Summary
Background
Direct‐acting anti‐virals (DAA) are safe, effective treatment of hepatitis C virus (HCV). Suboptimal linkage to specialists and access to DAAs are the leading barriers to ...treatment; however, data are limited.
Aim
To determine predictors of follow‐up, receipt of DAAs, and reasons for the lack thereof.
Methods
We used clinical data from retrospective cohort of HCV‐infected patients with previously established HCV care in the US Department of Veterans Affairs to examine predictors of follow‐up in HCV clinics and DAA treatment (during 12/1/2013‐4/30/2015). We then conducted a structured review of medical charts of HCV patients to determine reasons for lack of follow‐up and treatment.
Results
We identified 84 221 veterans who were previously seen in HCV clinics during the pre‐DAA era. Of these, 47 165 (56.0%) followed‐up in HCV specialty clinics, 13 532 (28.7%) of whom received DAAs. Older age, prior treatment, presence of cirrhosis or HCC, HIV/HBV co‐infection and psychiatric illness were predictors of follow‐up. Alcohol/drug abuse and medical co‐morbidity were predictors of lack of treatment. Of the 905 prospectively recruited patients, 56.2% patients had a specialist visit and 28% received DAAs. Common reasons for lack of follow‐up were relocation (n = 148, 37.4%) and missed/cancelled appointments (n = 63, 15.9%). Reasons for lack of treatment included waiting for newer therapy (n = 99, 38.8%), co‐morbidities (n = 66, 25.9%) and alcohol/drug abuse (n = 63, 24.7%).
Conclusions
Half of patients with established HCV care were followed‐up in the DAA era and only 29% received DAAs. Targeted efforts focusing on patient and system‐levels may improve the reach of treatment with the new DAAs.
Summary
Elbasvir/grazoprevir (EBR/GZR) is an all‐oral direct‐acting antiviral agent (DAA) with high sustained virologic response (SVR) in clinical trials. This study's primary objective was to ...evaluate effectiveness of EBR/GZR among HCV‐infected patients in a real‐world clinical setting. We conducted a nationwide retrospective observational cohort study of HCV‐infected patients in the US Department of Veterans Affairs (VA) using the VA Corporate Data Warehouse. The study population included patients with positive HCV RNA who initiated EBR/GZR from February 1 to August 1, 2016. We calculated the 95% confidence interval for binomial proportions for SVR overall and by demographic subgroups. Clinical and demographic characteristics were also evaluated. We included 2436 patients in the study cohort. Most were male (96.5%), African American (57.5%), with mean age of 63.5 (SD = 5.9) and 95.4% infected with genotype (GT) 1 GT1a (34.7%), GT1b (58.6%). Other comorbidities included diabetes (53.2%), depression (57.2%) and HIV (3.0%). More than 50% had history of drug or alcohol abuse (53.9% and 60.5%, respectively). 33.2% of the cohort had cirrhosis. A total of 95.6% (2,328/2,436; 95% CI: 94.7%‐96.4%) achieved SVR. The SVR rates by subgroups were: male, 95.5% (2245/2350); female, 96.5% (83/86); GT1a, 93.4%, GT1b, 96.6%, GT4, 96.9%, African American, 95.9% (1,342/1,400); treatment‐experienced, 96.3% (310/322); cirrhosis, 95.6% (732/766); stage 4‐5 CKD, 96.3% (392/407); and HIV, 98.6% (73/74). SVR rates were high overall and across patient subgroups regardless of gender, race/ethnicity, cirrhosis, renal impairment or HIV. This study provided important data regarding the effectiveness of EBR/GZR in a large clinical setting.
Summary
Background
Most clinical practice guidelines recommend screening for HCC in patients with cirrhosis. However, patients with compensated cirrhosis are often asymptomatic and may remain ...unrecognised for years.
Aims
To determine the extent to which cirrhosis is unrecognised in a US Veteran population with HCC, and to evaluate the association between lack of cirrhosis recognition and stage of HCC at diagnosis.
Methods
We reviewed the electronic medical records of a random sample of HCC cases diagnosed in the national Veterans Affairs system between 2005 and 2011. We conducted multivariable analyses adjusting for patients’ demographics, comorbidity, aetiology of underlying disease and healthcare utilisation including HCC surveillance.
Results
Of 1201 patients with HCC and cirrhosis, 24.6% had unrecognised cirrhosis prior to HCC diagnosis. Older patients >65 years, odds ratio (OR) 2.32, African Americans (OR 1.93), patients with alcoholic or NAFLD liver disease (OR 1.69 and 4.77 respectively), HIV (OR 3.02), and fewer comorbidities (Deyo 0 vs. 3, OR 2.42) had significantly higher odds of having unrecognised cirrhosis than comparison groups. Furthermore, patients with unrecognised cirrhosis were 6.5 times more likely to have advanced stage HCC at diagnosis. The effect of cirrhosis recognition on HCC stage remained significant after adjusting for pre‐specified covariates (OR 3.37).
Conclusions
In one quarter of patients, cirrhosis was unrecognised prior to HCC diagnosis, and this group was significantly more likely to have advanced stage HCC. These findings emphasise the importance of timely evaluation for cirrhosis in at‐risk populations as a critical step to improving outcomes for patients with HCC.
Summary
Background
Proton pump inhibitors (PPIs) and histamine‐2 receptor antagonists (H2RAs) may reduce the risk of oesophageal adenocarcinoma (OAC) in Barrett's oesophagus; however, current ...epidemiologic studies are inconclusive.
Aim
To evaluate the independent effects of PPIs and H2RAs on risk of OAC in patients with Barrett's oesophagus.
Methods
We conducted a nested case‐control study of male veterans diagnosed with Barrett's oesophagus. Cases with incident OAC were matched by incidence density sampling on birth year and Barrett's diagnosis date to controls with Barrett's oesophagus who did not develop OAC. We identified prescription medication usage 1 year prior to Barrett's oesophagus diagnosis to 3 months prior to the OAC diagnosis. Odds ratios (OR) and 95% CI were estimated using conditional logistic regression.
Results
Compared with 798 controls, the 300 cases were less likely to use PPIs (90.0% vs 94.5%, P = 0.01) and H2RAs (19.7% vs 25.7%, P = 0.04). In the multivariable model including the use of statins, H2RAs, aspirin and nonsteroidal anti‐inflammatory drugs, PPI use was associated with 41% lower risk of OAC (OR 0.59, 95% CI 0.35‐0.99). While risk reduction of OAC was stronger for high‐dose PPIs (omeprazole daily dose >40 mg, adjusted OR 0.11, 95% 0.04‐0.36), we did not find a dose‐response relationship with PPI duration (P trend = 0.45). Likewise, H2RA use was independently associated with 30% lower risk of OAC (OR 0.70, 95% CI 0.50‐0.99).
Conclusion
Use of PPIs and H2RAs among patients with Barrett's oesophagus are associated with lower risk of OAC. Further clinical trials are needed to confirm this possible chemopreventive effect.
Background and aim:Gastro-oesophageal reflux disease (GORD) has been linked to a number of extra-esophageal symptoms and disorders, primarily in the respiratory tract. This systematic review aimed to ...provide an estimate of the strength and direction of the association between GORD and asthma.Methods:Studies that assessed the prevalence or incidence of GORD in individuals with asthma, or of asthma in individuals with GORD, were identified in Medline and EMBASE via a systematic search strategy.Results:Twenty-eight studies met the selection criteria. The sample size weighted average prevalence of GORD symptoms in asthma patients was 59.2%, whereas in controls it was 38.1%. In patients with asthma, the average prevalence of abnormal oesophageal pH, oesophagitis and hiatal hernia was 50.9%, 37.3% and 51.2%, respectively. The average prevalence of asthma in individuals with GORD was 4.6%, whereas in controls it was 3.9%. Pooling the odds ratios gave an overall ratio of 5.5 (95% CI 1.9–15.8) for studies reporting the prevalence of GORD symptoms in individuals with asthma, and 2.3 (95% CI 1.8–2.8) for those studies measuring the prevalence of asthma in GORD. One longitudinal study showed a significant association between a diagnosis of asthma and a subsequent diagnosis of GORD (relative risk 1.5; 95% CI 1.2–1.8), whereas the two studies that assessed whether GORD precedes asthma gave inconsistent results. The severity–response relationship was examined in only nine studies, with inconsistent findings.Conclusions:This systematic review indicates that there is a significant association between GORD and asthma, but a paucity of data on the direction of causality.
Summary
Background
Functional dyspepsia (FD), a common functional gastrointestinal disorder, is defined by the Rome III criteria as symptoms of epigastric pain or discomfort (prevalence in FD of ...89–90%), postprandial fullness (75–88%), and early satiety (50–82%) within the last 3 months with symptom onset at least 6 months earlier. Patients cannot have any evidence of structural disease to explain symptoms and predominant symptoms of gastroesophageal reflux are exclusionary. Symptoms of FD are non‐specific and the pathophysiology is diverse, which explains in part why a universally effective treatment for FD remains elusive.
Aim
To present current management options for the treatment of FD (therapeutic gain/response rate noted when available).
Results
The utility of Helicobacter pylori eradication for the treatment of FD is modest (6–14% therapeutic gain), while the therapeutic efficacy of proton pump inhibitors (PPI) (7–10% therapeutic gain), histamine‐type‐2‐receptor antagonists (8–35% therapeutic gain), prokinetic agents (18–45%), tricyclic antidepressants (TCA) (response rates of 64–70%), serotonin reuptake inhibitors (no better than placebo) is limited and hampered by inadequate data. This review discusses dietary interventions and analyses studies involving complementary and alternative medications, and psychological therapies.
Conclusions
A reasonable treatment approach based on current evidence is to initiate therapy with a daily PPI in H. pylori‐negative FD patients. If symptoms persist, a therapeutic trial with a tricyclic antidepressant may be initiated. If symptoms continue, the clinician can possibly initiate therapy with an anti‐nociceptive agent, a prokinetic agent, or some form of complementary and alternative medications, although evidence from prospective studies to support this approach is limited.
Summary
Background Peptic ulcer disease (PUD) is most commonly associated with Helicobacter pylori infection and the use of acetylsalicylic acid (ASA) and nonsteroidal anti‐inflammatory drugs ...(NSAIDs). The management of H. pylori infection has improved radically in recent years; however, the prescription of ASA and NSAIDs has increased over the same period.
Aim To evaluate the current global incidence and prevalence of PUD by systematic review of the literature published over the last decade.
Methods Systematic searches of PubMed, EMBASE and the Cochrane library.
Results The annual incidence rates of PUD were 0.10–0.19% for physician‐diagnosed PUD and 0.03–0.17% when based on hospitalization data. The 1‐year prevalence based on physician diagnosis was 0.12–1.50% and that based on hospitalization data was 0.10–0.19%. The majority of studies reported a decrease in the incidence or prevalence of PUD over time.
Conclusions Peptic ulcer disease remains a common condition, although reported incidence and prevalence are decreasing. This decrease may be due to a decrease in H. pylori‐associated PUD.
Sleep duration is dependent on circadian rhythm that controls a variety of key cellular functions. Circadian disruption has been implicated in colorectal tumorigenesis in experimental studies. We ...prospectively examined the association between sleep duration and risk of colorectal cancer (CRC).
In the Women's Health Initiative Observational Study, 75 828 postmenopausal women reported habitual sleep duration at baseline 1993-1998. We used Cox proportional hazards regression model to estimate the hazard ratio (HR) of CRC and its associated 95% confidence interval (CI).
We ascertained 851 incident cases of CRC through 2010, with an average 11.3 years of follow-up. Compared with 7 h of sleep, the HRs were 1.36 (95% CI 1.06-1.74) and 1.47 (95% CI 1.10-1.96) for short (≤5 h) and long (≥9 h) sleep duration, respectively, after adjusting for age, ethnicity, fatigue, hormone replacement therapy (HRT), physical activity, and waist to hip ratio. The association was modified by the use of HRT (P-interaction=0.03).
Both extreme short and long sleep durations were associated with a moderate increase in the risk of CRC in postmenopausal women. Sleep duration may be a novel, independent, and potentially modifiable risk factor for CRC.
Cohort studies, mainly based on questionnaires and interviews, have reported high rates of reflux recurrence after antireflux surgery, which may have contributed to a decline in its use. Reflux ...recurrence after laparoscopic antireflux surgery has not been assessed in a long-term population-based study of unselected patients.
To determine the risk of reflux recurrence after laparoscopic antireflux surgery and to identify risk factors for recurrence.
Nationwide population-based retrospective cohort study in Sweden between January 1, 2005, and December 31, 2014, based on all Swedish health care and including 2655 patients who underwent laparoscopic antireflux surgery according to the Swedish Patient Registry. Their records were linked to the Swedish Causes of Death Registry and Prescribed Drug Registry.
Primary laparoscopic antireflux surgery due to gastroesophageal reflux disease in adults (>18 years).
The outcome was recurrence of reflux, defined as use of antireflux medication (proton pump inhibitors or histamine2 receptor antagonists for >6 months) or secondary antireflux surgery. Multivariable Cox regression was used to assess risk factors for reflux recurrence.
Among all 2655 patients who underwent antireflux surgery (median age, 51.0 years; interquartile range, 40.0-61.0 years; 1354 men 51.0%) and were followed up for a median of 5.6 years, 470 patients (17.7%) had reflux recurrence; 393 (83.6%) received long-term antireflux medication and 77 (16.4%) underwent secondary antireflux surgery. Risk factors for reflux recurrence included female sex (hazard ratio HR, 1.57 95% CI, 1.29-1.90; 286 of 1301 women 22.0% and 184 of 1354 men 13.6% had recurrence of reflux), older age (HR, 1.41 95% CI, 1.10-1.81 for age ≥61 years compared with ≤45 years; recurrence among 156 of 715 patients and 133 of 989 patients, respectively), and comorbidity (HR, 1.36 95% CI, 1.13-1.65 for Charlson comorbidity index score ≥1 compared with 0; recurrence among 180 of 804 patients and 290 of 1851 patients, respectively). Hospital volume of antireflux surgery was not associated with risk of reflux recurrence (HR, 1.09 95% CI, 0.77-1.53 for hospital volume ≤24 surgeries compared with ≥76 surgeries; recurrence among 38 of 266 patients 14.3% and 271 of 1526 patients 17.8%, respectively).
Among patients who underwent primary laparoscopic antireflux surgery, 17.7% experienced recurrent gastroesophageal reflux requiring long-term medication use or secondary antireflux surgery. Risk factors for recurrence were older age, female sex, and comorbidity. Laparoscopic antireflux surgery was associated with a relatively high rate of recurrent gastroesophageal reflux disease requiring treatment, diminishing some of the benefits of the operation.