Outcome of New Direct Acting Agents For Hepatitis C A Community Based Experience
2 other identifiers
observational
340
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 19, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedJune 30, 2015
June 1, 2015
3 years
June 19, 2015
June 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SVR 12
12 weeks post treatment
Secondary Outcomes (1)
Safety and Tolerability as measured by the number of participants with AEs, Change in baseline laboratory results
24 weeks
Interventions
Hepatitis C treatment using Direct Acting Agents
Eligibility Criteria
Targeted subjects are HCV patients are ARMC who received one of the SOF based treatment regimens from December 20, 2013 to May 2015
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arrowhead Regional Medical Center
Colton, California, 92347, United States
Related Publications (3)
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 virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014 Feb 8;383(9916):515-23. doi: 10.1016/S0140-6736(13)62121-2. Epub 2013 Nov 5.
PMID: 24209977RESULTGane 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 danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet. 2010 Oct 30;376(9751):1467-75. doi: 10.1016/S0140-6736(10)61384-0. Epub 2010 Oct 14.
PMID: 20951424RESULTLawitz 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 AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
PMID: 23607594RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zeid Kayali, MD,MBA
Arrowhead Regional Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,MBA
Study Record Dates
First Submitted
June 19, 2015
First Posted
June 30, 2015
Study Start
November 1, 2013
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
June 30, 2015
Record last verified: 2015-06