Objectives: To determine the severity of hepatic histological lesions in anti-HCV positive parenteral drug abusers and to correlate it with the level of ALT activity and HCV RNA determined by polymerase chain reaction (PCR).

Methods: Twenty-nine of the 62 anti-HCV-positive parenteral drug abusers who consecutively entered a Rehabilitation Center of Athens consented to liver biopsy and were prospectively and thoroughly followed up for a mean of 12.9 (range 6-33) months. Anti-HCV was detected by a second-generation enzyme immunoassay and confirmed by a second-generation recombinant immunoblot assay. Serum samples were tested for HCV RNA by nested PCR with primers from the highly conserved 5' untranslated region of the HCV genome.

Results: Liver biopsy revealed lesions compatible with chronic hepatitis in 26 (89.6%) and a normal liver in three (10.4%) of the 29 patients. In particular, 11 (37.9%) had minimal and 15 (57.1%) had mild chronic hepatitis; fibrosis was absent or mild in all cases. Histological grade and stage were significantly milder in patients with persistently normal ALT activity than in those with increased ALT activity. However, chronic hepatitis was observed in five (62.5%) of the eight patients with normal ALT levels. The presence of serum HCV RNA was not significantly correlated with the severity of histological lesions. HCV RNA was detected in 16 (57.1%) of the 28 cases tested. In particular, HCV RNA was detected in one (33.3%) of the three cases with normal liver and in three (37.5%) of the eight patients with normal ALT levels.

Conclusions: Liver biopsy appears to be the method of choice for the accurate evaluation of anti-HCV positive parenteral drug abusers, irrespective of ALT activity and presence of serum HCV RNA. Chronic hepatitis is observed in the majority and the state of "healthy" carrier of HCV in the minority of this epidemiological setting.

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