Outcome of New Direct Acting Agents For Hepatitis C A Community Based Experience
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/2/2016 |
| Start Date: | November 2013 |
| End Date: | November 2016 |
| Contact: | Zeid Kayali, MD,MBA |
| Phone: | 909 883-2999 |
Outcome of New Direct Acting Agents For Hepatitis C
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
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
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.
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.
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
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