The occurrence of HBV-associated liver complications is reduced by antiviral therapy. However, prior studies using local institutional cohorts have suggested that evaluation and treatment are ...suboptimal. We aimed to determine the proportion of patients with chronic HBV infection who received adequate evaluation, were treatment eligible, and received antiviral treatment using a large, nationwide cohort.
This retrospective analysis utilized claims data of approximately 73 million enrollees across the US from Optum’s de-identified Clinformatics® Data Mart Database, 2003-2019. Adults observed for ≥6 months before and after an index diagnosis of chronic HBV infection were identified via ICD-9/ICD-10 codes, with the diagnosis confirmed by positive HBsAg, HBeAg or HBV DNA PCR.
We included 12,608 eligible patients in the study analysis (mean age 45.7 years, 52.1% male, 54.6% Asian, 18.1% Caucasian, 10.5% African American). About half of the cohort (n = 6,559, 52.3%) did not have a complete laboratory evaluation (defined as having HBeAg, HBV DNA, and ALT tests) and only 72.4% (n = 9,129) had an “adequate” evaluation (at least HBV DNA and ALT) during the entire study period. Of those with an adequate evaluation, 11.2% were treatment eligible by AASLD criteria and 13.9% by EASL criteria; 60.4% of AASLD eligible patients and 54.3% of EASL eligible patients received treatment within 12 months from becoming eligible.
Half of patients with chronic HBV infection in the US with private insurance did not have a complete laboratory assessment. Over one-third of treatment-eligible patients did not receive antiviral therapy. Patients who visited a specialist had a higher chance of receiving adequate evaluation and treatment. Urgent intervention is needed to identify and address the barriers to optimal care.
In this study, we used a national database that includes laboratory data in addition to medical and pharmacy claims data to assess the current real-world management of chronic HBV infection in the US. Among the 12,608 patients with chronic HBV infection included in our study, 52.3% never had a complete laboratory evaluation and only 73% had an adequate evaluation. Among those who were treatment eligible according to major society guidelines, only 60.4% and 54.3% received treatment within 12 months, respectively.
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•We determined the proportion of patients with chronic HBV infection who received adequate evaluation and treatment (if eligible).•Among 12,608 patients with chronic HBV infection, 52.3% did not have a complete evaluation and only 73% had an adequate evaluation.•In the 9,129 patients who had an adequate evaluation, 11.2% and 13.9% were treatment eligible by AASLD or EASL criteria, respectively.•Among those who were treatment eligible by AASLD or EASL criteria, only 60.4% and 54.3% received treatment within 12 months, respectively.
Regular monitoring/surveillance for liver complications is crucial to reduce morbidity and mortality in patients with cirrhosis. Recommendations from professional societies are available but ...adherence is not well studied, especially outside of academic centers. We aimed to determine the frequencies and factors associated with laboratory monitoring, and hepatocellular carcinoma (HCC) and esophageal varices (EV) surveillance in patients with cirrhosis.
We identified 82,427 patients with cirrhosis (43,280 compensated and 39,147 decompensated) from the Truven Health MarketScan Research Database®, 2007–2016. We calculated the proportion of patients with cirrhosis with various frequencies of procedures/testing: laboratory (complete blood count, comprehensive metabolic panel, and prothrombin time), HCC and EV surveillance. We also used multivariable logistic regression to determine factors associated with having procedures.
The proportions of patients undergoing HCC surveillance (8.78%), laboratory testing (29.72%) at least every 6–12 months, or EV surveillance (10.6%) at least every 1–2 years were suboptimal. The majority did not have HCC (45.4%) or EV (80.3%) surveillance during the entire study period. On multivariable regression, age 41–55 (vs. <41) years, preferred provider organization (vs. health maintenance organization) insurance plan, specialist care (vs. primary care and other specialties), diagnosis between 2013–2016 (vs. 2007–2009), decompensated (vs. compensated) cirrhosis, non-alcoholic fatty liver disease (vs. viral hepatitis), and higher Charlson comorbidity index were associated with significantly higher odds of undergoing procedures/testing every 6–12 months and EV surveillance every 1–2 years.
Despite modest improvements in more recent years, routine monitoring and surveillance for patients with cirrhosis is suboptimal. Further efforts including provider awareness, patient education, and system/incentive-based quality improvement measures are urgently needed.
Patients with cirrhosis should undergo health monitoring for liver complications to achieve early detection and treatment. In a large nationwide cohort of 82,427 patients with cirrhosis in the United States, we found a low rate of adherence (well less than half) to routine blood test monitoring and surveillance for liver cancer and esophageal varices (swollen blood vessels in the abdomen that could lead to fatal bleeding). Adherence has increased in the recent years, but much more improvement is needed.
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•Adherence to monitoring/surveillance for liver complications was assessed in patients with cirrhosis.•Adherence rates for HCC surveillance (8.78%), laboratory testing (29.72%) and EV surveillance (10.6%) were disappointing.•Adherence rates did improve in more recent years.•Age, insurance plan, being followed up by specialist, severity of cirrhosis, and comorbidities were linked to adherence.
Although oral antiviral therapy (OAV) is reported to improve outcomes in patients with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC), it is underutilized. We determined the rate and ...factors associated with OAV utilization among patients with HBV-related HCC in a US population with health insurance.
Patients with HBV-related HCC were identified from the de-identified administrative health claims database for patients with private insurance, Optum Clinformatics (2003-2021).
We identified 2129 patients with HBV-related HCC: 71% male, mean age 62.7 ± 12.5 years, 40% Asian individuals, 72% with cirrhosis, and 37% received OAV. The treatment rate improved over time (40.5% after 2010 vs 26.3% earlier; P < .001). Significantly lower treatment rates were noted for females, non-Asian patients, noncirrhotic patients, and patients without gastroenterologist/hepatologist or infectious disease (GI/ID) specialist care (P < .0001). OAV treatment predictors included Asian race and ethnicity (adjusted odds ratio aOR, 3.6; 95% CI, 2.8-4.5; P < .001), male sex (aOR, 1.6; 95% CI, 1.3-2.0; P < .001), seeing a GI/ID specialist (aOR, 1.5; 95% CI, 1.10-1.99; P = .0091), having compensated cirrhosis (aOR, 2.2; 95% CI, 1.7-2.8; P < .001), and being treated from 2011 to 2021 (aOR, 2.3; 95% CI, 1.8-3.0; P < .001); being younger (aOR, 0.98; 95% CI, 0.98-0.99; P < .001) was less likely for treatment. OAV initiated at or before HCC diagnosis was associated independently with improved survival (adjusted hazard ratio, 0.84; 95% CI, 0.72-0.99; P = .037).
Among patients with HBV-related HCC, only 1 in 3 received OAV despite having insurance coverage. Efforts must continue to develop ways to improve HBV OAV treatment, especially among females, non-Asian patients, and patients without cirrhosis or not seen by specialists.
Summary
Background
Since the inception of the interferon‐free direct‐acting antiviral agents (DAAs) for hepatitis C virus (HCV) infection, guidelines as to who should receive this potentially ...curative treatment have evolved. Treatment with DAAs is now considered for all patients except for those considered moribund.
Aim
To determine the DAA treatment rate for patients with HCV‐related hepatocellular carcinoma (HCC).
Methods
This was a retrospective study from January 2015 to March 2021 of a national sample of privately insured patients with HCV‐related HCC using Optum's Clinformatics® Data Mart (CDM) Database – a large, de‐identified, adjudicated claims database.
Results
We identified 3922 patients with HCV‐related HCC: 922 (23.5%) received DAA. Compared to untreated patients, DAA‐treated patients were younger (65.2 ± 7.5 vs. 66.4 ± 7.5 years, p < 0.001), more frequently saw a gastroenterology/infectious disease (GI/ID) physician (41.2% vs. 34.2%), and had decompensated cirrhosis (56% vs. 53%, p = 0.001). In multivariable analysis, younger age (HR: 0.98, 95% CI: 0.97–0.99, p < 0.001), GI/ID care (HR: 3.06, 95% CI: 2.13–4.51, p < 0.001), and having cirrhosis (compensated: HR: 1.60, 95% CI: 1.18–2.21, p = 0.003; decompensated: HR: 1.45, 95% CI: 1.07–1.98, p = 0.02) were associated with receiving DAA treatment, but not sex, race, or ethnicity. DAA‐treated patients had significantly higher 5‐year survival than untreated patients (47.2% vs. 35.2%, p < 0.001). Following adjustment for age, sex, race/ethnicity, Charlson Comorbidity Index, and HCC treatment, receiving DAA treatment was associated with lower mortality (aHR: 0.61, 95% CI: 0.53–0.69, p < 0.001).
Conclusion
DAA treatment remains underutilised in insured patients with HCV‐related HCC; fewer than one in four patients received treatment. Seeing a specialist and having decompensated cirrhosis were predictors for DAA treatment; additional efforts are needed to increase awareness of HCV treatment.
Treatment of hepatitis C remains suboptimal in HCV‐related HCC patients.
Summary
Background
Advanced practice providers (APP) may be able to play a role in improving the linkage to care in patients with chronic hepatitis B (CHB), but data are limited.
Aim
To compare ...management of patients with CHB under APP‐assisted versus physician‐only care
Methods
This retrospective analysis identified patients with CHB infection from Optum's de‐identified Clinformatics® Data Mart Database (2003–2021) using ICD‐9/ICD‐10 codes. We compared the proportion of patients with CHB who had adequate evaluation for treatment (defined as ALT, HBV DNA, ± HBeAg), and the proportion of treatment‐eligible patients with CHB who received treatment between APP versus physician‐only care.
Results
We included 42,140 eligible patients (mean age: 51.9 ± 15.1; 56.1% male). Overall, 34.3% received APP care with increasing utilisation over time. Compared to physician‐only care, patients who also received APP care were more likely to have viral co‐infection, and more likely to have been seen by a specialist (72.1%). Overall, 62.8% and 56.2% of treatment‐eligible patients based on AASLD and EASL guidelines, respectively, received treatment. APP care patients were more likely to be treated (AASLD adjusted HR: 1.18, 95%CI: 1.03–1.34; EASL adjusted HR:1.24, 95%CI: 1.09–1.41) after adjustment for age, sex, race/ethnicity, viral dual infection, baseline cirrhosis/liver cancer, number of HBV DNA and alanine aminotransferase measurements, and physician provider type.
Conclusion
Treatment‐eligible patients with CHB receiving APP care were more likely to receive antiviral therapy. APP care may help to expand the pool of providers for patients with CHB, and to improve current suboptimal treatment rates.
Quality of care of chronic hepatitis B patients with private insurance in the US.
Introduction: NAFLD is increasingly prevalent in Asia, where people suffer more metabolic comorbidities at a lower body mass index (BMI), suggesting potential differences in their clinical profile. ...Therefore, we attempted to characterize the clinical profile of Asians with NAFLD via a meta-analytic approach. Methods: We searched PubMed, EMBASE, and Cochrane databases from January 1, 2000, to January 17, 2019. Two authors independently reviewed and selected 104 articles (2,247,754 persons) that identified NAFLD in Asians and reported relevant data, especially BMI and ALT, and excluded individuals with other liver disease and excessive alcohol consumption. Individual patient-level data were obtained from seven cohorts in Asia to complement meta-analyzed data. Results: Overall, the mean age was 52.07 (95% CI: 51.28–52.85) years, with those from Southeast Asia (42.66, 95% CI: 32.23–53.11) being significantly younger. The mean BMI was 26.2 kg/m 2 , higher in moderate-severe versus mild hepatic steatosis (28.3 vs. 25.7) patients and NFS ≥ −1.455 versus <−1.455 (27.09 vs. 26.02), with 34% having nonobese NAFLD. The mean ALT was 31.74 U/L, higher in NFS < −1.455 versus ≥−1.455 (33.74 vs. 27.83), though no differences were found by obesity or steatosis severity. The majority of males (85.7%) and females (60.7%) had normal to minimally elevated ALT (1–1.5 × 95% ULN). Individual patient-level data analysis (N = 7,668) demonstrated similar results. Conclusion: About one-third of Asians with NAFLD were nonobese, and the majority did not have markedly elevated ALT. Therefore, abnormal ALT or BMI is not recommended as a criterion for NAFLD screening in this population. Additionally, there were significant differences in the clinical profiles of NAFLD among the different regions of Asia.
Underdiagnosis of HCV infection may hinder the obtainment of 2030 elimination goal.
To estimate the pre-DAA HCV diagnosis rate to inform future public health effort.
Data were obtained from three ...nationwide databases (Truven Health MarketScan Research Database 2007-2014, US Census Bureau 2012-2016 and NHANES 2007-2014). HCV diagnosis was defined with either one inpatient or two outpatient HCV International Classification of Disease 9 codes, providing the number of patients with diagnosed HCV (Truven). US Census Bureau data were used for age- and sex-standardization. We derived the total (diagnosed and undiagnosed) HCV infection using the NHANES database. To determine the rate and number of undiagnosed HCV, we subtracted diagnosed HCV burden (Truven) from the total HCV burden (NHANES).
Of the 198 073 302 privately insured Americans, 1.49% (2 951 490 persons) had HCV infection. However, only 362 672 (12.29%) persons were diagnosed with HCV, leaving 2 588 818 (87.71%) undiagnosed. About two-third (68.04%) and one-third (33.04%) of diagnosed HCV patients had HCV RNA or genotype tests overall, with even lower rates for the ≥65 age group, respectively.
In the pre-DAA era, only 12% of insured Americans with HCV were diagnosed. While this grim statistic is expected to rise, much more effort is needed to enhance the HCV care cascade.
Oral antiviral therapy with nucleos(t)ide analogues (NAs) for chronic hepatitis B (CHB) is well-tolerated and lifesaving, but real-world data on utilization are limited. We examined rates of ...evaluation and treatment in patients from the REAL-B consortium.
This was a cross-sectional study nested within our retrospective multinational clinical consortium (2000-2021). We determined the proportions of patients receiving adequate evaluation, meeting AASLD treatment criteria, and initiating treatment at any time during the study period. We also identified factors associated with receiving adequate evaluation and treatment using multivariable logistic regression analyses.
We analyzed 12,566 adult treatment-naïve patients with CHB from 25 centers in 9 countries (mean age 47.1 years, 41.7% female, 96.1% Asian, 49.6% Western region, 8.7% cirrhosis). Overall, 73.3% (9,206 patients) received adequate evaluation. Among the adequately evaluated, 32.6% (3,001 patients) were treatment eligible by AASLD criteria, 83.3% (2,500 patients) of whom were initiated on NAs, with consistent findings in analyses using EASL criteria. On multivariable logistic regression adjusting for age, sex, cirrhosis, and ethnicity plus region, female sex was associated with adequate evaluation (adjusted odds ratio aOR 1.13, p = 0.004), but female treatment-eligible patients were about 50% less likely to initiate NAs (aOR 0.54, p <0.001). Additionally, the lowest evaluation and treatment rates were among Asian patients from the West, but no difference was observed between non-Asian patients and Asian patients from the East. Asian patients from the West (vs. East) were about 40-50% less likely to undergo adequate evaluation (aOR 0.60) and initiate NAs (aOR 0.54) (both p <0.001).
Evaluation and treatment rates were suboptimal for patients with CHB in both the East and West, with significant sex and ethnic disparities. Improved linkage to care with linguistically competent and culturally sensitive approaches is needed.
Significant sex and ethnic disparities exist in hepatitis B evaluation and treatment, with female treatment-eligible patients about 50% less likely to receive antiviral treatment and Asian patients from Western regions also about 50% less likely to receive adequate evaluation or treatment compared to Asians from the East (there was no significant difference between Asian patients from the East and non-Asian patients). Improved linkage to care with linguistically competent and culturally sensitive approaches is needed.
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•Among 12,566 patients with chronic HBV infection, about one-quarter were not adequately evaluated.•Among adequately evaluated patients, about one-third were treatment eligible by international guidelines.•Among those who were treatment eligible, about 80-85% were treated.•Treatment rates were lower in females and Asian Americans (vs. Asians from the East or non-Asians).
In this systematic review and meta‐analysis of 86 studies and 526,641 individuals without viral hepatitis and hepatic steatosis, the ALT upper threshold was 39 in overweight patients versus 28 in ...normal‐weight individuals, and 36 in diabetics versus 33 in nondiabetics. These findings were validated in a multicenter cohort of 6,058 patients. Diabetic and overweight patients with ALT values within these thresholds can potentially avoid extensive and possibly harmful invasive investigations after excluding viral hepatitis and nonalcoholic fatty liver disease. However, close monitoring and management of metabolic factors are required.
The current alanine aminotransferase (ALT) upper limit of normal was defined using selected healthy Caucasian blood donors. Given the global rise in obesity and different body habitus in Asians, we aimed to perform a systematic review and meta‐analysis combined with bootstrap modeling and individual patient data validation to estimate the ALT upper threshold for Asians, including the overweight and diabetics. We included studies from PubMed, Embase, and Cochrane database searches that identified individuals without known liver diseases (i.e., viral hepatitis, alcohol, and ultrasound‐detected nonalcoholic fatty liver disease). The mean ALT (U/L) was estimated using a random‐effects mixed model and upper threshold (95th‐percentile value, U/L) via a bootstrap model with 10,000 resamples. We screened 4,995 studies and identified 86 studies that reported ALT values for 526,641 individuals without excessive alcohol intake or known liver diseases, yielding a mean ALT of 19 and ALT upper threshold of 32. The ALT upper threshold was 37 in males versus 31 in females, 39 in overweight versus 28 in normal‐weight individuals, and 36 for diabetics versus 33 for nondiabetics. We validated our study level data with individual patient level data in 6,058 individuals from five study centers in Japan. Consistent with our study‐level data, we found that the ALT upper threshold in our individual patient data analysis was indeed higher in overweight versus normal‐weight individuals (39 vs. 32) and in diabetics versus nondiabetics (42 vs. 33). Conclusion: We provide validated reference ranges for ALT upper threshold derived from Asians without known liver disease, including individuals with ultrasound‐detected nonalcoholic fatty liver disease who are normal weight, overweight, nondiabetic, and diabetic, to inform practice.
Background and Aim
Globally, China has the highest chronic hepatitis C (CHC) burden, but its real‐world direct‐acting antiviral (DAA) data are limited. Our aim is to investigate the real‐world ...outcome of China Food and Drug Administration‐approved DAA therapies across mainland China including those with genotype (GT) 3.
Methods
The REAL‐C is a multinational real‐world interferon‐free DAA‐treated CHC registry of several mainland China and other Asian centers. We evaluated the sustained virological response rate 12 weeks after end of treatment (SVR12), adverse events, and treatment effect on liver function and fibrosis (fibrosis‐4 index).
Results
We analyzed 859 DAA‐treated CHC patients (6/1/2017–5/30/2019) from 12 mainland China centers (three municipalities and nine provinces): median age 52, 49.9% male, 33.1% cirrhosis, 95% treatment naïve, and 2.5% HBsAg+. The most common GT was GT1b (523, 62.2%), followed by GT2a (156, 18.5%), GT3b (74, 8.8%), GT3a (41, 4.9%), and GT6 (37, 4.4%). SVR12 rates were 98.0% overall (95% confidence interval 96.9–98.8%), 98.1% for GT1b, 96.8% GT2a, 100% GT3a, 97.3% GT3b, and 100% GT6. Baseline cirrhosis and male sex but not prior treatment history, renal dysfunction, age, and GTs were associated with SVR12. For both cirrhotic and non‐cirrhotic patients, there were significant improvement in liver function tests, alpha fetoprotein, and fibrosis‐4 index with SVR12. Serious adverse events were rare (1.1%) with only nine patients discontinuing therapy prematurely and anemia being the most common adverse event (13.1%, mostly with ribavirin).
Conclusions
In real‐world Chinese patients with diverse GTs, Chinese Food and Drug Administration‐approved interferon‐free DAAs were well tolerated, provided high cure rates (98.0% overall) including GT3a/3b, and led to improvement of liver function.
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