scale studies are required before antepartum antiviral therapy is routinely recommended in patients with detectable viral loads.

A performance and theoretical cost analysis of endobronchial ultrasound-guided transbronchial needle aspiration in a UK tertiary respiratory centre

New innovative techniques can improve patient care but may not be appropriately funded. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS) offers a minimally invasive mediastinal staging and diagnostic method for suspected lung cancer. We report the performance and cost analysis of a newly established EBUS service in a prospective real world cohort of patients to assess the impact of Payment by Results (PbR). Prospective cohort study. Fifty-four patients between June 2008 and April 2009 underwent EBUS for evaluation of unexplained mediastinal lymphadenopathy on CT. Cost analysis was performed from local Trust financial data and 2008-09 tariffs. EBUS had an 89% sensitivity, 75% negative predictive value and 92% accuracy for malignancy. EBUS coding was inaccurate in 15.6% of cases. The actual cost of an EBUS is 1252-1433 pounds but is coded as a standard bronchoscopy (561 pounds). EBUS reduces health community costs by 107824 pounds/year, as a result of a Primary Care Trust cost saving of 113968 pounds/year and a Trust cost deficit of 6144 pounds/year. Coding inaccuracies further alter the Primary Care Trust costs. Medical innovation is fundamental to improved patient care. EBUS can potentially reduce morbidity for lung cancer patients and save health community costs. However, with PbR the service provider delivers this at a loss as the tariffs do not reflect innovation and because of coding inaccuracies. We suggest tariffs for innovative procedures need to reflect the true cost.