Impact of Hepatitis C Therapy and Bone Health

• Status: Terminated
• Trial end date: 2018-11-30
• Target enrollment: 0
• Participant gender: Male

Summary

An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dallas VA Medical Center
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Elbasvir-grazoprevir drug combination

Criteria

Inclusion Criteria:

1. HCV antibody and HCV RNA positive

2. HCV Genotype 1a, 1b, or 4

3. Liver staging assessment:

a. Cirrhosis will be defined by any of the following: i. A liver biopsy prior to day 1 of this study showing cirrhosis (F4) ii. Fibroscan within 12 calendar months of day 1 of this study showing cirrhosis with result > 12.5 kPa iii. FibroSURE performed during screening with a score > 0.75 and APRI > 2 b. Absence of cirrhosis will be defined by any of the following: i. Liver biopsy performed within 24 months of day 1 of this study showing absence of cirrhosis ii. Fibroscan performed within 12 months of day 1 of this study with a result of ≤ 12.5 kPa iii. FibroSURE score ≤ 0.48 and APRI ≤ 1 during screening

4. If HIV co-infected, HAART regimen will consist of two NRTIs (abacavir, tenofovir disoproxil fumarate or tenofovir alafenamide, each in combination with lamivudine or emtricitabine) with one of the following 3rd agents:

1. raltegravir

2. dolutegravir

3. rilpivirine HIV co-infected patients must be on their stable HAART regimen for at least 6 months, with HIV viral load < 50 c/mL at screening

Exclusion Criteria:

1. Hepatitis B surface antigen positivity

2. Decompensated cirrhosis (Child Pugh B or C)

3. Any prior hepatitis C treatment

4. Pregnant or nursing

5. Treatment with any medication specifically contraindicated with EBR/GZR or not recommended for concomitant use as per the prescribing label (Table 2)

6. Age less than 18

7. Prisoners or subjects otherwise involuntarily incarcerated

8. Absence of signed informed consent by patient or appropriate surrogate

9. Known hypersensitivity to elbasvir or grazoprevir

10. For patients with genotype 1a, one more of the following mutations on baseline NS5A genotype: M28, Q30, L31, or Y93