Impact of Hepatitis C Therapy and Bone Health

NCT03221582 | Terminated Phase 4 FDA Drug

• 1 other identifier: MISP 54850
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients and HIV/HCV co-infected patients

  Cardiovascular health will be assessed by serologic markers of inflammation; in addition to, positron emission tomography (PET) scanning for arterial inflammation, coronary calcification and myocardial viability.

  48 weeks

Secondary Outcomes (10)

• Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.

  Biomarkers of inflammation and bone turnover measured at week 0 of therapy.

• Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.

  Bone mineral density measured at week 0 of therapy

• Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.

  Biomarkers of inflammation and bone turnover measured at week 12 of therapy.

• Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.

  Biomarkers of inflammation and bone turnover measured at week 24 of therapy.

• Impact of EBR/GZR HCV therapy on the cardiovascular risk and bone health of HCV mono-infected patients.

  Bone mineral density measured at week 48 of therapy.

Study Arms (2)

EBR/GZR (Zepatier) - HCV/HIV co-infected

EXPERIMENTAL

Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.

Drug: EBR/GZR

EBR/GZR (Zepatier) - HCV monoinfected

EXPERIMENTAL

Drug: Elbasvir (EBR) 50 mg and Grazoprevir (GZR) 100 mg single tablet by mouth, once daily.

Drug: EBR/GZR

Interventions

EBR/GZR DRUG

Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.

Also known as: Zepatier

EBR/GZR (Zepatier) - HCV monoinfected; EBR/GZR (Zepatier) - HCV/HIV co-infected

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV antibody and HCV RNA positive
• HCV Genotype 1a, 1b, or 4
• 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
• 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:
• raltegravir
• dolutegravir
• 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

You may not qualify if:

• Hepatitis B surface antigen positivity
• Decompensated cirrhosis (Child Pugh B or C)
• Any prior hepatitis C treatment
• Pregnant or nursing
• Treatment with any medication specifically contraindicated with EBR/GZR or not recommended for concomitant use as per the prescribing label (Table 2)
• Age less than 18
• Prisoners or subjects otherwise involuntarily incarcerated
• Absence of signed informed consent by patient or appropriate surrogate
• Known hypersensitivity to elbasvir or grazoprevir
• For patients with genotype 1a, one more of the following mutations on baseline NS5A genotype: M28, Q30, L31, or Y93

Sponsors & Collaborators

• Dallas VA Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Roger Bedimo, MD

  Dallas VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 18, 2017
• Study Start: August 28, 2017
• Primary Completion: November 26, 2018
• Study Completion: November 30, 2018
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)