Hepatitis Central

Analysis of the Community Liver Health Program Data Base

12-15-96

Quarterly Results Analysis of the Community Liver Health Program Data Base Introduction:
At the time of this analysis (12-15-96), 3522 chronic HCV patients have been enrolled into the Community Liver Health Program. This is an increase of over 100% since the last quarterly analysis. None of these patients have completed a course of interferon treatment. Thus, the only analysis that will be presented in this quarterly analysis will be those baseline characteristics specified in the Data Analysis Plan (see Data Analysis Plan for more detail). I. Analysis of the Distribution of baseline HCV RNA concentrations. The distribution of the baseline HCV RNA concentrations for 3310 anti-HCV (ELISA) positive patients who are participating in the Community Liver Health is shown in Figure 1. HCV RNA was assessed using the SUPERQUANT® test. As illustrated by Figure 1, the cut-off for the lower 25th percentile of this population (low titer) was 810,000 copies/mL. The median for this population was 3,200,000 copies/mL with the distribution of the median titer ranging from >810,000 copies/mL to 5,000,000 copies/mL. Finally, the cut-off for the upper 25th percentile of this population (high titer) was >5,000,000 copies/mL.

The distribution of HCV RNA did not significantly change from the last quarterly analysis. More specifically analysis of the 1510 patients for the September, 1996 was revealed the cut-off for the lower 25th percentile of this population was 820,000 copies/mL. The median for this population was 3,200,000 copies/mL and the cut-off for the upper 25th percentile of this population "high titer" was >5,000,000 copies/mL. II. Analysis of the Genotype Distribution HCV genotype for 3538 anti-HCV (ELISA) positive patients participating in the Community Liver Health program was assessed using the Inno-lipa assay. The distribution of the HCV genotype for this population is shown in table 1.

table 1: Distribution of HCV Genotype in the Community Liver Health Program Patients

In order to simplify the analysis, the genotype classifications were collapsed into their respective higher order categories. For example HCV genotype 1, 1a and 1 b were combined into the category 1. The distribution of HCV genotype by collapsed category is shown in Figure 2. As illustrated by the figure, the population is dominated by HCV genotype 1 patients (73%). The next most frequently observed HCV genotype was genotype 2 followed by genotypes 3, and mixed. The genotype distribution seen in this update of the CLHP analysis is not different than the distribution seen in the last analysis in that both analyses demonstrated that the population of chronic HCV patients has a higher distribution of genotype 1 patients than has previously been reported for patients participating in clinical trials. The reason for the discrepancy is unknown at this time.

In order to discern if there are any regional difference in HCV genotype distribution in the United States, the distribution for this population was examine by individual State (table 2). As seen by table 2, there are no regional difference with respect to HCV genotype distribution in the United States.

table 2 HCV Genotype by State73.5%