May 20-23, 2001
Treatment of Chronic Hepatitis C Virus (HCV) in the Inmate Setting: Does Compliance Effect Response in African-Americans (AA)?
Richard K. Sterling, Riaz Gill, Ahmed Hegab, Charlotte M. Hofmann, Velimir A. Luketic, Arun J. Sanyal, Melissa J. Contos, MCV/VCU, Richmond, VA; Veron Smith, Virginia Dept Corrections, Richmond, VA; Mitchell L. Shiffman, MCV/VCU, Richmond, VA
Chronic HCV is common in the inmate population. Infection can progress to cirrhosis with morbidity that is both disruptive and costly to the prison system. We have recently demonstrated (AASLD 2000) that 70% of inmates in the VA Dept of Corrections (DOC) have significant HCV (defined by a histologic activity index [HAI] > 4 or any fibrosis) and that 40% of this population are AA. Interferon (IFN) has the potential to decrease disease progression. However, since AA respond poorly to IFN, this population may have questionable benefit. This study was therefore conducted to explore the efficacy of treating HCV in the inmate population.
METHODS: All inmates in the VA DOC are offered HCV testing. Those postive for HCV RNA (Amplicor, Roche) are offered liver biopsy. Inmates with at least 2 years of incarceration remaining and who meet tx criteria (significant HCV as defined above, HBsAg/HIV (-) and no other medical contraindications)are offered IFN a-2b 3 MU TIW and ribavirin (RVN)1000-1200 mg/d administered under direct observation. Inmates are followed by Telemedicine at tx mos 1, 3, 6, 9 and 12 and after tx at mos 15 and 18 to assess for sustained virologic response (SVR). Pts with genotype (GT)1 who become HCV RNA (-) at 6 mos are treated for 12 mos. Tx is discontinued after 6 mos in pts with GT non-1 and in non-responders (NR); those pts HCV RNA (+) after 3-6 mos.
RESULTS: 60 Inmates have been treated with a mean age of 41 (range 28-52). 83% are male, 55% white and 45% African-American. ALT is 105 at baseline and 31% had normal ALT. HCV RNA was 5.68 log (22% >10 million [106} copies/ml), 73% genotype 1; HAI 7.9 (27% bridging fibrosis and 14% cirrhosis).
Of the 60 patients treated, 35 are "responders" (58%) and 25 (42%) nonresponders: 8 SVR, 3 relapse, 13 on treatment still in follow-up, and 11 lost to follow-up (4 ETR, 7 on treatment).
Comparing responders and non-responders, there were no differences in baseline biochemical (LFTs), virologic, and histologic parameters. Nonresponders were more likely to be older 943 vs 40 yrs), African-Americans (60% vs 32%), genotype 1 (94% vs 60%).
Comparing whites to blacks there were no differences in baseline biochemical, virologic, and histologic parameters. There were significant differences in: weight 83 kg vs 91 kg, Ribavirin (mg/kg/d): 14.2 vs 12.8, genotype 1: 65% vs 82%.
32% of responders were African-American, so Aas did not respond as well as whites, and 60% of nonresponders were Aas.
73% of whites were responders and 42% of blacks were responders. 82% of blacks were genotype 1, and 65% of whites were genotype 1. 39% of AA genotype 1 were responders and 67% of white genotype 1 were responders.
The authors conclude: Inmate treatment is feasible with similar response rates as expected. Although a better response was seen in whites, the favorable response seen in AAs suggests that both compliance and the use of RBV with IFN are needed to achieve virologic response in this population.