A5320: Long-Term HCV

Viral Hepatitis C Infection Long-term Cohort Study (V-HICS)

Study Description

A5320 (also known as the V-HICS study) is an observational, prospective, long-term follow-up study for men and women who have hepatitis C virus (HCV) infection alone (mono-infected) or who have both HCV and HIV-1 infection (co-infected).  Persons who were treated with a direct-acting anti-viral (DAA) therapy as a component of their hepatitis C treatment regimen in a clinical trial are eligible.

Treatment Category

Hepatitis

Why is this study being done?

This study will help to understand the impact of successful (sustained viral response, SVR) or unsuccessful HCV treatment on a person’s health over many years. It will also help us understand how long resistance to new hepatitis C medications lasts and whether it affects future hepatitis C treatments.  The study will look at each person’s HCV and genetic differences that might play a role in the success or failure of the HCV treatments. This study will also measure how treatment success or failure affects a person’s quality of life.

Who can join?

  • Hepatitis C mono-infected OR HCV and HIV co-infected
  • Men and women age at least 18 years
  • Receipt of at least one HCV/DAA medication within the past 12 months as part of an ACTG or other clinical trial.
    • Only candidates who were treated with a DAA (such as boceprevir, sofosbuvir, etc.) as a component of their HCV regimen are eligible.
    • Individuals who prematurely discontinued HCV/DAA treatment for safety or other reasons are eligible
  • Documentation of treatment response (SVR or non-SVR) as defined by the HCV/DAA treatment study
  • Not currently on HCV treatment. (Note: Following V-HICS entry, participant may begin new HCV treatment.)

What do I need to do in the study?

Participants will be enrolled after HCV/DAA treatment outcome determination (SVR), provided it is within 1 year after end of treatment in the HCV/DAA treatment study and prior to initiation of any subsequent HCV treatment.

Participants will attend visits twice a year for about 5 years.

The study will collect blood and will use a questionnaire to measure quality of life.   

What treatments or drugs are involved with this study?

None.  This is an observational study and does not provide any medication for HCV or HIV.  Participants can begin a new HCV treatment as part of a clinical trial after V-HICS study enrollment.

Study Status: