Outcome of New Direct Acting Agents For Hepatitis C A Community Based Experience

Hepatitis C Clinical Trial

Official title:

Outcome of New Direct Acting Agents For Hepatitis C

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02485262
• Other study ID #: 1234
• Secondary ID: 14-25
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2015
• Last updated: June 29, 2015
• Start date: November 2013
• Est. completion date: November 2016

Study information

• Verified date: June 2015
• Source: Arrowhead Regional Medical Center
• Contact: Zeid Kayali, MD,MBA
• Phone: 909 883-2999
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Chronic Hepatitis C virus (HCV) infection is the leading cause of advanced liver disease worldwide. The virus successfully evades host immune detection and has highly restricted requirements for growth in vitro that for many years hampered efforts to find a safe, uncomplicated, and reliable oral antiviral therapy. Ten years after discovery, pegylated interferon-alpha and ribavirin (PR) treatment for 24-48 weeks became the standard of care (1-5). PR therapy offered limited performance and availability across the diverse spectrum of HCV disease and was fraught with excessive and often limiting side effects. The first direct acting agents (DAAs) were protease inhibitors (PIs) that were introduced in 2011 and could only be used only in combination with PR because of concerns for rapid PI viral resistance. Although the first generation PIs added increased efficacy to the PR regimen, they also added new side effects and untoward drug interactions (6-8). Sofosbuvir (SOF) is a potent nucleoside inhibitor (NI) that has recently been approved for treatment of HCV. The drug has low toxicity, high resistance barrier, and minimal drug interactions with other HCV DAAs such as PIs and anti-NS5A agents. SOF is safe and effective across different viral genotypes, disease stages, and special patient groups such as those co-infected with HIV. When used in combination with ribavirin or another DAA, SOF has revolutionized the HCV treatment spectrum and set the stage for nearly universal HCV antiviral therapy. Sustained virologic response (SVR12) for SOF plus ribavirin and pegylated interferon (PR) is 90% for genotype 1 and 85-94% for genotypes 2 and 3 (9-16). SOF plus simeprevir (protease inhibitor) showed a 94% SVR12 for genotype 1 (9-16). More so than any other anti-HCV drug developed to date, SOF offers the widest applicability for all infected patients yet can be given in a personalized regimen to maximize performance

Description:

SOF plus simeprevir or PR became the backbone of HCV treatment. The demographics and characteristics of HCV patients in the Inland Empire are different than the cohort enrolled in SOF trials. There is a need to determine if the community based outcomes at match the outcome reported in the clinical trials.

Aim of the study

To propectively evaluate the efficacy and tolerability of the SOF treatment regimens prescribed at the ARMC and compare them to outcomes reported in the clinical trials that were the basis for FDA approval.

Study Description

This is a prospective registry study conducted at the ARMC. Targeted subjects are HCV patients are ARMC who received one of the SOF based treatment regimens from December 20, 2013 to December 19, 2014.

Primary end Point is sustained virological response at 12 weeks (SVR 12) and secondary end point is compliance and safety. Safety and compliance will be determined based on symptoms reported during clinic visits and number of refills and doses dispensed for every patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult Chronic HCV patients aged >18

• Treatment naïve

• Patient with cirrhosis and no cirrhosis. Cirrhosis defined as stage 4 fibrosis on liver biopsy or Fibro sure results indicating cirrhosis or has clinical findings suggestive of cirrhosis

• Patients meet the indication to receive one of the SOF treatment based regimens

Exclusion Criteria:

• Co-infected patients with HIV or Hepatitis B

• Patient received one of the DAAs regimens

• Patient with active substance abuse and alcohol abuse

• Patient received prior DAA regimen

• Decompensated cirrhotic patients

• Patient has contraindication to receive SOF

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Sofosbuvir and simeprevir
Hepatitis C treatment using Direct Acting Agents

Locations

Country	Name	City	State
United States	Arrowhead Regional Medical Center	Colton	California

Sponsors (1)

Lead Sponsor	Collaborator
Arrowhead Regional Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gane EJ, Roberts SK, Stedman CA, Angus PW, Ritchie B, Elston R, Ipe D, Morcos PN, Baher L, Najera I, Chu T, Lopatin U, Berrey MM, Bradford W, Laughlin M, Shulman NS, Smith PF. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and da — View Citation

Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh — View Citation

Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C vir — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR 12		12 weeks post treatment	No
Secondary	Safety and Tolerability as measured by the number of participants with AEs, Change in baseline laboratory results	Number of participants with AEs, Change in baseline laboratory results	24 weeks	No