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      Population Health And Economic Impacts Of Reaching Chronic Hepatitis B Diagnosis And Treatment Targets In The US

      1 , 2 , 3
      Health Affairs
      Health Affairs (Project Hope)

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          Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-naïve patients is rare through 5 years of therapy.

          Patients with chronic hepatitis B virus (HBV) infection who develop antiviral resistance lose benefits of therapy and may be predisposed to further resistance. Entecavir (ETV) resistance (ETVr) results from HBV reverse transcriptase substitutions at positions T184, S202, or M250, which emerge in the presence of lamivudine (LVD) resistance substitutions M204I/V +/- L180M. Here, we summarize results from comprehensive resistance monitoring of patients with HBV who were continuously treated with ETV for up to 5 years. Monitoring included genotypic analysis of isolates from all patients at baseline and when HBV DNA was detectable by polymerase chain reaction (> or = 300 copies/mL) from Years 1 through 5. In addition, genotyping was performed on isolates from patients experiencing virologic breakthrough (> or = 1 log(10) rise in HBV DNA). In vitro phenotypic ETV susceptibility was determined for virologic breakthrough isolates, and for HBV containing novel substitutions emerging during treatment. The results over 5 years of therapy showed that in nucleoside-naïve patients, the cumulative probability of genotypic ETVr and genotypic ETVr associated with virologic breakthrough was 1.2% and 0.8%, respectively. In contrast, a reduced barrier to resistance was observed in LVD-refractory patients, as the LVD resistance substitutions, a partial requirement for ETVr, preexist, resulting in a 5-year cumulative probability of genotypic ETVr and genotypic ETVr associated with breakthrough of 51% and 43%, respectively. Importantly, only four patients who achieved < 300 copies/mL HBV DNA subsequently developed ETVr. Long-term monitoring showed low rates of resistance in nucleoside-naïve patients during 5 years of ETV therapy, corresponding with potent viral suppression and a high genetic barrier to resistance. These findings support ETV as a primary therapy that enables prolonged treatment with potent viral suppression and minimal resistance.
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            Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B.

            Tenofovir disoproxil fumarate (TDF), a nucleotide analogue and potent inhibitor of hepatitis B virus (HBV) polymerase, showed superior efficacy to adefovir dipivoxil in treatment of chronic hepatitis B through 48 weeks. We evaluated long-term efficacy and safety of TDF monotherapy in patients with chronic hepatitis B who were positive or negative for hepatitis B e antigen (HBeAg(+) or HBeAg(-)). After 48 weeks of double-blind comparison of TDF to adefovir dipivoxil, patients who underwent liver biopsy were eligible to continue the study on open-label TDF for 7 additional years; data presented were collected up to 3 years (week 144) from 85% of participants. Primary efficacy end points at week 144 included levels of HBV DNA and alanine aminotransferase, development of resistance mutations, and presence of HBeAg or hepatitis B surface antigen (HBsAg). At week 144, 87% of HBeAg(-) and 72% of HBeAg(+) patients treated with TDF had levels of HBV DNA <400 copies/mL. Among patients who had previously received adefovir dipivoxil and then received TDF, 88% of the HBeAg(-) and 71% of the HBeAg(+) patients had levels of HBV DNA <400 copies/mL; overall, 81% and 74%, respectively, maintained normalized levels of alanine aminotransferase and 34% had lost HBeAg. Amino acid substitutions in HBV DNA polymerase that are associated with resistance to tenofovir were not detected in any patient. Cumulatively, 8% of HBeAg(+) patients lost HBsAg. TDF maintained a favorable safety profile for up to 3 years. TDF was safe and effective in the long-term management of HBeAg(+) and HBeAg(-) patients with chronic hepatitis B. Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
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              The prevalence of hepatitis B virus infection in the United States in the era of vaccination.

              Our objective was to assess trends in the prevalence of hepatitis B virus (HBV) infection in the United States after widespread hepatitis B vaccination. The prevalence of HBV infection and immunity was determined in a representative sample of the US population for the periods 1999-2006 and 1988-1994. National Health and Nutrition Examination Surveys participants 6 years of age were tested for antibody to hepatitis B core antigen (anti-HBc), hepatitis B surface antigen (HBsAg), and antibody to hepatitis B surface antigen (anti-HBs). Prevalence estimates were weighted and age-adjusted. During the period 1999-2006, age-adjusted prevalences of anti-HBc (4.7%) and HBsAg (0.27%) were not statistically different from what they were during 1988-1994 (5.4% and 0.38%, respectively). The prevalence of anti-HBc decreased among persons 6-19 years of age (from 1.9% to 0.6%; P < .01) and 20-49 years of age (from 5.9% to 4.6%; P < .01) but not among persons 50 years of age (7.2% vs 7.7%). During 1999-2006, the prevalence of anti-HBc was higher among non-Hispanic blacks (12.2%) and persons of "Other" race (13.3%) than it was among non-Hispanic whites (2.8%) or Mexican Americans (2.9%), and it was higher among foreign-born participants (12.2%) than it was among US-born participants (3.5%). Prevalence among US-born children 6-19 years of age (0.5%) did not differ by race or ethnicity. Disparities between US-born and foreign-born children were smaller during 1999-1996 (0.5% vs 2.0%) than during 1988-1994 (1.0% vs 12.8%). Among children 6-19 years of age, 56.7% had markers of vaccine-induced immunity. HBV prevalence decreased among US children, which reflected the impact of global and domestic vaccination, but it changed little among adults, and approximately 730,000 US residents (95% confidence interval, 550,000-940,000) are chronically infected.
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                Author and article information

                Journal
                Health Affairs
                Health Affairs
                Health Affairs (Project Hope)
                0278-2715
                1544-5208
                July 2018
                July 2018
                : 37
                : 7
                : 1033-1040
                Affiliations
                [1 ]Mehlika Toy () is a research scientist at the Stanford University School of Medicine, in California.
                [2 ]David W. Hutton is an associate professor of health management and policy at the University of Michigan, in Ann Arbor.
                [3 ]Samuel So is a professor of surgery at the Stanford University School of Medicine.
                Article
                10.1377/hlthaff.2018.0035
                29985701
                1dc32167-95e4-48cd-b8aa-232a81fae490
                © 2018
                History

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