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Understudied populations with hepatitis C
1Veterans Affairs Medical Center and Georgetown University School of Medicine, Washington, DC 20422, USA. doris.strader@med.va.gov
Insights
Current hepatitis C virus (HCV) treatments are limited, excluding many patients and yielding suboptimal response rates. New approaches are needed to expand access to antiviral therapy for understudied HCV populations.
Area of Science:
- Hepatology
- Virology
- Clinical Trial Design
Background:
- Hepatitis C virus (HCV) infection management relies on peginterferon and ribavirin antiviral therapy.
- Current treatment guidelines are based on highly selected patient populations, excluding over half of all HCV-infected individuals.
- Limited data exist on the safety and efficacy of HCV therapy in diverse and comorbid patient groups.
Purpose of the Study:
- To highlight the limitations of current HCV treatment eligibility criteria.
- To identify patient populations excluded from existing clinical trials.
- To advocate for expanded antiviral therapy access for understudied HCV populations.
Main Methods:
- Review of existing clinical trial inclusion and exclusion criteria for HCV antiviral therapy.
- Analysis of patient characteristics that render individuals ineligible for current treatment protocols.
- Identification of barriers to treatment, including cost and side effects.
Main Results:
- Less than 50% of patients in clinical trials achieve sustained virological response (SVR).
- Numerous patient groups, including those with mild disease, advanced liver disease, comorbidities (HIV, renal disease, autoimmune disorders), children, elderly, and those with substance abuse issues, are excluded from trials.
- Cost and side effects limit treatment accessibility for patients on public assistance, in correctional facilities, or institutions.
Conclusions:
- Current HCV treatment strategies are not inclusive, leading to suboptimal outcomes and limited access.
- Significant unmet needs exist for developing and evaluating antiviral therapies in underrepresented patient populations.
- New research and therapeutic approaches are essential to broaden eligibility and improve HCV management for all patients.
Abstract:
Managing patients with hepatitis C virus (HCV) infection consists primarily of antiviral treatment, currently with peginterferon and ribavirin. Unfortunately, treatment recommendations derive largely from trials that have focused on highly selected patient populations. As a consequence of the strict inclusion and exclusion criteria in these studies, more than half of all HCV-infected patients would be ineligible for enrollment. Even among the selected patients enrolled into studies, only 50% achieve a sustained virological response (SVR). Patients not eligible for current therapies include those with mild disease and normal alanine aminotransferase (ALT) levels, patients with advanced and decompensated liver disease, children, the elderly, patients with ongoing or recent alcohol and substance abuse, renal disease, human immunodeficiency virus (HIV) infection, severe psychiatric or neurologic illness, autoimmune disorders, solid organ transplant, and other significant comorbid conditions. Because these patients have been excluded from most clinical trials, little is known about the safety or efficacy of therapy in these populations. The expense and side effects of therapy are also an impediment to treatment of patients who are on public assistance, in prisons, and in institutions. Clearly, new efforts and new approaches are needed to expand the eligibility for antiviral therapy of hepatitis C and make treatment more available for understudied populations with this disease.