<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01726439</url>
  </required_header>
  <id_info>
    <org_study_id>AI463-952</org_study_id>
    <nct_id>NCT01726439</nct_id>
  </id_info>
  <brief_title>Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China</brief_title>
  <acronym>EVOLVE</acronym>
  <official_title>A 5-year Prospective and Observational Study to Evaluate the Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Chronic Hepatitis B (CHB) Patients Naive to NUC in Real World Practice at Hospitals in Tier 2 Cities in China (the EVOLVE Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of&#xD;
      Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy,&#xD;
      de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B&#xD;
      (CHB) patients who are naive to NUC at enrollment to this study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sampling Method: Consecutive patient sampling&#xD;
&#xD;
      Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of&#xD;
      this study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who achieve virology response (defined as HBV DNA &lt; 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy</measure>
    <time_frame>48 weeks after initial NUC antiviral therapy</time_frame>
    <description>Virology response is defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) &lt; 300 copies/mL by a highly sensitive assay such as Roche COBAS or Abbott Real Time Polymerase chain reaction (PCR) performed in a one central laboratory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean HBV DNA reductions after 48 weeks of treatment from baseline for ETV and LAM-based therapy patients (stratifying by the 3 LAM-based subgroups)</measure>
    <time_frame>Baseline (Day 1) and 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 weeks and 96 weeks of treatment (stratifying by the 3 LAM based subgroups)</measure>
    <time_frame>24 weeks and 96 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24 weeks, 48 weeks, and 96 weeks of treatment among all treatment options</measure>
    <time_frame>24 weeks, 48 weeks and 96 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks of treatment</measure>
    <time_frame>24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks</time_frame>
    <description>HBV DNA levels at week 24 will be analyzed at the laboratories of hospitals where the patients are treated while evaluation of HBV DNA levels after 48 and 96 weeks of treatment will be conducted at the central laboratory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance</measure>
    <time_frame>24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms</measure>
    <time_frame>48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3434</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>CHB patients who are naive to NUC treatment</arm_group_label>
    <description>CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitals in Chinese tier 2 cities. The definition of these hospitals is the following:&#xD;
&#xD;
          -  Hospitals where 300 or more CHB patients are treated monthly&#xD;
&#xD;
          -  Hospitals where PCR can be performed in the hospital's laboratory to measure HBV DNA&#xD;
             serum levels&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CHB patients, or CHB patients with compensated cirrhosis, as defined by the current&#xD;
             Chinese guidelines&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Either Hepatitis B e antigen (HBeAg) positive or negative&#xD;
&#xD;
          -  Naïve to NUC (defined as no previous exposure to NUC treatment as based on patient&#xD;
             self-report)&#xD;
&#xD;
          -  Has compensated liver disease&#xD;
&#xD;
          -  Patients with compensated cirrhosis&#xD;
&#xD;
          -  Patients who consent to participate in this study&#xD;
&#xD;
          -  Local residents with medical reimbursement coverage preferred&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-infected with hepatitis C virus (HCV)&#xD;
&#xD;
          -  CHB patients with decompensated cirrhosis, liver failure, hepatocellular carcinoma, or&#xD;
             any other types of malignancy at the screening phase&#xD;
&#xD;
          -  CHB patients who are being treated by interferon therapy within 6 months immediately&#xD;
             prior to the screening phase of this study&#xD;
&#xD;
          -  CHB patients with a confirmed pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Quanzhou</city>
        <state>Fujian</state>
        <zip>362002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>1361009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Foshan</city>
        <state>Guangdong</state>
        <zip>528000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>528000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local institution</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>55000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Daqing</city>
        <state>Heilongjiang</state>
        <zip>163461</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haerbin</city>
        <state>Heilongjiang</state>
        <zip>150086</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shiyan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Erdos</city>
        <state>Inner Mongolia</state>
        <zip>17000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Changshu</city>
        <state>Jiangsu</state>
        <zip>215500</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <zip>213001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nangchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local institution</name>
      <address>
        <city>Yanji</city>
        <state>Jilin</state>
        <zip>133000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Instution</name>
      <address>
        <city>Fushun</city>
        <state>Liaoning</state>
        <zip>113000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shengyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <zip>264001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>30000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <zip>830001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wulumuqi</city>
        <state>Xinjiang</state>
        <zip>830001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wulumuqi</city>
        <state>Xinjiang</state>
        <zip>830052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local institution</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Jinghua</city>
        <state>Zhejiang</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726439
org study id: AI463-952
nct id: NCT01726439
lead sponsor: 
has dmc: No
To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of
      Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy,
      de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B
      (CHB) patients who are naive to NUC at enrollment to this study
Sampling Method: Consecutive patient sampling

      Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of
      this study
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy
time frame: 48 weeks after initial NUC antiviral therapy
description: Virology response is defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) < 300 copies/mL by a highly sensitive assay such as Roche COBAS or Abbott Real Time Polymerase chain reaction (PCR) performed in a one central laboratory
measure: Mean HBV DNA reductions after 48 weeks of treatment from baseline for ETV and LAM-based therapy patients (stratifying by the 3 LAM-based subgroups)
time frame: Baseline (Day 1) and 48 weeks
measure: Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 weeks and 96 weeks of treatment (stratifying by the 3 LAM based subgroups)
time frame: 24 weeks and 96 weeks
measure: Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24 weeks, 48 weeks, and 96 weeks of treatment among all treatment options
time frame: 24 weeks, 48 weeks and 96 weeks
measure: Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks of treatment
time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
description: HBV DNA levels at week 24 will be analyzed at the laboratories of hospitals where the patients are treated while evaluation of HBV DNA levels after 48 and 96 weeks of treatment will be conducted at the central laboratory
measure: Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance
time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
measure: Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms
time frame: 48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
arm group label: CHB patients who are naive to NUC treatment
description: CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: China
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic