Comparison of Dolutegravir Effectiveness vs. Other Anchor Agent Effectiveness among Hepatitis C Virus Co-infected patients in the OPERA® Observational Database (207833)

Study type

• Study topic:
  Disease /health condition

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

  Other
• If ‘other’, further details on the scope of the study:
  Observational cohort analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DOLUTEGRAVIR

  DARUNAVIR

  RALTEGRAVIR

  ELVITEGRAVIR
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  The study sample will be identified from the OPERA Database for analysis according to the inclusion criteria defined below.; Patients initiating an anchor-of-interest-based regimen between August 12, 2013 and June 30, 2016 will be included in the study sample if they meet the following inclusion criteria:; 1) A diagnosis of HIV-1, a positive HIV-1 Western Blot, or a positive HIV-1 enzyme-linked immunosorbent assay (ELISA); and a detectable HIV-1 viral load test.; 2) A diagnosis of HCV and PCR or serology positive.; 3) At least 13 years of age at the index date.; 4) At least one HIV-1 viral load test on or up to 120 days prior to index date.; 5) Continuous clinical activity in the year following anchor-of-interest-based regimen initiation, defined as at least one clinical contact (visit or telephone contact); Subjects with the following criteria will be excluded from the study sample:; 1) HIV negative.; 2) HCV negative.; 3) A diagnosis of HIV-2, a positive HIV-1/HIV-2 Multispot, a positive HIV-2-specific ELISA, a positive HIV-2 Western Blot or a detectable HIV-2 viral load test.; 4) Initial anchor-of-interest-based regimen treatment identified as a component of post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP).
• 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:
  Immunocompromised
• Estimated number of subjects:
  815

Study design details

• Main study objective:
  To describe the baseline demographic and clinical characteristics, to estimate and compare the frequency of liver enzyme elevations by grade and discontinuation due to hepatotoxicity, and to describe and compare time to virologic suppression (<50 copies/ml) among HIV+/HCV+ patients initiating dolutegravir, darunavir, raltegravir, or elvitegravir</50></50>
• Outcomes:
  Incidence of viral suppression (viral load < 50 copies/mL) 12 months after regimen initiation, incidence of and time to liver enzyme elevations (grade 3 or higher) after regimen initiation, and incidence of discontinuation/switching due to hepatotoxicity
• Data analysis plan:
  Descriptive statistics will be used to describe clinical and demographic patient characteristics of the overall HIV+/HCV+ population and those co-infected and initiating core-of-interest-based regimens. Clinical outcomes, including liver enzyme elevations (grading) and discontinuation due to hepatotoxicity, will be described using frequency distributions for categorical variables and medians with IQRs for continuous variables. Kaplan Meier methods and multivariable Cox proportional hazards models will be used to estimate and model time to virologic suppression in each group of patients by core-of-interest-based regimen prescribed.