Phase 4 study for people with Hepatitis C

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

- Participants must meet all inclusion criteria to be eligible to participate in this study:

1. Have voluntarily signed the informed consent form.

2. 18 years of age or older.

3. Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.

4. Quantifiable HCV RNA at screening.

5. HCV treatment naïve (no prior treatment with an approved or investigation anti-HCV medication).

6. Liver fibrosis stage F0-F2, defined by at least one of the following:

   1. Liver stiffness measurement <9.5 kPa by transient elastography (FibroScan®)
   2. AST to platelet ratio index (APRI) <0.5
   3. Liver biopsy

7. If co-infection with HIV is documented, the subject must meet the following criteria:

   • ART naïve with CD4 T cell count >500 cells/mm3; OR
   • On a stable ART regimen (containing only permissible ART - see protocol section 6.3) for >8 weeks prior to screening visit, with CD4 T cell count >200 cells/mm3 and a plasma HIV RNA level below the limit of detection.

8. Negative pregnancy test at screening and baseline (females of childbearing potential only).

9. All fertile females must be using effective contraception during treatment and during the 30 days after treatment end.

Exclusion Criteria:

• Participants who meet any of the exclusion criteria are not to be enrolled in this study.

  1. History of any of the following:

     1. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
     2. Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage).
     3. Solid organ transplant.
     4. History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.

  2. Any of the following lab parameters at screening:

     1. ALT > 10 x ULN
     2. AST > 10 x ULN
     3. Direct bilirubin > ULN
     4. Platelets < 150,000/μL (cells/mm3)
     5. Creatinine clearance (CLcr) < 50 mL/min
     6. Albumin < LLN
     7. INR > 1.5 ULN

  3. Pregnant or breastfeeding female.

  4. HBV infection (HBsAg positive).

  5. Use of prohibited concomitant medications as described in protocol section 6.3.

  6. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks).

  7. Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) ≤6 months prior to the first dose of study drug.

  8. Any investigational drug ≤6 weeks prior to the first dose of study drug.

  9. Ongoing severe psychiatric disease as judged by the treating physician.

  10. Inability or unwillingness to provide informed consent or abide by the requirements of the study.