Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs

Launched by KIRBY INSTITUTE · Jun 6, 2019

Keywords

ClinConnect Summary

The TOPIC trial is studying a new way to help patients with Hepatitis C (a liver infection) who are in the hospital, especially those who have been injecting drugs. The goal is to see how many of these patients can achieve what is called a sustained virologic response (SVR12), which means that the virus is undetectable in their blood 12 weeks after starting treatment. This study is important because it aims to improve care for people who may face barriers to getting treatment outside the hospital.

To be eligible for this study, participants must be at least 18 years old, have injected drugs in the last six months, and be hospitalized for an infection related to drug use with an expected stay of more than a week. They also need to have a positive Hepatitis C test and a specific type of liver disease that is not advanced. Participants can expect to receive treatment while in the hospital and will be monitored to see how well the treatment works. It's important to know that certain conditions, like severe liver problems or being pregnant, may prevent someone from joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must meet all of the following 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. Injected drugs within the last 6 months
• • 4. Hospitalised with an IRID with an anticipated inpatient stay of \> 1 week
• • Participants must meet the following additional inclusion criteria to be treated in this study.
• • 5. HCV RNA positive
• • 6. Compensated liver disease
• • 7. Documented non-cirrhotic at enrolment with a qualifying liver FibroScan ≤ 9.5 kpA
• 8. If co-infection with HIV is documented, the subject must meet the following criteria:
• • 1. ART naïve with CD4 T cell count \>500 cells/mm3; OR
• • 2. On a stable ART regimen (containing only permissible ART) for \>4 weeks prior to screening visit, with CD4 T cell count ≥200 cells/mm3 and a plasma HIV RNA level below the limit of detection.
• Exclusion Criteria:
• • Participants who meet any of the exclusion criteria are not to be enrolled in this study.
• • 1. Inability or unwillingness to provide informed consent or abide by the requirements of the study
• • 2. Actively intoxicated.
• • Participants that meet any of the additional exclusion criteria are not to be treated in this study.
• 3. History of any of the following:
• • b. Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal haemorrhage) c. Solid organ transplant d. History of severe, life-threatening or other significant sensitivity to study drugs (glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs
• • 4. Creatinine clearance (CLcr) \< 30 mL/min at screening (Cohort B only)
• • 5. Pregnant or nursing female
• • 6. Decompensated liver disease
• • 7. Use of prohibited concomitant medications
• • 8. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent \> 10 mg/day for \>2 weeks)
• • 9. Prior treatment failure with an NS5A based DAA regimen
• • Patients without an IRID but who fulfill all other criteria and are admitted with an expected duration of stay \> 1 week may also be included at discretion of study team.