Jiayi Li

Similar treatment response to peginterferon and ribavirin in Asian and Caucasian patients with chronic hepatitis C.

OBJECTIVES:Previous studies have found ethnicity to be an important predictor of outcomes of treatment with peginterferon (PEG-IFN) and ribavirin (RBV) in chronic hepatitis C. Although the expected sustained virological response (SVR) rates of Hispanics and African Americans are lower than those of Caucasians, SVR rates in Asians appear to be more favorable. However, in some of these studies, hepatitis C virus (HCV) genotype was identified by INNO-LiPA assay, which can mistype the easier-to-treat HCV genotype 6 as genotype 1. Our goal was to compare SVR rates among Caucasian and Asian-American patients with genotype 1 and 2/3 infection whose HCV genotypes were accurately classified by core sequencing testing.METHODS:A cohort of 269 consecutive treatment-naive HCV-infected patients with genotype 1 or 2/3 (157 Caucasians and 112 Asians) treated with PEG-IFN+RBV from January 2001 to November 2007 at four community-based gastroenterology clinics in Northern California were studied. The analysis of data was by intention-to-treat.RESULTS:The SVR rates for patients with genotype 1 were 45% for Caucasians and 52% for Asians (P=0.37). The SVR rates for patients with genotype 2/3 infection was 77% for Asians and 74% for Caucasians (P=0.7). On multivariate logistic regression analyses adjusting for age, alanine aminotransferase (ALT), baseline viral load, HCV genotype, and treatment adherence, we did not find Asian ethnicity to predict SVR. On a separate analysis, we found that Asians who had HCV genotype 1 or 1b by the less accurate INNO-LiPA assay had significantly higher SVR rates than Caucasians with genotype 1 (64% vs. 45%, respectively, P=0.03).CONCLUSIONS:SVR rates were similar in Asian Americans and Caucasians infected with HCV genotype 1 or 2/3 when HCV genotype classification was accurately determined.

Tenofovir is superior to entecavir for achieving complete viral suppression in HBeAg-positive chronic hepatitis B patients with high HBV DNA.

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.

Reduction of chronic hepatitis B-related hepatocellular carcinoma with anti-viral therapy, including low risk patients

Anti‐viral therapy in chronic hepatitis B (CHB) is associated with a reduced risk of hepatocellular carcinoma (HCC) primary described in patients with cirrhosis.

Tenofovir-based alternate therapies for chronic hepatitis B patients with partial virological response to entecavir.

Entecavir (ETV) is a first‐line antiviral therapy for treating chronic hepatitis B (CHB); however, some patients have suboptimal response to ETV. Currently, there are limited data on how to approach these patients. Therefore, our aim was to compare the effectiveness of two alternate therapies – tenofovir (TDF) monotherapy and combination therapy of ETV+TDF – in CHB patients with ETV partial virological response. We conducted a retrospective study of 68 patients who had partial virological response to ETV, defined as having detectable HBV DNA following at least 12 months of ETV, and were switched to TDF monotherapy (n = 25) or ETV+TDF (n = 43). Patients were seen in seven US liver/community‐based clinics and started on ETV between 2005 and 2009. The majority of patients were male; the vast majority were Asian and had positive hepatitis B e antigen (HBeAg). Patients in both groups had similar pretreatment characteristics. Complete viral suppression (CVS) rates with TDF monotherapy and ETV+TDF were similar after 6 months (71% vs 83%, P = 0.23) and 12 months (86% vs 84%, P = 0.85), and there was no statistically significant difference in CVS rates even when only patients with higher HBV DNA levels at switch (>1000 IU/mL) were evaluated. Multivariate analysis indicated that ETV+TDF was not an independent predictor of CVS compared to TDF monotherapy (OR = 1.19, P = 0.63). In conclusion, TDF monotherapy and ETV+TDF are comparable in achieving CVS in CHB patients with partial virological response to ETV. Long‐term alternate therapy with one pill (TDF monotherapy) vs two pills (ETV+TDF) could lead to lower nonadherence rates and better treatment outcomes.

Poor adherence and low persistency rates for hepatocellular carcinoma surveillance in patients with chronic hepatitis B.

AbstractOur goal was to examine rates and predictors for hepatocellular carcinoma (HCC) surveillance adherence and persistency, since studies of such adherence and persistency in patients with chronic hepatitis (CHB) are currently limited.Consecutive CHB patients (N = 1329) monitored for ≥1 year at 4 US clinics from January 1996 to July 2013 were retrospectively studied. Surveillance adherence was evaluated based on the American Association for the Study of Liver Diseases guidelines. Kaplan–Meier method was used to analyze surveillance persistency of 510 patients who had initially fair adherence (having at least annual surveillance imaging with further follow-up).Mean age was 48, with the majority being male (58%), Asian (92%), foreign-born (95%), and medically insured (97%). Patients with cirrhosis and those seen at university liver clinics were more likely to have optimal HCC surveillance than those without cirrhosis and those seen at community clinics (38.4% vs 21.6%, P <0.001 and 33.5% vs 14.4%, P < 0.001, respectively). HCC diagnosed in optimally adherent patients trended toward smaller tumor size (P < 0.08). On multivariate analysis also inclusive of age, sex, clinical visits, cirrhosis, clinic setting and antiviral therapy use, strong independent predictors for having at least annual imaging were a history of more frequent clinical visits (odds ratio [OR] = 2.5, P < 0.001) and university-based care (OR = 5.2, P < 0.001). Even for those with initially fair adherence, persistency dropped to 70% at 5 years.Adherence and persistency to HCC surveillance in CHB patients is generally poor. More frequent clinic visits and university-based settings were significant and strong predictors of at least annual HCC surveillance adherence.

Lower liver cancer risk with antiviral therapy in chronic hepatitis B patients with normal to minimally elevated ALT and no cirrhosis

Abstract For chronic hepatitis B (CHB), alanine aminotransferase (ALT) ≥2 × upper limit of normal (ULN) is often used as a major criteria to initiate treatment in absence of cirrhosis, though patients with lower ALT may not be free from future risk of hepatocellular carcinoma (HCC). We aimed to examine the effect of antiviral therapy on HCC incidence based on ALT levels. We performed a retrospective study on 3665 patients consisting of United States and Taiwanese REVEAL-HBV cohort who were consecutive, treatment-naïve, noncirrhotic CHB patients aged ≥40 years. Patients were categorized by ALT cutoffs (≥2 × ULN vs <2 × ULN) and subgrouped by treatment status. Kaplan–Meier and Cox proportional hazards models were used to calculate cumulative incidence and hazard ratio (HR) of HCC adjusting for REACH-B scores. A total of 202 patients developed HCC. Antiviral treatment significantly reduced HCC risk: HR 0.24, 95% confidence interval 0.10–0.58; P = 0.001. HCC incidence per 100,000 person-years was significantly higher in untreated versus treated patients, even for those with ALT < 2 × ULN: 314.46 versus 0 per 100,000 person-years, P = 0.0042. For patients with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) ≥ 2000 IU/mL, the number-needed-to-treat (NNT) were 15 and 14 to prevent 1 incident HCC at year 10 for patients with ALT < 2 × ULN and ≥2 × ULN, respectively. After adjustment by REACH-B score, antiviral treatment significantly decreased HCC incidence even in patients with ALT < 2 × ULN. NNT to prevent 1 incident HCC after 10 years of therapy was low (14–15) in patients with mildly elevated HBV DNA ≥ 2000 IU/mL regardless of ALT levels.

Chronic hepatitis B treatment eligibility and actual treatment rates in patients in community gastroenterology and primary care settings.

Goals: This study aims to compare the eligibility and treatment rates of patients evaluated by gastroenterology [gastrointestinal (GI)] specialists for chronic hepatitis B (CHB) and patients followed by their primary care physicians (PCPs) only. Background: Guidelines have been devised to direct the care of patients with CHB but data on the application of these guidelines, especially in primary care settings, has been limited to date. Study: Consecutive CHB patients were enrolled retrospectively from several community clinics in the San Francisco Bay Area: 2 GI referral clinics, 3 primary care clinics, and a multispecialty medical center. Patients were classified as group 1 if they saw a gastroenterologist for CHB within 6 months of presentation or as group 2 if they only saw PCPs. Eligibility according to AASLD 2009 and US Panel 2008 guidelines was determined using clinical and laboratory data available within 6 months of presentation. Results: Patients in group 2 had lower eligibility rates according to both US Panel 2008 (32% vs. 51%, P<0.001) and AASLD 2009 (8% vs. 24%, P<0.001) guidelines. GI specialists treated US Panel–eligible patients more readily than PCPs (45% vs. 25%, P<0.001), and treatment rates in AASLD-eligible patients suggested a similar trend (68% vs. 50%, P=0.080). Conclusions: GI specialists were more likely than PCPs to see patients who were treatment eligible, and also more likely to initiate antiviral therapy. However, there are still a considerable number of patients from both settings who did not receive treatment despite being eligible.

Ethnic differences in incidence of hepatitis B surface antigen seroclearance in a real‐life multicenter clinical cohort of 4737 patients with chronic hepatitis B infection

Hepatitis B surface antigen (HBsAg) positivity is associated with increased risk for cirrhosis and hepatocellular carcinoma (HCC). HBsAg seroclearance is thought to be rare in general, but cohort data from US patients are limited.

Racial/ethnic- and county-specific prevalence of chronic hepatitis B and its burden in California

BackgroundIn the United States, the highest burden of chronic hepatitis B (CHB) and CHB-related liver cancer is in the state of California, primarily in the San Francisco (SF) Bay and Los Angeles (LA) areas. The aim of this study was to estimate county-specific hepatitis B surface antigen (HBsAg) prevalence and quantify CHB cases by age, race/ethnicity, nativity, and disease activity status.MethodsTwelve counties in SF Bay Area and three large counties in LA area were included for this analysis. Race/ethnicity-specific prevalence of HBsAg for each county and the state of California as a whole, was estimated by including prevalence data from the National Health and Nutrition Examination Survey and various studies that estimated HBsAg prevalence in US and foreign-born Asian Pacific Islanders, Hispanic, and Black populations. In addition, clinical data of 2000 consecutive CHB patients (collected between 2009 and 2014) from a large clinical consortium in the SF Bay area were used to calculate the age-specific disease burden.ResultsOf the 15 counties analyzed, SF had the highest HBsAg prevalence (1.78%), followed by Santa Clara (1.63%) and Alameda (1.45%). The majority of CHB cases were estimated to be in LA County (83,770), followed by Santa Clara (31,273), and Alameda (23,764). Among the CHB cases, 12.7% is active HBeAg positive, 24.2% is active HBeAg negative, and 10.6% has cirrhosis.ConclusionThis study confirms and quantifies the current burden of CHB in high endemic counties in the state of California using population-level estimates combined with clinical data including those from the community.

Poor Adherence to Guidelines for Treatment of Chronic HBV Infection at Primary Care and Referral Practices

BACKGROUND & AIMS: The American Association for the Study of Liver Diseases (AASLD) guidelines for treatment of chronic hepatitis B virus (HBV) infection have changed with time. We assessed rates of treatment evaluation and initiation in patients with chronic HBV infection from different practice settings in the past 14 years. METHODS: Treatment‐naive patients with chronic HBV infection were recruited from different practice settings in California from January 2002 through December 2016. The study population comprised 4130 consecutive, treatment‐naive patients with chronic HBV infection seen by community primary care physicians (n = 616), community gastroenterologists (n = 2251), or university hepatologists (n = 1263). Treatment eligibility was assessed using data from the first 6 months after initial presentation based on AASLD criteria adjusted for changes over time. RESULTS: Within the first 6 months of care, the proportions of patients evaluated by all 3 relevant tests (measurements of alanine aminotransferase, hepatitis B virus e antigen, and HBV DNA levels) were as follows: 36.69% in community primary care, 59.80% in gastroenterologist care, and 79.97% in hepatology care (P < .0001 among the 3 groups). Higher proportions of patients were eligible for treatment in specialty practices: 12.76% in community primary care, 24.96% in gastroenterologist care, and 29.43% in hepatology care (P < .0001). Among treatment‐eligible patients, there was no significant difference in the proportions of patients who began antiviral therapy between those receiving treatment from a gastroenterologist (55.65%) vs a hepatologist (57.90%; P = .56). Of 243 evaluable patients receiving community primary care, only 31 were eligible for treatment and only 12 of these (38.71%) received treatment. CONCLUSIONS: In an analysis of patients receiving care for chronic HBV infection, we found the proportions evaluated and receiving treatment to be suboptimal, according to AASLD criteria, in all practice settings. However, rates of evaluation and treatment were lowest for patients receiving community primary care.