GS-EU-337-1820 - An Observational Drug Utilization Study of Ledipasvir/Sofosbuvir and Tenofovir Disoproxil Fumarate + Pharmacokinetic Enhancer Co-Administration in Adults Co-Infected with Chronic Hepatitis C and HIV-1 Infections (HAVEN co-infection study)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Drug interaction study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AX65) sofosbuvir and ledipasvir

  sofosbuvir and ledipasvir
• Medical condition to be studied:
  Hepatitis C

  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  Hepatitis C virus and HIV-1 co-infected subjects receiving anti-retroviral therapy who initiate treatment with Harvoni.
• 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:
  Hepatic impaired

  Immunocompromised
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To characterize the frequency of co-administration of Harvoni with Tenofovir Disoproxil Fumarate + Pharmacokinetic Enhancer in the post-marketing setting.
• Data analysis plan:
  The proportion of subjects with concomitant Harvoni and TDF+PK enhancer use will be estimated with 95% confidence intervals (CIs) among all HCV-HIV co-infected, Harvoni-treated subjects included in the study. Also, baseline information on subject demographics and other clinical characteristics will be summarized using descriptive statistics (i.e. sample size, mean, standard deviation, median, and interquartile range) for continuous data and by the numbers and percentages of subjects for categorical data. The incidence rate of renal AEs with 95% CIs will be assessed, taking into account the person-time of subjects with concomitant Harvoni and TDF+PK enhancer utilization. In addition, the incidence rates of specific renal AEs that have been previously studied in TDF-treated patients will be estimated. Also, the clinical characteristics and changes in renal-associated laboratory measurements of subjects will be evaluated

Documents

Study results

GS-EU-337-1820 Annual Progress Report

Study report

GS-EU-337-1820 Interim Progress Report