A Study to Compare the Effectiveness and Safety of ABT-493/ABT-530 to Sofosbuvir Given Together with Declatasvir in Adults with a Chronic Hepatitis C Virus Infection

Overview

About this study

The purpose of this study is to compare the safety and effectiveness of using ABT-493/ABT-530, to the combination of sofosbuvir and daclatasvir in treating adults with genotype 3 chronic hepatitis C virus infection.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Chronic Hepatitis C virus infection
  • Screening laboratory result indicating Hepatitis C virus genotype 3 infection
  • Must be new to treatment
  • Must be non-cirrhotic

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs
  • Female who is pregnant, planning to become pregnant during the study, or breastfeeding
  • Male whose partner is pregnant or planning to become pregnant during the study
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator
  • Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

More information

Publications

  • Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection. Read More on PubMed
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CLS-20318083

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