A Single-Arm Retrospective Study to Evaluate Safety and Efficacy in Patients with Acute Hepatitis C Virus (HCV) Infection Treated with 8 Weeks of Glecaprevir/Pibrentasvir

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Single-arm, retrospective study (patient chart review)

Study drug and medical condition

• Medicinal product name, other:
  Mavyret
• Medical condition to be studied:
  Acute hepatitis C

Population studied

• Short description of the study population:
  The study population included adolescent and adult patients with acute hepatitis C virus (HCV) infection who had prescribed treatment with glecaprevir plus pibrentasvir (GLE/PIB) identified through the medical charts.; Inclusion criteria: ; 1. Evidence of acute HCV infection is defined as physician diagnosis of acute HCV infection and 1 of the following:; a. negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen followed by initiating GLE/PIB treatment within a 9-month period; OR; b. negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen followed by initiating GLE/PIB treatment within a 12-month period; AND risk behaviour 6 months prior to positive HCV RNA or HCV core antigen; OR; c. clinical signs and symptoms compatible with acute hepatitis (ALT > 5 × ULN and/or jaundice) in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen followed by initiating GLE/PIB treatment within a 9-month period; AND risk behaviour 6 months prior to positive HCV RNA or HCV core antigen; OR; d. negative anti-HCV antibody with a positive HCV RNA or HCV core antigen followed by initiating GLE/PIB treatment within a 6-month period; 2. Age 12 years or older.; 3. Treatment-naïve, i.e., no prior treatment, including interferon, for this HCV infection.; 4. Evidence of 8 weeks total of GLE/PIB prescription provided to patient.; 5. Patient received treatment with GLE/PIB, as confirmed by investigator.; ; Exclusion criteria:; • History of liver decompensation.; • Liver or kidney transplant history.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with acute HCV infection
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  The primary objective of this study is to demonstrate the efficacy of GLE/PIB prescribed for 8 weeks in patients with acute HCV genotype (GT)1 – GT6 infection by comparing the SVR12 rate from this study to the historical SVR12 rate in people with chronic HCV infection who were treated with GLE/PIB.
• Outcomes:
  The primary efficacy endpoint is the achievement of SVR12 (sustained virologic response 12 weeks after the last dose of the drug) for each patient in the modified Full Analysis Set (mFAS) population. The secondary efficacy endpoints are: -Achievement of SVR12 for each patient in the FAS population. -On-treatment virologic failure for each patient in the FAS population. -Post-treatment relapse for each patient in the FAS population who completed treatment as planned. -Post-treatment reinfection with HCV for each patient in the FAS population.
• Data analysis plan:
  The primary and secondary endpoints will be summarized with counts and percentages. Two-sided 95% confidence intervals for the percentages will also be calculated using Wilson's score method.