Correlates of a Sustained Virologic Response in the Treatment of HCV

Abstract

Purpose: The quantitative liver spleen scan (QLSS) was assessed along with other markers of liver disease severity for correlates of an sustained virologic response (SVR) and relapse (R) compared to Non-response (NR). It is our hypothesis that the QLSS parameters will correlate with treatment response. Methods: Patients: 106 consecutive patients complelting treatment for hepatitis C with pegylated interferon alpha 2a and ribavirin were retrospectively evaluated for treatment response. Routine laboratory tests (106 patients), histology (101), virologic tests, prior treatment and QLSS results at baseline (95) were recorded. The PHM, liver volume (LV/IBW) and spleen volume (SV/IBW) (ideal body weight = IBW in lb}. Early virologic response (EVR) was < 1/100 baseline RNA at 12 weeks treatment. Statistics: Chi-square test compared treatment response and discrete variables. Analysis of variance tested for differences in treatment response for mean values of continuous predictors. Logistic regression determined the most parsimonious set of predictors of virologic reponse. Results: The patients were Caucasian (80%), naïve (70%), 59% male, age (52 ± 9 yrs), and height (68 ± 4 inches), and weight (174 ± 39 lbs). The baseline blood tests and QLSS PHM, LV/IBW, and SV/IBWare in the table. Fibrosis stage was 0 (10), 1 (25), 2 (16), 3 (19) and 4 (31) (where 4 indicated cirrhosis), Genotype 1,4,6 (81) and 2,3 (25) and RNA levels 3,639,022 ± 6,342,534 IU/ml. Treatment resulted in an SVR in 46, R in 27 and NR in 33. No differences in treatment response were noted for sex, race, ALT, Alb, INR. Significant differences (p <.01) to treatment from univariate analysis were found for EVR (p <.0001), prior treatment (p <.001), genotype (p=.004), cirrhosis (p=.02), platelets (p=.0029) and LV/IBW (p=.0089). By multivariate analysis, SVR compared to NR correlated with gender (p=.0128), prior treatment (p=.0006), IBW (p=.0079) and LV/IBW (p=.0219). By multivariate analysis, R compared to NR was associated with Caucasian race (p=.02), prior treatment (p=.0029) and LV/IBW (p=.042). For 74 naïve patients, significant differences by multivariate analysis between groups were found for platelets (p < 0.001) and for LV/IBW (p < 0.05).Table: Liver TestsConclusions: Prior treatment and LV/IBW were major determinants of the SVR and relapse compared to non-response.