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A prospective non-A, non-B follow-up program, implemented in a hepatitis B surface antigen-free dialysis unit, enabled us to report on the natural history of hepatitis C virus (HCV) infection in hemodialyzed patients between 1980 and 1992. For this program, every patient was prospectively monitored every two weeks for alanine amino transferase (ALT) activity, and every month for gammaglutamyl transpeptidase (GGT) activity and systematic collection of frozen sera. Sequences of stored sera from 217 patients were repeatedly tested for anti-HCV antibodies using second generation assays. Eighty-six of the 217 patients (39.6%), including 61 of the 67 patients with non-A, non-B hepatitis (91%), had HCV infection repeatedly evidenced by positive ELISA in all, and confirmed by RIBA in 84 of 86 (97.5%). In addition, 19 out of 23 patients (82.6%) were positive for HCV RNA by the polymerase chain reaction (PCR). Of the 86 anti-HCV positive patients, 41 had previously acquired HCV infection, and 45 seroconverted during chronic dialysis. Of these, all but one patient developed hepatitis with raised ALT activity which lasted for at least six months in all. Only 29 of 45 patients (64.5%) had a history of blood transfusion. Seventy-eight of the 86 patients (91%) who were followed up for one to 11.5 years (median 5) retained anti-HCV for several years. Nineteen liver biopsies performed in 16 patients showed chronic active hepatitis in 8 (50%) and hepatocellular carcinoma without cirrhosis in one patient.(ABSTRACT TRUNCATED AT 250 WORDS)

Nine patients with atypical HIV-1 western blot profiles were diagnosed as having HIV-1 subtype O infection. All the patients were living in France; eight originated from Cameroon and one from France. Lymphocyte DNA amplification by the polymerase chain reaction was only positive when HIV-1 subtype O specific primers were used. Preliminary sequence analysis of amplified products and serological reactivity against a specific subtype O synthetic env peptide confirmed HIV-1 subtype O infection. HIV-1/HIV-2 enzyme-linked immunosorbent assays, especially those based on env peptides or on the sandwich format, can be negative in HIV-1 subtype O infection.

HCV RNA was determined by the polymerase chain reaction (PCR) in 41 haemodialysed patients with a known anti-HCV status (ELISA and RIBA-2) and a monthly alanine aminotransferase (ALT) level determination. No histological examination of the liver tissue was available. Four samples from each patient were collected at 6 month intervals for 18 months. Seven patients negative for anti-HCV during the entire follow-up gave negative PCR results on the four samples. Two patients who were anti-HCV-negative upon entry into the study seroconverted to HCV during follow-up. HCV RNA was detected during the acute phase of hepatitis. HCV RNA was no longer detectable after antiviral therapy was administered to one patient. Out of 27 anti-HCV-positive patients, 24 had persistent viraemia, 2 had transient viraemia (1 sample PCR-negative and 3 samples PCR-positive) and 1 was PCR-negative on the 4 samples. Thirteen of the 26 viraemic patients had a normal ALT level during the preceding 3 years. Three patients with a C22-3 band alone by RIBA-2 were negative by PCR, whereas two patients with a C33-c band alone were PCR-positive on the four samples. These results suggest that HCV viraemia was strongly associated with anti-HCV in haemodialysed patients with or without biological hepatitis.

A vaccine against hepatitis B surface antigen (Institut Pasteur Production) was assessed in staff members from forty-eight French haemodialysis units where the risk of hepatitis B was high. Of 318 subjects who completed the protocol, 164 received three monthly injections of vaccine and 154 received corresponding injections of placebo. Hepatitis B infection was observed in 3.6% of the vaccine group and 12.3% of the placebo group (p less than 0.005). The 6 infections in the vaccine group all arose within 63 days from the first injections, whereas the 19 in the placebo group arose throughout the 12 months of follow-up. The rate of side-effects after injection did not differ in the two groups. 94% of the vaccine recipients had an immune response ( greater than 10 mIU/ml in at least 5 successive specimens). 4 months after the first injection the mean + or - 2 SE peak level of anti-HBs was 2433 + or - 1077 mIU/ml.

A vaccine against hepatitis B surface antigen (Institut Pasteur Production) was assessed in 138 haemodialysis patients in a placebo-controlled randomised double-blind trial. In an interim analysis, hepatitis B infections were observed in 21% of the vaccine group and 45% of the placebo group (p less than 0.02). 2 of the infections in the vaccine group and 12 of the infections in the placebo group occurred after the third injection. 60% of the vaccine recipients had an immune response. 4 months after the first injection the mean titre of anti-HBs was 120 mlU/ml.