<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/NCT01667081</url>
  </required_header>
  <id_info>
    <org_study_id>5172-017</org_study_id>
    <secondary_id>2012-002232-85</secondary_id>
    <nct_id>NCT01667081</nct_id>
  </id_info>
  <brief_title>Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)</brief_title>
  <official_title>A Long-Term Follow-Up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated With MK-5172 in a Prior Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a three-year (except for participants with chronic kidney disease [CKD] or cirrhosis)&#xD;
      multicenter study to follow participants who received at least one dose of grazoprevir&#xD;
      (MK-5172) in a previous study to determine whether they remain hepatitis C virus&#xD;
      (HCV)-Ribonucleic acid (RNA) negative over time, and to determine if they have developed&#xD;
      antiviral resistance. The study will also evaluate long-term adverse events in this&#xD;
      population. Participants from MK-5172-052 (NCT02092350) with CKD or cirrhosis will be&#xD;
      followed for five years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As of Amendment 03, the study design is revised such that continued enrollment will only be&#xD;
      for participants who failed prior therapy with a grazoprevir regimen. Participants with CKD&#xD;
      enrolled from MK-5172-052 (NCT02092350) will continue enrollment regardless of prior&#xD;
      treatment-response and remain in this study for five years, while participants enrolled from&#xD;
      all other studies with HCV RNA less than the lower limit of quantitation (LLOQ) will be&#xD;
      discontinued and end their participation after the next scheduled visit. In addition,&#xD;
      participants who receive other HCV treatments concurrent with this follow-up study or&#xD;
      received other HCV treatments prior to this study will be discontinued and their data&#xD;
      excluded from analysis.&#xD;
&#xD;
      As of Amendment 04, the protocol has been updated to include enrollment of pediatric&#xD;
      participants from protocol MK-5172-079 (NCT03379506). Enrollment is limited to participants&#xD;
      who experienced virologic failure associated with 1 or more treatment-emergent resistant&#xD;
      associated substitutions (RASs) present at 12 weeks after receiving grazoprevir treatment in&#xD;
      prior treatment study MK-5172-079 (NCT03379506).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2012</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>Time to Viral Relapse</measure>
    <time_frame>Up to ~60 months after enrollment in this study</time_frame>
    <description>Viral relapse is defined as any participant who has confirmed HCV Ribonucleic acid (RNA) ≥ Lower limit of quantification (LLoQ) of 15 IU/mL and had achieved sustained virologic response (SVR) in the follow up in the prior treatment study. Time to relapse is defined as the time from last dose of study therapy taken in the prior treatment study until the date where HCV RNA is ≥LLoQ.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections</measure>
    <time_frame>Up to ~60 months after enrollment in this study</time_frame>
    <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With HCV Genotype 1b Infections</measure>
    <time_frame>Up to ~60 months after enrollment in this study</time_frame>
    <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With Genotype 4 Infections</measure>
    <time_frame>Up to ~60 months after enrollment in this study</time_frame>
    <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experienced a Drug-Related Adverse Event (AE) During the Long-Term Follow-Up</measure>
    <time_frame>Up to ~ 60 months after enrollment in this study</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The study investigator determined whether the adverse event was drug-related.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up</measure>
    <time_frame>Up to ~60 months after enrollment in this study</time_frame>
    <description>A serious adverse event (SAE) is any adverse experience occurring at any dose that either results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose (whether accidental or intentional), or other important medical events that may not result in death, not be life threatening, or not require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed previously. The study investigator determined whether the adverse event was drug-related.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up</measure>
    <time_frame>Up to ~60 months after enrollment in this study</time_frame>
    <description>An ECI includes spontaneous bacterial peritonitis, variceal bleeding, ascites, encephalopathy, hepatorenal syndrome, hepatocellular carcinoma, liver transplant, cardiovascular disease limited to angina and myocardial infarction, neurologic disorders limited to transient ischemic attack (TIA) or stroke, graft rejection in participants who have undergone liver or kidney transplant, or one of the following in participants from the MK-5172-052 (NCT02092350) base study: kidney transplant, decreased estimated glomerular filtration rate (eGFR), new onset diabetes, cryoglobulinemia, or post transplantation glomerulonephritis.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2438</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Grazoprevir</arm_group_label>
    <description>Participants who previously received grazoprevir as study treatment on a prior study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Grazoprevir</intervention_name>
    <description>Participants previously received study treatment with grazoprevir at the dose and frequency specified in the study protocol. Grazoprevir was not administered to participants in the course of this follow-up study.</description>
    <arm_group_label>Grazoprevir</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be collected and retained for purposes of Deoxyribonucleic acid (DNA)&#xD;
      testing and plasma will be retained for future biomedical research.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult and pediatric participants previously treated with a grazoprevir-containing regimen&#xD;
        while enrolled in a Merck study. All participants enrolled having failed therapy from prior&#xD;
        studies (except MK-5172-052 [NCT02092350]) will be followed for 3 years in the current&#xD;
        follow-up study, and all participants enrolled from MK-5172-052 (irrespective of prior&#xD;
        response) will be followed for 5 years in the current follow-up study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously participated in a HCV treatment protocol that included grazoprevir in the&#xD;
             treatment regimen&#xD;
&#xD;
          -  Must enroll in the present study within three months of the last study visit of their&#xD;
             previous protocol in which they received a grazoprevir-containing regimen&#xD;
&#xD;
          -  For Amendment 03: Adult participants must have received a grazoprevir-containing&#xD;
             regimen in a prior trial and have been identified as having failed therapy in that&#xD;
             study&#xD;
&#xD;
          -  For Amendment 04: Pediatric participants must have received at least 1 dose of a&#xD;
             grazoprevir-containing regimen and experienced virologic failure with 1 or more&#xD;
             associated treatment-emergent RASs at Follow-up Week 12 in MK-5172-079 (NCT03379506)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received HCV therapy after completion of the protocol-defined grazoprevir&#xD;
             treatment trial regimen and before or after entry into this follow-up study&#xD;
&#xD;
          -  For Amendment 03: Has failed therapy due to re-infection, defined as an HCV RNA sample&#xD;
             with a different genotype than the baseline genotype in the prior treatment study, or&#xD;
             an HCV RNA sample determined to be reinfection by phylogenetic analysis with&#xD;
             comparison to the baseline sequence in the prior treatment study&#xD;
&#xD;
          -  For Amendment 03: Has failed therapy and received retreatment with HCV therapy, except&#xD;
             in the case where they were re-treated in a Merck-sponsored protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <reference>
    <citation>Lahser F, Galloway A, Hwang P, Palcza J, Brunhofer J, Wahl J, Robertson M, Barr E, Black T, Asante-Appiah E, Haber B. Interim analysis of a 3-year follow-up study of NS5A and NS3 resistance-associated substitutions after treatment with grazoprevir-containing regimens in participants with chronic HCV infection. Antivir Ther. 2018;23(7):593-603. doi: 10.3851/IMP3253. Epub 2018 Jul 24.</citation>
    <PMID>30038064</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>March 7, 2022</results_first_submitted>
  <results_first_submitted_qc>March 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2022</results_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</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 A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Grazoprevir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT01667081/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 2438 adult Hepatitis C Virus (HCV)-infected participants who were previously treated in 18 prior clinical trials, enrolled in this study.</recruitment_details>
      <pre_assignment_details>Of the 2438 participants, three participants were excluded from all analyses. Two participants enrolled in error failed to receive at least 1 dose of Grazoprevir (GZR) in a prior study (each received a comparator regimen in a prior base study) and 1 participant had insufficient long-term follow-up data (participant withdrew consent on Day 27).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Grazoprevir (GZR) 100 mg + Elbasvir (EBR) 50 mg +/- Ribavirin (RBV)</title>
          <description>Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.</description>
        </group>
        <group group_id="P2">
          <title>Other GZR Regimen</title>
          <description>Participants previously received at least one dose of GZR in a prior study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1909"/>
                <participants group_id="P2" count="526"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="132"/>
                <participants group_id="P2" count="169"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1777"/>
                <participants group_id="P2" count="357"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participants were discontinued due to amendment 3 which modified the study discontinuation criteria</title>
              <participants_list>
                <participants group_id="P1" count="1529"/>
                <participants group_id="P2" count="269"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GZR 100 mg + EBR 50 mg +/- RBV</title>
          <description>Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.</description>
        </group>
        <group group_id="B2">
          <title>Other GZR Regimen</title>
          <description>Participants previously received at least one dose of GZR in a prior study</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1909"/>
            <count group_id="B2" value="526"/>
            <count group_id="B3" value="2435"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.9" spread="11.0"/>
                    <measurement group_id="B2" value="49.7" spread="11.4"/>
                    <measurement group_id="B3" value="51.4" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="785"/>
                    <measurement group_id="B2" value="238"/>
                    <measurement group_id="B3" value="1023"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1124"/>
                    <measurement group_id="B2" value="288"/>
                    <measurement group_id="B3" value="1412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="203"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1730"/>
                    <measurement group_id="B2" value="444"/>
                    <measurement group_id="B3" value="2174"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="283"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="295"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="253"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="288"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1345"/>
                    <measurement group_id="B2" value="470"/>
                    <measurement group_id="B3" value="1815"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Viral Relapse</title>
        <description>Viral relapse is defined as any participant who has confirmed HCV Ribonucleic acid (RNA) ≥ Lower limit of quantification (LLoQ) of 15 IU/mL and had achieved sustained virologic response (SVR) in the follow up in the prior treatment study. Time to relapse is defined as the time from last dose of study therapy taken in the prior treatment study until the date where HCV RNA is ≥LLoQ.</description>
        <time_frame>Up to ~60 months after enrollment in this study</time_frame>
        <population>All participants who achieved SVR during the follow-up period of the prior treatment study and did not start any new HCV therapy between the end of the prior treatment study and entry in this study</population>
        <group_list>
          <group group_id="O1">
            <title>GZR 100 mg + EBR 50 mg +/- RBV</title>
            <description>Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.</description>
          </group>
          <group group_id="O2">
            <title>Other GZR Regimen</title>
            <description>Participants previously received at least one dose of GZR in a prior study</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Viral Relapse</title>
          <description>Viral relapse is defined as any participant who has confirmed HCV Ribonucleic acid (RNA) ≥ Lower limit of quantification (LLoQ) of 15 IU/mL and had achieved sustained virologic response (SVR) in the follow up in the prior treatment study. Time to relapse is defined as the time from last dose of study therapy taken in the prior treatment study until the date where HCV RNA is ≥LLoQ.</description>
          <population>All participants who achieved SVR during the follow-up period of the prior treatment study and did not start any new HCV therapy between the end of the prior treatment study and entry in this study</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1837"/>
                <count group_id="O2" value="495"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median time to viral relapse and interquartile range not reached due to the low rate of late virologic relapse.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Median time to viral relapse and interquartile range not reached due to the low rate of late virologic relapse.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections</title>
        <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
        <time_frame>Up to ~60 months after enrollment in this study</time_frame>
        <population>Participants met the criteria of virologic failure either in the prior base study or had HCV RNA Target detected, quantifiable [TD(q)] at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included.</population>
        <group_list>
          <group group_id="O1">
            <title>EBR/GZR +/- RBV: NS3 RASs</title>
            <description>Participants previously received EBR and GZR with or without RBV in a prior study and had treatment-emergent NS3 RASs</description>
          </group>
          <group group_id="O2">
            <title>EBR/GZR +/- RBV: NS5A RASs</title>
            <description>Participants previously received EBR and GZR with or without RBV in a prior study and had treatment-emergent NS5A RASs</description>
          </group>
          <group group_id="O3">
            <title>EBR/GZR +/-RBV: Both NS3 and NS5A RASs</title>
            <description>Participants previously received EBR and GZR with or without RBV in a prior study and had both treatment-emergent NS3 and NS5A RASs</description>
          </group>
          <group group_id="O4">
            <title>GZR + Pegylated Interferon/Ribavirin (PR): NS3 RASs</title>
            <description>Participants previously received GZR and PR for 12 weeks in a prior study and had treatment-emergent NS3 RASs</description>
          </group>
        </group_list>
        <measure>
          <title>Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections</title>
          <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
          <population>Participants met the criteria of virologic failure either in the prior base study or had HCV RNA Target detected, quantifiable [TD(q)] at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 weeks post failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 weeks post failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96 weeks post failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥144 weeks post failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With HCV Genotype 1b Infections</title>
        <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
        <time_frame>Up to ~60 months after enrollment in this study</time_frame>
        <population>Participants met the criteria of virologic failure either in the prior base study or had HCV RNA TD(q) at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included.</population>
        <group_list>
          <group group_id="O1">
            <title>EBR/GZR+/- RBV: NS3 RASs</title>
            <description>Participants previously received EBR and GZR with or without RBV in a prior study and had treatment-emergent NS3 RASs</description>
          </group>
          <group group_id="O2">
            <title>EBR/GZR +/- RBV: NS5A RASs</title>
            <description>Participants previously received EBR and GZR with or without RBV in a prior study and had treatment-emergent NS5A RASs</description>
          </group>
          <group group_id="O3">
            <title>EBR/GZR +/-RVB: Both NS3 and NS5A RASs</title>
            <description>Participants previously received EBR and GZR with or without RBV in a prior study and had both treatment-emergent NS3 and NS5A RASs</description>
          </group>
          <group group_id="O4">
            <title>GZR + RBV or PR: NS3 RASs</title>
            <description>Participants previously received GZR and RBV or PR for 12 weeks in a prior study and had treatment-emergent NS3 RASs</description>
          </group>
        </group_list>
        <measure>
          <title>Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With HCV Genotype 1b Infections</title>
          <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
          <population>Participants met the criteria of virologic failure either in the prior base study or had HCV RNA TD(q) at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 weeks post failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 weeks post failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96 weeks post failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥144 weeks post failure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With Genotype 4 Infections</title>
        <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
        <time_frame>Up to ~60 months after enrollment in this study</time_frame>
        <population>Participants met the criteria of virologic failure either in the prior base study or had HCV RNA TD(q) at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included.</population>
        <group_list>
          <group group_id="O1">
            <title>EBR/GZR: NS3 RASs</title>
            <description>Participants previously received EBR and GZR in a prior study and had treatment-emergent NS3 RASs</description>
          </group>
          <group group_id="O2">
            <title>EBR/GZR: NS5A RASs</title>
            <description>Participants previously received EBR and GZR in a prior study and had treatment-emergent NS5A RASs</description>
          </group>
          <group group_id="O3">
            <title>EBR/GZR: Both NS3 and NS5A RASs</title>
            <description>Participants previously received EBR and GZR in a prior study and had both treatment-emergent NS3 and NS5A RASs</description>
          </group>
        </group_list>
        <measure>
          <title>Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With Genotype 4 Infections</title>
          <description>In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.</description>
          <population>Participants met the criteria of virologic failure either in the prior base study or had HCV RNA TD(q) at entry in current study. Participants did not receive new HCV therapy between the end of the prior base study and entry into this study. Only HCV genotype infections that had adequate reference information were included.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 weeks post failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 weeks post failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96 weeks post failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥144 weeks post failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced a Drug-Related Adverse Event (AE) During the Long-Term Follow-Up</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The study investigator determined whether the adverse event was drug-related.</description>
        <time_frame>Up to ~ 60 months after enrollment in this study</time_frame>
        <population>All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27).</population>
        <group_list>
          <group group_id="O1">
            <title>GZR 100 mg + EBR 50 mg +/- RBV</title>
            <description>Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.</description>
          </group>
          <group group_id="O2">
            <title>Other GZR Regimen</title>
            <description>Participants previously received at least one dose of GZR in a prior study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced a Drug-Related Adverse Event (AE) During the Long-Term Follow-Up</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The study investigator determined whether the adverse event was drug-related.</description>
          <population>All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1909"/>
                <count group_id="O2" value="526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up</title>
        <description>A serious adverse event (SAE) is any adverse experience occurring at any dose that either results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose (whether accidental or intentional), or other important medical events that may not result in death, not be life threatening, or not require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed previously. The study investigator determined whether the adverse event was drug-related.</description>
        <time_frame>Up to ~60 months after enrollment in this study</time_frame>
        <population>All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27).</population>
        <group_list>
          <group group_id="O1">
            <title>GZR 100 mg + EBR 50 mg +/- RBV</title>
            <description>Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.</description>
          </group>
          <group group_id="O2">
            <title>Other GZR Regimen</title>
            <description>Participants previously received at least one dose of GZR in a prior study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up</title>
          <description>A serious adverse event (SAE) is any adverse experience occurring at any dose that either results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose (whether accidental or intentional), or other important medical events that may not result in death, not be life threatening, or not require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed previously. The study investigator determined whether the adverse event was drug-related.</description>
          <population>All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1909"/>
                <count group_id="O2" value="526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up</title>
        <description>An ECI includes spontaneous bacterial peritonitis, variceal bleeding, ascites, encephalopathy, hepatorenal syndrome, hepatocellular carcinoma, liver transplant, cardiovascular disease limited to angina and myocardial infarction, neurologic disorders limited to transient ischemic attack (TIA) or stroke, graft rejection in participants who have undergone liver or kidney transplant, or one of the following in participants from the MK-5172-052 (NCT02092350) base study: kidney transplant, decreased estimated glomerular filtration rate (eGFR), new onset diabetes, cryoglobulinemia, or post transplantation glomerulonephritis.</description>
        <time_frame>Up to ~60 months after enrollment in this study</time_frame>
        <population>All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27).</population>
        <group_list>
          <group group_id="O1">
            <title>GZR 100 mg + EBR 50 mg +/- RBV</title>
            <description>Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.</description>
          </group>
          <group group_id="O2">
            <title>Other GZR Regimen</title>
            <description>Participants previously received at least one dose of GZR in a prior study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up</title>
          <description>An ECI includes spontaneous bacterial peritonitis, variceal bleeding, ascites, encephalopathy, hepatorenal syndrome, hepatocellular carcinoma, liver transplant, cardiovascular disease limited to angina and myocardial infarction, neurologic disorders limited to transient ischemic attack (TIA) or stroke, graft rejection in participants who have undergone liver or kidney transplant, or one of the following in participants from the MK-5172-052 (NCT02092350) base study: kidney transplant, decreased estimated glomerular filtration rate (eGFR), new onset diabetes, cryoglobulinemia, or post transplantation glomerulonephritis.</description>
          <population>All participants treated with GZR in a prior study. Three participants were excluded from analysis; two participants enrolled in error failed to receive at least one dose of GZR in a prior study (each received a comparator regimen in a prior base study) and one participant had insufficient long-term follow-up data (participant withdrew consent on Day 27).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1909"/>
                <count group_id="O2" value="526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first visit in follow-up (Screening/Baseline) up to ~60 months after enrollment in this study</time_frame>
      <desc>The all-cause mortality population includes all enrolled participants (N=2438). The serious adverse events and other adverse events population excludes three enrolled participants- two enrolled in error who received a comparator regimen in a prior base study and one participant had insufficient long-term follow up data (participant withdrew consent on day 27).</desc>
      <group_list>
        <group group_id="E1">
          <title>GZR 100 mg + EBR 50 mg +/- RBV</title>
          <description>Participants previously received GZR 100mg +EBR 50mg with or without RBV in a prior study.</description>
        </group>
        <group group_id="E2">
          <title>Other GZR Regimen</title>
          <description>Participants previously received at least one dose of GZR in a prior study</description>
        </group>
        <group group_id="E3">
          <title>Non-GZR Regimen</title>
          <description>Participants received a non-GZR regimen in a prior study</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="1909"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="527"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="100" subjects_at_risk="1909"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pulseless electrical activity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic hepatic failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1909"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney transplant rejection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Transplant dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Diffuse large B-cell lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="1909"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Non-small cell lung cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Optic neuritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1909"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1909"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis chronic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asphyxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1909"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1909"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1909"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01667081
org study id: 5172-017
secondary id: 2012-002232-85
nct id: NCT01667081
lead sponsor: 
has dmc: No
This is a three-year (except for participants with chronic kidney disease [CKD] or cirrhosis)
      multicenter study to follow participants who received at least one dose of grazoprevir
      (MK-5172) in a previous study to determine whether they remain hepatitis C virus
      (HCV)-Ribonucleic acid (RNA) negative over time, and to determine if they have developed
      antiviral resistance. The study will also evaluate long-term adverse events in this
      population. Participants from MK-5172-052 (NCT02092350) with CKD or cirrhosis will be
      followed for five years.
As of Amendment 03, the study design is revised such that continued enrollment will only be
      for participants who failed prior therapy with a grazoprevir regimen. Participants with CKD
      enrolled from MK-5172-052 (NCT02092350) will continue enrollment regardless of prior
      treatment-response and remain in this study for five years, while participants enrolled from
      all other studies with HCV RNA less than the lower limit of quantitation (LLOQ) will be
      discontinued and end their participation after the next scheduled visit. In addition,
      participants who receive other HCV treatments concurrent with this follow-up study or
      received other HCV treatments prior to this study will be discontinued and their data
      excluded from analysis.

      As of Amendment 04, the protocol has been updated to include enrollment of pediatric
      participants from protocol MK-5172-079 (NCT03379506). Enrollment is limited to participants
      who experienced virologic failure associated with 1 or more treatment-emergent resistant
      associated substitutions (RASs) present at 12 weeks after receiving grazoprevir treatment in
      prior treatment study MK-5172-079 (NCT03379506).
observational model: Cohort
time perspective: Prospective
measure: Time to Viral Relapse
time frame: Up to ~60 months after enrollment in this study
description: Viral relapse is defined as any participant who has confirmed HCV Ribonucleic acid (RNA) ≥ Lower limit of quantification (LLoQ) of 15 IU/mL and had achieved sustained virologic response (SVR) in the follow up in the prior treatment study. Time to relapse is defined as the time from last dose of study therapy taken in the prior treatment study until the date where HCV RNA is ≥LLoQ.
measure: Persistence of Treatment-Emergent Nonstructural Protein (NS)3 and NS5A Resistance-associated Substitutions (RASs) in Participants With HCV Genotype (GT) 1a Infections
time frame: Up to ~60 months after enrollment in this study
description: In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.
measure: Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With HCV Genotype 1b Infections
time frame: Up to ~60 months after enrollment in this study
description: In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.
measure: Persistence of Treatment-Emergent NS3 and NS5A RASs in Participants With Genotype 4 Infections
time frame: Up to ~60 months after enrollment in this study
description: In adult participants with HCV RNA ≥1000 IU/mL at entry or during the study period, HCV sequence analysis was performed to evaluate the presence of RASs and the persistence of RASs over time.
measure: Number of Participants Who Experienced a Drug-Related Adverse Event (AE) During the Long-Term Follow-Up
time frame: Up to ~ 60 months after enrollment in this study
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The study investigator determined whether the adverse event was drug-related.
measure: Number of Participants Who Experienced a Drug-Related Serious Adverse Event (SAE) During the Long-Term Follow-Up
time frame: Up to ~60 months after enrollment in this study
description: A serious adverse event (SAE) is any adverse experience occurring at any dose that either results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose (whether accidental or intentional), or other important medical events that may not result in death, not be life threatening, or not require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed previously. The study investigator determined whether the adverse event was drug-related.
measure: Number of Participants Who Experienced an Event of Clinical Interest (ECI) During the Long-Term Follow-Up
time frame: Up to ~60 months after enrollment in this study
description: An ECI includes spontaneous bacterial peritonitis, variceal bleeding, ascites, encephalopathy, hepatorenal syndrome, hepatocellular carcinoma, liver transplant, cardiovascular disease limited to angina and myocardial infarction, neurologic disorders limited to transient ischemic attack (TIA) or stroke, graft rejection in participants who have undergone liver or kidney transplant, or one of the following in participants from the MK-5172-052 (NCT02092350) base study: kidney transplant, decreased estimated glomerular filtration rate (eGFR), new onset diabetes, cryoglobulinemia, or post transplantation glomerulonephritis.
arm group label: Grazoprevir
description: Participants who previously received grazoprevir as study treatment on a prior study.
intervention type: Drug
intervention name: Grazoprevir
description: Participants previously received study treatment with grazoprevir at the dose and frequency specified in the study protocol. Grazoprevir was not administered to participants in the course of this follow-up study.
arm group label: Grazoprevir
Blood samples will be collected and retained for purposes of Deoxyribonucleic acid (DNA)
      testing and plasma will be retained for future biomedical research.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
citation: Lahser F, Galloway A, Hwang P, Palcza J, Brunhofer J, Wahl J, Robertson M, Barr E, Black T, Asante-Appiah E, Haber B. Interim analysis of a 3-year follow-up study of NS5A and NS3 resistance-associated substitutions after treatment with grazoprevir-containing regimens in participants with chronic HCV infection. Antivir Ther. 2018;23(7):593-603. doi: 10.3851/IMP3253. Epub 2018 Jul 24.
PMID: 30038064
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Grazoprevir
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 