ABSTRACT
BACKGROUND/AIMS: Interferon-based regimens (alone or with ribavairin) are standard therapies for chronic hepatitis C. The aim of this study was to compare a 24-week regimen of interferon alpha-2b + ribavirin (IFN + RIBA) to interferon alpha-2b + amantadine (IFN + AMANT) in non-responders to previous interferon monotherapy. METHODS: In a multi-center, double-blind clinical trial, 118 patients (non-responders to previous interferon monotherapy) were equally randomized into the two arms: interferon alpha-2b (3 MU thrice weekly) and ribavirin (800 mg daily) vs. interferon alpha-2b (3 MU thrice weekly) and amantadine (200 mg daily). RESULTS: After 24 weeks of therapy, HCV RNA became undetectable in 34.8% (95% CI: 23.7-49.2) of IFN + RIBA and 19.6% (95% CI: 10.6-34.7) of IFN + AMANT (P = 0.10). This response was sustained in 3.9% (95% CI: 1.0-14.9) of IFN + RIBA and 0% of IFN + AMANT (P = 0.16). Ten patients from IFN + AMANT (17%) and 12 patients (20%) from IFN + RIBA were discontinued before completion of therapy. Of these, 7% in IFN + AMANT and 12% in IFN + RIBA were discontinued due to adverse effects. CONCLUSIONS: Re-treatment of interferon non-responders with a 24-week course of IFN + AMANT was not associated with any sustained viral eradication. Although IFN + RIBA in this group was associated with a reasonable end of treatment response, relapses were common and sustained responses were low.
Subject(s)
Amantadine/administration & dosage , Antiviral Agents/administration & dosage , Hepatitis C, Chronic/drug therapy , Interferon-alpha/therapeutic use , Ribavirin/administration & dosage , Adult , Aged , Double-Blind Method , Drug Therapy, Combination , Female , Hemoglobins/analysis , Hepatitis C, Chronic/psychology , Hepatitis C, Chronic/virology , Humans , Interferon alpha-2 , Interferon-alpha/administration & dosage , Male , Middle Aged , Quality of Life , Recombinant Proteins , Thyrotropin/bloodABSTRACT
On Jan. 9, 1998, The Health Care Financing Administration (HCFA) issued long-awaited Proposed Regulations for what has become known as Stark II. The regulations are subject to a comment period and later refinement. However, they lay out HCFA's basic understanding of what kinds of practices constitute an illegal kickback. In general terms, the law prohibits physicians from referring Medicare or Medicaid patients to entities with which they (or an immediate family member) have a "financial relationship" for the delivery of a specific list of designated health services. There are, however, exceptions also included in the new proposal. Group practices will want to pay special attention to HCFA's new definition of group practice.
