A Prospective cohort study on the use of Sofosbuvir-based regimens in HCV-infected patients in clinical practice in France (HELIOS)

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:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multi-centre, prospective, study

Study drug and medical condition

• Medical condition to be studied:
  Chronic hepatitis C

Population studied

• Short description of the study population:
  Adults patients aged 18 years or older with hepatitis C virus (HCV) infection received treatment with sofosbuvir, ledipasvir/sofosbuvir or sofosbuvir/velpatasvir in clinical practice in France.; Inclusion Criteria:;  Age ≥ 18 years;  HCV-infected patients (HCV RNA positive);  Patient initiating treatment with Sofosbuvir*, Ledipasvir/Sofosbuvir* or Sofosbuvir/Velpatasvir*;  Signed Patient Information Form; * prescribed according to the respective SmPC; ; Exclusion Criteria:;  Concurrent participation in a HCV clinical trial (except trials not testing investigational medicinal product);  Patients presenting a risk of not being able to be followed during 2 years (patients planning to move home, or leave the country in a foreseeable future)
• Age groups:
  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 hepatitis C virus infection
• Estimated number of subjects:
  1031

Study design details

• Main study objective:
  The primary objective of this study was to assess the efficacy of sofosbuvir-based regimens in adult patients with chronic hepatitis C virus infection treated in routine clinical practice.
• Outcomes:
  The proportion of subjects with sustained virologic response 12 weeks after discontinuation of therapy (SVR12). Rates of Adverse Drug Reaction, proportion of subjects with virologic response at 24 weeks post treatment, quality of life, patient adherence to HCV treatment, work productivity and activity Impairment, rate of consultations/hospitalizations due to HCV and/or liver disease and/or HCV treatment, treatment occurrence for anemia, thrombopenia and/or neutropenia
• Data analysis plan:
  Descriptive analysis Binary, categorical and ordinal variables were described by counts and frequencies of each modality (over the total number of responses), and comparisons between groups were tested using chi square tests and/or Fisher’s exact tests. Continuous variables were described by means, standard errors, 95% confidence intervals, medians, minima, and maxima. Differences in means and medians between groups were tested using t-tests and non-parametric tests, respectively. When deemed necessary, sub-group comparisons and/or between time point comparisons may have been implemented. Multivariable analysis As part of the secondary objectives of this study, rates of events per person-time of exposure were computed using Poisson regression, after adjusting for potential confounding factors. These events included medication switching, medication discontinuation, co-medication use, ADRs and SADRs and fatal AEs.

Documents

Study results

GS-FR-334-1530-CSR synopsis_f-redact